Perindopril Erbumine side effects: what 5,567 FDA adverse event reports show
Drug class
Not stated in label
Who reports
5,567 reports · 98% serious · 589 with death outcome · 47% female
Used for
Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension. (1.1) Perindopril erbumine tablets are indicated for treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. (1.2) 1.1 Hypertension Perindopril erbumine tablets are indicated for the treatment of patients with essential hypertension.
What it is
Perindopril erbumine tablets USP contain the tert-butylamine salt of perindopril, the ethyl ester of a non-sulfhydryl angiotensin-converting enzyme (ACE) inhibitor. Perindopril erbumine is che.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.4) ] .
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 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. 442 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 |
|---|---|---|---|---|---|---|
| Renal failure acute | 160 | 14.1 12.1–16.4ROR 14.4 · χ² 1,923 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · 90% clinician | no trial data cached |
| Nephropathy toxic | 40 | 13.6 10.0–18.5ROR 13.7 · χ² 452 / p 1e-100 | 13.3 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 92% (drug 47%) | no trial data cached |
| Blood pressure systolic increased | 65 | 12.5 9.8–16.0ROR 12.7 · χ² 677 / p 2e-149 | 12.3 EB05 9.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Sleep apnoea syndrome | 59 | 11.7 9.0–15.0ROR 11.8 · χ² 563 / p 1e-124 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · ♀ 90% (drug 47%) | no trial data cached |
| Blood test abnormal | 43 | 11.6 8.6–15.6ROR 11.7 · χ² 404 / p 4e-90 | 11.2 EB05 8.5 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.3 · ♀ 90% (drug 47%) | no trial data cached |
| Full blood count abnormal | 32 | 11.5 8.1–16.2ROR 11.5 · χ² 295 / p 3e-66 | 10.9 EB05 7.8 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 8.9 · ♀ 100% (drug 47%) | no trial data cached |
| Nephropathy | 28 | 11.3 7.8–16.3ROR 11.3 · χ² 251 / p 7e-57 | 10.6 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · ♀ 100% (drug 47%) | no trial data cached |
| Carpal tunnel syndrome | 41 | 11.0 8.1–15.0ROR 11.1 · χ² 363 / p 3e-81 | 10.6 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 100% (drug 47%) | no trial data cached |
| International normalised ratio increased | 80 | 10.5 8.4–13.0ROR 10.6 · χ² 677 / p 2e-149 | 10.2 EB05 8.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 | no trial data cached |
| Fibromyalgia | 65 | 10.1 7.9–12.9ROR 10.2 · χ² 523 / p 4e-116 | 9.8 EB05 7.9 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 100% (drug 47%) | no trial data cached |
| Contraindicated product administered | 77 | 9.6 7.7–12.0ROR 9.8 · χ² 587 / p 6e-130 | 9.4 EB05 7.7 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 7.0 · ♀ 91% (drug 47%) | no trial data cached |
| Blood iron decreased | 30 | 9.6 6.7–13.7ROR 9.7 · χ² 222 / p 1e-50 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Hepatic steatosis | 46 | 9.3 7.0–12.5ROR 9.4 · χ² 333 / p 8e-75 | 8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · ♀ 74% (drug 47%) | no trial data cached |
| Cardiomyopathy | 36 | 9.2 6.6–12.7ROR 9.2 · χ² 254 / p 2e-57 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.3 · ♀ 11% (drug 47%) | no trial data cached |
| Melaena (black stool) | 53 | 9.1 6.9–11.9ROR 9.1 · χ² 372 / p 3e-83 | 8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Sleep disorder due to a general medical condition | 38 | 8.9 6.5–12.2ROR 8.9 · χ² 257 / p 4e-58 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · ♀ 100% (drug 47%) | no trial data cached |
| Hyperkalaemia (high potassium) | 82 | 8.9 7.2–11.0ROR 9.0 · χ² 564 / p 5e-125 | 8.6 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.3 · 96% clinician | no trial data cached |
| Eosinophilia | 39 | 8.4 6.2–11.5ROR 8.5 · χ² 247 / p 5e-56 | 7.9 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 · ♀ 13% (drug 47%) | no trial data cached |
| Anorexia | 29 | 8.4 5.8–12.0ROR 8.4 · χ² 181 / p 2e-41 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Blood pressure fluctuation | 53 | 8.3 6.4–10.9ROR 8.4 · χ² 333 / p 9e-75 | 7.9 EB05 6.2 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 | no trial data cached |
| Ventricular fibrillation | 24 | 8.1 5.5–12.1ROR 8.2 · χ² 143 / p 3e-33 | 7.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Toxic skin eruption | 20 | 7.5 4.8–11.6ROR 7.5 · χ² 106 / p 5e-25 | 6.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Blood urea increased | 33 | 7.4 5.3–10.4ROR 7.4 · χ² 176 / p 2e-40 | 6.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.8 · 100% clinician | no trial data cached |
| Neutrophil count increased | 20 | 7.3 4.7–11.4ROR 7.4 · χ² 103 / p 2e-24 | 6.4 EB05 4.3 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 | no trial data cached |
| Lip swelling | 64 | 7.3 5.7–9.3ROR 7.3 · χ² 340 / p 4e-76 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.8 · 94% clinician | no trial data cached |
| Serotonin syndrome | 36 | 7.1 5.1–9.8ROR 7.1 · χ² 182 / p 7e-42 | 6.6 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 100% (drug 47%) | no trial data cached |
| Cardiac failure (heart failure) | 151 | 7.1 6.1–8.3ROR 7.3 · χ² 786 / p 4e-173 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Heart rate decreased | 66 | 7.1 5.6–9.0ROR 7.1 · χ² 337 / p 1e-75 | 6.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Hyponatraemia (low sodium) | 105 | 7.0 5.8–8.5ROR 7.2 · χ² 539 / p 1e-119 | 6.9 EB05 5.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · ♀ 69% (drug 47%) · 91% clinician | no trial data cached |
| Mitral valve incompetence | 21 | 7.0 4.6–10.7ROR 7.0 · χ² 102 / p 3e-24 | 6.2 EB05 4.2 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 90% clinician | no trial data cached |
| Depressed level of consciousness | 73 | 7.0 5.6–8.8ROR 7.1 · χ² 368 / p 3e-82 | 6.7 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 87% (drug 47%) | no trial data cached |
| Electrocardiogram qt prolonged | 65 | 6.8 5.3–8.7ROR 6.9 · χ² 317 / p 4e-71 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 72% (drug 47%) | no trial data cached |
| Hypothyroidism | 56 | 6.6 5.1–8.6ROR 6.7 · χ² 262 / p 3e-59 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · ♀ 83% (drug 47%) | no trial data cached |
| Angioedema (deep swelling of face/throat) | 76 | 6.5 5.2–8.1ROR 6.6 · χ² 348 / p 6e-78 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.0 | no trial data cached |
| Body temperature decreased | 17 | 6.5 4.0–10.4ROR 6.5 · χ² 73 / p 7e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 29 | 6.3 4.4–9.0ROR 6.3 · χ² 123 / p 7e-29 | 5.7 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.2 · 100% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 68 | 6.2 4.9–7.8ROR 6.2 · χ² 289 / p 4e-65 | 5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 90% clinician | no trial data cached |
| Tooth fracture | 18 | 6.2 3.9–9.8ROR 6.2 · χ² 73 / p 8e-18 | 5.4 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Drug interaction | 254 | 6.0 5.4–6.8ROR 6.3 · χ² 1,069 / p 8e-235 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Drug toxicity | 22 | 6.0 4.0–9.1ROR 6.0 · χ² 87 / p 6e-21 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 | 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) | 361 | 2.4 2.2–2.7ROR 2.5 · χ² 303 / p 4e-68 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Malaise (feeling unwell) | 319 | 2.7 2.5–3.0ROR 2.8 · χ² 357 / p 7e-80 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Fall | 288 | 3.3 2.9–3.7ROR 3.4 · χ² 457 / p 9e-102 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Hypertension (high blood pressure) | 259 | 4.6 4.1–5.2ROR 4.8 · χ² 734 / p 5e-162 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.4 · ♀ 72% (drug 47%) | no trial data cached |
| Drug interaction | 254 | 6.0 5.4–6.8ROR 6.3 · χ² 1,069 / p 8e-235 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | no trial data cached |
| Arthralgia (joint pain) | 234 | 2.1 1.9–2.4ROR 2.2 · χ² 142 / p 6e-33 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Cough | 188 | 2.5 2.2–2.9ROR 2.6 · χ² 175 / p 3e-40 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Hypotension (low blood pressure) | 185 | 3.5 3.0–4.0ROR 3.6 · χ² 328 / p 2e-73 | 3.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 2.4 | no trial data cached |
| Pain in extremity | 164 | 2.1 1.8–2.4ROR 2.1 · χ² 94 / p 2e-22 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.2 · ♀ 69% (drug 47%) | no trial data cached |
| Renal failure acute | 160 | 14.1 12.1–16.4ROR 14.4 · χ² 1,923 / p <1e-300 | 14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 · 90% clinician | no trial data cached |
| Cardiac failure (heart failure) | 151 | 7.1 6.1–8.3ROR 7.3 · χ² 786 / p 4e-173 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Abdominal pain | 143 | 2.3 2.0–2.7ROR 2.4 · χ² 107 / p 2e-25 | 2.3 EB05 2.0 · IC025 +0.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 1.8 · ♀ 73% (drug 47%) | no trial data cached |
| Renal failure (kidney failure) | 140 | 3.9 3.4–4.6ROR 4.0 · χ² 307 / p 6e-69 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Blood pressure increased | 132 | 3.2 2.7–3.8ROR 3.3 · χ² 204 / p 1e-46 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Chest pain | 125 | 2.5 2.1–3.0ROR 2.6 · χ² 116 / p 2e-27 | 2.5 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | 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.
- Nephropathy toxic — n=40, PRR 13.6
- Sleep apnoea syndrome — n=59, PRR 11.7
- Nephropathy — n=28, PRR 11.3
- Carpal tunnel syndrome — n=41, PRR 11.0
- Fibromyalgia — n=65, PRR 10.1
- Hepatic steatosis — n=46, PRR 9.3
- Melaena — n=53, PRR 9.1
- Sleep disorder due to a general medical condition — n=38, PRR 8.9
- Anorexia — n=29, PRR 8.4
- Ventricular fibrillation — n=24, PRR 8.1
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 Perindopril Erbumine?
In FDA FAERS, the most frequently co-reported reaction terms for Perindopril Erbumine are dyspnoea, malaise, fall, hypertension, arthralgia, cough. 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 Perindopril Erbumine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue perindopril erbumine as soon as possible [see Warnings and Precautions (5.4) ]. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus [see Warnings and Precautions (5.4) ] .
Do FAERS signals prove that Perindopril Erbumine 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 87768fbf-7c63-47da-8925-0316f343d6ef, effective 20240313; matched on
openfda.generic_name.exact:"PERINDOPRIL ERBUMINE") - 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, 482 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.