What the label lists and what reports show
Isradipine side effects
Isradipine's FDA label: “The following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related.” FAERS holds 554 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (31 reports).
- Generic listed
Check it at the source: the isradipine FDA label on DailyMed (effective November 30, 2023, Teva Pharmaceuticals USA, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following table shows the most common adverse reactions, volunteered or elicited, considered by the investigator to be at least possibly drug related.
From the label: adverse reactions, continuedIn 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. studies. 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.
Source: FDA drug label, Teva Pharmaceuticals USA, Inc., effective November 30, 2023 (SPL set bf3425e0-428d-4bdb-ac9a-3b9d483df83a), via openFDA; the full label on DailyMed
What do FAERS reports show?
554 reports list isradipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 65 are coded as a death and 298 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Isradipine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions