Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS In multiple dose U.S.
studies in hypertension, 1228 patients received isradipine alone or in combination with other agents, principally a thiazide diuretic, 934 of them in controlled comparisons with placebo or active agents.
An additional 652 patients (which includes 374 normal volunteers) received isradipine in U.S.
studies of conditions other than hypertension, and 1321 patients received isradipine in non-U.S.
About 500 patients received isradipine in long-term hypertension studies, 410 of them for at least 6 months.
The adverse reaction rates given below are principally based on controlled hypertension studies, but rarer serious events are derived from all exposures to isradipine, including foreign marketing experience.
Most adverse reactions were mild and related to the vasodilatory effects of isradipine (dizziness, edema, palpitations, flushing, tachycardia), and many were transient.
About 5% of isradipine patients left studies prematurely because of adverse reactions (vs.
3% of placebo patients and 6% of active control patients), principally due to headache, edema, dizziness, palpitations, and gastrointestinal disturbances.
The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related.
WARNINGS None
Like all medications, Isradipine can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: