Nimodipine side effects: what 1,103 FDA adverse event reports show

Nimodipine · 40 reaction terms · 517 drug–reaction co-reports · data 2026-09-14

Drug class

Dihydropyridine Calcium Channel Blocker

FDA label (Established Pharmacologic Class) · compare the class

Who reports

1,103 reports · 87% serious · 112 with death outcome · 65% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Nimodipine is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I to V).

FDA label, Indications and Usage

What it is

DESCRIPTION Nimodipine belongs to the class of pharmacological agents known as calcium channel blockers. Nimodipine is isopropyl 2-methoxyethyl 1,4-dihydro-2,6-dimethyl-4-( m -nitrophenyl)-3,5-pyridinedicarboxylate. It has a molecular weight of 418.5 and a molecular formula of C 21 H 26 N 2 O 7 .

FDA label, Description section

Boxed warning

DO NOT ADMINISTER NIMODIPINE INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF NIMODIPINE CAPSULES HAVE BEEN INJECTED PARENTERALLY (See WARNINGS and DOSAGE AND ADMINISTRATION ).

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 21 strongest signals

Labeled — boxed warning 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 2Not in label — unassessed 15

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 19 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Subarachnoid haemorrhage	42	78.5 58.3–105.6ROR 81.5 · χ² 3,124 / p <1e-300	75.6 EB05 58.3 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 51.6	no trial data cached
Posterior reversible encephalopathy syndrome	23	46.0 30.7–69.0ROR 47.0 · χ² 967 / p 1e-212	44.4 EB05 31.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.3 · 96% clinician	no trial data cached
Brain injury	22	41.8 27.6–63.2ROR 42.6 · χ² 833 / p 1e-183	40.3 EB05 28.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · ♀ 0% (drug 65%) · 100% clinician	no trial data cached
Sinus bradycardia	21	41.3 27.0–63.1ROR 42.1 · χ² 785 / p 6e-173	39.8 EB05 27.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.0 · 100% clinician	no trial data cached
Cardiogenic shock	27	36.0 24.8–52.3ROR 36.9 · χ² 884 / p 2e-194	35.2 EB05 25.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.7 · ♀ 8% (drug 65%) · 100% clinician	no trial data cached
Polyneuropathy	20	32.0 20.7–49.4ROR 32.6 · χ² 570 / p 3e-126	31.1 EB05 21.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% clinician	no trial data cached
Brain oedema	16	24.1 14.8–39.2ROR 24.5 · χ² 332 / p 2e-74	23.4 EB05 15.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached
Cholestasis (bile flow blockage)	20	19.9 12.9–30.8ROR 20.3 · χ² 341 / p 2e-76	19.5 EB05 13.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.3	no trial data cached
Lactic acidosis	27	16.0 11.0–23.2ROR 16.4 · χ² 365 / p 1e-81	15.7 EB05 11.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.6 · ♀ 21% (drug 65%) · 96% clinician	no trial data cached
Premature baby	22	13.9 9.2–21.0ROR 14.1 · χ² 250 / p 1e-56	13.3 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · 100% clinician	no trial data cached
Impaired work ability	15	13.3 8.0–22.0ROR 13.5 · χ² 159 / p 1e-36	12.2 EB05 7.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Cerebral infarction	17	13.2 8.2–21.2ROR 13.4 · χ² 180 / p 2e-41	12.3 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Ischaemic stroke	11	11.7 6.5–21.1ROR 11.8 · χ² 97 / p 3e-23	9.8 EB05 5.2 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 7.7	no trial data cached
Hemiparesis	10	11.2 6.0–20.7ROR 11.3 · χ² 83 / p 5e-20	9.1 EB05 4.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 8.0	no trial data cached
Cardiovascular disorder	15	11.2 6.7–18.4ROR 11.3 · χ² 129 / p 4e-30	9.8 EB05 5.8 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9	no trial data cached
Nervous system disorder	17	10.3 6.4–16.6ROR 10.5 · χ² 134 / p 3e-31	9.1 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Cognitive disorder	25	10.2 6.9–15.1ROR 10.4 · χ² 199 / p 2e-45	9.4 EB05 6.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 5% (drug 65%) · 96% clinician	no trial data cached
Intentional overdose	26	7.8 5.3–11.3ROR 7.9 · χ² 147 / p 5e-34	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · ♀ 0% (drug 65%) · 100% clinician	no trial data cached
Cerebral haemorrhage	14	7.4 4.4–12.5ROR 7.5 · χ² 72 / p 1e-17	6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 4.9	no trial data cached
Sedation	10	7.3 3.9–13.5ROR 7.4 · χ² 48 / p 2e-12	5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Foetal exposure during pregnancy	22	5.1 3.4–7.8ROR 5.2 · χ² 70 / p 3e-17	4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · ♀ 85% (drug 65%) · 100% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Subarachnoid haemorrhage	42	78.5 58.3–105.6ROR 81.5 · χ² 3,124 / p <1e-300	75.6 EB05 58.3 · IC025 +4.8 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 51.6	no trial data cached
Lactic acidosis	27	16.0 11.0–23.2ROR 16.4 · χ² 365 / p 1e-81	15.7 EB05 11.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.6 · ♀ 21% (drug 65%) · 96% clinician	no trial data cached
Cardiogenic shock	27	36.0 24.8–52.3ROR 36.9 · χ² 884 / p 2e-194	35.2 EB05 25.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 23.7 · ♀ 8% (drug 65%) · 100% clinician	no trial data cached
Intentional overdose	26	7.8 5.3–11.3ROR 7.9 · χ² 147 / p 5e-34	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3 · ♀ 0% (drug 65%) · 100% clinician	no trial data cached
Cognitive disorder	25	10.2 6.9–15.1ROR 10.4 · χ² 199 / p 2e-45	9.4 EB05 6.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 5% (drug 65%) · 96% clinician	no trial data cached
Posterior reversible encephalopathy syndrome	23	46.0 30.7–69.0ROR 47.0 · χ² 967 / p 1e-212	44.4 EB05 31.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.3 · 96% clinician	no trial data cached
Foetal exposure during pregnancy	22	5.1 3.4–7.8ROR 5.2 · χ² 70 / p 3e-17	4.7 EB05 3.3 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 3.5 · ♀ 85% (drug 65%) · 100% clinician	no trial data cached
Premature baby	22	13.9 9.2–21.0ROR 14.1 · χ² 250 / p 1e-56	13.3 EB05 8.8 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.3 · 100% clinician	no trial data cached
Brain injury	22	41.8 27.6–63.2ROR 42.6 · χ² 833 / p 1e-183	40.3 EB05 28.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 27.9 · ♀ 0% (drug 65%) · 100% clinician	no trial data cached
Sinus bradycardia	21	41.3 27.0–63.1ROR 42.1 · χ² 785 / p 6e-173	39.8 EB05 27.5 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 28.0 · 100% clinician	no trial data cached
Cholestasis (bile flow blockage)	20	19.9 12.9–30.8ROR 20.3 · χ² 341 / p 2e-76	19.5 EB05 13.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 13.3	no trial data cached
Polyneuropathy	20	32.0 20.7–49.4ROR 32.6 · χ² 570 / p 3e-126	31.1 EB05 21.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 21.3 · 100% clinician	no trial data cached
Nervous system disorder	17	10.3 6.4–16.6ROR 10.5 · χ² 134 / p 3e-31	9.1 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Cerebral infarction	17	13.2 8.2–21.2ROR 13.4 · χ² 180 / p 2e-41	12.3 EB05 7.5 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Brain oedema	16	24.1 14.8–39.2ROR 24.5 · χ² 332 / p 2e-74	23.4 EB05 15.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.1	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Posterior reversible encephalopathy syndrome — n=23, PRR 46.0
Brain injury — n=22, PRR 41.8
Sinus bradycardia — n=21, PRR 41.3
Cardiogenic shock — n=27, PRR 36.0
Polyneuropathy — n=20, PRR 32.0
Cholestasis — n=20, PRR 19.9
Lactic acidosis — n=27, PRR 16.0
Premature baby — n=22, PRR 13.9
Cognitive disorder — n=25, PRR 10.2

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Nimodipine?

In FDA FAERS, the most frequently co-reported reaction terms for Nimodipine are subarachnoid haemorrhage, lactic acidosis, cardiogenic shock, cognitive disorder, posterior reversible encephalopathy syndrome, premature baby. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Nimodipine have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: DO NOT ADMINISTER NIMODIPINE INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF NIMODIPINE CAPSULES HAVE BEEN INJECTED PARENTERALLY (See WARNINGS and DOSAGE AND ADMINISTRATION ).

Do FAERS signals prove that Nimodipine causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID a323ebd8-ef1b-439b-93d1-ba73a5b0127d, effective 20240816; matched on openfda.generic_name.exact:"NIMODIPINE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 40 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.