Captopril side effects: what 9,557 FDA adverse event reports show
Drug class
Angiotensin Converting Enzyme Inhibitor
Who reports
9,557 reports · 89% serious · 1,564 with death outcome · 55% female
Used for
Hypertension: Captopril tablets, USP are indicated for the treatment of hypertension. In using captopril, consideration should be given to the risk of neutropenia/agranulocytosis (see WARNINGS ). Captopril may be used as initial therapy for patients with normal renal function, in whom the risk is relatively low.
What it is
DESCRIPTION Captopril tablets, USP are a specific competitive inhibitor of angiotensin I-converting enzyme (ACE), the enzyme responsible for the conversion of angiotensin I to angiotensin II. .
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue captopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity .
Causality screen of the 40 strongest signals
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.
- 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.
- 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. 1,093 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Segmental diverticular colitis | 20 | 2,704.7 1,402.0–5,217.8ROR 2,710.3 · χ² 22,837 / p <1e-300 | 557.5 EB05 381.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 55%) | no trial data cached |
| Cardiopulmonary exercise test abnormal | 13 | 2,344.0 1,069.8–5,135.9ROR 2,347.2 · χ² 13,511 / p <1e-300 | 422.8 EB05 262.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious n=13 | no trial data cached |
| Pedal pulse abnormal | 20 | 1,138.8 662.9–1,956.3ROR 1,141.2 · χ² 14,160 / p <1e-300 | 434.8 EB05 297.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 55%) | no trial data cached |
| Meniscopathy | 12 | 811.4 418.1–1,574.9ROR 812.4 · χ² 6,487 / p <1e-300 | 304.2 EB05 185.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Pelvic misalignment | 12 | 701.8 366.0–1,345.3ROR 702.6 · χ² 5,822 / p <1e-300 | 287.4 EB05 175.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Factor vii deficiency | 14 | 582.5 323.0–1,050.7ROR 583.4 · χ² 5,953 / p <1e-300 | 282.3 EB05 178.7 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Peroneal nerve injury | 13 | 284.1 159.4–506.4ROR 284.5 · χ² 2,996 / p <1e-300 | 183.9 EB05 114.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Sacroiliac joint dysfunction | 13 | 240.4 135.6–426.3ROR 240.7 · χ² 2,578 / p <1e-300 | 164.6 EB05 102.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Neurofibroma | 14 | 229.5 132.3–398.0ROR 229.8 · χ² 2,677 / p <1e-300 | 162.1 EB05 102.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Calcium ionised decreased | 20 | 196.7 124.5–310.8ROR 197.1 · χ² 3,392 / p <1e-300 | 154.1 EB05 105.4 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=20 · ♀ 100% (drug 55%) | no trial data cached |
| Scleroderma renal crisis | 25 | 157.7 105.1–236.6ROR 158.1 · χ² 3,484 / p <1e-300 | 132.4 EB05 94.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | no trial data cached |
| Labile hypertension | 15 | 126.8 75.4–213.3ROR 127.0 · χ² 1,651 / p <1e-300 | 104.3 EB05 67.1 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | no trial data cached |
| Merycism | 14 | 115.6 67.6–197.9ROR 115.8 · χ² 1,403 / p <1e-300 | 95.8 EB05 60.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Feeding intolerance | 21 | 108.7 70.2–168.4ROR 108.9 · χ² 2,032 / p <1e-300 | 94.9 EB05 65.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 55%) | no trial data cached |
| Insulin autoimmune syndrome | 14 | 93.2 54.6–159.1ROR 93.3 · χ² 1,137 / p 1e-249 | 80.0 EB05 50.6 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Kidney small | 10 | 78.1 41.6–146.8ROR 78.2 · χ² 662 / p 3e-146 | 66.3 EB05 38.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Myosclerosis | 12 | 73.3 41.3–130.3ROR 73.4 · χ² 760 / p 2e-167 | 64.1 EB05 39.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Patellofemoral pain syndrome | 14 | 61.2 36.0–104.1ROR 61.3 · χ² 749 / p 4e-165 | 55.3 EB05 35.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Reduced facial expression | 27 | 60.7 41.4–89.0ROR 60.9 · χ² 1,485 / p <1e-300 | 56.8 EB05 41.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 55%) · 100% clinician | no trial data cached |
| Helicobacter test positive | 15 | 60.6 36.3–101.1ROR 60.6 · χ² 798 / p 9e-176 | 55.0 EB05 35.4 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Joint hyperextension | 10 | 57.1 30.5–106.9ROR 57.1 · χ² 484 / p 2e-107 | 50.6 EB05 29.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Vestibular neuronitis | 13 | 54.9 31.7–95.2ROR 55.0 · χ² 620 / p 4e-137 | 49.9 EB05 31.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Neurogenic shock | 13 | 53.7 31.0–93.0ROR 53.8 · χ² 605 / p 6e-134 | 48.9 EB05 30.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Cervicobrachial syndrome | 14 | 50.6 29.8–85.9ROR 50.6 · χ² 617 / p 2e-136 | 46.5 EB05 29.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Orthostatic intolerance | 16 | 50.3 30.7–82.6ROR 50.4 · χ² 708 / p 2e-156 | 46.7 EB05 30.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Stasis dermatitis | 14 | 45.7 26.9–77.5ROR 45.8 · χ² 556 / p 3e-123 | 42.4 EB05 26.8 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Renal ischaemia | 11 | 45.3 25.0–82.3ROR 45.4 · χ² 425 / p 1e-94 | 41.5 EB05 24.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blood growth hormone increased | 10 | 39.5 21.1–73.8ROR 39.5 · χ² 332 / p 2e-74 | 36.3 EB05 21.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Solar lentigo | 15 | 34.9 20.9–58.0ROR 34.9 · χ² 453 / p 9e-101 | 33.0 EB05 21.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Extensor plantar response | 14 | 33.6 19.8–56.9ROR 33.6 · χ² 404 / p 3e-90 | 31.8 EB05 20.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Blood ketone body increased | 11 | 31.4 17.3–57.0ROR 31.5 · χ² 290 / p 2e-65 | 29.5 EB05 17.5 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Pulmonary hypoplasia | 11 | 30.8 17.0–55.7ROR 30.8 · χ² 284 / p 6e-64 | 28.9 EB05 17.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Aortic dilatation | 15 | 30.6 18.4–50.9ROR 30.6 · χ² 394 / p 5e-88 | 29.1 EB05 18.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Osteochondrosis | 16 | 30.4 18.6–49.8ROR 30.4 · χ² 420 / p 1e-93 | 29.1 EB05 18.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Therapeutic product cross-reactivity | 12 | 29.5 16.7–52.1ROR 29.5 · χ² 298 / p 4e-67 | 27.9 EB05 16.9 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | no trial data cached |
| Left ventricular hypertrophy | 52 | 26.9 20.5–35.4ROR 27.1 · χ² 1,257 / p 1e-275 | 26.4 EB05 20.9 · IC025 +4.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=52 | no trial data cached |
| Pulmonary valve incompetence | 17 | 26.4 16.4–42.5ROR 26.4 · χ² 385 / p 4e-86 | 25.4 EB05 16.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Gingival hypertrophy | 16 | 23.6 14.4–38.6ROR 23.7 · χ² 321 / p 5e-72 | 22.8 EB05 14.7 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=14 | no trial data cached |
| Nodal rhythm | 15 | 22.6 13.6–37.6ROR 22.7 · χ² 286 / p 2e-64 | 21.8 EB05 13.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Venous occlusion | 18 | 21.8 13.7–34.6ROR 21.8 · χ² 333 / p 1e-74 | 21.1 EB05 14.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Dyspnoea (shortness of breath) | 610 | 2.4 2.2–2.6ROR 2.5 · χ² 493 / p 1e-109 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Drug ineffective (drug did not work) | 599 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.488 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Hypertension (high blood pressure) | 536 | 5.6 5.1–6.0ROR 5.8 · χ² 2,014 / p <1e-300 | 5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.4 | no trial data cached |
| Nausea | 504 | 1.4 1.3–1.5ROR 1.4 · χ² 60 / p 5e-15 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled — boxed warning exact term | serious PRR 1.6 | no trial data cached |
| Diarrhoea (diarrhea) | 463 | 1.6 1.4–1.7ROR 1.6 · χ² 101 / p 5e-24 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Pain | 455 | 1.6 1.5–1.8ROR 1.7 · χ² 111 / p 3e-26 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled — boxed warning exact term | serious PRR 1.5 | no trial data cached |
| Dizziness | 447 | 2.0 1.8–2.2ROR 2.0 · χ² 218 / p 1e-49 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Asthenia (weakness) | 423 | 2.5 2.2–2.7ROR 2.5 · χ² 375 / p 9e-84 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Headache | 398 | 1.4 1.3–1.5ROR 1.4 · χ² 45 / p 8e-12 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Vomiting | 396 | 1.9 1.7–2.0ROR 1.9 · χ² 158 / p 1e-36 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled — boxed warning exact term | serious PRR 1.7 | no trial data cached |
| Fatigue (tiredness) | 391 | 1.1 1.0–1.2ROR 1.1 · χ² 4 / p 0.024 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Pneumonia (lung infection) | 374 | 2.5 2.3–2.8ROR 2.6 · χ² 353 / p 6e-79 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 1.7 | no trial data cached |
| Hypotension (low blood pressure) | 346 | 3.8 3.4–4.2ROR 3.9 · χ² 715 / p 9e-158 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Malaise (feeling unwell) | 345 | 1.7 1.6–1.9ROR 1.7 · χ² 106 / p 4e-25 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 · ♀ 75% (drug 55%) | no trial data cached |
| Fall | 342 | 2.3 2.0–2.5ROR 2.3 · χ² 242 / p 7e-55 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | 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.
- Segmental diverticular colitis — n=20, PRR 2,704.7
- Pedal pulse abnormal — n=20, PRR 1,138.8
- Scleroderma renal crisis — n=25, PRR 157.7
- Feeding intolerance — n=21, PRR 108.7
- Reduced facial expression — n=27, PRR 60.7
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 Captopril?
In FDA FAERS, the most frequently co-reported reaction terms for Captopril are dyspnoea, hypertension, nausea, diarrhoea, pain, dizziness. 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 Captopril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue captopril as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity .
Do FAERS signals prove that Captopril 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 3362b7a8-026a-b277-e063-6394a90a9dc6, effective 20250422; matched on
openfda.generic_name.exact:"CAPTOPRIL") - 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, 1,133 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.