Drug · FAERS side-effect profile with label screen

Amlodipine and Benazepril side effects: what 634 FDA adverse event reports show

Amlodipine Besylate And Benazepril Hydrochloride · 1,072 reaction terms · 37,765 drug–reaction co-reports · data 2026-09-14

Drug class

Calcium channel blocker and may be

FDA label, Indications wording of the closest related product

Label matched

Amlodipine (Katerzia)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

634 reports · 57% serious · 66 with death outcome · 46% female

openFDA FAERS counts, all years, deduplication not applied

Used for

KATERZIA is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension ( 1.1 ) KATERZIA is indicated for the treatment of hypertension in adults and children 6 years and older, to lower blood pressure.

FDA label, Indications and Usage

What it is

KATERZIA oral suspension contains 1.30 mg/mL amlodipine benzoate, equivalent to 1 mg/mL amlodipine, a long-acting calcium channel blocker. Amlodipine benzoate is chemically described as 3-Ethy.

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

Likely indication confounding 14Not in label — unassessed 26

What the badges mean

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.
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. 1,032 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Angioneurotic oedema	70	60.7 47.9–76.9ROR 61.2 · χ² 3,947 / p <1e-300	58.3 EB05 47.7 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hyperparathyroidism secondary	42	38.5 28.4–52.2ROR 38.7 · χ² 1,472 / p <1e-300	37.3 EB05 28.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Chronic kidney disease-mineral and bone disorder	17	36.7 22.7–59.2ROR 36.7 · χ² 546 / p 6e-121	34.8 EB05 23.0 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Brash syndrome	20	34.2 22.0–53.1ROR 34.2 · χ² 602 / p 3e-133	32.7 EB05 22.4 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Sick sinus syndrome	15	29.8 17.9–49.5ROR 29.8 · χ² 384 / p 9e-86	28.4 EB05 18.3 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Blood pressure inadequately controlled	75	28.6 22.8–35.9ROR 28.8 · χ² 1,945 / p <1e-300	28.1 EB05 23.1 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=3	no trial data cached
Nephrogenic anaemia	54	26.7 20.4–34.9ROR 26.8 · χ² 1,294 / p 1e-283	26.2 EB05 20.8 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=7	no trial data cached
Diabetes mellitus non-insulin-dependent	17	26.7 16.5–43.0ROR 26.7 · χ² 390 / p 4e-87	25.7 EB05 16.9 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Joint sprain	12	26.1 14.8–46.2ROR 26.2 · χ² 263 / p 2e-59	24.9 EB05 15.0 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Colonic polyp	18	24.8 15.6–39.4ROR 24.8 · χ² 383 / p 1e-85	24.0 EB05 16.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Hypertensive heart disease	18	22.0 13.9–35.0ROR 22.1 · χ² 338 / p 1e-75	21.3 EB05 14.2 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	–	no trial data cached
Muscle cramp	16	20.5 12.5–33.5ROR 20.5 · χ² 275 / p 5e-62	19.7 EB05 12.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Lumbar radiculopathy	10	19.7 10.6–36.7ROR 19.7 · χ² 158 / p 2e-36	18.3 EB05 9.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Carotid artery stenosis	26	17.0 11.6–25.0ROR 17.1 · χ² 374 / p 1e-83	16.6 EB05 11.7 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Rebound acid hypersecretion	22	16.5 10.9–25.1ROR 16.5 · χ² 303 / p 4e-68	16.0 EB05 10.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=4	no trial data cached
Ventricular hypertrophy	16	14.5 8.9–23.7ROR 14.5 · χ² 187 / p 7e-43	13.6 EB05 8.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Lacunar infarction	15	14.4 8.7–23.9ROR 14.4 · χ² 173 / p 9e-40	13.4 EB05 7.9 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1	no trial data cached
Diabetic neuropathy	31	14.3 10.1–20.4ROR 14.3 · χ² 368 / p 2e-82	13.9 EB05 10.0 · IC025 +3.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Concomitant disease progression	12	14.0 7.9–24.6ROR 14.0 · χ² 131 / p 1e-30	12.5 EB05 6.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Ischaemic cardiomyopathy	18	13.3 8.4–21.2ROR 13.4 · χ² 192 / p 5e-44	12.4 EB05 7.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Coronary artery disease	172	12.9 11.2–15.0ROR 13.2 · χ² 1,876 / p <1e-300	12.8 EB05 11.3 · IC025 +3.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 3.3	no trial data cached
End stage renal disease	103	12.8 10.6–15.6ROR 13.0 · χ² 1,107 / p 4e-243	12.7 EB05 10.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.0	no trial data cached
Stomach discomfort	29	12.7 8.8–18.3ROR 12.7 · χ² 300 / p 2e-67	12.2 EB05 8.6 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Left ventricular hypertrophy	22	11.8 7.8–17.9ROR 11.8 · χ² 205 / p 7e-47	10.9 EB05 7.2 · IC025 +2.5 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1	no trial data cached
Renal failure chronic	40	11.8 8.6–16.1ROR 11.8 · χ² 382 / p 3e-85	11.3 EB05 8.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Spinal column stenosis	24	11.5 7.7–17.2ROR 11.5 · χ² 219 / p 9e-50	10.7 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=1	no trial data cached
Difficulty in walking	17	11.2 6.9–18.0ROR 11.2 · χ² 147 / p 4e-34	10.0 EB05 6.2 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Therapeutic agent toxicity	16	10.9 6.6–17.7ROR 10.9 · χ² 133 / p 5e-31	9.5 EB05 5.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Angina unstable	31	10.8 7.6–15.4ROR 10.9 · χ² 266 / p 4e-60	10.2 EB05 7.3 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Tricuspid valve incompetence	37	10.7 7.8–14.8ROR 10.8 · χ² 316 / p 6e-71	10.2 EB05 7.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Excoriation	12	10.7 6.1–18.8ROR 10.7 · χ² 95 / p 7e-23	8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Mitral valve incompetence	51	10.3 7.9–13.6ROR 10.4 · χ² 419 / p 2e-93	9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Peripheral vascular disorder	23	10.2 6.8–15.3ROR 10.2 · χ² 180 / p 2e-41	9.2 EB05 6.2 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Essential hypertension	11	9.7 5.4–17.6ROR 9.7 · χ² 77 / p 7e-19	7.8 EB05 4.4 · IC025 +1.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Hyperlipidaemia	48	9.2 6.9–12.2ROR 9.2 · χ² 341 / p 2e-76	8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree	Likely indication confounding term in indications	–	no trial data cached
Cardiomegaly	49	9.1 6.8–12.0ROR 9.1 · χ² 342 / p 1e-76	8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 2.8	no trial data cached
Diastolic dysfunction	12	8.9 5.0–15.6ROR 8.9 · χ² 76 / p 2e-18	7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	–	no trial data cached
Rhinitis allergic	17	8.8 5.4–14.1ROR 8.8 · χ² 109 / p 8e-26	7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Arteriosclerosis coronary artery	25	8.7 5.9–12.8ROR 8.7 · χ² 162 / p 3e-37	7.8 EB05 5.4 · IC025 +2.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=1	no trial data cached
Cardiac failure congestive	305	8.6 7.7–9.6ROR 8.9 · χ² 2,047 / p <1e-300	8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.1	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
Nausea	621	1.8 1.7–1.9ROR 1.9 · χ² 228 / p 9e-52	1.8 EB05 1.7 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 1.3 · 76% consumer	no trial data cached
Fatigue (tiredness)	533	1.6 1.4–1.7ROR 1.6 · χ² 113 / p 1e-26	1.6 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	serious PRR 1.6 · 82% consumer	no trial data cached
Drug ineffective (drug did not work)	527	0.9 0.8–1.0ROR 0.9 · χ² 4 / p 0.018	0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.8 · 76% consumer	no trial data cached
Dizziness	480	2.2 2.0–2.4ROR 2.3 · χ² 322 / p 3e-72	2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.1	no trial data cached
Diarrhoea (diarrhea)	455	1.6 1.5–1.8ROR 1.6 · χ² 110 / p 6e-26	1.6 EB05 1.5 · IC025 +0.5	Not in label — unassessed	serious PRR 2.5 · 77% consumer	no trial data cached
Dyspnoea (shortness of breath)	427	1.7 1.6–1.9ROR 1.8 · χ² 133 / p 5e-31	1.7 EB05 1.6 · IC025 +0.6	Not in label — unassessed	serious PRR 1.7 · ♀ 72% (drug 46%)	no trial data cached
Headache	417	1.5 1.4–1.7ROR 1.5 · χ² 76 / p 1e-18	1.5 EB05 1.4 · IC025 +0.4	Not in label — unassessed	serious PRR 1.8 · ♀ 71% (drug 46%) · 81% consumer	no trial data cached
Pain	400	1.5 1.3–1.6ROR 1.5 · χ² 65 / p 4e-16	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 1.2	no trial data cached
Asthenia (weakness)	386	2.3 2.1–2.6ROR 2.4 · χ² 302 / p 6e-68	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 1.5	no trial data cached
Myocardial infarction (heart attack)	352	4.6 4.1–5.1ROR 4.7 · χ² 988 / p 4e-217	4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 0.4	no trial data cached
Renal failure (kidney failure)	321	5.5 4.9–6.1ROR 5.7 · χ² 1,180 / p 9e-259	5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Hypertension (high blood pressure)	319	3.4 3.1–3.8ROR 3.5 · χ² 555 / p 7e-123	3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree	Likely indication confounding term in indications	serious PRR 1.6	no trial data cached
Vomiting	309	1.5 1.3–1.7ROR 1.5 · χ² 53 / p 2e-13	1.5 EB05 1.4 · IC025 +0.4	Not in label — unassessed	serious PRR 2.2	no trial data cached
Cerebrovascular accident (stroke)	306	4.1 3.7–4.6ROR 4.2 · χ² 723 / p 1e-159	4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 0.2	no trial data cached
Cardiac failure congestive	305	8.6 7.7–9.6ROR 8.9 · χ² 2,047 / p <1e-300	8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 2.1	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.

Angioneurotic oedema — n=70, PRR 60.7
Hyperparathyroidism secondary — n=42, PRR 38.5
Brash syndrome — n=20, PRR 34.2
Nephrogenic anaemia — n=54, PRR 26.7
Carotid artery stenosis — n=26, PRR 17.0
Rebound acid hypersecretion — n=22, PRR 16.5
End stage renal disease — n=103, PRR 12.8
Stomach discomfort — n=29, PRR 12.7
Renal failure chronic — n=40, PRR 11.8
Spinal column stenosis — n=24, PRR 11.5

✓ A hand-written Bradford Hill causality assessment exists for this drug: Amlodipine (dihydropyridine CCBs) ↔ Peripheral oedema.

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 Amlodipine and Benazepril?

In FDA FAERS, the most frequently co-reported reaction terms for Amlodipine and Benazepril are nausea, fatigue, dizziness, diarrhoea, dyspnoea, headache. 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 Amlodipine and Benazepril have an FDA boxed warning?

No. The FDA label retrieved for Amlodipine and Benazepril has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Amlodipine and 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 df673a4d-acb8-444c-a472-c87ab8cbd366, effective 20251216; matched on openfda.generic_name.exact:"AMLODIPINE")
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, field patient.drug.openfda.generic_name.exact, 1,072 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.