Drug · FAERS side-effect profile with label screen
Quinapril side effects: what 6,799 FDA adverse event reports show
Drug class
Not stated in label
Who reports
6,799 reports · 61% serious · 550 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Hypertension Quinapril tablets USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benef.
FDA label, Indications and Usage
What it is
DESCRIPTION Quinapril hydrochloride is the hydrochloride salt of quinapril, the ethyl ester of a non-sulfhydryl, angiotensin-converting enzyme (ACE) inhibitor, quinaprilat. Quinapril hydrochlo.
FDA label, Description section
Boxed warning
FETAL TOXICITY • When pregnancy is detected, discontinue quinapril tablets 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
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 40 strongest signals
Labeled — boxed warning 1Labeled adverse reaction 3Labeled (related wording) 1Likely indication confounding 5Reporting / coding artifact 2Lab value / disease marker 7Not in label — unassessed 21
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 adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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. 499 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 156 | 43.2 37.0–50.5ROR 44.2 · χ² 6,306 / p <1e-300 | 42.4 EB05 37.1 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 50.6 · ♀ 95% (drug 53%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 188 | 33.6 29.1–38.7ROR 34.5 · χ² 5,849 / p <1e-300 | 33.1 EB05 29.3 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.7 · ♀ 95% (drug 53%) | no trial data cached |
| Sedation | 176 | 21.0 18.1–24.3ROR 21.5 · χ² 3,306 / p <1e-300 | 20.8 EB05 18.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.1 · ♀ 92% (drug 53%) | no trial data cached |
| Cognitive disorder | 194 | 12.9 11.2–14.8ROR 13.3 · χ² 2,115 / p <1e-300 | 12.8 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 16.9 · ♀ 96% (drug 53%) | no trial data cached |
| Flank pain | 38 | 12.6 9.1–17.3ROR 12.6 · χ² 392 / p 2e-87 | 12.2 EB05 9.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 87% (drug 53%) · 71% consumer | no trial data cached |
| Depressed level of consciousness | 158 | 12.4 10.6–14.5ROR 12.7 · χ² 1,639 / p <1e-300 | 12.3 EB05 10.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 · ♀ 97% (drug 53%) | no trial data cached |
| Bladder disorder | 33 | 10.3 7.3–14.4ROR 10.3 · χ² 266 / p 5e-60 | 9.6 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 87% (drug 53%) | no trial data cached |
| End stage renal disease | 59 | 9.9 7.7–12.8ROR 10.0 · χ² 462 / p 7e-103 | 9.5 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Neoplasm | 33 | 8.9 6.3–12.5ROR 8.9 · χ² 222 / p 2e-50 | 8.2 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 · ♀ 0% (drug 53%) | no trial data cached |
| Haematocrit decreased | 55 | 8.5 6.5–11.1ROR 8.6 · χ² 357 / p 7e-80 | 8.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 8.7 · ♀ 21% (drug 53%) | no trial data cached |
| Blood pressure systolic increased | 52 | 8.2 6.3–10.8ROR 8.3 · χ² 321 / p 4e-72 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 8.5 · ♀ 14% (drug 53%) | no trial data cached |
| Balance disorder | 220 | 7.9 6.9–8.9ROR 8.1 · χ² 1,311 / p 2e-287 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 84% (drug 53%) | no trial data cached |
| Mobility decreased | 175 | 7.6 6.5–8.7ROR 7.7 · χ² 989 / p 2e-217 | 7.4 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 · ♀ 82% (drug 53%) | no trial data cached |
| Nephropathy | 22 | 7.2 4.8–11.0ROR 7.3 · χ² 112 / p 2e-26 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Supraventricular tachycardia | 22 | 7.1 4.7–10.8ROR 7.1 · χ² 109 / p 7e-26 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Glycosylated haemoglobin increased | 56 | 6.9 5.3–8.9ROR 6.9 · χ² 275 / p 6e-62 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 12.6 · ♀ 15% (drug 53%) | no trial data cached |
| Chronic kidney disease | 167 | 6.7 5.8–7.8ROR 6.9 · χ² 810 / p 2e-178 | 6.6 EB05 5.8 · IC025 +2.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 6.4 | no trial data cached |
| Sleep disorder due to a general medical condition | 33 | 6.3 4.5–8.9ROR 6.3 · χ² 142 / p 5e-33 | 5.8 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 100% (drug 53%) · 71% consumer | no trial data cached |
| Arteriosclerosis | 19 | 6.2 4.0–9.8ROR 6.2 · χ² 78 / p 5e-19 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Angina pectoris | 57 | 6.1 4.7–7.9ROR 6.1 · χ² 238 / p 5e-54 | 5.8 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 · ♀ 77% (drug 53%) | no trial data cached |
| Economic problem | 30 | 6.0 4.2–8.6ROR 6.0 · χ² 120 / p 3e-28 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Hypotonia | 19 | 5.9 3.7–9.2ROR 5.9 · χ² 72 / p 1e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Renal tubular necrosis | 18 | 5.7 3.6–9.0ROR 5.7 · χ² 64 / p 5e-16 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Blood pressure fluctuation | 43 | 5.5 4.1–7.4ROR 5.5 · χ² 154 / p 9e-36 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · ♀ 77% (drug 53%) | no trial data cached |
| Mitral valve incompetence | 20 | 5.5 3.5–8.5ROR 5.5 · χ² 68 / p 7e-17 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Dementia | 47 | 5.2 3.9–6.9ROR 5.2 · χ² 156 / p 5e-36 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 79% (drug 53%) | no trial data cached |
| Gamma-glutamyltransferase increased | 37 | 5.2 3.7–7.1ROR 5.2 · χ² 120 / p 4e-28 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 6% (drug 53%) | no trial data cached |
| Dyspnoea exertional | 62 | 5.1 4.0–6.5ROR 5.1 · χ² 200 / p 9e-46 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Myocarditis | 18 | 4.9 3.1–7.8ROR 4.9 · χ² 52 / p 3e-13 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.7 | no trial data cached |
| Red blood cell count decreased | 45 | 4.9 3.6–6.5ROR 4.9 · χ² 134 / p 3e-31 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.9 · ♀ 16% (drug 53%) | no trial data cached |
| Blood potassium decreased | 47 | 4.8 3.6–6.4ROR 4.8 · χ² 139 / p 3e-32 | 4.6 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · ♀ 26% (drug 53%) | no trial data cached |
| Renal failure acute | 67 | 4.8 3.8–6.1ROR 4.8 · χ² 198 / p 3e-45 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.6 | no trial data cached |
| Hypotension (low blood pressure) | 296 | 4.6 4.1–5.1ROR 4.7 · χ² 827 / p 5e-182 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Coronary artery occlusion | 20 | 4.5 2.9–6.9ROR 4.5 · χ² 51 / p 6e-13 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 63 | 4.4 3.4–5.6ROR 4.4 · χ² 163 / p 2e-37 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.3 | no trial data cached |
| Hyperlipidaemia | 17 | 4.4 2.7–7.0ROR 4.4 · χ² 41 / p 8e-11 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.6 | no trial data cached |
| Productive cough (cough with phlegm) | 67 | 4.4 3.4–5.5ROR 4.4 · χ² 171 / p 2e-39 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 70% consumer | no trial data cached |
| Renal injury | 42 | 4.3 3.2–5.8ROR 4.3 · χ² 104 / p 1e-24 | 4.1 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Leukocytosis | 25 | 4.3 2.9–6.3ROR 4.3 · χ² 59 / p 7e-15 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 27% (drug 53%) | no trial data cached |
| Expired product administered | 45 | 4.2 3.1–5.6ROR 4.2 · χ² 106 / p 4e-25 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious n=37 · ♀ 12% (drug 53%) | 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 |
|---|---|---|---|---|---|---|
| Fall | 429 | 4.0 3.6–4.4ROR 4.2 · χ² 970 / p 4e-213 | 4.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 77% (drug 53%) | no trial data cached |
| Dyspnoea (shortness of breath) | 408 | 2.2 2.0–2.4ROR 2.3 · χ² 281 / p 2e-63 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Nausea | 407 | 1.6 1.4–1.7ROR 1.6 · χ² 92 / p 4e-22 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled — boxed warning exact term | serious PRR 1.8 | no trial data cached |
| Pain | 388 | 1.9 1.8–2.1ROR 2.0 · χ² 183 / p 7e-42 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled — boxed warning exact term | serious PRR 2.3 · ♀ 73% (drug 53%) | no trial data cached |
| Diarrhoea (diarrhea) | 351 | 1.7 1.5–1.9ROR 1.7 · χ² 100 / p 9e-24 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Hypotension (low blood pressure) | 296 | 4.6 4.1–5.1ROR 4.7 · χ² 827 / p 5e-182 | 4.5 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Constipation | 288 | 4.1 3.7–4.6ROR 4.2 · χ² 680 / p 3e-150 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 · ♀ 83% (drug 53%) | no trial data cached |
| Dizziness | 264 | 1.6 1.5–1.8ROR 1.7 · χ² 66 / p 2e-16 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 · 72% consumer | no trial data cached |
| Asthenia (weakness) | 253 | 2.1 1.8–2.3ROR 2.1 · χ² 142 / p 4e-33 | 2.1 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Balance disorder | 220 | 7.9 6.9–8.9ROR 8.1 · χ² 1,311 / p 2e-287 | 7.7 EB05 6.9 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 · ♀ 84% (drug 53%) | no trial data cached |
| Malaise (feeling unwell) | 217 | 1.5 1.3–1.7ROR 1.5 · χ² 39 / p 2e-10 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| No adverse event | 205 | 3.6 3.1–4.1ROR 3.6 · χ² 379 / p 1e-84 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | 96% consumer | no trial data cached |
| Pain in extremity | 202 | 2.1 1.8–2.4ROR 2.1 · χ² 119 / p 6e-28 | 2.1 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Weight decreased (weight loss) | 202 | 2.2 1.9–2.6ROR 2.3 · χ² 138 / p 3e-32 | 2.2 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Blood glucose increased | 195 | 3.2 2.8–3.7ROR 3.2 · χ² 292 / p 1e-65 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | 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.
- Sedation — n=176, PRR 21.0
- Cognitive disorder — n=194, PRR 12.9
- Flank pain — n=38, PRR 12.6
- Depressed level of consciousness — n=158, PRR 12.4
- Bladder disorder — n=33, PRR 10.3
- End stage renal disease — n=59, PRR 9.9
- Neoplasm — n=33, PRR 8.9
- Balance disorder — n=220, PRR 7.9
- Mobility decreased — n=175, PRR 7.6
- Nephropathy — n=22, PRR 7.2
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 Quinapril?
In FDA FAERS, the most frequently co-reported reaction terms for Quinapril are fall, dyspnoea, nausea, pain, diarrhoea, hypotension. 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 Quinapril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY • When pregnancy is detected, discontinue quinapril tablets 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 Quinapril 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 8ded0773-3aec-4e89-9836-d22a5a84abf0, effective 20231214; matched on
openfda.generic_name.exact:"QUINAPRIL") - 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, 539 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.