Nimotop Side Effects

Generic Name: nimodipine

Please note - some side effects for Nimotop 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 Nimotop - for the Consumer

Nimotop

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 Nimotop:

Diarrhea; flushing; headache; nausea.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; depression; fast, slow, or irregular heartbeat; severe dizziness; shortness of breath; severe or persistent constipation; swelling of the feet or hands; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

Nimotop Side Effects - for the Professional

Nimotop

Adverse experiences were reported by 92 of 823 patients with subarachnoid hemorrhage (11.2%) who were given nimodipine. The most frequently reported adverse experience was decreased blood pressure in 4.4% of these patients. Twenty-nine of 479 (6.1%) placebo treated patients also reported adverse experiences. The events reported with a frequency greater than 1% are displayed below by dose.

There were no other adverse experiences reported by the patients who were given 0.35 mg/kg q4h, 30 mg q4h or 120 mg q4h. Adverse experiences with an incidence rate of less than 1% in the 60 mg q4h dose group were: hepatitis; itching; gastrointestinal hemorrhage; thrombocytopenia; anemia; palpitations; vomiting; flushing; diaphoresis; wheezing; phenytoin toxicity; lightheadedness; dizziness; rebound vasospasm; jaundice; hypertension; hematoma.

Adverse experiences with an incidence rate less than 1% in the 90 mg q4h dose group were: itching, gastrointestinal hemorrhage; thrombocytopenia; neurological deterioration; vomiting; diaphoresis; congestive heart failure; hyponatremia; decreasing platelet count; disseminated intravascular coagulation; deep vein thrombosis.

As can be seen from the table, side effects that appear related to nimodipine use based on increased incidence with higher dose or a higher rate compared to placebo control, included decreased blood pressure, edema and headaches which are known pharmacologic actions of calcium channel blockers. It must be noted, however, that SAH is frequently accompanied by alterations in consciousness which lead to an under reporting of adverse experiences. Patients who received nimodipine in clinical trials for other indications reported flushing (2.1%), headache (4.1%) and fluid retention (0.3%), typical responses to calcium channel blockers. As a calcium channel blocker, nimodipine may have the potential to exacerbate heart failure in susceptible patients or to interfere with A-V conduction, but these events were not observed.

No clinically significant effects on hematologic factors, renal or hepatic function or carbohydrate metabolism have been causally associated with oral nimodipine. Isolated cases of non-fasting elevated serum glucose levels (0.8%), elevated LDH levels (0.4%), decreased platelet counts (0.3%), elevated alkaline phosphatase levels (0.2%) and elevated SGPT levels (0.2%) have been reported rarely.

Side Effects by Body System

Cardiovascular

Cardiovascular effects have frequently been associated with the use of nimodipine, and are related to its vasodilatory properties. Mild to moderate hypotension has been reported in up to 5% of patients, and was the reason less than 1% of patients chose to discontinue therapy. Bradycardia has been reported and may be severe in rare cases. Rare cardiovascular side effects have included tachycardia, hypertension, peripheral edema, dizziness, and flushing. A case of pulmonary vasoconstriction has been associated with the use of this drug.

Nervous system

The incidence of nervous system side effects associated with the use of nimodipine has been similar to placebo in large studies. Headache has been reported in 4% of patients, and is believed to be due to the vasodilatory properties of nimodipine.

Hepatic

Hepatic effects include transient, reversible elevations in liver function tests.

Hematologic

Hematologic side effects are rare and have included thrombocytopenia and anemia.

Gastrointestinal

Gastrointestinal intolerance occurs occasionally.

Dermatologic

Dermatologic effects include occasional cases of rash.

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