Drug · FAERS side-effect profile with label screen
Quinapril Hydrochloride side effects: what 7,842 FDA adverse event reports show
Drug class
Not stated in label
Who reports
7,842 reports · 64% serious · 613 with death outcome · 56% 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 adverse reaction 1Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 7Not in label — unassessed 26
What the badges mean
- 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. 986 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 |
|---|---|---|---|---|---|---|
| Heart sounds | 60 | 4,395.6 2,909.5–6,640.7ROR 4,429.5 · χ² 97,215 / p <1e-300 | 1,077.3 EB05 867.3 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=60 · ♀ 100% (drug 56%) | no trial data cached |
| Blood mercury abnormal | 41 | 1,930.9 1,291.4–2,887.1ROR 1,941.1 · χ² 44,550 / p <1e-300 | 731.6 EB05 562.2 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 0% (drug 56%) | no trial data cached |
| 5-hydroxyindolacetic acid in urine increased | 21 | 1,629.0 945.9–2,805.2ROR 1,633.3 · χ² 20,126 / p <1e-300 | 523.9 EB05 361.5 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=21 · ♀ 0% (drug 56%) | no trial data cached |
| 5-hydroxyindolacetic acid increased | 20 | 1,226.7 722.0–2,084.1ROR 1,229.8 · χ² 15,892 / p <1e-300 | 464.1 EB05 317.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 0% (drug 56%) | no trial data cached |
| Prolonged expiration | 61 | 804.4 604.4–1,070.5ROR 810.7 · χ² 36,894 / p <1e-300 | 516.2 EB05 416.4 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 100% (drug 56%) | no trial data cached |
| Sedation complication | 537 | 733.4 668.3–804.9ROR 787.3 · χ² 306,782 / p <1e-300 | 562.5 EB05 523.7 · IC025 +8.4 3/3 methods agree | Reporting / coding artifact | serious n=537 · ♀ 96% (drug 56%) | no trial data cached |
| Creatinine renal clearance decreased | 517 | 394.1 360.3–431.1ROR 421.8 · χ² 176,047 / p <1e-300 | 338.7 EB05 314.9 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | serious n=517 · ♀ 100% (drug 56%) | no trial data cached |
| Bronchomalacia | 16 | 366.9 217.6–618.7ROR 367.7 · χ² 4,810 / p <1e-300 | 232.9 EB05 152.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Multiple drug therapy | 75 | 322.2 253.7–409.0ROR 325.3 · χ² 21,113 / p <1e-300 | 267.6 EB05 220.5 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=74 · ♀ 100% (drug 56%) | no trial data cached |
| Creatinine renal clearance increased | 57 | 219.5 167.7–287.3ROR 221.1 · χ² 11,243 / p <1e-300 | 189.9 EB05 152.0 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=57 · ♀ 100% (drug 56%) · 93% clinician | no trial data cached |
| Fibrous histiocytoma | 24 | 193.6 128.0–292.8ROR 194.2 · χ² 4,106 / p <1e-300 | 158.0 EB05 111.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 56%) | no trial data cached |
| Blood follicle stimulating hormone increased | 24 | 173.4 114.8–261.9ROR 173.9 · χ² 3,700 / p <1e-300 | 144.3 EB05 102.1 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious n=24 · ♀ 0% (drug 56%) | no trial data cached |
| Blood calcium decreased | 525 | 130.5 119.9–142.0ROR 139.8 · χ² 64,197 / p <1e-300 | 123.8 EB05 115.2 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious PRR 139.8 · ♀ 98% (drug 56%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 622 | 98.8 91.5–106.7ROR 107.2 · χ² 58,008 / p <1e-300 | 95.0 EB05 88.9 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 97.2 · ♀ 98% (drug 56%) | no trial data cached |
| Low density lipoprotein decreased | 41 | 79.6 58.4–108.5ROR 80.0 · χ² 3,012 / p <1e-300 | 74.7 EB05 57.4 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=41 · ♀ 0% (drug 56%) | no trial data cached |
| Recalled product administered | 205 | 63.7 55.6–73.0ROR 65.4 · χ² 12,298 / p <1e-300 | 61.9 EB05 55.1 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=9 · 99% consumer | no trial data cached |
| Sedation | 578 | 60.6 56.0–65.6ROR 65.4 · χ² 33,109 / p <1e-300 | 59.2 EB05 55.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 73.3 · ♀ 98% (drug 56%) | no trial data cached |
| Depressive symptom | 61 | 47.2 36.7–60.8ROR 47.6 · χ² 2,666 / p <1e-300 | 45.8 EB05 36.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 100% (drug 56%) | no trial data cached |
| Cogwheel rigidity | 16 | 41.2 25.2–67.5ROR 41.3 · χ² 579 / p 3e-128 | 38.9 EB05 25.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Renal function test abnormal | 69 | 40.8 32.2–51.7ROR 41.1 · χ² 2,598 / p <1e-300 | 39.8 EB05 32.5 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=69 · ♀ 100% (drug 56%) · 93% clinician | no trial data cached |
| Cognitive disorder | 634 | 36.9 34.3–39.8ROR 40.1 · χ² 21,871 / p <1e-300 | 36.4 EB05 34.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 45.7 · ♀ 98% (drug 56%) | no trial data cached |
| Depressed level of consciousness | 537 | 36.9 34.0–40.0ROR 39.5 · χ² 18,477 / p <1e-300 | 36.3 EB05 33.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 · ♀ 99% (drug 56%) | no trial data cached |
| Hepatic neoplasm | 44 | 36.5 27.2–49.2ROR 36.7 · χ² 1,466 / p <1e-300 | 35.6 EB05 27.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 7% (drug 56%) | no trial data cached |
| Head titubation | 16 | 31.3 19.1–51.2ROR 31.3 · χ² 434 / p 1e-96 | 29.9 EB05 19.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Rales | 67 | 31.2 24.5–39.6ROR 31.5 · χ² 1,906 / p <1e-300 | 30.6 EB05 24.9 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=67 · ♀ 94% (drug 56%) | no trial data cached |
| Appetite disorder | 63 | 26.1 20.4–33.4ROR 26.3 · χ² 1,482 / p <1e-300 | 25.7 EB05 20.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 56%) | no trial data cached |
| Respiration abnormal | 65 | 25.7 20.1–32.7ROR 25.9 · χ² 1,502 / p <1e-300 | 25.3 EB05 20.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 100% (drug 56%) | no trial data cached |
| Arteriosclerosis coronary artery | 51 | 20.8 15.8–27.4ROR 20.9 · χ² 934 / p 2e-205 | 20.5 EB05 16.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=51 · ♀ 10% (drug 56%) | no trial data cached |
| Mobility decreased | 545 | 20.5 18.9–22.2ROR 22.0 · χ² 10,043 / p <1e-300 | 20.3 EB05 18.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 · ♀ 93% (drug 56%) | no trial data cached |
| Anticholinergic syndrome | 12 | 20.3 11.5–35.8ROR 20.3 · χ² 200 / p 1e-45 | 19.2 EB05 11.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hyperparathyroidism secondary | 19 | 20.2 12.9–31.7ROR 20.3 · χ² 325 / p 5e-73 | 19.6 EB05 13.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Nephrogenic anaemia | 35 | 20.2 14.5–28.1ROR 20.2 · χ² 614 / p 9e-136 | 19.8 EB05 14.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Balance disorder | 644 | 20.0 18.6–21.6ROR 21.7 · χ² 11,585 / p <1e-300 | 19.9 EB05 18.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 94% (drug 56%) | no trial data cached |
| Flank pain | 66 | 19.0 14.9–24.2ROR 19.1 · χ² 1,099 / p 3e-241 | 18.8 EB05 15.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · ♀ 92% (drug 56%) | no trial data cached |
| Rebound acid hypersecretion | 19 | 16.7 10.6–26.1ROR 16.7 · χ² 263 / p 2e-59 | 16.1 EB05 10.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Cardiopulmonary failure | 23 | 15.8 10.5–23.8ROR 15.8 · χ² 302 / p 5e-68 | 15.3 EB05 10.4 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 | no trial data cached |
| Haemorrhagic anaemia | 20 | 12.0 7.8–18.7ROR 12.1 · χ² 191 / p 1e-43 | 11.1 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Bladder disorder | 40 | 10.8 7.9–14.7ROR 10.8 · χ² 344 / p 4e-77 | 10.3 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 89% (drug 56%) | no trial data cached |
| Sleep disorder due to a general medical condition | 64 | 10.6 8.3–13.6ROR 10.7 · χ² 546 / p 4e-121 | 10.3 EB05 8.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 100% (drug 56%) | no trial data cached |
| Blood pressure diastolic decreased | 29 | 10.5 7.3–15.1ROR 10.5 · χ² 239 / p 4e-54 | 9.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 9.9 · ♀ 7% (drug 56%) | 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 | 907 | 7.3 6.9–7.8ROR 8.1 · χ² 5,001 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 · ♀ 88% (drug 56%) | no trial data cached |
| Pain | 757 | 3.3 3.1–3.5ROR 3.5 · χ² 1,241 / p 4e-272 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.1 · ♀ 86% (drug 56%) | no trial data cached |
| Hypotension (low blood pressure) | 716 | 9.6 8.9–10.3ROR 10.5 · χ² 5,533 / p <1e-300 | 9.5 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 · ♀ 87% (drug 56%) | no trial data cached |
| Constipation | 713 | 8.8 8.2–9.5ROR 9.6 · χ² 4,981 / p <1e-300 | 8.8 EB05 8.2 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 · ♀ 92% (drug 56%) | no trial data cached |
| Balance disorder | 644 | 20.0 18.6–21.6ROR 21.7 · χ² 11,585 / p <1e-300 | 19.9 EB05 18.6 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · ♀ 94% (drug 56%) | no trial data cached |
| Cognitive disorder | 634 | 36.9 34.3–39.8ROR 40.1 · χ² 21,871 / p <1e-300 | 36.4 EB05 34.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 45.7 · ♀ 98% (drug 56%) | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 622 | 98.8 91.5–106.7ROR 107.2 · χ² 58,008 / p <1e-300 | 95.0 EB05 88.9 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 97.2 · ♀ 98% (drug 56%) | no trial data cached |
| Sedation | 578 | 60.6 56.0–65.6ROR 65.4 · χ² 33,109 / p <1e-300 | 59.2 EB05 55.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 73.3 · ♀ 98% (drug 56%) | no trial data cached |
| Mobility decreased | 545 | 20.5 18.9–22.2ROR 22.0 · χ² 10,043 / p <1e-300 | 20.3 EB05 18.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 · ♀ 93% (drug 56%) | no trial data cached |
| Depressed level of consciousness | 537 | 36.9 34.0–40.0ROR 39.5 · χ² 18,477 / p <1e-300 | 36.3 EB05 33.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 · ♀ 99% (drug 56%) | no trial data cached |
| Sedation complication | 537 | 733.4 668.3–804.9ROR 787.3 · χ² 306,782 / p <1e-300 | 562.5 EB05 523.7 · IC025 +8.4 3/3 methods agree | Reporting / coding artifact | serious n=537 · ♀ 96% (drug 56%) | no trial data cached |
| Toxicity to various agents | 535 | 8.5 7.9–9.3ROR 9.1 · χ² 3,575 / p <1e-300 | 8.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 92% (drug 56%) | no trial data cached |
| Blood calcium decreased | 525 | 130.5 119.9–142.0ROR 139.8 · χ² 64,197 / p <1e-300 | 123.8 EB05 115.2 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious PRR 139.8 · ♀ 98% (drug 56%) | no trial data cached |
| Creatinine renal clearance decreased | 517 | 394.1 360.3–431.1ROR 421.8 · χ² 176,047 / p <1e-300 | 338.7 EB05 314.9 · IC025 +7.9 3/3 methods agree | Lab value / disease marker | serious n=517 · ♀ 100% (drug 56%) | no trial data cached |
| Drug ineffective (drug did not work) | 510 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.214 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.1 | 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.
- Heart sounds — n=60, PRR 4,395.6
- 5-hydroxyindolacetic acid increased — n=20, PRR 1,226.7
- Prolonged expiration — n=61, PRR 804.4
- Fibrous histiocytoma — n=24, PRR 193.6
- Sedation — n=578, PRR 60.6
- Depressive symptom — n=61, PRR 47.2
- Cognitive disorder — n=634, PRR 36.9
- Depressed level of consciousness — n=537, PRR 36.9
- Hepatic neoplasm — n=44, PRR 36.5
- Rales — n=67, PRR 31.2
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, pain, hypotension, constipation, balance disorder, cognitive disorder. 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, 1,026 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.