Medical Information
United States
 

In order to provide you with relevant and meaningful content we need to know more about you.

Please choose the category that best describes you.

This content is intended for U.S. Healthcare Professionals. Would you like to proceed?

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
Not a healthcare professional? Go to the patient or caregiver website.

NIFEDIPINE Capsules (GREENSTONE LLC) Adverse Reactions

ADVERSE REACTIONS

In multiple-dose United States and foreign controlled studies 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 capsules.

Adverse EffectNifedipine capsules (%)
(N=226)
Placebo (%)
(N=235)
Dizziness, lightheadedness, giddiness2715
Flushing, heat sensation258
Headache2320
Weakness1210
Nausea, heartburn118
Muscle cramps, tremor83
Peripheral edema71
Nervousness, mood changes74
Palpitation75
Dyspnea, cough, wheezing63
Nasal congestion, sore throat68

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 most common adverse events were:

Incidence Approximately 10%

 
Cardiovascular: peripheral edema
 
Central Nervous System: dizziness or lightheadedness
 
Gastrointestinal: nausea
 
Systemic: headache and flushing, weakness

Incidence Approximately 5%

 
Cardiovascular: transient hypotension

Incidence 2% or Less

 
Cardiovascular: palpitation
 
Respiratory: nasal and chest congestion, shortness of breath
 
Gastrointestinal: diarrhea, constipation, cramps, flatulence
 
Musculoskeletal: inflammation, joint stiffness, muscle cramps
 
Central Nervous System: shakiness, nervousness, jitteriness, sleep disturbances, blurred vision, difficulties in balance
 
Other: dermatitis, pruritus, urticaria, fever, sweating, chills, sexual difficulties

Incidence Approximately 0.5%

 
Cardiovascular: syncope (mostly with initial dosing and/or an increase in dose), erythromelalgia

Incidence Less Than 0.5%

 
Hematologic: thrombocytopenia, anemia, leukopenia, purpura
 
Gastrointestinal: allergic hepatitis
 
Face and Throat: angioedema (mostly oropharyngeal edema with breathing difficulty in a few patients), gingival hyperplasia
 
CNS: depression, paranoid syndrome
 
Special Senses: transient blindness at the peak of plasma level, tinnitus
 
Urogenital: nocturia, polyuria
 
Other: arthritis with ANA (+), exfoliative dermatitis, gynecomastia
 
Musculoskeletal: myalgia

Several of these side effects appear to be dose related. Peripheral edema occurred in about one in 25 patients at doses less than 60 mg per day and in about one patient in eight at 120 mg per day or more. Transient hypotension, generally of mild to moderate severity and seldom requiring discontinuation of therapy, occurred in one of 50 patients at less than 60 mg per day and in one of 20 patients at 120 mg per day or more.

Very rarely, introduction of Nifedipine capsules therapy was associated with an increase in anginal pain, possibly due to associated hypotension. Transient unilateral loss of vision has also occurred.

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 capsules with concomitant beta blocker therapy, the pattern and incidence of adverse experiences were not different from that of the entire group of Nifedipine capsules treated patients. (See PRECAUTIONS.)

In a subgroup of approximately 250 patients with a diagnosis of congestive heart failure as well as angina pectoris (about 10% of the total patient population), 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.

Did you find an answer to your question? Yes No
Did you find an answer to your question? Yes No
Didn’t find what you were looking for? Contact us.
Report Adverse Event