Benazepril side effects: what 7,281 FDA adverse event reports show
Drug class
Angiotensin-converting enzyme (ace) inhibitor
Label matched
Benazepril Hydrochloride (Benazepril Hydrochloride)
Who reports
7,281 reports · 63% serious · 579 with death outcome · 55% female
Used for
Benazepril hydrochloride tablets 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 benefit.
What it is
Benazepril hydrochloride, USP is a white to off-white crystalline powder, soluble (> 100 mg/mL) in water, in ethanol, and in methanol.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See full prescribing information for complete boxed warning.
Causality screen of the 40 strongest signals
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.
- 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. 669 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 |
|---|---|---|---|---|---|---|
| Coronary artery disease | 168 | 15.9 13.7–18.5ROR 16.3 · χ² 2,327 / p <1e-300 | 15.8 EB05 13.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 | no trial data cached |
| Hyperlipidaemia | 64 | 15.5 12.1–19.7ROR 15.6 · χ² 846 / p 2e-186 | 15.3 EB05 12.3 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 14.7 | no trial data cached |
| Arteriosclerosis | 43 | 13.2 9.8–17.8ROR 13.3 · χ² 470 / p 1e-104 | 12.9 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Mitral valve incompetence | 50 | 12.8 9.7–16.8ROR 12.9 · χ² 529 / p 3e-117 | 12.5 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Cardiomegaly | 54 | 12.6 9.6–16.4ROR 12.7 · χ² 562 / p 1e-124 | 12.3 EB05 9.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.7 | no trial data cached |
| Economic problem | 63 | 11.8 9.2–15.1ROR 11.9 · χ² 611 / p 4e-135 | 11.5 EB05 9.2 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.5 | no trial data cached |
| Atelectasis | 30 | 8.9 6.2–12.8ROR 9.0 · χ² 203 / p 2e-46 | 8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Cardiac failure congestive | 241 | 8.6 7.6–9.7ROR 8.8 · χ² 1,607 / p <1e-300 | 8.5 EB05 7.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 | no trial data cached |
| Myocardial ischaemia | 32 | 8.0 5.7–11.4ROR 8.1 · χ² 190 / p 2e-43 | 7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.3 · ♀ 34% (drug 55%) | no trial data cached |
| Coronary artery occlusion | 37 | 7.7 5.6–10.7ROR 7.8 · χ² 210 / p 6e-48 | 7.2 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Iron deficiency anaemia | 24 | 7.5 5.1–11.2ROR 7.6 · χ² 129 / p 3e-30 | 6.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 | no trial data cached |
| Renal injury | 76 | 7.3 5.8–9.1ROR 7.4 · χ² 407 / p 9e-91 | 7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| End stage renal disease | 46 | 7.2 5.4–9.6ROR 7.2 · χ² 239 / p 3e-54 | 6.8 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Fear | 67 | 7.1 5.6–9.1ROR 7.2 · χ² 347 / p 1e-77 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Acute myocardial infarction | 73 | 7.1 5.7–8.9ROR 7.2 · χ² 377 / p 3e-84 | 6.8 EB05 5.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.5 · ♀ 26% (drug 55%) | no trial data cached |
| Renal failure acute | 106 | 7.1 5.9–8.6ROR 7.2 · χ² 550 / p 7e-122 | 6.9 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Cardiomyopathy | 34 | 6.6 4.7–9.3ROR 6.7 · χ² 157 / p 3e-36 | 6.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.1 | no trial data cached |
| Pharmaceutical product complaint | 60 | 6.6 5.1–8.5ROR 6.6 · χ² 278 / p 1e-62 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.1 | no trial data cached |
| Diabetes mellitus inadequate control | 40 | 6.5 4.8–8.9ROR 6.5 · χ² 181 / p 1e-41 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Blood urea increased | 37 | 6.3 4.6–8.7ROR 6.4 · χ² 161 / p 4e-37 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Sleep apnoea syndrome | 42 | 6.3 4.7–8.6ROR 6.4 · χ² 183 / p 5e-42 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Anhedonia | 58 | 6.3 4.9–8.2ROR 6.4 · χ² 254 / p 2e-57 | 6.0 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Multi-organ failure | 38 | 6.2 4.5–8.6ROR 6.3 · χ² 162 / p 2e-37 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Blood triglycerides increased | 38 | 6.2 4.5–8.5ROR 6.2 · χ² 160 / p 6e-37 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Renal tubular necrosis | 21 | 6.2 4.0–9.4ROR 6.2 · χ² 86 / p 1e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Type 2 diabetes mellitus | 72 | 6.1 4.9–7.7ROR 6.2 · χ² 305 / p 1e-68 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Ventricular tachycardia | 35 | 6.1 4.4–8.5ROR 6.1 · χ² 144 / p 2e-33 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Injury | 147 | 6.0 5.1–7.0ROR 6.1 · χ² 608 / p 1e-134 | 5.9 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 | no trial data cached |
| Blood pressure systolic increased | 40 | 5.9 4.3–8.0ROR 5.9 · χ² 157 / p 2e-36 | 5.5 EB05 4.2 · IC025 +1.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.2 | no trial data cached |
| Intervertebral disc degeneration | 19 | 5.9 3.8–9.2ROR 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 6.1 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 69 | 5.9 4.6–7.4ROR 5.9 · χ² 274 / p 8e-62 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Flank pain | 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 5.5 | no trial data cached |
| Pulmonary hypertension | 41 | 5.7 4.2–7.7ROR 5.7 · χ² 152 / p 3e-35 | 5.3 EB05 4.1 · IC025 +1.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.2 | no trial data cached |
| Hiatus hernia | 25 | 5.6 3.8–8.2ROR 5.6 · χ² 89 / p 2e-21 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Musculoskeletal chest pain | 29 | 5.4 3.8–7.8ROR 5.4 · χ² 99 / p 1e-23 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 82 | 5.4 4.3–6.6ROR 5.4 · χ² 286 / p 2e-64 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.6 | no trial data cached |
| Osteoarthritis | 76 | 5.2 4.1–6.5ROR 5.2 · χ² 251 / p 9e-57 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Renal failure (kidney failure) | 239 | 5.2 4.5–5.8ROR 5.3 · χ² 799 / p 4e-176 | 5.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 | no trial data cached |
| Myocardial infarction (heart attack) | 312 | 5.1 4.6–5.7ROR 5.3 · χ² 1,036 / p 1e-227 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 | no trial data cached |
| Obesity | 28 | 5.1 3.5–7.3ROR 5.1 · χ² 87 / p 5e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 450 | 1.6 1.5–1.8ROR 1.7 · χ² 117 / p 2e-27 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 1.8 | no trial data cached |
| Fatigue (tiredness) | 414 | 1.5 1.4–1.7ROR 1.6 · χ² 79 / p 2e-19 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Dizziness | 397 | 2.3 2.1–2.5ROR 2.4 · χ² 296 / p 1e-66 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 386 | 2.0 1.8–2.2ROR 2.0 · χ² 187 / p 7e-43 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Pain | 365 | 1.7 1.5–1.9ROR 1.7 · χ² 110 / p 6e-26 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled — boxed warning exact term | serious PRR 1.8 | no trial data cached |
| Diarrhoea (diarrhea) | 364 | 1.6 1.5–1.8ROR 1.7 · χ² 91 / p 8e-22 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Headache | 355 | 1.6 1.5–1.8ROR 1.7 · χ² 89 / p 2e-21 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Myocardial infarction (heart attack) | 312 | 5.1 4.6–5.7ROR 5.3 · χ² 1,036 / p 1e-227 | 5.1 EB05 4.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 | no trial data cached |
| Hypertension (high blood pressure) | 302 | 4.1 3.7–4.6ROR 4.2 · χ² 712 / p 3e-157 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.0 | no trial data cached |
| Asthenia (weakness) | 274 | 2.1 1.9–2.4ROR 2.1 · χ² 159 / p 8e-37 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Vomiting | 260 | 1.6 1.4–1.8ROR 1.6 · χ² 59 / p 9e-15 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled — boxed warning exact term | serious PRR 1.6 | no trial data cached |
| Cough | 259 | 2.7 2.4–3.0ROR 2.7 · χ² 272 / p 3e-61 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Anxiety | 253 | 2.6 2.3–2.9ROR 2.6 · χ² 241 / p 1e-54 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | no trial data cached |
| Cerebrovascular accident (stroke) | 250 | 4.2 3.8–4.8ROR 4.4 · χ² 619 / p 5e-137 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Arthralgia (joint pain) | 242 | 1.7 1.5–1.9ROR 1.7 · χ² 68 / p 1e-16 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.8 | 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.
- Coronary artery disease — n=168, PRR 15.9
- Arteriosclerosis — n=43, PRR 13.2
- Mitral valve incompetence — n=50, PRR 12.8
- Atelectasis — n=30, PRR 8.9
- Coronary artery occlusion — n=37, PRR 7.7
- Iron deficiency anaemia — n=24, PRR 7.5
- End stage renal disease — n=46, PRR 7.2
- Fear — n=67, PRR 7.1
- Sleep apnoea syndrome — n=42, PRR 6.3
- Anhedonia — n=58, PRR 6.3
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 Benazepril?
In FDA FAERS, the most frequently co-reported reaction terms for Benazepril are nausea, fatigue, dizziness, dyspnoea, pain, diarrhoea. 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 Benazepril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue benazepril hydrochloride tablets as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions ( 5.1 )]. WARNING-FETAL TOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Benazepril 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 01a3c9f6-41aa-47a7-8c56-5462c6b54416, effective 20260319; matched on
openfda.generic_name.exact:"BENAZEPRIL HYDROCHLORIDE") - 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, 709 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.