Nifedipine Extended-Release Tablets Side Effects
Please note - some side effects for Nifedipine Extended-Release Tablets may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Nifedipine Extended-Release Tablets Side Effects - for the Professional
Nifedipine Extended-Release Tablets
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:
| NIFEDIPINE EXTENDED RELEASE TABLETS (%) |
||
|---|---|---|
| Adverse Effect | (N=707) | Placebo (%) (N=266) |
| Headache | 15.8 | 9.8 |
| Fatigue | 5.9 | 4.1 |
| Dizziness | 4.1 | 4.5 |
| Constipation | 3.3 | 2.3 |
| Nausea | 3.3 | 1.9 |
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.
Gastrointestinal obstruction resulting in hospitalization and surgery, including the need for bezoar removal, has occurred in association with nifedipine extended release tablets, even in patients with no prior history of gastrointestinal disease.
Ulcers in the gastrointestinal wall surrounding the nifedipine extended release tablet shells have been observed with and without gastrointestinal obstruction by nifedipine extended release tablets.
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.
| NIFEDIPINE IMMEDIATE-RELEASE CAPSULES (%) |
Placebo (%) | |
|---|---|---|
| Adverse Effect | (N=226) | (N=235) |
| Dizziness, lightheadedness, giddiness | 27 | 15 |
| Flushing, heat sensation | 25 | 8 |
| Headache | 23 | 20 |
| Weakness | 12 | 10 |
| Nausea, heartburn | 11 | 8 |
| Muscle cramps, tremor | 8 | 3 |
| Peripheral edema | 7 | 1 |
| Nervousness, mood changes | 7 | 4 |
| Palpitations | 7 | 5 |
| Dyspnea, cough, wheezing | 6 | 3 |
| Nasal congestion, sore throat | 6 | 8 |
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. Acute generalized exanthematous pustulosis also has been reported.
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