What the label lists and what reports show
Nimodipine side effects
Nimodipine's FDA label: “Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.” FAERS holds 1,103 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 hypotension (57 reports).
- Generic listed
Check it at the source: the nimodipine FDA label on DailyMed (effective August 30, 2024, Azurity Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia.
DOSE q4h Number of Patients (%) Nimodipine
This table is printed in the nimodipine label published by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. of August 16, 2024; the label quoted above does not print one.
| Sign/Symptom | 0.35 mg/kg (n=82) | 30 mg (n=71) | 60 mg (n=494) | 90 mg (n=172) | 120 mg (n=4) | Placebo (n=479) |
|---|---|---|---|---|---|---|
| Blood Pressure | 1 (1.2) | 0 | 19 (3.8) | 14 (8.1) | 2 (50.0) | 6 (1.2) |
| Function Test | 1 (1.2) | 0 | 2 (0.4) | 1 (0.6) | 0 | 7 (1.5) |
| Edema | 0 | 0 | 2 (0.4) | 2 (1.2) | 0 | 3 (0.6) |
| Diarrhea | 0 | 3 (4.2) | 0 | 3 (1.7) | 0 | 3 (0.6) |
| Rash | 2 (2.4) | 0 | 3 (0.6) | 2 (1.2) | 0 | 3 (0.6) |
| Headache | 0 | 1 (1.4) | 6 (1.2) | 0 | 0 | 1 (0.2) |
| Symptoms | 2 (2.4) | 0 | 0 | 2 (1.2) | 0 | 0 |
| Nausea | 1 (1.2) | 1 (1.4) | 6 (1.2) | 1 (0.6) | 0 | 0 |
| Dyspnea | 1 (1.2) | 0 | 0 | 0 | 0 | 0 |
| EKG Abnormalities | 0 | 1 (1.4) | 0 | 1 (0.6) | 0 | 0 |
| Tachycardia | 0 | 1 (1.4) | 0 | 0 | 0 | 0 |
| Bradycardia | 0 | 0 | 5 (1.0) | 1 (0.6) | 0 | 0 |
| Muscle Pain/Cramp | 0 | 1 (1.4) | 1 (0.2) | 1 (0.6) | 0 | 0 |
| Acne | 0 | 1 (1.4) | 0 | 0 | 0 | 0 |
| Depression | 0 | 1 (1.4) | 0 | 0 | 0 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe safety and efficacy of NYMALIZE (nimodipine oral solution) in the treatment of patients with SAH is based on adequate and well-controlled studies of nimodipine oral capsules in patients with SAH. NYMALIZE (nimodipine oral solution) has comparable bioavailability to nimodipine oral capsules. The following clinically significant adverse reaction appears in other sections of the labeling: Hypotension [see Warnings and Precautions (5.1) ]. Most common adverse reactions (incidence ≥1% and ≥1% placebo) were hypotension, headache, nausea, and bradycardia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In clinical trials of nimodipine oral capsules in patients with SAH, eleven percent (92 of 823) of nimodipine-treated patients reported adverse events compared to six percent (29 of 479) of placebo-treated patients. The most common adverse event was decreased blood pressure in 4.4% of nimodipine-treated patients. …
Source: FDA drug label, Azurity Pharmaceuticals, Inc., effective August 30, 2024 (SPL set e660fa26-b5c4-4d6d-8887-9e22b6666a10), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,103 reports list nimodipine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 112 are coded as a death and 466 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, 3 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?
- Nimodipine: 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