Enalaprilat side effects: what 250 FDA adverse event reports show
Drug class
Not stated in label
Who reports
250 reports · 75% serious · 29 with death outcome · 50% female
Used for
Enalaprilat injection, USP is indicated for the treatment of hypertension when oral therapy is not practical. Enalaprilat injection, USP has been studied with only one other antihypertensive agent, furosemide, which showed approximately additive effects on blood pressure.
What it is
DESCRIPTION Enalaprilat injection, USP is a sterile aqueous solution for intravenous administration. Enalaprilat is an angiotensin converting enzyme inhibitor. It is chemically described as (S)-1-[N-(1-carboxy-3-phenylpropyl)-L-alanyl]-L-proline dihydrate.
Boxed warning
USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalaprilat injection, USP should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality .
Causality screen of the 10 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.
- 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. 0 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 |
|---|---|---|---|---|---|---|
| Intestinal perforation | 14 | 104.6 62.9–174.1ROR 110.8 · χ² 1,334 / p 2e-292 | 91.8 EB05 58.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 80.3 | no trial data cached |
| Blood pressure systolic increased | 18 | 77.1 49.4–120.4ROR 83.0 · χ² 1,277 / p 5e-280 | 71.4 EB05 47.8 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 64.4 | no trial data cached |
| Body temperature decreased | 7 | 59.2 28.5–122.9ROR 60.8 · χ² 344 / p 4e-77 | 51.3 EB05 26.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 50.3 | no trial data cached |
| Pulmonary congestion | 8 | 50.7 25.6–100.3ROR 52.4 · χ² 342 / p 1e-76 | 45.5 EB05 24.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 45.2 | no trial data cached |
| Sinus congestion | 8 | 49.6 25.1–98.1ROR 51.2 · χ² 334 / p 6e-75 | 44.7 EB05 24.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Heart rate decreased | 19 | 45.2 29.3–69.6ROR 48.8 · χ² 778 / p 1e-171 | 43.3 EB05 29.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 43.1 | no trial data cached |
| Nodule | 7 | 45.0 21.7–93.4ROR 46.3 · χ² 259 / p 2e-58 | 40.3 EB05 20.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 53.3 | no trial data cached |
| Diverticulitis | 12 | 36.4 21.0–63.3ROR 38.2 · χ² 379 / p 9e-85 | 34.6 EB05 21.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.6 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 13 | 24.7 14.6–42.0ROR 26.0 · χ² 273 / p 1e-61 | 23.8 EB05 14.7 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.9 | no trial data cached |
| Bone density decreased | 8 | 21.2 10.7–41.9ROR 21.9 · χ² 135 / p 2e-31 | 19.4 EB05 9.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 20.3 | 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 |
|---|---|---|---|---|---|---|
| Heart rate decreased | 19 | 45.2 29.3–69.6ROR 48.8 · χ² 778 / p 1e-171 | 43.3 EB05 29.3 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 43.1 | no trial data cached |
| Blood pressure systolic increased | 18 | 77.1 49.4–120.4ROR 83.0 · χ² 1,277 / p 5e-280 | 71.4 EB05 47.8 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious PRR 64.4 | no trial data cached |
| Intestinal perforation | 14 | 104.6 62.9–174.1ROR 110.8 · χ² 1,334 / p 2e-292 | 91.8 EB05 58.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 80.3 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 13 | 24.7 14.6–42.0ROR 26.0 · χ² 273 / p 1e-61 | 23.8 EB05 14.7 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 13.9 | no trial data cached |
| Diverticulitis | 12 | 36.4 21.0–63.3ROR 38.2 · χ² 379 / p 9e-85 | 34.6 EB05 21.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 29.6 | no trial data cached |
| Bone density decreased | 8 | 21.2 10.7–41.9ROR 21.9 · χ² 135 / p 2e-31 | 19.4 EB05 9.2 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 20.3 | no trial data cached |
| Sinus congestion | 8 | 49.6 25.1–98.1ROR 51.2 · χ² 334 / p 6e-75 | 44.7 EB05 24.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Pulmonary congestion | 8 | 50.7 25.6–100.3ROR 52.4 · χ² 342 / p 1e-76 | 45.5 EB05 24.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 45.2 | no trial data cached |
| Nodule | 7 | 45.0 21.7–93.4ROR 46.3 · χ² 259 / p 2e-58 | 40.3 EB05 20.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 53.3 | no trial data cached |
| Body temperature decreased | 7 | 59.2 28.5–122.9ROR 60.8 · χ² 344 / p 4e-77 | 51.3 EB05 26.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 50.3 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Enalaprilat?
In FDA FAERS, the most frequently co-reported reaction terms for Enalaprilat are heart rate decreased, blood pressure systolic increased, intestinal perforation, angioedema, diverticulitis, bone density decreased. 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 Enalaprilat have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: USE IN PREGNANCY When used in pregnancy during the second and third trimesters, ACE inhibitors can cause injury and even death to the developing fetus. When pregnancy is detected, enalaprilat injection, USP should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality .
Do FAERS signals prove that Enalaprilat 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 eabae489-e254-4987-ab90-7cda20a6f856, effective 20240104; matched on
openfda.generic_name.exact:"ENALAPRILAT") - 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, 10 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.