Drug · FAERS side-effect profile with label screen
Nicardipine Hydrochloride side effects: what 2,187 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Nicardipine Hydrochloride
openFDA label
Who reports
2,187 reports · 97% serious · 293 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
I. Stable Angina Nicardipine hydrochloride capsules are indicated for the management of patients with chronic stable angina (effort-associated angina). Nicardipine hydrochloride capsules may be used alone or in combination with beta-blockers. II. Hypertension Nicardipine hydrochloride capsules are indicated for the treatment of hypertension.
FDA label, Indications and Usage
What it is
DESCRIPTION Nicardipine hydrochloride capsules for oral administration each contain 20 mg or 30 mg of nicardipine hydrochloride, USP. Nicardipine hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker).
FDA label, Description section
Boxed warning
None in the current 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 40 strongest signals
Labeled (related wording) 1Reporting / coding artifact 4Lab value / disease marker 3Not in label — unassessed 32
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- 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. 62 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatic cytolysis | 58 | 45.7 35.4–59.0ROR 46.9 · χ² 2,482 / p <1e-300 | 44.9 EB05 36.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · 98% clinician | no trial data cached |
| Premature baby | 95 | 30.3 24.8–36.8ROR 31.6 · χ² 2,654 / p <1e-300 | 30.0 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Premature delivery | 49 | 29.5 22.3–38.9ROR 30.1 · χ² 1,315 / p 3e-288 | 29.1 EB05 22.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 100% (drug 53%) · 94% clinician | no trial data cached |
| Caesarean section | 31 | 25.3 17.9–36.0ROR 25.7 · χ² 699 / p 2e-154 | 24.9 EB05 18.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 · ♀ 77% (drug 53%) | no trial data cached |
| Eosinophilia | 38 | 20.9 15.2–28.6ROR 21.2 · χ² 699 / p 2e-154 | 20.7 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 100% clinician | no trial data cached |
| Thrombotic microangiopathy | 19 | 18.8 12.0–29.5ROR 19.0 · χ² 303 / p 4e-68 | 18.4 EB05 12.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Poisoning deliberate | 17 | 17.5 10.9–28.2ROR 17.7 · χ² 249 / p 3e-56 | 17.0 EB05 10.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Rash maculo-papular | 40 | 17.3 12.8–23.6ROR 17.6 · χ² 599 / p 1e-132 | 17.1 EB05 13.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 92% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 15 | 15.1 9.1–25.1ROR 15.2 · χ² 184 / p 3e-42 | 14.2 EB05 8.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Pneumonia aspiration | 39 | 15.0 11.0–20.5ROR 15.3 · χ² 496 / p 3e-110 | 14.8 EB05 11.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Cerebral infarction | 37 | 14.5 10.6–20.0ROR 14.8 · χ² 452 / p 1e-100 | 14.3 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · 100% clinician | no trial data cached |
| Drug exposure during pregnancy | 52 | 14.5 11.1–18.9ROR 14.8 · χ² 639 / p 3e-141 | 14.3 EB05 11.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 84% (drug 53%) · 95% clinician | no trial data cached |
| Toxic skin eruption | 14 | 13.3 7.9–22.4ROR 13.4 · χ² 147 / p 4e-34 | 12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 19 | 12.1 7.7–18.9ROR 12.2 · χ² 182 / p 8e-42 | 11.2 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Cholestasis (bile flow blockage) | 23 | 11.6 7.7–17.4ROR 11.7 · χ² 211 / p 3e-48 | 10.8 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 95% clinician | no trial data cached |
| Subarachnoid haemorrhage | 11 | 10.3 5.7–18.6ROR 10.4 · χ² 84 / p 3e-20 | 8.4 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Hepatic function abnormal | 37 | 9.6 7.0–13.2ROR 9.7 · χ² 276 / p 3e-62 | 9.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 97% clinician | no trial data cached |
| Circulatory collapse | 17 | 9.5 5.9–15.3ROR 9.6 · χ² 121 / p 1e-28 | 8.3 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Respiratory distress | 27 | 9.4 6.4–13.7ROR 9.5 · χ² 194 / p 2e-44 | 8.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 90% clinician | no trial data cached |
| Maternal exposure during pregnancy | 85 | 9.2 7.5–11.4ROR 9.6 · χ² 619 / p 6e-137 | 9.0 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 82% (drug 53%) | no trial data cached |
| Cerebral haemorrhage | 34 | 9.1 6.5–12.7ROR 9.3 · χ² 238 / p 5e-54 | 8.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 100% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 52 | 8.9 6.8–11.6ROR 9.1 · χ² 356 / p 9e-80 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 98% clinician | no trial data cached |
| Foetal exposure during pregnancy | 73 | 8.6 6.9–10.8ROR 8.9 · χ² 486 / p 6e-108 | 8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 22 | 8.3 5.4–12.5ROR 8.3 · χ² 133 / p 4e-31 | 7.3 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 100% clinician | no trial data cached |
| Pancreatitis acute | 19 | 8.2 5.2–12.8ROR 8.2 · χ² 113 / p 1e-26 | 7.1 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 34 | 7.8 5.6–10.9ROR 7.9 · χ² 196 / p 7e-45 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 13 | 7.8 4.5–13.5ROR 7.9 · χ² 71 / p 2e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.9 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 14 | 7.7 4.6–13.0ROR 7.7 · χ² 75 / p 2e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Product administration error | 16 | 7.7 4.7–12.5ROR 7.7 · χ² 87 / p 7e-21 | 6.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.1 | no trial data cached |
| Multi-organ failure | 14 | 7.7 4.5–12.9ROR 7.7 · χ² 74 / p 3e-18 | 6.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Hyperkalaemia (high potassium) | 27 | 7.4 5.1–10.8ROR 7.5 · χ² 144 / p 2e-33 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 100% clinician | no trial data cached |
| Blood urea increased | 13 | 7.4 4.3–12.7ROR 7.4 · χ² 66 / p 3e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 | no trial data cached |
| Gamma-glutamyltransferase increased | 17 | 7.4 4.6–11.8ROR 7.4 · χ² 87 / p 5e-21 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 114 | 7.2 6.0–8.6ROR 7.5 · χ² 604 / p 1e-133 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Altered state of consciousness | 16 | 7.1 4.4–11.6ROR 7.2 · χ² 78 / p 5e-19 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Disseminated intravascular coagulation | 10 | 6.8 3.7–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 13 | 6.7 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Bradycardia (slow heart rate) | 37 | 6.7 4.9–9.2ROR 6.8 · χ² 173 / p 7e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Encephalopathy | 17 | 6.7 4.1–10.7ROR 6.7 · χ² 76 / p 1e-18 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Epilepsy | 21 | 6.6 4.3–10.1ROR 6.7 · χ² 94 / p 1e-22 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Acute kidney injury (sudden kidney damage) | 114 | 7.2 6.0–8.6ROR 7.5 · χ² 604 / p 1e-133 | 7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 100% clinician | no trial data cached |
| Premature baby | 95 | 30.3 24.8–36.8ROR 31.6 · χ² 2,654 / p <1e-300 | 30.0 EB05 25.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 | no trial data cached |
| Maternal exposure during pregnancy | 85 | 9.2 7.5–11.4ROR 9.6 · χ² 619 / p 6e-137 | 9.0 EB05 7.5 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 82% (drug 53%) | no trial data cached |
| Foetal exposure during pregnancy | 73 | 8.6 6.9–10.8ROR 8.9 · χ² 486 / p 6e-108 | 8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.2 | no trial data cached |
| Hepatic cytolysis | 58 | 45.7 35.4–59.0ROR 46.9 · χ² 2,482 / p <1e-300 | 44.9 EB05 36.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.9 · 98% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 52 | 8.9 6.8–11.6ROR 9.1 · χ² 356 / p 9e-80 | 8.5 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 98% clinician | no trial data cached |
| Drug exposure during pregnancy | 52 | 14.5 11.1–18.9ROR 14.8 · χ² 639 / p 3e-141 | 14.3 EB05 11.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · ♀ 84% (drug 53%) · 95% clinician | no trial data cached |
| Premature delivery | 49 | 29.5 22.3–38.9ROR 30.1 · χ² 1,315 / p 3e-288 | 29.1 EB05 22.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.8 · ♀ 100% (drug 53%) · 94% clinician | no trial data cached |
| Rash maculo-papular | 40 | 17.3 12.8–23.6ROR 17.6 · χ² 599 / p 1e-132 | 17.1 EB05 13.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · 92% clinician | no trial data cached |
| Pneumonia aspiration | 39 | 15.0 11.0–20.5ROR 15.3 · χ² 496 / p 3e-110 | 14.8 EB05 11.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Eosinophilia | 38 | 20.9 15.2–28.6ROR 21.2 · χ² 699 / p 2e-154 | 20.7 EB05 15.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · 100% clinician | no trial data cached |
| Cardiac arrest (heart stopping) | 37 | 4.3 3.1–5.9ROR 4.3 · χ² 90 / p 1e-21 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 94% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 37 | 6.7 4.9–9.2ROR 6.8 · χ² 173 / p 7e-40 | 6.2 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Hepatic function abnormal | 37 | 9.6 7.0–13.2ROR 9.7 · χ² 276 / p 3e-62 | 9.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 97% clinician | no trial data cached |
| Cerebral infarction | 37 | 14.5 10.6–20.0ROR 14.8 · χ² 452 / p 1e-100 | 14.3 EB05 10.6 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 · 100% clinician | 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.
- Hepatic cytolysis — n=58, PRR 45.7
- Premature baby — n=95, PRR 30.3
- Premature delivery — n=49, PRR 29.5
- Caesarean section — n=31, PRR 25.3
- Eosinophilia — n=38, PRR 20.9
- Rash maculo-papular — n=40, PRR 17.3
- Pneumonia aspiration — n=39, PRR 15.0
- Cholestasis — n=23, PRR 11.6
- Hepatic function abnormal — n=37, PRR 9.6
- Respiratory distress — n=27, PRR 9.4
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 Nicardipine?
In FDA FAERS, the most frequently co-reported reaction terms for Nicardipine are acute kidney injury, premature baby, hepatic cytolysis, hyponatraemia, premature delivery, rash maculo-papular. 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 Nicardipine have an FDA boxed warning?
No. The FDA label retrieved for Nicardipine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Nicardipine 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 79304b0f-53d3-4065-8c81-7031d1141694, effective 20241003; matched on
openfda.generic_name.exact:"NICARDIPINE") - 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, fieldpatient.drug.openfda.generic_name.exact, 102 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.