Adalat

Applies to nifedipine: oral capsule, oral capsule liquid filled, oral tablet, oral tablet extended release

Along with its needed effects, nifedipine (the active ingredient contained in Adalat) 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 while taking nifedipine:

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• cough
• difficult or labored breathing
• dizziness or lightheadedness
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of warmth
• headache
• muscle cramps
• rapid weight gain
• shakiness in the legs, arms, hands, or feet
• shortness of breath
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the hands or feet
• unusual weight gain or loss
• weakness
• wheezing

• Blue lips and fingernails
• chest congestion
• chest pain
• chills
• coughing that sometimes produces a pink frothy sputum
• decreased urine output
• difficult, fast, or noisy breathing, sometimes with wheezing
• dilated neck veins
• extreme fatigue
• fever
• increased sweating
• irregular breathing
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pale skin
• severe unusual tiredness or weakness
• sweating
• troubled breathing
• vomiting

• Black, tarry stools
• bleeding gums
• blood in the eyes
• blood in the urine or stools
• bloody stools
• bluish color
• blurred vision
• body aches or pain
• changes in skin color
• cold sweats
• dark urine
• difficulty with swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• dryness or soreness of throat
• ear congestion or pain
• extra heartbeats
• eye pain
• feeling unusually cold
• general tiredness and weakness
• headache, severe and throbbing
• hoarseness
• increased urge to urinate during the night
• irritation in the mouth
• itching
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• nasal congestion
• neck pain
• nervousness
• no blood pressure or pulse
• noisy breathing
• pain
• pain in the groin or genitals
• pain or burning while urinating
• painful or difficult urination
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness and swelling of the gums
• redness in the whites of the eyes
• runny nose
• shakiness and unsteady walk
• sharp back pain just below ribs
• shivering
• skin rash
• small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stopping of heart
• swelling around the eyes
• swollen glands
• tenderness
• tender, swollen glands in the neck
• troubled breathing with exertion
• unconsciousness
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual bleeding or bruising
• upper right abdominal or stomach pain
• vision changes
• voice changes
• vomiting of blood or material that looks like coffee grounds
• waking to urinate at night
• yellow eyes and skin

Some side effects of nifedipine 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:

• Belching
• feeling of indigestion
• mood changes
• pain in the chest below the breastbone
• redness of the face, neck, arms, and occasionally, upper chest

• Abnormal ejaculation
• bloody nose
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• decreased interest in sexual intercourse
• decreased sexual performance or desire
• diarrhea
• difficulty having a bowel movement (stool)
• excess air or gas in stomach or intestines
• feeling of constant movement of self or surroundings
• full feeling
• general feeling of discomfort or illness
• inability to have or keep an erection
• increased need to urinate
• joint stiffness
• leg cramps or pain
• loss in sexual ability, desire, drive, or performance
• nervousness
• passing gas
• passing urine more often
• sneezing
• stuffy nose
• trouble sleeping

• Acid or sour stomach
• ankle, knee, or great toe joint pain
• cracks in the skin
• difficulty with moving
• discouragement
• excessive muscle tone
• fear or nervousness
• feeling sad or empty
• hair loss or thinning of the hair
• heartburn
• increased sensitivity of the skin to sunlight
• irritability
• itching, pain, redness, swelling, tenderness, or warmth on the skin
• lack of appetite
• lack or loss of strength
• loss of heat from the body
• loss of interest or pleasure
• loss of strength or energy
• loss in sexual ability, desire, drive, or performance
• lower back or side pain
• muscle pain or weakness
• muscle stiffness
• muscle tension or tightness
• pain or burning in the throat
• red, swollen skin
• redness or other discoloration of the skin
• scaly skin
• severe sunburn
• sleepiness or unusual drowsiness
• sleeplessness
• stomach discomfort, upset, or pain
• swelling of the breasts or breast soreness in both females and males
• tiredness
• trouble concentrating
• unable to sleep

For Healthcare Professionals

Applies to nifedipine: compounding powder, oral capsule, oral tablet extended release

General

The most commonly reported side effects included dizziness, giddiness, and lightheadedness.[Ref]

Nervous system

Syncope typically occurred with initial doses and/or dose titrations.[Ref]

Very common (10% or more): Dizziness (up to 27%), giddiness (up to 27%), lightheadedness (up to 27%), headache (up to 23%)
Common (1% to 10%): Tremor
Uncommon (0.1% to 1%): Migraine, syncope, vertigo
Rare (0.01% to 0.1%): Paresthesia, dysesthesia
Frequency not reported: Ataxia, cerebral ischemia, balance difficulty, hypertonia, hypoesthesia, shakiness, somnolence
Postmarketing reports: Taste perversion[Ref]

Other

Very common (10% or more): Heat sensation (up to 25%), weakness (up to 12%)
Common (1% to 10%): Asthenia, fatigue, feeling unwell
Uncommon (0.1% to 1%): Chills, malaise, pain, unspecific pain
Frequency not reported: Abnormal lab test, fever, inflammation, jitteriness, tinnitus[Ref]

Cardiovascular

Very common (10% or more): Flushing (up to 25%)
Common (1% to 10%): Congestive heart failure, edema/peripheral edema, myocardial infarction, palpitations, transient hypotension, vasodilation
Uncommon (0.1% to 1%): Angina pectoris/chest pain (excluding unstable), erythromelalgia, hypotension, postural hypotension, syncope, tachycardia
Rare (0.01% to 0.1%): Cardiovascular disorder, substernal chest pain
Frequency not reported: Arrhythmia, atrial fibrillation, bradycardia, cardiac arrest, conduction disturbances, extrasystole, hot flashes, increased angina, myocardial ischemia, nonspecific chest pain, phlebitis, ventricular arrhythmias[Ref]

Gastrointestinal

Very common (10% or more): Heartburn (up to 11%), nausea (up to 11%)
Common (1% to 10%): Constipation, cramps, diarrhea, flatulence
Uncommon (0.1% to 1%): Abdominal/gastrointestinal (GI) pain, dyspepsia, dry mouth, gum hyperplasia
Rare (0.01% to 0.1%): Gingival hyperplasia
Frequency not reported: Bezoar, dysphagia, eructation, esophagitis, gastroesophageal reflux, gastroesophageal sphincter insufficiency, GI bleeding, GI disorder, GI hemorrhage, GI irritation, GI obstruction, GI ulceration, gum disorder, gum hemorrhage, melena, tablet adherence to GI wall, vomiting[Ref]

Respiratory

Common (1% to 10%): Dyspnea, chest congestion, cough, nasal congestion, shortness of breath, sore throat, wheezing
Uncommon (0.1% to 1%): Larynx edema, nosebleed
Frequency not reported: Epistaxis, increased cough, pharyngitis, pulmonary edema, rales, respiratory disorder, rhinitis, rigors, sinusitis, stridor, upper respiratory tract infection[Ref]

Psychiatric

Common (1% to 10%): Mood changes, nervousness
Uncommon (0.1% to 1%): Anxiety reactions, insomnia, sleep disorders
Frequency not reported: Anxiety, confusion, decreased libido, depression, paroniria/paranoid syndrome, sleep disturbances[Ref]

Musculoskeletal

Common (1% to 10%): Muscle cramps
Uncommon (0.1% to 1%): Joint pain
Frequency not reported: Arthralgia, arthritis with antinuclear antibody positive tests, back pain, joint disorder, joint stiffness, leg cramps, leg pain, myalgia, myasthenia, neck pain, worsening of myasthenia gravis[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria, erectile dysfunction, polyuria
Frequency not reported: Breast engorgement, breast pain, hematuria, impotence, nocturia, pelvic pain, sexual difficulties, urinary frequency, urogenital disorder[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction, allergic edema, angioedema/oropharyngeal edema
Frequency not reported: Anaphylactic/anaphylactoid reaction, systemic allergic reactions[Ref]

Dermatologic

Uncommon (0.1% to 1%): Erythema, face edema
Rare (0.01% to 0.1%): Pruritus, rash, urticaria
Frequency not reported: Cellulitis, cutaneous angiectases, dermatitis, exfoliative dermatitis, palpable purpura, pemphigoid reaction, petechial rash, photosensitivity allergic reaction, sweating/increased sweating, telangiectasia, toxic epidermal necrolysis
Postmarketing reports: Acute generalized exanthematous pustulosis, alopecia, bullous skin adverse events, erythema multiforme, Stevens-Johnson syndrome[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests, transient liver enzyme increase
Frequency not reported: Allergic hepatitis, gamma glutamyltransferase increased, intra-hepatic cholestasis, jaundice[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances
Frequency not reported: Abnormal lacrimation, abnormal vision, amblyopia, blurred vision, conjunctivitis, diplopia, eye disorder, eye hemorrhage, eye pain, periorbital edema, transient blindness (at Cmax), transient unilateral vision loss[Ref]

Hematologic

Frequency not reported: Anemia, agranulocytosis, eosinophilia, leukopenia, lymphadenopathy, purpura, thrombocytopenia[Ref]

Metabolic

Frequency not reported: Gout, hyperglycemia, weight gain/loss[Ref]

Renal

Frequency not reported: Kidney calculus[Ref]

Endocrine

Frequency not reported: Gynecomastia[Ref]