Varenicline

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

The following serious adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the labeling:

• Neuropsychiatric symptoms and suicidality [see BOXED WARNING, WARNINGS AND PRECAUTIONS]
• Seizures [see WARNINGS AND PRECAUTIONS]
• Interaction with alcohol [see WARNINGS AND PRECAUTIONS]
• Accidental injury [see WARNINGS AND PRECAUTIONS]
• Cardiovascular events [see WARNINGS AND PRECAUTIONS]
• Somnambulism [see WARNINGS AND PRECAUTIONS]
• Angioedema and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS]
• Serious skin reactions [see WARNINGS AND PRECAUTIONS]

In the placebo-controlled premarketing studies, the most common adverse events associated with CHANTIX ( > 5% and twice the rate seen in placebo-treated patients) were nausea, abnormal (vivid, unusual, or strange) dreams, constipation, flatulence, and vomiting.

The treatment discontinuation rate due to adverse events in patients dosed with 1 mg twice daily was 12% for CHANTIX, compared to 10% for placebo in studies of three months�?T treatment. In this group, the discontinuation rates that are higher than placebo for the most common adverse events in CHANTIX-treated patients were as follows: nausea (3% vs. 0.5% for placebo), insomnia (1.2% vs. 1.1% for placebo), and abnormal dreams (0.3% vs. 0.2% for placebo).

Smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness.

Clinical Trials Experience

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

During the premarketing development of CHANTIX, over 4500 subjects were exposed to CHANTIX, with over 450 treated for at least 24 weeks and approximately 100 for a year. Most study participants were treated for 12 weeks or less.

The most common adverse event associated with CHANTIX treatment is nausea, occurring in 30% of patients treated at the recommended dose, compared with 10% in patients taking a comparable placebo regimen [see WARNINGS AND PRECAUTIONS].

Table 5 shows the adverse events for CHANTIX and placebo in the 12-week fixed dose premarketing studies with titration in the first week [Studies 2 (titrated arm only), 4, and 5]. Adverse events were categorized using the Medical Dictionary for Regulatory Activities (MedDRA, Version 7.1).

MedDRA High Level Group Terms (HLGT) reported in ≥ 5% of patients in the CHANTIX 1 mg twice daily dose group, and more commonly than in the placebo group, are listed, along with subordinate Preferred Terms (PT) reported in ≥ 1% of CHANTIX patients (and at least 0.5% more frequent than placebo). Closely related Preferred Terms such as �?~Insomnia�?T, �?~Initial insomnia�?T, �?~Middle insomnia�?T, �?~Early morning awakening�?T were grouped, but individual patients reporting two or more grouped events are only counted once.

Table 5: Common Treatment Emergent AEs (%) in the Fixed-Dose, Placebo-Controlled Studies (HLGTs > 5% of patients in the 1 mg BID CHANTIX Group and more commonly than Placebo and PT ≥ 1% in the 1 mg BID CHANTIX Group, and 1 mg BID CHANTIX at least 0.5% more than Placebo)

The overall pattern and frequency of adverse events during the longer-term premarketing trials was similar to those described in Table 5, though several of the most common events were reported by a greater proportion of patients with long-term use (e.g., nausea was reported in 40% of patients treated with CHANTIX 1 mg twice daily in a one year study, compared to 8% of placebo-treated patients).

Following is a list of treatment-emergent adverse events reported by patients treated with CHANTIX during all premarketing clinical trials and updated based on pooled data from 18 placebo-controlled pre-and post-marketing studies, including approximately 5,000 patients treated with varenicline. Adverse events were categorized using MedDRA, Version 16.0. 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.

Blood and Lymphatic System Disorders. Infrequent: anemia, lymphadenopathy. Rare: leukocytosis, splenomegaly, thrombocytopenia.

Cardiac Disorders. Infrequent: angina pectoris, myocardial infarction, palpitations, tachycardia. Rare: acute coronary syndrome, arrhythmia, atrial fibrillation, bradycardia, cardiac flutter, cor pulmonale, coronary artery disease, ventricular extrasystoles.

Ear and Labyrinth Disorders. Infrequent: tinnitus, vertigo. Rare: deafness, Meniere�?Ts disease.

Endocrine Disorders. Infrequent: thyroid gland disorders.

Eye Disorders. Infrequent: conjunctivitis, eye irritation, eye pain, vision blurred, visual impairment. Rare: blindness transient, cataract subcapsular, dry eye, night blindness, ocular vascular disorder, photophobia, vitreous floaters.

Gastrointestinal Disorders. Frequent: diarrhea, toothache. Infrequent: dysphagia, eructation, gastritis, gastrointestinal hemorrhage, mouth ulceration. Rare: enterocolitis, esophagitis, gastric ulcer, intestinal obstruction, pancreatitis acute.

General Disorders and Administration Site Conditions. Frequent: chest pain. Infrequent: chest discomfort, chills, edema, influenza-like illness, pyrexia.

Hepatobiliary Disorders. Rare: gall bladder disorder.

Investigations. Frequent: liver function test abnormal, weight increased. Infrequent: electrocardiogram abnormal. Rare: muscle enzyme increased, urine analysis abnormal.

Metabolism and Nutrition Disorders. Infrequent: diabetes mellitus, hypoglycemia. Rare: hyperlipidemia, hypokalemia.

Musculoskeletal and Connective Tissue Disorders. Frequent: arthralgia, back pain, myalgia. Infrequent: arthritis, muscle cramp, musculoskeletal pain. Rare: myositis, osteoporosis.

Nervous System Disorders. Frequent: disturbance in attention, dizziness. Infrequent: amnesia, convulsion, migraine, parosmia, syncope, tremor. Rare: balance disorder, cerebrovascular accident, dysarthria, mental impairment, multiple sclerosis, VIIth nerve paralysis, nystagmus, psychomotor hyperactivity, psychomotor skills impaired, restless legs syndrome, sensory disturbance, transient ischemic attack, visual field defect.

Psychiatric Disorders. Infrequent: dissociation, libido decreased, mood swings, thinking abnormal. Rare: bradyphrenia, disorientation, euphoric mood.

Renal and Urinary Disorders. Infrequent: nocturia, pollakiuria, urine abnormality. Rare: nephrolithiasis, polyuria, renal failure acute, urethral syndrome, urinary retention.

Reproductive System and Breast Disorders. Frequent: menstrual disorder. Infrequent: erectile dysfunction. Rare: sexual dysfunction.

Respiratory, Thoracic and Mediastinal Disorders. Frequent: respiratory disorders. Infrequent: asthma, epistaxis, rhinitis allergic, upper respiratory tract inflammation. Rare: pleurisy, pulmonary embolism.

Skin and Subcutaneous Tissue Disorders. Infrequent: acne, dry skin, eczema, erythema, hyperhidrosis, urticaria. Rare: photosensitivity reaction, psoriasis.

Vascular Disorders. Infrequent: hot flush. Rare: thrombosis.

CHANTIX has also been studied in postmarketing trials including (1) a trial conducted in patients with chronic obstructive pulmonary disease (COPD), (2) a trial conducted in generally healthy patients (similar to those in the premarketing studies) in which they were allowed to select a quit date between days 8 and 35 of treatment (“alternative quit date instruction trial”), (3) a trial conducted in patients who did not succeed in stopping smoking during prior CHANTIX therapy, or who relapsed after treatment (“re-treatment trial”), (4) a trial conducted in patients with stable cardiovascular disease, (5) a trial conducted in patients with stable schizophrenia or schizoaffective disorder (6) a trial conducted in patients with major depressive disorder and (7) a trial in patients who were not able or willing to quit abruptly and who were instructed to quit gradually (“gradual approach to quitting smoking trial”).

Adverse events in the trial of patients with COPD, in the alternative quit date instruction trial, and in the gradual approach to quitting smoking trial were similar to those observed in premarketing studies. In the re-treatment trial, the profile of common adverse events was similar to that previously reported, but, in addition, varenicline-treated patients also commonly reported diarrhea (6% vs. 4% in placebo-treated patients), depressed mood disorders and disturbances (6% vs. 1%), and other mood disorders and disturbances (5% vs. 2%).

In the trial of patients with stable cardiovascular disease, more types and a greater number of cardiovascular events were reported compared to premarketing studies. Treatment-emergent (on-treatment or 30 days after treatment) cardiovascular events reported with a frequency ≥ 1% in either treatment group in this study were angina pectoris (3.7% and 2.0% for varenicline and placebo, respectively), chest pain (2.5% vs. 2.3%), peripheral edema (2.0% vs. 1.1%), hypertension (1.4% vs. 2.6%), and palpitations (0.6 % vs. 1.1%). Deaths and serious cardiovascular events occurring over the 52 weeks of the study (treatment emergent and non-treatment emergent) were adjudicated by a blinded, independent committee. The following treatment-emergent adjudicated events occurred with a frequency > 1% in either treatment group: nonfatal MI (1.1% vs. 0.3% for varenicline and placebo, respectively), and hospitalization for angina pectoris (0.6% vs. 1.1%). During non-treatment follow-up to 52 weeks, the adjudicated events included need for coronary revascularization (2.0% vs. 0.6%), hospitalization for angina pectoris (1.7% vs. 1.1%), and new diagnosis of peripheral vascular disease (PVD) or admission for a PVD procedure (1.4% vs. 0.6%). Some of the patients requiring coronary revascularization underwent the procedure as part of management of nonfatal MI and hospitalization for angina. Cardiovascular death occurred in 0.3% of patients in the varenicline arm and 0.6% of patients in the placebo arm over the course of the 52-week study.

In the trial of patients with stable schizophrenia or schizoaffective disorder, 128 smokers on antipsychotic medication were randomized 2:1 to varenicline (1 mg twice daily) or placebo for 12 weeks with 12-week non-drug follow-up. The most common adverse events in patients taking varenicline were nausea (24% vs. 14.0% on placebo), headache (11% vs. 19% on placebo) and vomiting (11% vs. 9% on placebo). Among reported neuropsychiatric adverse events, insomnia was the only event that occurred in either treatment group in ≥ 5% of subjects at a rate higher in the varenicline group than in placebo (10% vs. 5%). These common and neuropsychiatric adverse events occurred on treatment or within 30 days after the last dose of study drug. There was no consistent worsening of schizophrenia in either treatment group as measured by the Positive and Negative Syndrome Scale. There were no overall changes in extra-pyramidal signs, as measured by the Simpson-Angus Rating Scale. The Columbia-Suicide Severity Rating Scale was administered at baseline and at clinic visits during the treatment and non-treatment follow-up phases. Over half of the patients had a lifetime history of suicidal behavior and/or ideation (62% on varenicline vs. 51% on placebo), but at baseline, no patients in the varenicline group reported suicidal behavior and/or ideation vs. one patient in the placebo group (2%). Suicidal behavior and/or ideation were reported in 11% of the vareniclinetreated and 9% of the placebo-treated patients during the treatment phase. During the post-treatment phase, suicidal behavior and/or ideation were reported in 11% of patients in the varenicline group and 5% of patients in the placebo group. Many of the patients reporting suicidal behavior and ideation in the follow-up phase had not reported such experiences in the treatment phase. However, no new suicidal ideation or behavior emerged in either treatment group shortly (within one week) after treatment discontinuation (a phenomenon noted in post-marketing reporting). There were no completed suicides. There was one suicide attempt in a varenicline-treated patient. The limited data available from this single smoking cessation study are not sufficient to allow conclusions to be drawn.

In the trial of patients with major depressive disorder, the most common adverse events ( ≥ 10%) in subjects taking varenicline were nausea (27% vs. 10% on placebo), headache (17 vs 11%), abnormal dreams (11% vs 8%), insomnia (11% vs 5%) and irritability (11% vs. 8%). Additionally, the following psychiatric AEs were reported in ≥ 2% of patients in either treatment group (varenicline or placebo, respectively): anxiety (7% vs. 9%), agitation (7% vs. 4%), depressed mood disorders and disturbances (11% vs. 9%), tension (4% vs. 3%), hostility (2% vs. 0.4%) and restlessness (2% vs. 2%). Patients treated with varenicline were more likely than patients treated with placebo to report one of various events related to hostility and aggression (3% vs 1%). Psychiatric scales showed no differences between the varenicline and placebo groups and no overall worsening of depression during the study in either treatment group. The percentage of subjects with suicidal ideation and/or behavior was similar between the varenicline and placebo groups during treatment (6% and 8%, respectively) and the non-treatment follow-up (6% and 6%, respectively). There was one event of intentional self-injury/possible suicide attempt during treatment (Day 73) in a subject in the placebo group. Suicide could not be ruled out in one subject who died by an overdose of illicit drugs 76 days after last dose of study drug in the varenicline group.

Postmarketing Experience

The following adverse events have been reported during post-approval use of CHANTIX. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

There have been reports of depression, mania, psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, anxiety, and panic, as well as suicidal ideation, suicide attempt, and completed suicide in patients attempting to quit smoking while taking CHANTIX [see BOXED WARNING, WARNINGS AND PRECAUTIONS]. Smoking cessation with or without treatment is associated with nicotine withdrawal symptoms and the exacerbation of underlying psychiatric illness. Not all patients had known pre-existing psychiatric illness and not all had discontinued smoking.

There have been postmarketing reports of new or worsening seizures in patients treated with CHANTIX [see WARNINGS AND PRECAUTIONS].

There have been postmarketing reports of patients experiencing increased intoxicating effects of alcohol while taking CHANTIX. Some reported neuropsychiatric events, including unusual and sometimes aggressive behavior [see WARNINGS AND PRECAUTIONS].

There have been reports of hypersensitivity reactions, including angioedema [see WARNINGS AND PRECAUTIONS].

There have also been reports of serious skin reactions, including Stevens-Johnson Syndrome and erythema multiforme, in patients taking CHANTIX [see WARNINGS AND PRECAUTIONS].

There have been reports of myocardial infarction (MI) and cerebrovascular accident (CVA) including ischemic and hemorrhagic events in patients taking CHANTIX. In the majority of the reported cases, patients had pre-existing cardiovascular disease and/or other risk factors. Although smoking is a risk factor for MI and CVA, based on temporal relationship between medication use and events, a contributory role of varenicline cannot be ruled out [see WARNINGS AND PRECAUTIONS].

There have been reports of hyperglycemia in patients following initiation of CHANTIX.

There have been reports of somnambulism, some resulting in harmful behavior to self, others, or property in patients treated with CHANTIX [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Chantix (Varenicline)

Varenicline is a prescription medicine to help adults quit smoking.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Varenicline is part of the drug class:

• Drugs used in nicotine dependence

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• insulin
• asthma medicines
• blood thinners 
• alcohol (Chantix can change the way people react to alcohol)

When you stop smoking, there may be a change in how these and other medicines work for you.

You should not use varenicline while using other medicines to quit smoking.

Before you take varenicline, tell your doctor if you:

• have ever had depression or other mental health problems.
• have kidney problems or get kidney dialysis. Your doctor may prescribe a lower dose of varenicline for you.
• are allergic to varenicline or any ingredients in varenicline.
• have any other medical conditions
• are pregnant or plan to become pregnant. Ask your doctor for help to stop smoking before you get pregnant because smoking during pregnancy puts you and your baby at risk for problems during pregnancy. Varenicline has not been studied in pregnant women. It is not known if varenicline will harm your unborn baby.
• are breastfeeding. Varenicline has not been studied in breastfeeding women. It is not known if varenicline passes into breast milk. You and your doctor should talk about the best way to feed your baby if you take varenicline.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if varenicline is excreted in human breastmilk or if it will harm your nursing baby.

WARNING: SERIOUS NEUROPSYCHIATRIC EVENTS

Serious neuropsychiatric events including, but not limited to, depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking varenicline. Some reported cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking. Depressed mood may be a symptom of nicotine withdrawal. Depression, rarely including suicidal ideation, has been reported in smokers undergoing a smoking cessation attempt without medication. However, some of these symptoms have occurred in patients taking varenicline who continued to smoke.

All patients being treated with varenicline should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide, have been reported in some patients attempting to quit smoking while taking varenicline in the postmarketing experience. When symptoms were reported, most were during varenicline treatment, but some were following discontinuation of varenicline therapy.

These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the premarketing studies of varenicline, and the safety and efficacy of varenicline in such patients has not been established.

Advise patients and caregivers that the patient should stop taking varenicline and contact a healthcare provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many postmarketing cases, resolution of symptoms after discontinuation of varenicline was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

The risks of varenicline should be weighed against the benefits of its use. Varenicline has been demonstrated to increase the likelihood of abstinence from smoking for as long as one year compared to treatment with placebo. The health benefits of quitting smoking are immediate and substantial. 

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:

• Difficult or labored breathing
• hyperventilation
• tightness in the chest

• Anger
• anxiety
• behavior changes
• discouragement
• feeling sad or empty
• feelings of panic
• irregular heartbeats
• irritability
• loss of interest or pleasure
• mood swings
• restlessness
• seeing, hearing, or feeling things that are not there
• sleepwalking
• thoughts of killing oneself

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:

• Abnormal dreams
• bloated or full feeling
• change in taste
• difficulty having a bowel movement (stool)
• dry mouth
• excess air or gas in the stomach or intestines
• general feeling of discomfort or illness
• headache
• lack or loss of strength
• loss of taste
• nausea
• passing gas
• stomach pain
• trouble sleeping
• unusual tiredness or weakness

• Acid or sour stomach
• belching
• body aches or pain
• chills
• cough
• decreased appetite
• dizziness
• ear congestion
• fever
• heartburn
• increased appetite
• indigestion
• itching skin or rash
• loss of appetite
• loss of voice
• nightmares
• sleepiness or unusual drowsiness
• sneezing or sore throat
• stomach discomfort or upset
• stuffy or runny nose
• trouble concentrating
• unusual drowsiness, dullness, or feeling of sluggishness
• 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.

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Chantix: 0.5 mg, 1 mg

Chantix Continuing Month Pak: 1 mg

Chantix Starting Month Pak: 0.5 mg x 11 & 1 mg x 42

Partial neuronal α4 β2 nicotinic receptor agonist; prevents nicotine stimulation of mesolimbic dopamine system associated with nicotine addiction. Also binds to 5-HT3 receptor (significance not determined) with moderate affinity. Varenicline stimulates dopamine activity but to a much smaller degree than nicotine does, resulting in decreased craving and withdrawal symptoms.

Absorption

Well absorbed; unaffected by food

Metabolism

Minimal (<10% of clearance is through metabolism)

Excretion

Urine (92% as unchanged drug)

Time to Peak

Plasma: ~3 to 4 hours

Half-Life Elimination

~24 hours

Protein Binding

≤20%

Smoking cessation: As an aid to smoking cessation treatment

>10%:

Central nervous system: Headache (12% to 19%), insomnia (9% to 19%), abnormal dreams (8% to 13%), irritability (11%), suicidal ideation (11%), depression (4% to 11%)

Gastrointestinal: Nausea (16% to 40%), vomiting (5% to 11%)

1% to 10%:

Cardiovascular: Angina pectoris (4%), chest pain (3%), peripheral edema (2%), myocardial infarction (≤1%)

Central nervous system: Anxiety (8%), malaise (7%), agitation (5% to 7%), sleep disorder (3% to 5%), tension (4%), drowsiness (3%), hostility (2% to 3%), lethargy (1% to 2%), nightmares (1% to 2%)

Dermatologic: Skin rash (3%)

Gastrointestinal: Flatulence (6% to 9%), constipation (5% to 8%), dysgeusia (5% to 8%), abdominal pain (7%), diarrhea (6%), xerostomia (6%), dyspepsia (5%), increased appetite (3% to 4%), anorexia (≤2%), decreased appetite (≤2%), gastroesophageal reflux disease (1%)

Respiratory: Upper respiratory tract infection (5% to 7%), dyspnea (2%), rhinorrhea (≤1%)

<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, abnormality in thinking, abnormal urinalysis, accidental injury, acne vulgaris, acute coronary syndrome, acute renal failure, aggressive behavior, allergic rhinitis, altered sense of smell, amnesia, anemia, angioedema, arthralgia, asthma, atrial fibrillation, back pain, behavioral changes, Bell palsy, blurred vision, bradycardia, cardiac arrhythmia, cardiac flutter, cataract (subcapsular), cerebrovascular accident, chills, conjunctivitis, cor pulmonale, coronary artery disease, deafness, decreased libido, decreased mental acuity, decreased visual acuity, delusions, diabetes mellitus, difficulty thinking, disorientation, dissociative disorder, dizziness, dysarthria, dysphagia, ECG abnormality, eczema, edema, elevation in serum levels of skeletal-muscle enzymes, emotional disturbance, emotional lability, enterocolitis, epistaxis, equilibrium disturbance, erectile dysfunction, eructation, erythema, erythema multiforme, esophagitis, euphoria, eye irritation, eye pain, fever, flu-like symptoms, flushing, gallbladder disease, gastric ulcer, gastritis, gastrointestinal hemorrhage, hallucination, homicidal ideation, hyperglycemia, hyperhidrosis, hyperlipidemia, hypersensitivity reaction, hypoglycemia, hypokalemia, intestinal obstruction, lack of concentration, leukocytosis, loss of consciousness, lymphadenopathy, mania, Meniere disease, menstrual disease, migraine, multiple sclerosis, muscle cramps, musculoskeletal pain, myalgia, myositis, nephrolithiasis, nocturia, nocturnal amblyopia, nystagmus, ophthalmic vascular disease, oral mucosa ulcer, osteoporosis, palpitations, pancreatitis, panic, paranoia, photophobia, pleurisy, pollakiuria, polyuria, psoriasis, psychomotor agitation, psychomotor retardation, psychosis, pulmonary embolism, respiratory tract disease, restless leg syndrome, seizure, sensory disturbance, sexual difficulty, skin photosensitivity, somnambulism, splenomegaly, Stevens-Johnson syndrome, syncope, tachycardia, thrombocytopenia, thrombosis, thyroid disease, tinnitus, toothache, transient blindness, transient ischemic attacks, tremor, upper respiratory tract inflammation, urethral disease, urinary retention, urine abnormality, urticaria, ventricular premature contractions, vertigo, visual field defect, vitreous opacity, weight gain, xeroderma, xerophthalmia

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience flatulence, insomnia, headache, nightmares, constipation, dry mouth, abdominal pain, change in taste, common cold symptoms, or loss of strength and energy. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), hallucinations, psychosis, anxiety, agitation, mood changes, behavioral changes, signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of a heart attack (angina; pain in arms, back, neck, jaw, or abdomen; shortness of breath; cold sweats; severe dizziness; passing out; or severe nausea or vomiting), shortness of breath, severe nausea, vomiting, seizures, confusion, sleepwalking, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.