Trandolapril side effects: what 2,025 FDA adverse event reports show
Drug class
Angiotensin Converting Enzyme Inhibitor
Who reports
2,025 reports · 87% serious · 195 with death outcome · 45% female
Used for
Hypertension Trandolapril tablets are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medication such as hydrochlorothiazide. Heart Failure Post Myocardial Infarction or Left-Ventricular D.
What it is
DESCRIPTION Trandolapril is the ethyl ester prodrug of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor, trandolaprilat. Trandolapril is chemically described as (2S,3aR,7aS)-1-[(S)-N-[(S)-1-Carboxy-3-phenylpropyl] alanyl] hexahydro-2-indolinecarboxylic acid, 1-ethyl ester.
Boxed warning
FETAL TOXICITY When pregnancy is detected, discontinue trandolapril 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 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. 75 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 |
|---|---|---|---|---|---|---|
| Lactic acidosis | 64 | 20.7 16.3–26.3ROR 21.3 · χ² 1,179 / p 1e-258 | 20.5 EB05 16.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 95% clinician | no trial data cached |
| Cardiogenic shock | 28 | 20.4 14.1–29.4ROR 20.6 · χ² 495 / p 5e-110 | 20.0 EB05 14.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 | no trial data cached |
| Psychotic disorder | 45 | 15.8 11.8–21.1ROR 16.1 · χ² 609 / p 1e-134 | 15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 17% (drug 45%) | no trial data cached |
| Sinus bradycardia | 13 | 13.9 8.1–23.9ROR 14.0 · χ² 143 / p 3e-33 | 12.6 EB05 7.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Hyperkalaemia (high potassium) | 45 | 13.4 10.0–17.8ROR 13.6 · χ² 503 / p 1e-111 | 13.1 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Spinal pain | 15 | 13.3 8.0–22.0ROR 13.4 · χ² 158 / p 1e-36 | 12.2 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Body temperature decreased | 12 | 12.5 7.1–22.0ROR 12.6 · χ² 116 / p 2e-27 | 10.9 EB05 5.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.2 | no trial data cached |
| Vaginal discharge | 12 | 12.4 7.0–21.8ROR 12.5 · χ² 114 / p 5e-27 | 10.8 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Libido decreased (lower sex drive) | 14 | 11.7 6.9–19.7ROR 11.8 · χ² 127 / p 1e-29 | 10.3 EB05 6.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.7 | no trial data cached |
| Tachypnoea | 15 | 11.5 6.9–19.0ROR 11.6 · χ² 133 / p 4e-31 | 10.2 EB05 6.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Hypothermia | 11 | 11.2 6.2–20.3ROR 11.3 · χ² 93 / p 3e-22 | 9.3 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Coagulopathy | 18 | 11.2 7.1–17.8ROR 11.3 · χ² 158 / p 2e-36 | 10.1 EB05 6.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Blood pressure systolic increased | 21 | 11.1 7.3–17.0ROR 11.2 · χ² 183 / p 5e-42 | 10.2 EB05 6.7 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 | no trial data cached |
| Intestinal perforation | 12 | 11.1 6.3–19.5ROR 11.1 · χ² 100 / p 8e-24 | 9.3 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Pulmonary congestion | 14 | 11.0 6.5–18.5ROR 11.0 · χ² 117 / p 2e-27 | 9.5 EB05 5.5 · IC025 +2.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.4 | no trial data cached |
| Coronary artery occlusion | 14 | 10.5 6.2–17.7ROR 10.6 · χ² 111 / p 3e-26 | 9.0 EB05 5.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Glomerular filtration rate decreased | 12 | 10.3 5.8–18.1ROR 10.3 · χ² 91 / p 6e-22 | 8.5 EB05 4.8 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 10 | 10.2 5.5–18.9ROR 10.2 · χ² 74 / p 4e-18 | 8.1 EB05 4.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Ventricular extrasystoles | 10 | 10.0 5.4–18.5ROR 10.0 · χ² 72 / p 1e-17 | 7.9 EB05 4.2 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Melaena (black stool) | 20 | 9.4 6.1–14.5ROR 9.5 · χ² 142 / p 6e-33 | 8.3 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 20% (drug 45%) | no trial data cached |
| Ventricular tachycardia | 15 | 9.4 5.7–15.5ROR 9.4 · χ² 104 / p 1e-24 | 8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Obstructive airways disorder | 10 | 9.3 5.0–17.2ROR 9.3 · χ² 66 / p 2e-16 | 7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Cardiomegaly | 11 | 9.2 5.1–16.6ROR 9.2 · χ² 72 / p 9e-18 | 7.4 EB05 4.1 · IC025 +1.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.2 | no trial data cached |
| Haematocrit decreased | 17 | 8.8 5.5–14.2ROR 8.9 · χ² 110 / p 4e-26 | 7.6 EB05 4.9 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 | no trial data cached |
| Ankylosing spondylitis | 11 | 8.7 4.9–15.8ROR 8.8 · χ² 68 / p 9e-17 | 7.0 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Aggression | 42 | 8.7 6.4–11.7ROR 8.8 · χ² 278 / p 1e-62 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 10% (drug 45%) | no trial data cached |
| Renal failure acute | 36 | 8.7 6.3–12.0ROR 8.8 · χ² 237 / p 1e-53 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 14 | 8.3 4.9–14.0ROR 8.4 · χ² 83 / p 4e-20 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 38 | 8.1 5.9–11.1ROR 8.2 · χ² 230 / p 3e-52 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 91% clinician | no trial data cached |
| Abscess | 12 | 7.8 4.4–13.7ROR 7.8 · χ² 64 / p 5e-16 | 6.3 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Hepatic steatosis | 14 | 7.8 4.6–13.1ROR 7.8 · χ² 76 / p 1e-18 | 6.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Obesity | 12 | 7.8 4.4–13.7ROR 7.8 · χ² 64 / p 5e-16 | 6.3 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Sleep apnoea syndrome | 14 | 7.6 4.5–12.8ROR 7.6 · χ² 74 / p 5e-18 | 6.3 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pancreatitis acute | 16 | 7.4 4.6–12.1ROR 7.5 · χ² 83 / p 5e-20 | 6.3 EB05 4.1 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.9 | no trial data cached |
| Spinal fracture | 14 | 7.3 4.3–12.3ROR 7.3 · χ² 70 / p 4e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Poor quality sleep | 15 | 7.3 4.4–12.0ROR 7.3 · χ² 75 / p 2e-18 | 6.1 EB05 3.9 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Gastroenteritis | 10 | 7.1 3.8–13.2ROR 7.1 · χ² 47 / p 4e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Sleep disorder | 48 | 7.1 5.4–9.4ROR 7.3 · χ² 246 / p 8e-56 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 79% (drug 45%) | no trial data cached |
| Oxygen saturation decreased | 38 | 7.1 5.1–9.7ROR 7.2 · χ² 192 / p 6e-44 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 80% (drug 45%) | no trial data cached |
| Tendonitis | 10 | 6.7 3.6–12.4ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 93 | 6.1 5.0–7.4ROR 6.3 · χ² 392 / p 2e-87 | 5.9 EB05 5.0 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 91% clinician | no trial data cached |
| Toxicity to various agents | 78 | 4.8 3.9–6.0ROR 5.0 · χ² 234 / p 5e-53 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Lactic acidosis | 64 | 20.7 16.3–26.3ROR 21.3 · χ² 1,179 / p 1e-258 | 20.5 EB05 16.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 95% clinician | no trial data cached |
| Inappropriate schedule of product administration | 53 | 3.1 2.4–4.0ROR 3.2 · χ² 74 / p 4e-18 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · ♀ 13% (drug 45%) | no trial data cached |
| Sleep disorder | 48 | 7.1 5.4–9.4ROR 7.3 · χ² 246 / p 8e-56 | 6.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 79% (drug 45%) | no trial data cached |
| Hyperkalaemia (high potassium) | 45 | 13.4 10.0–17.8ROR 13.6 · χ² 503 / p 1e-111 | 13.1 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Psychotic disorder | 45 | 15.8 11.8–21.1ROR 16.1 · χ² 609 / p 1e-134 | 15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 · ♀ 17% (drug 45%) | no trial data cached |
| Cardiac failure (heart failure) | 44 | 5.7 4.2–7.6ROR 5.8 · χ² 165 / p 4e-38 | 5.4 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.7 | no trial data cached |
| Aggression | 42 | 8.7 6.4–11.7ROR 8.8 · χ² 278 / p 1e-62 | 8.2 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 10% (drug 45%) | no trial data cached |
| Oxygen saturation decreased | 38 | 7.1 5.1–9.7ROR 7.2 · χ² 192 / p 6e-44 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 · ♀ 80% (drug 45%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 38 | 8.1 5.9–11.1ROR 8.2 · χ² 230 / p 3e-52 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 91% clinician | no trial data cached |
| Renal failure acute | 36 | 8.7 6.3–12.0ROR 8.8 · χ² 237 / p 1e-53 | 8.1 EB05 6.0 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Mobility decreased | 35 | 5.1 3.6–7.0ROR 5.1 · χ² 110 / p 4e-26 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Flushing | 34 | 3.4 2.5–4.8ROR 3.5 · χ² 57 / p 2e-14 | 3.3 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Intentional overdose | 30 | 4.9 3.4–7.0ROR 4.9 · χ² 89 / p 2e-21 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | 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.
- Lactic acidosis — n=64, PRR 20.7
- Psychotic disorder — n=45, PRR 15.8
- Melaena — n=20, PRR 9.4
- Aggression — n=42, PRR 8.7
- Hypoglycaemia — n=38, PRR 8.1
- Sleep disorder — n=48, PRR 7.1
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 Trandolapril?
In FDA FAERS, the most frequently co-reported reaction terms for Trandolapril are toxicity to various agents, lactic acidosis, sleep disorder, hyperkalaemia, psychotic disorder, cardiac failure. 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 Trandolapril have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FETAL TOXICITY When pregnancy is detected, discontinue trandolapril 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 Trandolapril 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 514f53e6-ff6b-4d02-9db9-2575b15aa5f0, effective 20250905; matched on
openfda.generic_name.exact:"TRANDOLAPRIL") - 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, 115 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.