trandolapril Side Effects
Also known as: Mavik
Analysis of 1,978 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,978
Death-Related
192
9.7% of reports
Hospitalizations
987
49.9% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 192 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 37 |
| TOXICITY TO VARIOUS AGENTS | 22 |
| LACTIC ACIDOSIS | 18 |
| PNEUMONIA | 18 |
| RESPIRATORY FAILURE | 17 |
| BEZOAR | 16 |
| HYPOTENSION | 16 |
| OESOPHAGEAL OBSTRUCTION | 15 |
| PNEUMONIA ASPIRATION | 15 |
| DIARRHOEA | 14 |
| ACUTE KIDNEY INJURY | 13 |
| CARDIOGENIC SHOCK | 13 |
| HYPERKALAEMIA | 12 |
| SEPTIC SHOCK | 12 |
| COMPLETED SUICIDE | 11 |
| DEHYDRATION | 11 |
| DYSPNOEA | 11 |
| CARDIOVASCULAR DISORDER | 10 |
| DRUG INEFFECTIVE | 10 |
| FATIGUE | 10 |
Reactions in Hospitalization Reports
Top reactions in 987 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 82 |
| TOXICITY TO VARIOUS AGENTS | 67 |
| LACTIC ACIDOSIS | 62 |
| HYPOTENSION | 58 |
| DIZZINESS | 54 |
| ACUTE KIDNEY INJURY | 53 |
| DIARRHOEA | 52 |
| ASTHENIA | 51 |
| FATIGUE | 51 |
| PYREXIA | 50 |
| NAUSEA | 49 |
| FALL | 46 |
| DRUG INTERACTION | 44 |
| ABDOMINAL PAIN | 40 |
| PNEUMONIA | 40 |
| ANAEMIA | 39 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 39 |
| VOMITING | 39 |
| AGGRESSION | 38 |
| PRODUCT DOSE OMISSION ISSUE | 38 |
Nearby — Related Medications
What the FAERS Data Reveals About trandolapril Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,978 voluntary reports linked to trandolapril and its brand equivalents (Mavik), spanning 2004 through 2025. Of those, 192 (9.7%) listed death as an outcome and 987 (49.9%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 45% were female and 54% male; age distribution skews toward 75+, with 472 reports in that bracket. The single most reported reaction is dyspnoea with 137 submissions, followed by fatigue and off label use.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.