Fosinopril Sodium side effects: what 2,112 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Fosinopril Sodium
Who reports
2,112 reports · 77% serious · 219 with death outcome · 39% female
Used for
Fosinopril sodium tablets are indicated for the treatment of hypertension. It may be used alone or in combination with thiazide diuretics. Fosinopril sodium tablets are indicated in the management of heart failure as adjunctive therapy when added to conventional therapy including diuretics with or without digitalis (see DOSAGE AND ADMINISTRATION ).
What it is
DESCRIPTION Fosinopril sodium tablet, USP is the sodium salt of fosinopril USP, the ester prodrug of an angiotensin converting enzyme (ACE) inhibitor, fosinoprilat. It contains a phosphinate group capable of specific binding to the active site of angiotensin converting enzyme.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue fosinopril sodium 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
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. 72 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 | 112 | 25.9 21.6–31.0ROR 27.3 · χ² 2,655 / p <1e-300 | 25.7 EB05 22.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.2 · 93% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 70 | 20.0 15.8–25.1ROR 20.6 · χ² 1,241 / p 4e-272 | 19.8 EB05 16.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.3 · 98% clinician | no trial data cached |
| Blood urea increased | 25 | 14.8 10.0–21.8ROR 14.9 · χ² 307 / p 5e-69 | 14.3 EB05 9.9 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 11.7 · ♀ 4% (drug 39%) · 95% clinician | no trial data cached |
| Bradycardia (slow heart rate) | 71 | 13.3 10.6–16.7ROR 13.7 · χ² 795 / p 3e-175 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| International normalised ratio increased | 38 | 13.1 9.6–18.0ROR 13.3 · χ² 413 / p 3e-92 | 12.8 EB05 9.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Body temperature decreased | 13 | 13.0 7.6–22.4ROR 13.1 · χ² 132 / p 6e-31 | 11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 | no trial data cached |
| Cardiomegaly | 16 | 12.8 7.9–20.9ROR 12.9 · χ² 163 / p 2e-37 | 11.8 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Supraventricular tachycardia | 12 | 12.5 7.1–21.9ROR 12.5 · χ² 115 / p 3e-27 | 10.9 EB05 5.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Sinus bradycardia | 12 | 12.3 7.0–21.7ROR 12.4 · χ² 114 / p 8e-27 | 10.7 EB05 5.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 | no trial data cached |
| Atelectasis | 12 | 12.3 7.0–21.6ROR 12.4 · χ² 113 / p 9e-27 | 10.7 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Economic problem | 19 | 12.3 7.8–19.2ROR 12.4 · χ² 185 / p 2e-42 | 11.3 EB05 7.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 21 | 12.0 7.8–18.3ROR 12.1 · χ² 200 / p 1e-45 | 11.1 EB05 7.3 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 | no trial data cached |
| Mitral valve incompetence | 13 | 11.4 6.6–19.6ROR 11.5 · χ² 113 / p 9e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Coronary artery disease | 35 | 11.4 8.2–15.8ROR 11.6 · χ² 322 / p 3e-72 | 10.9 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Faeces discoloured | 23 | 10.5 7.0–15.8ROR 10.6 · χ² 189 / p 2e-43 | 9.7 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 90% clinician | no trial data cached |
| Gastroenteritis | 14 | 9.5 5.7–16.1ROR 9.6 · χ² 99 / p 1e-23 | 8.1 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Haematocrit decreased | 19 | 9.5 6.0–14.8ROR 9.5 · χ² 135 / p 1e-31 | 8.3 EB05 5.4 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 | no trial data cached |
| Ulcer | 15 | 9.4 5.6–15.5ROR 9.4 · χ² 104 / p 1e-24 | 8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 45 | 9.2 6.9–12.3ROR 9.4 · χ² 322 / p 3e-72 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 38 | 8.6 6.2–11.7ROR 8.7 · χ² 246 / p 8e-56 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.1 · 94% clinician | no trial data cached |
| Sleep apnoea syndrome | 16 | 8.3 5.1–13.5ROR 8.4 · χ² 96 / p 7e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Cardiac failure congestive | 67 | 8.2 6.5–10.4ROR 8.4 · χ² 418 / p 3e-93 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Swollen tongue | 25 | 7.9 5.4–11.7ROR 8.0 · χ² 145 / p 1e-33 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Drug toxicity | 11 | 7.9 4.4–14.3ROR 7.9 · χ² 60 / p 6e-15 | 6.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 12 | 7.6 4.3–13.3ROR 7.6 · χ² 62 / p 2e-15 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Diabetes mellitus inadequate control | 13 | 7.3 4.2–12.5ROR 7.3 · χ² 64 / p 5e-16 | 6.0 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Coordination abnormal | 10 | 7.1 3.8–13.1ROR 7.1 · χ² 46 / p 5e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Upper gastrointestinal haemorrhage | 12 | 7.1 4.0–12.4ROR 7.1 · χ² 57 / p 3e-14 | 5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Blood potassium increased | 11 | 6.7 3.7–12.1ROR 6.8 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Ventricular tachycardia | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Blood pressure systolic increased | 13 | 6.6 3.8–11.3ROR 6.6 · χ² 56 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 | no trial data cached |
| Multi-organ failure | 11 | 6.2 3.5–11.2ROR 6.3 · χ² 43 / p 2e-11 | 5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Blood creatinine increased | 41 | 6.2 4.6–8.4ROR 6.3 · χ² 175 / p 3e-40 | 5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Atrial fibrillation | 58 | 5.9 4.6–7.6ROR 6.0 · χ² 232 / p 9e-53 | 5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Mental status changes | 16 | 5.7 3.5–9.3ROR 5.8 · χ² 58 / p 2e-14 | 5.0 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Urinary incontinence | 17 | 5.7 3.6–9.2ROR 5.7 · χ² 61 / p 2e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Anhedonia | 15 | 5.6 3.4–9.3ROR 5.7 · χ² 53 / p 2e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Oral herpes | 11 | 5.6 3.1–10.1ROR 5.6 · χ² 37 / p 5e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 | no trial data cached |
| Transient ischaemic attack (mini-stroke) | 19 | 5.6 3.6–8.7ROR 5.6 · χ² 67 / p 2e-16 | 4.9 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Abasia | 13 | 5.2 3.0–8.9ROR 5.2 · χ² 39 / p 2e-10 | 4.4 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | 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 |
|---|---|---|---|---|---|---|
| Renal failure acute | 112 | 25.9 21.6–31.0ROR 27.3 · χ² 2,655 / p <1e-300 | 25.7 EB05 22.0 · IC025 +4.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 19.2 · 93% clinician | no trial data cached |
| Myocardial infarction (heart attack) | 84 | 4.7 3.8–5.9ROR 4.9 · χ² 246 / p 8e-56 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Bradycardia (slow heart rate) | 71 | 13.3 10.6–16.7ROR 13.7 · χ² 795 / p 3e-175 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.1 · 92% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 70 | 20.0 15.8–25.1ROR 20.6 · χ² 1,241 / p 4e-272 | 19.8 EB05 16.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.3 · 98% clinician | no trial data cached |
| Cardiac failure congestive | 67 | 8.2 6.5–10.4ROR 8.4 · χ² 418 / p 3e-93 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Atrial fibrillation | 58 | 5.9 4.6–7.6ROR 6.0 · χ² 232 / p 9e-53 | 5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Blood glucose increased | 52 | 2.7 2.1–3.6ROR 2.8 · χ² 56 / p 4e-14 | 2.7 EB05 2.1 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.4 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 45 | 9.2 6.9–12.3ROR 9.4 · χ² 322 / p 3e-72 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Blood creatinine increased | 41 | 6.2 4.6–8.4ROR 6.3 · χ² 175 / p 3e-40 | 5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 | no trial data cached |
| Diabetes mellitus | 38 | 4.9 3.6–6.8ROR 5.0 · χ² 115 / p 3e-27 | 4.7 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 38 | 8.6 6.2–11.7ROR 8.7 · χ² 246 / p 8e-56 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.1 · 94% clinician | no trial data cached |
| International normalised ratio increased | 38 | 13.1 9.6–18.0ROR 13.3 · χ² 413 / p 3e-92 | 12.8 EB05 9.5 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.3 | no trial data cached |
| Injury | 35 | 4.9 3.5–6.8ROR 5.0 · χ² 106 / p 4e-25 | 4.6 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.4 | no trial data cached |
| Coronary artery disease | 35 | 11.4 8.2–15.8ROR 11.6 · χ² 322 / p 3e-72 | 10.9 EB05 8.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Completed suicide (death by suicide) | 29 | 3.4 2.4–4.9ROR 3.5 · χ² 48 / p 3e-12 | 3.3 EB05 2.4 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.5 · ♀ 15% (drug 39%) · 96% clinician | 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=35, PRR 11.4
- Faeces discoloured — n=23, PRR 10.5
- Hypoglycaemia — n=45, PRR 9.2
- Swollen tongue — n=25, PRR 7.9
- Atrial fibrillation — n=58, PRR 5.9
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 Fosinopril?
In FDA FAERS, the most frequently co-reported reaction terms for Fosinopril are renal failure acute, myocardial infarction, bradycardia, hyperkalaemia, cardiac failure congestive, atrial fibrillation. 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 Fosinopril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue fosinopril sodium 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 Fosinopril 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 736fe52f-69fb-48b2-b1c5-f06531878538, effective 20230120; matched on
openfda.generic_name.exact:"FOSINOPRIL") - 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, 112 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.