AA Pharma Nifedipine

AA Pharma Nifedipine Adverse Reactions



AA Pharma


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Adverse Reactions
A safety analysis from the world literature (controlled and open studies) was carried out in a heterogeneous group of 7146 patients who were treated with nifedipine. Adverse effects were reported in 27.9% of patients and required discontinuation of treatment in 5.5% of patients.
The most common adverse effects, which generally result from the vasodilating effects of nifedipine were: Headache (7.2%); dizziness, lightheadedness and giddiness (6.7%), nausea and vomiting and gastrointestinal distress (6.7%), flushing and heat sensation (5.8%); peripheral edema (3.7%) and hypotension (2.0%).
As a part of the previously mentioned analysis a more comprehensive safety evaluation (controlled and open studies) was carried out in 3074 patients, some of whom were severely ill and were receiving a variety of concomitant drugs, such as beta-blockers, nitrates, antiarrhythmics, cardiac glycosides, diuretics and anti-platelet drugs, etc.
The following adverse effects divided by systems were reported, in these 3074 patients: (See Table 2.)

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Especially at the start of therapy, patients may occasionally experience angina attacks or patients with pre-existing angina pectoris may occasionally experience an increase in the frequency, duration and severity of angina attacks. There have been isolated reports of myocardial infarction. (See Table 3.)

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Two cases of hypersensitivity have been reported resulting in an allergic hepatitis which resolved when the drug was discontinued. In one case recurrence was observed on re-challenge.
Nifedipine has been reported to cause in a small number of patients gingival hyperplasia similar to that caused by diphenylhydantoin. The lesions usually regressed on discontinuation of nifedipine. However, on occasion, gingivectomy was necessary.
Laboratory Tests: Rare, mild to moderate transient elevations of enzymes such as alkaline phosphatase, CPK, LDH, SGOT and SGPT have been noted.
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