Lyrica

Name: Lyrica

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

If you forget to take a dose and remember a few hours later, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Lyrica Overview

Lyrica is a prescription medication used to treat pain from damaged nerves caused by diabetes, shingles, and spinal cord injury. It is also used to treat fibromyalgia and seizures. Lyrica belongs to a class of drugs called anticonvulsants, which may work by decreasing pain signals from the brain and slowing brain activity.

This medication comes in capsule form and liquid form and is usually taken 2 or 3 times daily, with or without food.

Common side effects include dizziness, blurred vision, weight gain, and drowsiness. Do not drive a car or operate heavy machinery until you know how Lyrica affects you.

Lyrica Precautions

Lyrica may cause serious side effects including:

Serious, even life-threatening, allergic reactions. Stop taking Lyrica  and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:

  • swelling of your face, mouth, lips, gums, tongue, throat or neck
  • trouble breathing
  • rash, hives (raised bumps) or blisters

Lyrica may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: 

  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood

​If you have suicidal thoughts or actions, do not stop Lyrica without first talking to a healthcare provider.

  • Stopping Lyrica suddenly can cause serious problems.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions? 

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

​Lyrica may cause other serious side effects including:

Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.

Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how Lyrica affects you. Ask your healthcare provider about when it will be okay to do these activities. Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away. Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight. Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.  Feeling "high," intoxicated, or euphoric (extreme feelings of joy or happiness).
  • Do not take Lyrica if you are allergic to Lyrica or any of the inactive ingredients in Lyrica. 
  • Do not drink alcohol while taking Lyrica.

Lyrica and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. There are no well-controlled studies that have been done in pregnant women. Lyrica should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

What is the most important information i should know about pregabalin (lyrica)?

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

If you are taking pregabalin to prevent seizures, keep taking the medication even if you feel fine.

Do not stop using pregabalin without first talking to your doctor, even if you feel fine. You may have increased seizures or withdrawal symptoms such as headache, sleep problems, nausea, and diarrhea. Ask your doctor how to avoid withdrawal symptoms when you stop using pregabalin.

Do not change your dose of pregabalin without your doctor's advice. Tell your doctor if the medication does not seem to work as well in treating your condition.

Wear a medical alert tag or carry an ID card stating that you take pregabalin. Any medical care provider who treats you should know that you take seizure medication.

Side effects

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In all controlled and uncontrolled trials across various patient populations during the premarketing development of LYRICA, more than 10,000 patients have received LYRICA. Approximately 5000 patients were treated for 6 months or more, over 3100 patients were treated for 1 year or longer, and over 1400 patients were treated for at least 2 years.

Adverse Reactions Most Commonly Leading To Discontinuation In All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all populations combined, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (4%) and somnolence (4%). In the placebo group, 1% of patients withdrew due to dizziness and less than 1% withdrew due to somnolence. Other adverse reactions that led to discontinuation from controlled trials more frequently in the LYRICA group compared to the placebo group were ataxia, confusion, asthenia, thinking abnormal, blurred vision, incoordination, and peripheral edema (1% each).

Most Common Adverse Reactions In All Premarketing Controlled Clinical Studies

In premarketing controlled trials of all patient populations combined, dizziness, somnolence, dry mouth, edema, blurred vision, weight gain, and “thinking abnormal” (primarily difficulty with concentration/attention) were more commonly reported by subjects treated with LYRICA than by subjects treated with placebo (greater than or equal to 5% and twice the rate of that seen in placebo).

Controlled Studies With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with neuropathic pain associated with diabetic peripheral neuropathy, 9% of patients treated with LYRICA and 4% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (3%) and somnolence (2%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the LYRICA group than in the placebo group, were asthenia, confusion, and peripheral edema. Each of these events led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 3 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with diabetic neuropathy in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 3: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with diabetic peripheral neuropathy (events in at least 1% of all LYRICA-treated patients and at least numerically more in all LYRICA than in the placebo group)

Body system Preferred term 75 mg/day
[N=77] %
150 mg/day
[N=212] %
300 mg/day
[N=321] %
600 mg/day
[N=369] %
All PGB*
[N=979] %
Placebo
[N=459] %
Body as a whole
Asthenia 4 2 4 7 5 2
Accidental injury 5 2 2 6 4 3
Back pain 0 2 1 2 2 0
Chest pain 4 1 1 2 2 1
Face edema 0 1 1 2 1 0
Digestive system
Dry mouth 3 2 5 7 5 1
Constipation 0 2 4 6 4 2
Flatulence 3 0 2 3 2 1
Metabolic and nutritional disorders
Peripheral edema 4 6 9 12 9 2
Weight gain 0 4 4 6 4 0
Edema 0 2 4 2 2 0
Hypoglycemia 1 3 2 1 2 1
Nervous system
Dizziness 8 9 23 29 21 5
Somnolence 4 6 13 16 12 3
Neuropathy 9 2 2 5 4 3
Ataxia 6 1 2 4 3 1
Vertigo 1 2 2 4 3 1
Confusion 0 1 2 3 2 1
Euphoria 0 0 3 2 2 0
Incoordination 1 0 2 2 2 0
Thinking abnormal† 1 0 1 3 2 0
Tremor 1 1 1 2 1 0
Abnormal gait 1 0 1 3 1 0
Amnesia 3 1 0 2 1 0
Nervousness 0 1 1 1 1 0
Respiratory system
Dyspnea 3 0 2 2 2 1
Special senses
Blurry vision† 3 1 3 6 4 2
Abnormal vision 1 0 1 1 1 0
* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
‡ Investigator term; summary level term is amblyopia

Controlled Studies In Postherpetic Neuralgia

Adverse Reactions Leading to Discontinuation

In clinical trials in patients with postherpetic neuralgia, 14% of patients treated with LYRICA and 7% of patients treated with placebo discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (4%) and somnolence (3%). In comparison, less than 1% of placebo patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring in greater frequency in the LYRICA group than in the placebo group, were confusion (2%), as well as peripheral edema, asthenia, ataxia, and abnormal gait (1% each).

Most Common Adverse Reactions

Table 4 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 1% of patients with neuropathic pain associated with postherpetic neuralgia in the combined LYRICA group for which the incidence was greater in this combined LYRICA group than in the placebo group. In addition, an event is included, even if the incidence in the all LYRICA group is not greater than in the placebo group, if the incidence of the event in the 600 mg/day group is more than twice that in the placebo group. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”. Overall, 12.4% of all pregabalin-treated patients and 9.0% of all placebo-treated patients had at least one severe event while 8% of pregabalin-treated patients and 4.3% of placebo-treated patients had at least one severe treatment-related adverse event.

Table 4: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with postherpetic neuralgia (events in at least 1% of all LYRICA-treated patients and at least numerically more in all LYRICA than in the placebo group)

Body system Preferred term 75 mg/d
[N=84] %
150 mg/d
[N=302] %
300 mg/d
[N=312] %
600 mg/d
[N=154] %
All PGB*
[N=852] %
Placebo
[N=398] %
Body as a whole
Infection 14 8 6 3 7 4
Headache 5 9 5 8 7 5
Pain 5 4 5 5 5 4
Accidental injury 4 3 3 5 3 2
Flu syndrome 1 2 2 1 2 1
Face edema 0 2 1 3 2 1
Digestive system
Dry mouth 7 7 6 15 8 3
Constipation 4 5 5 5 5 2
Flatulence 2 1 2 3 2 1
Vomiting 1 1 3 3 2 1
Metabolic and nutritional disorders
Peripheral edema 0 8 16 16 12 4
Weight gain 1 2 5 7 4 0
Edema 0 1 2 6 2 1
Musculoskeletal system
Myasthenia 1 1 1 1 1 0
Nervous system
Dizziness 11 18 31 37 26 9
Somnolence 8 12 18 25 16 5
Ataxia 1 2 5 9 5 1
Abnormal gait 0 2 4 8 4 1
Confusion 1 2 3 7 3 0
Thinking abnormal† 0 2 1 6 2 2
Incoordination 2 2 1 3 2 0
Amnesia 0 1 1 4 2 0
Speech disorder 0 0 1 3 1 0
Respiratory system
Bronchitis 0 1 1 3 1 1
Special senses
Blurry vision&Dagger 1 5 5 9 5 3
Diplopia 0 2 2 4 2 0
Abnormal vision 0 1 2 5 2 0
Eye Disorder 0 1 1 2 1 0
Urogenital System
Urinary Incontinence 0 1 1 2 1 0
* PGB: pregabalin
† Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and �slowed thinking.
‡ Investigator term; summary level term is amblyopia

Controlled Add-On Studies In Adjunctive Therapy For Adult Patients With Partial Onset Seizures

Adverse Reactions Leading to Discontinuation

Approximately 15% of patients receiving LYRICA and 6% of patients receiving placebo in add-on epilepsy trials discontinued prematurely due to adverse reactions. In the LYRICA treatment group, the adverse reactions most frequently leading to discontinuation were dizziness (6%), ataxia (4%), and somnolence (3%). In comparison, less than 1% of patients in the placebo group withdrew due to each of these events. Other adverse reactions that led to discontinuation of at least 1% of patients in the LYRICA group and at least twice as frequently compared to the placebo group were asthenia, diplopia, blurred vision, thinking abnormal, nausea, tremor, vertigo, headache, and confusion (which each led to withdrawal in 2% or less of patients).

Most Common Adverse Reactions

Table 5 lists all dose-related adverse reactions occurring in at least 2% of all LYRICA-treated patients. Dose-relatedness was defined as the incidence of the adverse event in the 600 mg/day group was at least 2% greater than the rate in both the placebo and 150 mg/day groups. In these studies, 758 patients received LYRICA and 294 patients received placebo for up to 12 weeks. Because patients were also treated with 1 to 3 other AEDs, it is not possible to determine whether the following adverse reactions can be ascribed to LYRICA alone, or the combination of LYRICA and other AEDs. A majority of pregabalin-treated patients in clinical studies had adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 5: Dose-related treatment-emergent adverse reaction incidence in controlled trials in adjunctive therapy for adult patients with partial onset seizures (events in at least 2% of all LYRICA-treated patients and the adverse reaction in the 600 mg/day group was greater than or equal to 2% the rate in both the placebo and 150 mg/day groups)

Body System Preferred Term 150 mg/d
[N = 185]%
300 mg/d
[N = 90] %
600 mg/d
[N = 395] %
All PGB*
[N = 670]† %
Placebo
[N = 294] %
Body as a Whole
Accidental Injury 7 11 10 9 5
Pain 3 2 5 4 3
Digestive System
Increased Appetite 2 3 6 5 1
Dry Mouth 1 2 6 4 1
Constipation 1 1 7 4 2
Metabolic and Nutritional Disorders
Weight Gain 5 7 16 12 1
Peripheral Edema 3 3 6 5 2
Nervous System
Dizziness 18 31 38 32 11
Somnolence 11 18 28 22 11
Ataxia 6 10 20 15 4
Tremor 3 7 11 8 4
Thinking Abnormal‡ 4 8 9 8 2
Amnesia 3 2 6 5 2
Speech Disorder 1 2 7 5 1
Incoordination 1 3 6 4 1
Abnormal Gait 1 3 5 4 0
Twitching 0 4 5 4 1
Confusion 1 2 5 4 2
Myoclonus 1 0 4 2 0
Special Senses
Blurred Vision§ 5 8 12 10 4
Diplopia 5 7 12 9 4
Abnormal Vision 3 1 5 4 1
* PGB: pregabalin
† Excludes patients who received the 50 mg dose in Study E1.
‡ Thinking abnormal primarily consists of events related to difficulty with concentration/attention but also includes events related to cognition and language problems and slowed thinking.
§ Investigat or term; summary level term is amblyopia.

Controlled Studies With Fibromyalgia

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with fibromyalgia, 19% of patients treated with pregabalin (150- 600 mg/day) and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were dizziness (6%) and somnolence (3%). In comparison, less than 1% of placebo-treated patients withdrew due to dizziness and somnolence. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue, headache, balance disorder, and weight increased. Each of these adverse reactions led to withdrawal in approximately 1% of patients.

Most Common Adverse Reactions

Table 6 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with fibromyalgia in the 'all pregabalin' treatment group for which the incidence was greater than in the placebo treatment group. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 6: Treatment-emergent adverse reaction incidence in controlled trials in fibromyalgia (events) in at least 2% of all LYRICA-treated patients and occurring more frequently in the all pregabalin-group than in the placebo treatment group)

System Organ Class Preferred term 150 mg/d
[N=132] %
300 mg/d
[N=502] %
450 mg/d
[N=505] %
600 mg/d
[N=378] %
All PGB*
[N=1517] %
Placebo
[N=505] %
Ear and Labyrinth Disorders
Vertigo 2 2 2 1 2 0
Eye Disorders
Vision blurred 8 7 7 12 8 1
Gastrointestinal Disorders
Dry mouth 7 6 9 9 8 2
Constipation 4 4 7 10 7 2
Vomiting 2 3 3 2 3 2
Flatulence 1 1 2 2 2 1
Abdominal distension 2 2 2 2 2 1
General Disorders and Administrative Site Conditions
Fatigue 5 7 6 8 7 4
Edema peripheral 5 5 6 9 6 2
Chest pain 2 1 1 2 2 1
Feeling abnormal 1 3 2 2 2 0
Edema 1 2 1 2 2 1
Feeling drunk 1 2 1 2 2 0
Infections and Infestations
Sinusitis 4 5 7 5 5 4
Investigations
Weight increased 8 10 10 14 11 2
Metabolism and Nutrition Disorders
Increased appetite 4 3 5 7 5 1
Fluid retention 2 3 3 2 2 1
Musculoskeletal and Connective Tissue Disorders
Arthralgia 4 3 3 6 4 2
Muscle spasms 2 4 4 4 4 2
Back pain 2 3 4 3 3 3
Nervous System Disorders
Dizziness 23 31 43 45 38 9
Somnolence 13 18 22 22 20 4
Headache 11 12 14 10 12 12
Disturbance in attention 4 4 6 6 5 1
Balance disorder 2 3 6 9 5 0
Memory impairment 1 3 4 4 3 0
Coordination abnormal 2 1 2 2 2 1
Hypoesthesia 2 2 3 2 2 1
Lethargy 2 2 1 2 2 0
Tremor 0 1 3 2 2 0
Psychiatric Disorders
Euphoric Mood 2 5 6 7 6 1
Confusional state 0 2 3 4 3 0
Anxiety 2 2 2 2 2 1
Disorientation 1 0 2 1 2 0
Depression 2 2 2 2 2 2
Respiratory, Thoracic and Mediastinal Disorders
Pharyngolaryngeal pain 2 1 3 3 2 2
* PGB: pregabalin

Controlled Studies In Neuropathic Pain Associated With Spinal Cord Injury

Adverse Reactions Leading to Discontinuation

In clinical trials of patients with neuropathic pain associated with spinal cord injury, 13% of patients treated with pregabalin and 10% of patients treated with placebo discontinued prematurely due to adverse reactions. In the pregabalin treatment group, the most common reasons for discontinuation due to adverse reactions were somnolence (3%) and edema (2%). In comparison, none of the placebo-treated patients withdrew due to somnolence and edema. Other reasons for discontinuation from the trials, occurring with greater frequency in the pregabalin treatment group than in the placebo treatment group, were fatigue and balance disorder. Each of these adverse reactions led to withdrawal in less than 2% of patients.

Most Common Adverse Reactions

Table 7 lists all adverse reactions, regardless of causality, occurring in greater than or equal to 2% of patients with neuropathic pain associated with spinal cord injury in the controlled trials. A majority of pregabalin-treated patients in clinical studies experienced adverse reactions with a maximum intensity of “mild” or “moderate”.

Table 7: Treatment-emergent adverse reaction incidence in controlled trials in neuropathic pain associated with spinal cord injury (events in at least 2% of all LYRICA-treated patients and occurring more frequently in the all pregabalin-group than in the placebo treatment group)

System Organ Class
Preferred term
PGB*
(N=182)%
Placebo
(N=174)%
Ear and labryrinth disorders
Vertigo 2.7 1.1
Eye disorders
Vision blurred 6.6 1.1
Gastrointestinal disorders
Dry mouth 11.0 2.9
Constipation 8.2 5.7
Nausea 4.9 4.0
Vomiting 2.7 1.1
General disorders and administration site conditions
Fatigue 11.0 4.0
Edema peripheral 10.4 5.2
Edema 8.2 1.1
Pain 3.3 1.1
Infections and infestations
Nasopharyngitis 8.2 4.6
Investigations
Weight increased 3.3 1.1
Blood creatine phosphokinase increased 2.7 0
Musculoskeletal and connective tissue disorders
Muscular weakness 4.9 1.7
Pain in extremity 3.3 2.3
Neck pain 2.7 1.1
Back pain 2.2 1.7
Joint swelling 2.2 0
Nervous system disorders
Somnolence 35.7 11.5
Dizziness 20.9 6.9
Disturbance in attention 3.8 0
Memory impairment 3.3 1.1
Paresthesia 2.2 0.6
Psychiatric disorders
Insomnia 3.8 2.9
Euphoric mood 2.2 0.6
Renal and urinary disorders
Urinary incontinence 2.7 1.1
Skin and subcutaneous tissue disorders
Decubitus ulcer 2.7 1.1
Vascular disorders
Hypertension 2.2 1.1
Hypotension 2.2 0
* PGB: Pregabalin

Other Adverse Reactions Observed During The Clinical Studies Of LYRICA

Following is a list of treatment-emergent adverse reactions reported by patients treated with LYRICA during all clinical trials. The listing does not include those events already listed in the previous tables or elsewhere in labeling, those events for which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life-threatening.

Events are categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse reactions are those occurring on one or more occasions in at least 1/100 patients; infrequent adverse reactions are those occurring in 1/100 to 1/1000 patients; rare reactions are those occurring in fewer than 1/1000 patients. Events of major clinical importance are described in the Warnings and Precautions section (5).

Body as a Whole - Frequent: Abdominal pain, Allergic reaction, Fever, Infrequent: Abscess, Cellulitis, Chills, Malaise, Neck rigidity, Overdose, Pelvic pain, Photosensitivity reaction, Rare: Anaphylactoid reaction, Ascites, Granuloma, Hangover effect, Intentional Injury, Retroperitoneal Fibrosis, Shock

Cardiovascular System - Infrequent: Deep thrombophlebitis, Heart failure, Hypotension, Postural hypotension, Retinal vascular disorder, Syncope; Rare: ST Depressed, Ventricular Fibrillation

Digestive System - Frequent: Gastroenteritis, Increased appetite; Infrequent: Cholecystitis, Cholelithiasis, Colitis, Dysphagia, Esophagitis, Gastritis, Gastrointestinal hemorrhage, Melena, Mouth ulceration, Pancreatitis, Rectal hemorrhage, Tongue edema; Rare: Aphthous stomatitis, Esophageal Ulcer, Periodontal abscess

Hemic and Lymphatic System - Frequent: Ecchymosis; Infrequent: Anemia, Eosinophilia, Hypochromic anemia, Leukocytosis, Leukopenia, Lymphadenopathy, Thrombocytopenia; Rare: Myelofibrosis, Polycythemia, Prothrombin decreased, Purpura, Thrombocythemia Metabolic and Nutritional Disorders - Rare: Glucose Tolerance Decreased, Urate Crystalluria

Musculoskeletal System - Frequent: Arthralgia, Leg cramps, Myalgia, Myasthenia; Infrequent: Arthrosis; Rare: Chondrodystrophy, Generalized Spasm

Nervous System - Frequent: Anxiety, Depersonalization, Hypertonia, Hypoesthesia, Libido decreased, Nystagmus, Paresthesia, Sedation, Stupor, Twitching; Infrequent: Abnormal dreams, Agitation, Apathy, Aphasia, Circumoral paresthesia, Dysarthria, Hallucinations, Hostility, Hyperalgesia, Hyperesthesia, Hyperkinesia, Hypokinesia, Hypotonia, Libido increased, Myoclonus, Neuralgia, Rare: Addiction, Cerebellar syndrome, Cogwheel rigidity, Coma, Delirium, Delusions, Dysautonomia, Dyskinesia, Dystonia, Encephalopathy, Extrapyramidal syndrome, Guillain-Barr� syndrome, Hypalgesia, Intracranial hypertension, Manic reaction, Paranoid reaction, Peripheral neuritis, Personality disorder, Psychotic depression, Schizophrenic reaction, Sleep disorder, Torticollis, Trismus

Respiratory System - Rare: Apnea, Atelectasis, Bronchiolitis, Hiccup, Laryngismus, Lung edema, Lung fibrosis, Yawn

Skin and Appendages - Frequent: Pruritus, Infrequent: Alopecia, Dry skin, Eczema, Hirsutism, Skin ulcer, Urticaria, Vesiculobullous rash; Rare: Angioedema, Exfoliative dermatitis, Lichenoid dermatitis, Melanosis, Nail Disorder, Petechial rash, Purpuric rash, Pustular rash, Skin atrophy, Skin necrosis, Skin nodule, Stevens-Johnson syndrome, Subcutaneous nodule

Special senses - Frequent: Conjunctivitis, Diplopia, Otitis media, Tinnitus; Infrequent: Abnormality of accommodation, Blepharitis, Dry eyes, Eye hemorrhage, Hyperacusis, Photophobia, Retinal edema, Taste loss, Taste perversion; Rare: Anisocoria, Blindness, Corneal ulcer, Exophthalmos, Extraocular palsy, Iritis, Keratitis, Keratoconjunctivitis, Miosis, Mydriasis, Night blindness, Ophthalmoplegia, Optic atrophy, Papilledema, Parosmia, Ptosis, Uveitis

Urogenital System - Frequent: Anorgasmia, Impotence, Urinary frequency, Urinary incontinence; Infrequent: Abnormal ejaculation, Albuminuria, Amenorrhea, Dysmenorrhea, Dysuria, Hematuria, Kidney calculus, Leukorrhea, Menorrhagia, Metrorrhagia, Nephritis, Oliguria, Urinary retention, Urine abnormality; Rare: Acute kidney failure, Balanitis, Bladder Neoplasm, Cervicitis, Dyspareunia, Epididymitis, Female lactation, Glomerulitis, Ovarian disorder, Pyelonephritis

Comparison Of Gender And Race

The overall adverse event profile of pregabalin was similar between women and men. There are insufficient data to support a statement regarding the distribution of adverse experience reports by race.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of LYRICA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Nervous System Disorders - Headache

Gastrointestinal Disorders - Nausea, Diarrhea

Reproductive System and Breast Disorders - Gynecomastia, Breast Enlargement

In addition, there are postmarketing reports of events related to reduced lower gastrointestinal tract function (e.g., intestinal obstruction, paralytic ileus, constipation) when LYRICA was co-administered with medications that have the potential to produce constipation, such as opioid analgesics. There are also postmarketing reports of respiratory failure and coma in patients taking pregabalin and other CNS depressant medications.

Read the entire FDA prescribing information for Lyrica (Pregabalin)

Read More »

Uses for Lyrica

Seizure Disorders

Management (in combination with other anticonvulsants) of partial seizures in adults.1 2 3 4 12

Neuropathic Pain

Management of postherpetic neuralgia (PHN) in adults.1 5 6

Management of pain associated with diabetic peripheral neuropathy (DPN) in adults.1 7 8

Fibromyalgia

Management of fibromyalgia in adults.1 17 18 19 20

Lyrica Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Difficult or labored breathing
  • shortness of breath
  • tightness in the chest
Rare
  • Blistering, peeling, or loosening of the skin
  • chills
  • cough
  • diarrhea
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • joint or muscle pain
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • skin rash
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Accidental injury
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • burning, tingling, numbness or pain in the hands, arms, feet, or legs
  • change in walking and balance
  • clumsiness
  • confusion
  • delusions
  • dementia
  • difficulty having a bowel movement (stool)
  • difficulty with speaking
  • double vision
  • dry mouth
  • fever
  • headache
  • hoarseness
  • increased appetite
  • lack of coordination
  • loss of memory
  • lower back or side pain
  • painful or difficult urination
  • problems with memory
  • rapid weight gain
  • seeing double
  • sensation of pins and needles
  • shakiness and unsteady walk
  • sleepiness or unusual drowsiness
  • stabbing pain
  • swelling
  • tingling of the hands or feet
  • trembling, or other problems with muscle control or coordination
  • unusual weight gain or loss
Less common
  • Anxiety
  • bloated or full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • cold sweats
  • coma
  • cool, pale skin
  • cough producing mucus
  • decrease or change in vision
  • depression
  • excess air or gas in the stomach or intestines
  • eye disorder
  • false or unusual sense of well-being
  • general feeling of discomfort or illness
  • increased hunger
  • joint pain
  • loss of appetite
  • loss of bladder control
  • loss of strength or energy
  • muscle aches and pains
  • muscle twitching or jerking
  • muscle weakness
  • nausea
  • nervousness
  • nightmares
  • noisy breathing
  • pain
  • passing gas
  • rhythmic movement of the muscles
  • runny nose
  • seizures
  • shivering
  • slurred speech
  • sweating
  • trouble sleeping
  • twitching
  • uncontrolled eye movements
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Lyrica Description

Pregabalin is described chemically as (S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C8H17NO2 and the molecular weight is 159.23. The chemical structure of pregabalin is:

Pregabalin is a white to off-white, crystalline solid with a pKa1 of 4.2 and a pKa2 of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35.

Lyrica (pregabalin) Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25, 50, 75, 100, 150, 200, 225, and 300 mg of pregabalin, along with lactose monohydrate, cornstarch, and talc as inactive ingredients. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and the white capsule shells contain sodium lauryl sulfate and colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells. The imprinting ink contains shellac, black iron oxide, propylene glycol, and potassium hydroxide.

Lyrica (pregabalin) oral solution, 20 mg/mL, is administered orally and is supplied as a clear, colorless solution contained in a 16 fluid ounce white HDPE bottle with a polyethylene-lined closure. The oral solution contains 20 mg/mL of pregabalin, along with methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water as inactive ingredients.

Clinical Studies

Neuropathic Pain Associated with Diabetic Peripheral Neuropathy

The efficacy of the maximum recommended dose of Lyrica for the management of neuropathic pain associated with diabetic peripheral neuropathy was established in three double-blind, placebo-controlled, multicenter studies with three times a day dosing, two of which studied the maximum recommended dose. Patients were enrolled with either Type 1 or Type 2 diabetes mellitus and a diagnosis of painful distal symmetrical sensorimotor polyneuropathy for 1 to 5 years. A total of 89% of patients completed Studies DPN 1 and DPN 2. The patients had a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). The baseline mean pain scores across the two studies ranged from 6.1 to 6.7. Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to pregabalin. Patients recorded their pain daily in a diary.

Study DPN 1: This 5-week study compared Lyrica 25, 100, or 200 mg three times a day with placebo. Treatment with Lyrica 100 and 200 mg three times a day statistically significantly improved the endpoint mean pain score and increased the proportion of patients with at least a 50% reduction in pain score from baseline. There was no evidence of a greater effect on pain scores of the 200 mg three times a day dose than the 100 mg three times a day dose, but there was evidence of dose dependent adverse reactions [see Adverse Reactions (6.1)]. For a range of levels of improvement in pain intensity from baseline to study endpoint, Figure 1 shows the fraction of patients achieving that level of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 1: Patients Achieving Various Levels of Improvement in Pain Intensity – Study DPN 1

Study DPN 2: This 8-week study compared Lyrica 100 mg three times a day with placebo. Treatment with Lyrica 100 mg three times a day statistically significantly improved the endpoint mean pain score and increased the proportion of patients with at least a 50% reduction in pain score from baseline. For various levels of improvement in pain intensity from baseline to study endpoint, Figure 2 shows the fraction of patients achieving that level of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 2: Patients Achieving Various Levels of Improvement in Pain Intensity– Study DPN 2

Postherpetic Neuralgia

The efficacy of Lyrica for the management of postherpetic neuralgia was established in three double-blind, placebo-controlled, multicenter studies. These studies enrolled patients with neuralgia persisting for at least 3 months following healing of herpes zoster rash and a minimum baseline score of greater than or equal to 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). Seventy-three percent of patients completed the studies. The baseline mean pain scores across the 3 studies ranged from 6 to 7. Patients were permitted up to 4 grams of acetaminophen per day as needed for pain, in addition to pregabalin. Patients recorded their pain daily in a diary.

Study PHN 1: This 13-week study compared Lyrica 75, 150, and 300 mg twice daily with placebo. Patients with creatinine clearance (CLcr) between 30 to 60 mL/min were randomized to 75 mg, 150 mg, or placebo twice daily. Patients with creatinine clearance greater than 60 mL/min were randomized to 75 mg, 150 mg, 300 mg or placebo twice daily. In patients with creatinine clearance greater than 60 mL/min treatment with all doses of Lyrica statistically significantly improved the endpoint mean pain score and increased the proportion of patients with at least a 50% reduction in pain score from baseline. Despite differences in dosing based on renal function, patients with creatinine clearance between 30 to 60 mL/min tolerated Lyrica less well than patients with creatinine clearance greater than 60 mL/min as evidenced by higher rates of discontinuation due to adverse reactions. For various levels of improvement in pain intensity from baseline to study endpoint, Figure 3 shows the fraction of patients achieving that level of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 3: Patients Achieving Various Levels of Improvement in Pain Intensity– Study PHN 1

Study PHN 2: This 8-week study compared Lyrica 100 or 200 mg three times a day with placebo, with doses assigned based on creatinine clearance. Patients with creatinine clearance between 30 to 60 mL/min were treated with 100 mg three times a day, and patients with creatinine clearance greater than 60 mL/min were treated with 200 mg three times daily. Treatment with Lyrica statistically significantly improved the endpoint mean pain score and increased the proportion of patients with at least a 50% reduction in pain score from baseline. For various levels of improvement in pain intensity from baseline to study endpoint, Figure 4 shows the fraction of patients achieving those levels of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 4: Patients Achieving Various Levels of Improvement in Pain Intensity – Study PHN 2

Study PHN 3: This 8-week study compared Lyrica 50 or 100 mg three times a day with placebo with doses assigned regardless of creatinine clearance. Treatment with Lyrica 50 and 100 mg three times a day statistically significantly improved the endpoint mean pain score and increased the proportion of patients with at least a 50% reduction in pain score from baseline. Patients with creatinine clearance between 30 to 60 mL/min tolerated Lyrica less well than patients with creatinine clearance greater than 60 mL/min as evidenced by markedly higher rates of discontinuation due to adverse reactions. For various levels of improvement in pain intensity from baseline to study endpoint, Figure 5 shows the fraction of patients achieving that level of improvement. The figure is cumulative, so that patients whose change from baseline is, for example, 50%, are also included at every level of improvement below 50%. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 5: Patients Achieving Various Levels of Improvement in Pain Intensity– Study PHN 3

Adjunctive Therapy for Adult Patients with Partial Onset Seizures

The efficacy of Lyrica as adjunctive therapy in partial onset seizures was established in three 12-week, randomized, double-blind, placebo-controlled, multicenter studies in adult patients. Patients were enrolled who had partial onset seizures with or without secondary generalization and were not adequately controlled with 1 to 3 concomitant antiepileptic drugs (AEDs). Patients taking gabapentin were required to discontinue gabapentin treatment 1 week prior to entering baseline. During an 8-week baseline period, patients had to experience at least 6 partial onset seizures with no seizure-free period exceeding 4 weeks. The mean duration of epilepsy was 25 years in these 3 studies and the mean and median baseline seizure frequencies were 22.5 and 10 seizures per month, respectively. Approximately half of the patients were taking 2 concurrent AEDs at baseline. Among the Lyrica-treated patients, 80% completed the double-blind phase of the studies.

Table 8 shows median baseline seizure rates and median percent reduction in seizure frequency by dose.

Table 8. Seizure Response in Controlled, Add-On Epilepsy Studies
Daily Dose of Pregabalin Dosing Regimen N Baseline Seizure Frequency/mo Median % Change from Baseline p-value, vs. placebo
Study E1
Placebo BID 100 9.5 0
50 mg/day BID 88 10.3 -9 0.4230
150 mg/day BID 86 8.8 -35 0.0001
300 mg/day BID 90 9.8 -37 0.0001
600 mg/day BID 89 9.0 -51 0.0001
Study E2
Placebo TID 96 9.3 1
150 mg/day TID 99 11.5 -17 0.0007
600 mg/day TID 92 12.3 -43 0.0001
Study E3
Placebo BID/TID 98 11 -1
600 mg/day BID 103 9.5 -36 0.0001
600 mg/day TID 111 10 -48 0.0001

In the first study (E1), there was evidence of a dose-response relationship for total daily doses of Lyrica between 150 and 600 mg/day; a dose of 50 mg/day was not effective. In the first study (E1), each daily dose was divided into two equal doses (twice a day dosing). In the second study (E2), each daily dose was divided into three equal doses (three times a day dosing). In the third study (E3), the same total daily dose was divided into two equal doses for one group (twice a day dosing) and three equal doses for another group (three times a day dosing). While the three times a day dosing group in Study E3 performed numerically better than the twice a day dosing group, this difference was small and not statistically significant.

A secondary outcome measure included the responder rate (proportion of patients with greater than or equal to 50% reduction from baseline in partial seizure frequency). The following figure displays responder rate by dose for two of the studies.

Figure 6: Responder rate by add-on epilepsy study

Figure 7: Seizure Reduction by Dose (All Partial Onset Seizures) for Studies E1, E2, and E3

Subset evaluations of the antiseizure efficacy of Lyrica showed no clinically important differences as a function of age, gender, or race.

Management of Fibromyalgia

The efficacy of Lyrica for management of fibromyalgia was established in one 14-week, double-blind, placebo-controlled, multicenter study (F1) and one six-month, randomized withdrawal study (F2). Studies F1 and F2 enrolled patients with a diagnosis of fibromyalgia using the American College of Rheumatology (ACR) criteria (history of widespread pain for 3 months, and pain present at 11 or more of the 18 specific tender point sites). The studies showed a reduction in pain by visual analog scale. In addition, improvement was demonstrated based on a patient global assessment (PGIC), and on the Fibromyalgia Impact Questionnaire (FIQ).

Study F1: This 14-week study compared Lyrica total daily doses of 300 mg, 450 mg and 600 mg with placebo. Patients were enrolled with a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numeric pain rating scale and a score of greater than or equal to 40 mm on the 100 mm pain visual analog scale (VAS). The baseline mean pain score in this trial was 6.7. Responders to placebo in an initial one-week run-in phase were not randomized into subsequent phases of the study. A total of 64% of patients randomized to Lyrica completed the study. There was no evidence of a greater effect on pain scores of the 600 mg daily dose than the 450 mg daily dose, but there was evidence of dose-dependent adverse reactions [see Adverse Reactions (6.1)]. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study. The results are summarized in Figure 8 and Table 9.

For various levels of improvement in pain intensity from baseline to study endpoint, Figure 8 shows the fraction of patients achieving that level of improvement. The figure is cumulative. Patients who did not complete the study were assigned 0% improvement. Some patients experienced a decrease in pain as early as Week 1, which persisted throughout the study.

Figure 8: Patients Achieving Various Levels of Improvement in Pain Intensity – Fibromyalgia Study F1

Table 9. Patient Global Response in Fibromyalgia Study F1
Patient Global Impression of Change
Treatment Group
(mg/day)
% Any Improvement 95% CI
PGB = Pregabalin
Placebo 47.6 (40.0,55.2)
PGB 300 68.1 (60.9, 75.3)
PGB 450 77.8 (71.5, 84.0)
PGB 600 66.1 (59.1, 73.1)

Study F2: This randomized withdrawal study compared Lyrica with placebo. Patients were titrated during a 6-week open-label dose optimization phase to a total daily dose of 300 mg, 450 mg, or 600 mg. Patients were considered to be responders if they had both: 1) at least a 50% reduction in pain (VAS) and, 2) rated their overall improvement on the PGIC as "much improved" or "very much improved." Those who responded to treatment were then randomized in the double-blind treatment phase to either the dose achieved in the open-label phase or to placebo. Patients were treated for up to 6 months following randomization. Efficacy was assessed by time to loss of therapeutic response, defined as 1) less than 30% reduction in pain (VAS) from open-label baseline during two consecutive visits of the double-blind phase, or 2) worsening of FM symptoms necessitating an alternative treatment. Fifty-four percent of patients were able to titrate to an effective and tolerable dose of Lyrica during the 6-week open-label phase. Of the patients entering the randomized treatment phase assigned to remain on Lyrica, 38% of patients completed 26 weeks of treatment versus 19% of placebo-treated patients.

When considering return of pain or withdrawal due to adverse events as loss of response (LTR), treatment with Lyrica resulted in a longer time to loss of therapeutic response than treatment with placebo. Fifty-three percent of the pregabalin-treated subjects compared to 33% of placebo patients remained on study drug and maintained a therapeutic response to Week 26 of the study. Treatment with Lyrica also resulted in a longer time to loss of response based on the FIQ1, and longer time to loss of overall assessment of patient status, as measured by the PGIC2.

Figure 9: Time to Loss of Therapeutic Response, Fibromyalgia Study F2 (Kaplan-Meier Analysis)

1 Time to worsening of the FIQ was defined as the time to a 1-point increase from double-blind baseline in each of the subscales, and a 5-point increase from double-blind baseline evaluation for the FIQ total score. 2 Time to PGIC lack of improvement was defined as time to PGIC assessments indicating less improvement than "much improvement."

Management of Neuropathic Pain Associated with Spinal Cord Injury

The efficacy of Lyrica for the management of neuropathic pain associated with spinal cord injury was established in two double-blind, placebo-controlled, multicenter studies. Patients were enrolled with neuropathic pain associated with spinal cord injury that persisted continuously for at least three months or with relapses and remissions for at least six months. A total of 63% of patients completed study 1 and 84% completed study 2. The patients had a minimum mean baseline pain score of greater than or equal to 4 on an 11-point numerical pain rating scale ranging from 0 (no pain) to 10 (worst possible pain). The baseline mean pain scores across the two studies ranged from 6.5 to 6.7.

Patients were allowed to take opioids, non-opioid analgesics, antiepileptic drugs, muscle relaxants, and antidepressant drugs if the dose was stable for 30 days prior to screening. Patients were allowed to take acetaminophen and nonsteroidal anti-inflammatory drugs during the studies.

Study SCI 1: This 12-week, randomized, double-blind, parallel-group, multicenter, flexible dose (150–600 mg/day) study compared pregabalin with placebo. The 12-week study consisted of a 3-week dose adjustment phase and a 9-week dose maintenance phase. Treatment with Lyrica 150–600 mg/day statistically significantly improved the endpoint weekly mean pain score, and increased the proportion of patients with at least a 30% and 50% reduction in pain score from baseline. The fraction of patients achieving various levels of improvement in pain intensity from baseline to Week 12 is presented in Figure 10. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the study.

Figure 10: Patients Achieving Various Levels of Improvement in Pain Intensity – Study SCI 1

Study SCI 2: This 16-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter, flexible dose (150–600 mg/day, in increments of 150 mg) study compared the efficacy, safety and tolerability of pregabalin with placebo. The 16-week study consisted of a 4-week dose adjustment phase and a 12-week dose maintenance phase. Treatment with Lyrica statistically significantly improved the endpoint weekly mean pain score, and increased the proportion of patients with at least a 30% and 50% reduction in pain score from baseline. The fraction of patients achieving various levels of improvement in pain intensity from baseline to Week 16 is presented in Figure 11. Some patients experienced a decrease in pain as early as week 1, which persisted throughout the study.

Figure 11: Patients Achieving Various Levels of Improvement in Pain Intensity – Study SCI 2

How Supplied/Storage and Handling

25 mg capsules:

White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 25" on the body; available in:

Bottles of 90: NDC 0071-1012-68

50 mg capsules:

White, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 50" and an ink band on the body, available in:

Bottles of 90: NDC 0071-1013-68
Unit-Dose Blister Packages of 100: NDC 0071-1013-41

75 mg capsules:

White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 75" on the body; available in:

Bottles of 90: NDC 0071-1014-68
Unit-Dose Blister Packages of 100: NDC 0071-1014-41

100 mg capsules:

Orange, hard-gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 100" on the body, available in:

Bottles of 90: NDC 0071-1015-68
Unit-Dose Blister Packages of 100: NDC 0071-1015-41

150 mg capsules:

White hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 150" on the body, available in:

Bottles of 90: NDC 0071-1016-68
Unit-Dose Blister Packages of 100: NDC 0071-1016-41

200 mg capsules:

Light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 200" on the body, available in:

Bottles of 90: NDC 0071-1017-68

225 mg capsules:

White/light orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 225" on the body; available in:

Bottles of 90: NDC 0071-1019-68

300 mg capsules:

White/orange hard gelatin capsule printed with black ink "Pfizer" on the cap, "PGN 300" on the body, available in:

Bottles of 90: NDC 0071-1018-68

20 mg/mL oral solution:

16 fluid ounce white high density polyethylene (HDPE) bottle with a polyethylene-lined closure:

16 fluid ounce bottle NDC 0071-1020-01

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).

See FDA-Approved Medication Guide

Patient Counseling Information

Medication Guide

Inform patients of the availability of a Medication Guide, and instruct them to read the Medication Guide prior to taking Lyrica. Instruct patients to take Lyrica only as prescribed.

Angioedema

Advise patients that Lyrica may cause angioedema, with swelling of the face, mouth (lip, gum, tongue) and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue Lyrica and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.1)].

Hypersensitivity

Advise patients that Lyrica has been associated with hypersensitivity reactions such as wheezing, dyspnea, rash, hives, and blisters. Instruct patients to discontinue Lyrica and immediately seek medical care if they experience these symptoms [see Warnings and Precautions (5.2)].

Suicidal Thinking and Behavior

Patients, their caregivers, and families should be counseled that AEDs, including Lyrica, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Report behaviors of concern immediately to healthcare providers [see Warnings and Precautions (5.4)].

Dizziness and Somnolence

Counsel patients that Lyrica may cause dizziness, somnolence, blurred vision and other CNS signs and symptoms. Accordingly, advise patients not to drive, operate complex machinery, or engage in other hazardous activities until they have gained sufficient experience on Lyrica to gauge whether or not it affects their mental, visual, and/or motor performance adversely. [see Warnings and Precautions (5.6)].

Weight Gain and Edema

Counsel patients that Lyrica may cause edema and weight gain. Advise patients that concomitant treatment with Lyrica and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure. [see Warnings and Precautions (5.5 and 5.7)].

Abrupt or Rapid Discontinuation

Advise patients to take Lyrica as prescribed. Abrupt or rapid discontinuation may result in insomnia, nausea, headache, anxiety, hyperhidrosis, or diarrhea. [see Warnings and Precautions (5.8)].

Ophthalmological Effects

Counsel patients that Lyrica may cause visual disturbances. Inform patients that if changes in vision occur, they should notify their physician [see Warnings and Precautions (5.10)].

Creatine Kinase Elevations

Instruct patients to promptly report unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever. [see Warnings and Precautions (5.11)].

CNS Depressants

Inform patients who require concomitant treatment with central nervous system depressants such as opiates or benzodiazepines that they may experience additive CNS side effects, such as somnolence [see Warnings and Precautions (5.6) and Drug Interactions (7)].

Alcohol

Tell patients to avoid consuming alcohol while taking Lyrica, as Lyrica may potentiate the impairment of motor skills and sedating effects of alcohol.

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Lyrica during pregnancy [see Use in Specific Populations (8.1)].

Lactation

Advise nursing mothers that breastfeeding is not recommended during treatment with Lyrica [see Use in Specific Populations (8.2)].

Male Fertility

Inform men being treated with Lyrica who plan to father a child of the potential risk of male-mediated teratogenicity. In preclinical studies in rats, pregabalin was associated with an increased risk of male-mediated teratogenicity. The clinical significance of this finding is uncertain [see Nonclinical Toxicology (13.1) and Use in specific populations (8.3)].

Dermatopathy

Instruct diabetic patients to pay particular attention to skin integrity while being treated with Lyrica. Some animals treated with pregabalin developed skin ulcerations, although no increased incidence of skin lesions associated with Lyrica was observed in clinical trials [see Nonclinical Toxicology (13.2)].

This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

LAB-0294-25.0

This Medication Guide has been approved by the U.S. Food and Drug Administration. December 2016
MEDICATION GUIDE
Lyrica (LEER-i-kah)
(pregabalin)
Capsules, CV
Lyrica (LEER-i-kah)
(pregabalin)
Oral Solution, CV
Read this Medication Guide before you start taking Lyrica and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Lyrica, ask your healthcare provider or pharmacist.
What is the most important information I should know about Lyrica?
Lyrica may cause serious side effects including:
  • Serious, even life-threatening, allergic reactions
  • Suicidal thoughts or actions
  • Swelling of your hands, legs and feet
  • Dizziness and sleepiness
These serious side effects are described below:
  • Serious, even life-threatening, allergic reactions.
    Stop taking Lyrica and call your healthcare provider right away if you have any of these signs of a serious allergic reaction:
    • swelling of your face, mouth, lips, gums, tongue, throat or neck
    • trouble breathing
    • rash, hives (raised bumps) or blisters
  • Like other antiepileptic drugs, Lyrica may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
  • thoughts about suicide or dying
  • attempts to commit suicide
  • new or worse depression
  • new or worse anxiety
  • feeling agitated or restless
  • panic attacks
 
  • trouble sleeping (insomnia)
  • new or worse irritability
  • acting aggressive, being angry, or violent
  • acting on dangerous impulses
  • an extreme increase in activity and talking (mania)
  • other unusual changes in behavior or mood
 

If you have suicidal thoughts or actions, do not stop Lyrica without first talking to a healthcare provider.

  • Stopping Lyrica suddenly can cause serious problems.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
 

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
  • Swelling of your hands, legs and feet. This swelling can be a serious problem for people with heart problems.
  • Dizziness and sleepiness. Do not drive a car, work with machines, or do other dangerous activities until you know how Lyrica affects you. Ask your healthcare provider about when it will be okay to do these activities.
What is Lyrica?
Lyrica is a prescription medicine used in adults, 18 years and older, to treat:
  • pain from damaged nerves (neuropathic pain) that happens with diabetes
  • pain from damaged nerves (neuropathic pain) that follows healing of shingles
  • partial seizures when taken together with other seizure medicines
  • fibromyalgia (pain all over your body)
  • pain from damaged nerves (neuropathic pain) that follows spinal cord injury
It is not known if Lyrica is safe and effective in children.
Who should not take Lyrica?
Do not take Lyrica if you are allergic to pregabalin or any of the ingredients in Lyrica.
See "What is the most important information I should know about Lyrica?" for the signs of an allergic reaction.
See the end of this leaflet for a complete list of ingredients in Lyrica.
What should I tell my healthcare provider before taking Lyrica?
Before taking Lyrica, tell your healthcare provider about all your medical conditions, including if you:
  • have or have had depression, mood problems or suicidal thoughts or behavior
  • have kidney problems or get kidney dialysis
  • have heart problems including heart failure
  • have a bleeding problem or a low blood platelet count
  • have abused prescription medicines, street drugs, or alcohol in the past
  • have ever had swelling of your face, mouth, tongue, lips, gums, neck, or throat (angioedema)
  • plan to father a child. Animal studies have shown that pregabalin, the active ingredient in Lyrica, made male animals less fertile and caused sperm to change. Also, in animal studies, birth defects were seen in the offspring (babies) of male animals treated with pregabalin. It is not known if these problems can happen in people who take Lyrica.
  • are pregnant or plan to become pregnant. It is not known if Lyrica will harm your unborn baby. You and your healthcare provider will decide if you should take Lyrica while you are pregnant.
    • If you become pregnant while taking Lyrica, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy. Information about the registry can also be found at the website, http://www.aedpregnancyregistry.org/.
  • are breastfeeding or plan to breastfeed. Lyrica passes into your breast milk. It is not known if Lyrica can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Lyrica. Breastfeeding is not recommended while taking Lyrica.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins or herbal supplements. Lyrica and other medicines may affect each other causing side effects. Especially tell your healthcare provider if you take:
  • angiotensin converting enzyme (ACE) inhibitors, which are used to treat many conditions, including high blood pressure.
    You may have a higher chance for swelling and hives if these medicines are taken with Lyrica.
  • Avandia (rosiglitazone) or Actos (pioglitazone) for diabetes. You may have a higher chance of weight gain or swelling of your hands or feet if these medicines are taken with Lyrica.
  • any narcotic pain medicine (such as oxycodone), tranquilizers or medicines for anxiety (such as lorazepam). You may have a higher chance for dizziness and sleepiness if these medicines are taken with Lyrica.
  • any medicines that make you sleepy
Know the medicines you take. Keep a list of them with you to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.
How should I take Lyrica?
  • Take Lyrica exactly as prescribed. Your healthcare provider will tell you how much Lyrica to take and when to take it.
  • Take Lyrica at the same times each day.
  • Lyrica may be taken with or without food.
  • Your healthcare provider may change your dose. Do not change your dose without talking to your healthcare provider.
  • Do not stop taking Lyrica without talking to your healthcare provider. If you stop taking Lyrica suddenly you may have headaches, nausea, diarrhea, trouble sleeping, increased sweating, or you may feel anxious. If you have epilepsy and you stop taking Lyrica suddenly, you may have seizures more often. Talk with your healthcare provider about how to stop Lyrica slowly.
  • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
  • If you take too much Lyrica, call your healthcare provider or poison control center, or go to the nearest emergency room right away.
What should I avoid while taking Lyrica?
  • Do not drive a car, work with machines, or do other dangerous activities until you know how Lyrica affects you.
  • Do not drink alcohol while taking Lyrica. Lyrica and alcohol can affect each other and increase side effects such as sleepiness and dizziness.
What are the possible side effects of Lyrica?
Lyrica may cause serious side effects, including:
  • See "What is the most important information I should know about Lyrica?"
  • Muscle problems, muscle pain, soreness, or weakness. If you have these symptoms, especially if you feel sick and have a fever, tell your healthcare provider right away.
  • Problems with your eyesight, including blurry vision. Call your healthcare provider if you have any changes in your eyesight.
  • Weight gain. If you have diabetes, weight gain may affect the management of your diabetes. Weight gain can also be a serious problem for people with heart problems.
  • Feeling "high"
The most common side effects of Lyrica are:
  • dizziness
  • blurry vision
  • weight gain
  • sleepiness
  • trouble concentrating
  • swelling of hands and feet
  • dry mouth
Lyrica caused skin sores in animal studies. Skin sores did not happen in studies in people. If you have diabetes, you should pay attention to your skin while taking Lyrica and tell your healthcare provider about any sores or skin problems.
Tell your healthcare provider about any side effect that bothers you or that does not go away.
These are not all the possible side effects of Lyrica. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Lyrica?
  • Store Lyrica capsules and oral solution at room temperature, 68°F to 77°F (20°C to 25°C) in its original package.
  • Safely throw away any Lyrica that is out of date or no longer needed.
Keep Lyrica and all medicines out of the reach of children.
General information about the safe and effective use of Lyrica
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Lyrica for a condition for which it was not prescribed. Do not give Lyrica to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Lyrica that is written for health professionals.
You can also visit the Lyrica website at www.Lyrica.com or call 1-866-459-7422 (1-866-4Lyrica).
What are the ingredients in Lyrica?
Active ingredient: pregabalin
Inactive ingredients:
Lyrica capsules: lactose monohydrate, cornstarch, talc
Capsule shell: gelatin and titanium dioxide; Orange capsule shell: red iron oxide; White capsule shell: sodium lauryl sulfate, colloidal silicon dioxide. Colloidal silicon dioxide is a manufacturing aid that may or may not be present in the capsule shells.
Imprinting ink: shellac, black iron oxide, propylene glycol, potassium hydroxide.
Lyrica oral solution: methylparaben, propylparaben, monobasic sodium phosphate anhydrous, dibasic sodium phosphate anhydrous, sucralose, artificial strawberry #11545 and purified water.

LAB-0299-14.0

PRINCIPAL DISPLAY PANEL - 75 mg Capsule Blister Pack Carton

Pfizer
NDC 0071-1014-41

Lyrica®
(pregabalin) capsules

CV

75 mg

ALWAYS DISPENSE WITH MEDICATION GUIDE

For in-institution use only

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack

Lyrica®
(pregabalin)
Capsule

CV

150 mg

DIST BY PARKE-DAVIS
DIV OF PFIZER INC, NY, NY 10017

LOT 00000VX EXP XXX 00

PRINCIPAL DISPLAY PANEL - 150 mg Capsule Blister Pack Carton

Pfizer
NDC 0071-1016-41

Lyrica®
(pregabalin) capsules

CV

150 mg

ALWAYS DISPENSE WITH MEDICATION GUIDE

For in-institution use only

100 Capsules
Rx only

What is Lyrica?

Lyrica (pregabalin) is an anti-epileptic drug, also called an anticonvulsant. It works by slowing down impulses in the brain that cause seizures. Pregabalin also affects chemicals in the brain that send pain signals across the nervous system.

Lyrica is used to control seizures and to treat fibromyalgia. It is also used to treat pain caused by nerve damage in people with diabetes (diabetic neuropathy), herpes zoster (post-herpetic neuralgia), or spinal cord injury.

Lyrica may also be used for purposes not listed in this medication guide.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Lyrica side effects

Lyrica can cause a severe allergic reaction. Stop taking this medicine and get emergency medical help if you have: hives or blisters on your skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, depression, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • vision problems;

  • swelling in your hands or feet, rapid weight gain (especially if you have diabetes or heart problems); or

  • unexplained muscle pain, tenderness, or weakness (especially if you also have fever, unusual tiredness, or dark colored urine).

If you have diabetes, tell your doctor right away if you have any new sores or other skin problems.

Common Lyrica side effects may include:

  • dizziness, drowsiness;

  • trouble concentrating;

  • swelling, weight gain;

  • dry mouth; or

  • blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Downsides

If you are between the ages of 18 and 60, take no other medication or have no other medical conditions, side effects you are more likely to experience include:

  • May cause dizziness, drowsiness, and affect a person's ability to drive or operate machinery. Alcohol should be avoided.
  • May cause edema (fluid retention), particularly in the feet or hands. This may be noticed as weight gain, although weight gain can occur independently of fluid retention. Rarely, may cause potentially life-threatening angioedema (a swelling of the face, mouth or neck). People taking other medications that have also been associated with angioedema (such as ACE inhibitors) may be more at risk.
  • Other side effects include a headache, tremor, abnormal thinking, dry mouth, constipation, blurred vision, lack of energy, changes in some laboratory test results, and ECG changes.
  • The dosage of Lyrica needs reducing in people with kidney disease.
  • Similar to other medicines used to treat seizures, Lyrica increases the risk of depression and suicidal thoughts.
  • Avoid abrupt or rapid discontinuation as discontinuation symptoms (including insomnia, nausea, headache, anxiety, increased sweating and diarrhea) have been reported. Taper dosage down gradually on a doctor's advice over a minimum of one week.
  • There is currently no generic version of Lyrica available in the United States.

Notes: In general, seniors or children, people with certain medical conditions (such as liver or kidney problems, heart disease, diabetes, seizures) or people who take other medications are more at risk of developing a wider range of side effects. For a complete list of all side effects, click here.

Pregabalin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Very limited data indicate that amounts of pregabalin in breastmilk are low. If pregabalin is required by the mother of an older infant, it is not a reason to discontinue breastfeeding, but until more data become available, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. In one woman, the breastmilk pregabalin level was about equal to the maternal serum concentration.[1]

Ten women who averaged 35.6 weeks postpartum (range 20 to 43 weeks) were given pregabalin 150 mg every 12 hours for 4 doses. Milk samples were obtained before the last dose and 5 times during the 24 hours after the last dose. Three additional collections were made between 24 and 48 hours after the last dose in 5 of the subjects. The average peak breastmilk pregabalin concentration was 4.63 mg/L and the average breastmilk pregabalin concentration was 2.05 mg/L. The average infant dosage was 0.31 mg/kg/day, or about 7% of the maternal weight-adjusted dosage.[2]

Infant Levels. The breastfed infant of a woman who was taking pregabalin (dose not specified) as an anticonvulsant during pregnancy and breastfeeding had a pregabalin serum concentration of 429 mcg/L at 48 hours postpartum, which was about 8% of the mother's serum concentration. Some of the infant's serum concentration could have been derived from transplacental passage, because the pregabalin half-life in this and another newborn averaged 17 hours.[1]

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

A study randomized pregnant women to either a single dose of pregabalin 150 mg (n = 45), 300 mg (n = 45), or placebo (n = 45) orally 1 hour before induction of anesthesia for an elective cesarean section to reduce postoperative analgesia requirements. Three infants of mothers in the pregabalin 300 mg group had difficulty latching on for breastfeeding for 8 hours after delivery, although none were sedated.[2]

References

1. Ohman I, De Flon P, Tomson T. Pregabalin kinetics in the neonatal period, and during lactation. Epilepsia. 2011;52 (Suppl 6):249-50. Abstract p824. DOI: doi:10.1111/j.1528-1167.2011.03207.x

2. Lockwood PA, Pauer L, Scavone JM et al. The pharmacokinetics of pregabalin in breast milk, plasma, and urine of healthy postpartum women. J Hum Lact. 2016;32:NP1-NP8. PMID: 26961752

3. El Kenany S, El Tahan MR. Effect of preoperative pregabalin on post-caesarean delivery analgesia: A dose-response study. Int J Obstet Anesth. 2016;26:24-31. PMID: 26718698

(web3)