Nifedipine Side Effects

Brand Names: Adalat CC, Procardia, Nifediac CC, Afeditab CR

Please note - some side effects for Nifedipine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nifedipine - for the Consumer

Nifedipine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nifedipine:

Constipation; dizziness; flushing; giddiness; headache; heat sensation; heartburn; lightheadedness; nausea; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irregular pulse; shortness of breath; swelling of the feet or hands; tender, bleeding, or swollen gums.

Nifedipine Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nifedipine Extended-Release Tablets:

Constipation; dizziness; drowsiness; headache; lightheadedness; nausea; stomach upset; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or dark, tarry stools; chest pain or tightness; confusion; dark urine; decreased sexual desire or ability; depression; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; hearing loss; numbness of an arm or leg; red, swollen, blistered, or peeling skin; ringing in the ears; severe or persistent dizziness or headache; severe or persistent nausea or diarrhea; severe or persistent tiredness or weakness; shortness of breath; stomach cramps or pain; sudden vision changes; swelling of the feet or hands; tender, bleeding, or swollen gums; tremor; unusual bruising or bleeding; vomit that looks like coffee grounds; vomiting; wheezing; yellowing of the skin or eyes.

Nifedipine Sustained-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nifedipine Sustained-Release Tablets:

Constipation; dizziness; flushing; giddiness; headache; heartburn; heat sensation; lightheadedness; nausea; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); irregular pulse; shortness of breath; swelling of the feet or hands; tender, bleeding, or swollen gums.

Nifedipine Side Effects - for the Professional

Nifedipine

Over 1000 patients from both controlled and open trials with Nifedipine extended-release tablets in hypertension and angina were included in the evaluation of adverse experiences. All side effects reported during Nifedipine extended-release tablet therapy were tabulated independent of their causal relation to medication. The most common side effect reported with Nifedipine extended-release was edema which was dose related and ranged in frequency from approximately 10% to about 30% at the highest dose studied (180 mg). Other common adverse experiences reported in placebo-controlled trials include:

Of these, only edema and headache were more common in Nifedipine extended-release patients than placebo patients.

The following adverse reactions occurred with an incidence of less than 3.0%. With the exception of leg cramps, the incidence of these side effects was similar to that of placebo alone.

Body as a Whole/Systemic: asthenia, flushing, pain
Cardiovascular: palpitations
Central Nervous System: insomnia, nervousness, paresthesia, somnolence
Dermatologic: pruritus, rash
Gastrointestinal: abdominal pain, diarrhea, dry mouth, dyspepsia, flatulence
Musculoskeletal: arthralgia, leg cramps
Respiratory: chest pain (nonspecific), dyspnea
Urogenital: impotence, polyuria

Other adverse reactions were reported sporadically with an incidence of 1.0% or less. These include:

Body as a Whole/Systemic: face edema, fever, hot flashes, malaise, periorbital edema, rigors
Cardiovascular: arrhythmia, hypotension, increased angina, tachycardia, syncope
Central Nervous System: anxiety, ataxia, decreased libido, depression, hypertonia, hypoesthesia, migraine, paroniria, tremor, vertigo
Dermatologic: alopecia, increased sweating, urticaria, purpura
Gastrointestinal: eructation, gastroesophageal reflux, gum hyperplasia, melena, vomiting, weight increase
Musculoskeletal: back pain, gout, myalgias
Respiratory: coughing, epistaxis, upper respiratory tract infection, respiratory disorder, sinusitis
Special Senses: abnormal lacrimation, abnormal vision, taste perversion, tinnitus
Urogenital/Reproductive: breast pain, dysuria, hematuria, nocturia

Adverse experiences which occurred in less than 1 in 1000 patients cannot be distinguished from concurrent disease states or medications.

The following adverse experiences, reported in less than 1% of patients, occurred under conditions (e.g., open trials, marketing experience) where a causal relationship is uncertain: gastrointestinal irritation, gastrointestinal bleeding, gynecomastia.

In multiple-dose U.S. and foreign controlled studies with Nifedipine capsules in which adverse reactions were reported spontaneously, adverse effects were frequent but generally not serious and rarely required discontinuation of therapy or dosage adjustment. Most were expected consequences of the vasodilator effects of Nifedipine.

There is also a large uncontrolled experience in over 2100 patients in the United States. Most of the patients had vasospastic or resistant angina pectoris, and about half had concomitant treatment with beta-adrenergic blocking agents. The relatively common adverse events were similar in nature to those seen with Nifedipine extended-release.

In addition, more serious adverse events were observed, not readily distinguishable from the natural history of the disease in these patients. It remains possible, however, that some or many of these events were drug related. Myocardial infarction occurred in about 4% of patients and congestive heart failure or pulmonary edema in about 2%. Ventricular arrhythmias or conduction disturbances each occurred in fewer than 0.5% of patients.

In a subgroup of over 1000 patients receiving Nifedipine immediate-release with concomitant beta blocker therapy, the pattern and incidence of adverse experiences was not different from that of the entire group of Nifedipine immediate-release treated patients.

In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina, dizziness or lightheadedness, peripheral edema, headache or flushing each occurred in one in eight patients. Hypotension occurred in about one in 20 patients. Syncope occurred in approximately one patient in 250. Myocardial infarction or symptoms of congestive heart failure each occurred in about one patient in 15. Atrial or ventricular dysrhythmias each occurred in about one patient in 150.

In post-marketing experience, there have been rare reports of exfoliative dermatitis caused by Nifedipine. There have been rare reports of exfoliative or bullous skin adverse events (such as erythema multiforme, Stevens-Johnson Syndrome, and toxic epidermal necrolysis) and photosensitivity reactions.

Side Effects by Body System

General

Recent data suggest that the use of short-acting nifedipine in moderate to high doses in patients with coronary artery disease (particularly in the elderly) has been associated with an increase in total mortality. In addition, in general, approximately 20% of patients have experienced side effects, mostly due to the vasodilatory properties of the drug (headache, flushing, dizziness). These effects have usually been transient and mild in severity, and have been minimized by dose reduction or addition of a beta-blocker (if indicated).

Nervous system

A 59-year-old man with hypertension (BP of 160/110) developed a severe headache, right-sided paresthesia, and complete bilateral loss of vision 30 minutes after receiving his first dose of nifedipine 20 mg orally. A CT scan confirmed the diagnosis of bilateral occipital lobe infarction resulting in cortical blindness with macular sparing. The authors of this case report believe that nifedipine may have caused a local cerebral vascular steal phenomenon or a global reduction in cerebral blood flow, and have located approximately four similar reports.

Nervous system side effects are the most common and have included headache (7% to 35%), weakness (10% to 12%), dizziness/lightheadedness/giddiness (3% to 27%), and tremor (1% or less to 8%). Paresthesia, insomnia, somnolence, and vertigo (3% or less); sleep disturbances and shakiness (2% or less); ataxia, decreased libido, hypertonia, hypesthesia, and migraine (1% or less); and dystonia, dysosmia, and dysgeusia have been reported. Rare cases of stroke associated with nifedipine-induced hypotension have been reported.

Cardiovascular

Nifedipine-induced hypotension may result in retinal, coronary, or cerebral ischemia in some patients, resulting in visual field defects, angina, or stroke. A single case report of profound hypotension and death associated with nifedipine in a 17-year-old woman with primary pulmonary hypertension (PPH) has been reported. The patient had extraordinarily high right atrial pressures and depressed cardiac output, indicating caution when one is testing the efficacy of calcium channel blockers in patients with PPH.

A 34-year-old woman experienced torsades de pointes leading to ventricular fibrillation after a 20 mg sublingual dose of nifedipine was administered to treat a hypertensive emergency.

Atrioventricular block is an unusual side effect of nifedipine therapy.

Rare cases of nifedipine-associated noncardiac pulmonary edema in patients with pulmonary hypertension and left ventricular outflow obstruction syndromes, such as aortic stenosis and hypertrophic cardiomyopathy have been reported.

Although relatively minor, the negative inotropic side effect of nifedipine may be important in patients with a history of congestive heart failure.

Cardiovascular side effects can be significant and have included peripheral edema (7% to 29%), hypotension (less than 1% to 5%), palpitations (less than 1% to 7%), myocardial infarction (4%), congestive heart failure (2%), and noncardiogenic edema (0.6% to 8%). Arrhythmia, increased angina, tachycardia, and syncope (1% or less); substernal chest pain, atrial fibrillation, bradycardia, cardiac arrest, extrasystole, phlebitis, postural hypotension, and cutaneous angiectases (less than 1%); erythromelalgia (0.5%); ventricular arrhythmias and conduction disturbances (less than 0.5%); and atrial and ventricular dysrhythmias have been reported. Patients with hypovolemia and/or concomitant antihypertensive therapy are at increased risk of hypotension associated with nifedipine. Some patients with exertional angina pectoris have reported increased chest pain after taking nifedipine. This may, however, reflect progressive disease rather than drug effect. Ventricular fibrillation has rarely been reported.

Gastrointestinal

Gastrointestinal (GI) side effects are common and have included nausea (2% to 11%); heartburn (11%); constipation (3.3% or less); abdominal pain, diarrhea, dry mouth, dyspepsia, and flatulence (3% or less); abdominal cramps (2% or less); eructation, gastroesophageal reflux, gingival hyperplasia, melena, taste perversion, and vomiting (1% or less); and dysphagia, esophagitis, GI disorder, GI hemorrhage, GI irritation, gum disorder, and gum hemorrhage (less than 1%). Rarely, gastrointestinal bezoar has been reported in patients taking extended-release nifedipine.

Hepatic

Hepatic side effects have included increased GGT (less than 1%); transient elevations of liver function tests and rare cases of hepatitis (approximately 0.5%); allergic hepatitis (less than 0.5%); and jaundice.

Nifedipine-associated hepatitis is dose-dependent, idiosyncratic, and thought to be due to hypersensitivity because it is often associated with fever, rash, eosinophilia, and arthritis. One case of alcoholic-like liver lesions, consisting of steatosis and Mallory bodies, has been associated with the use of nifedipine.

Some studies have shown that nifedipine may increase hepatic portal venous hypertension, which may be important in patients with severe liver disease. Frequent monitoring of liver function tests during nifedipine therapy is recommended in patients with underlying liver disease.

Renal

Renal side effects have included kidney calculus (less than 1%) and new or worsened renal insufficiency (less than 0.5%). Patients who are at higher risk include the elderly and patients with preexisting renal or arteriosclerotic vascular disease. Use of nifedipine has also been associated with improved glomerular filtration rate and effective renal plasma flow in hypertensive patients with moderate renal dysfunction, regardless of its antihypertensive effect.

Rare cases of immune-complex nephritis and nephrotic syndrome associated with nifedipine therapy have been reported. A case of acute, reversible renal failure attributable to nifedipine administration in a patient with congestive heart failure has been reported.

Hypersensitivity

Hypersensitivity side effects have included allergic reaction (less than 1%), angioedema (mostly oropharyngeal edema with difficulty breathing in a few patients; less than 0.5%), and anaphylactic reaction. Cases of urticarial eruptions and erythema multiforme, often associated with other findings of hypersensitivity, have been reported.

Hematologic

Hematologic side effects have included purpura (1% or less); eosinophilia and lymphadenopathy (less than 1%); and thrombocytopenia, anemia, and leukopenia (less than 0.5%).

Dermatologic

Dermatologic side effects have included rash and pruritus (3% or less); dermatitis, urticaria, and sweating (2% or less); alopecia (1% or less); angioedema, petechial rash, and photosensitivity reaction (less than 1%); and exfoliative dermatitis (less than 0.5%). Rare cases of erythromelalgia, pemphigus foliaceus, and pemphigoid nodularis have been reported. Exfoliative or bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis) have been reported during postmarketing experience.

A single case of pemphigus foliaceus associated with nifedipine, resolving after discontinuation of the drug, and recurring upon rechallenge has been reported. Prior to this case, only drugs with an active sulfhydryl group, such as penicillamine and captopril, were implicated in the development of pemphigus foliaceus.

Psychiatric

Psychiatric side effects have included nervousness (2% or less to 7%); mood changes (7%); jitteriness (2% or less); anxiety, depression, and paroniria (1% or less); confusion (less than 1%); paranoid syndrome (less than 0.5%); and agitation and psychosis.

Other

Other side effects have included edema (10% to 30%); flushing/heat sensation (less than 3% to 25%); fatigue (4% to 5.9%); asthenia (less than 1% to 4%); chest pain, leg pain, and pain (3% or less); difficulties in balance, fever, and chills (2% or less); facial edema, hot flashes, malaise, periorbital edema, rigors, and tinnitus (1% or less); and cellulitis, abnormal laboratory test (unspecified), neck pain, and pelvic pain (less than 1%). A single report of falsely elevated laboratory urinary vanillylmandelic acid (VMA) values by spectrophotometry during nifedipine therapy has been reported.

Respiratory

At least one case of acute pulmonary edema during tocolytic therapy with oral nifedipine has been reported. The patient developed pulmonary edema 3 days after starting nifedipine (two doses of 20 mg sublingually 30 minutes apart followed by 40 mg orally every 6 hours). Symptoms included dyspnea, orthopnea, tachypnea, and tachycardia which resolved following discontinuation of nifedipine.

Respiratory side effects have included dyspnea, cough, nasal congestion, sore throat, and wheezing (less than 1% to 6%); epistaxis and rhinitis (3% or less); pulmonary edema (2%); chest congestion (2% or less); and upper respiratory tract infection, respiratory disorder, and sinusitis (1% or less).

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