fosinopril Side Effects
Also known as: Monopril
Analysis of 4,213 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
4,213
Death-Related
398
9.4% of reports
Hospitalizations
1,936
46.0% of reports
Top Indication
Hypertension
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 398 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 95 |
| COMPLETED SUICIDE | 43 |
| RENAL FAILURE | 43 |
| PNEUMONIA | 31 |
| CARDIAC FAILURE CONGESTIVE | 27 |
| HYPOTENSION | 27 |
| FATIGUE | 26 |
| MYOCARDIAL INFARCTION | 26 |
| SEPSIS | 26 |
| DYSPNOEA | 23 |
| PAIN | 22 |
| PYREXIA | 22 |
| ACUTE KIDNEY INJURY | 21 |
| ATRIAL FIBRILLATION | 21 |
| DIARRHOEA | 21 |
| ANXIETY | 20 |
| FALL | 20 |
| HYPERTENSION | 18 |
| INJURY | 18 |
| RESPIRATORY FAILURE | 18 |
Reactions in Hospitalization Reports
Top reactions in 1,936 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 140 |
| ASTHENIA | 120 |
| ACUTE KIDNEY INJURY | 119 |
| RENAL FAILURE ACUTE | 117 |
| HYPOTENSION | 106 |
| BRADYCARDIA | 103 |
| CARDIAC FAILURE CONGESTIVE | 100 |
| MYOCARDIAL INFARCTION | 100 |
| DIARRHOEA | 97 |
| NAUSEA | 90 |
| FALL | 89 |
| DRUG INTERACTION | 86 |
| DIZZINESS | 85 |
| FATIGUE | 85 |
| RENAL FAILURE | 85 |
| ATRIAL FIBRILLATION | 77 |
| HYPERKALAEMIA | 77 |
| ANAEMIA | 74 |
| PYREXIA | 73 |
| PNEUMONIA | 72 |
Nearby — Related Medications
What the FAERS Data Reveals About fosinopril Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 4,213 voluntary reports linked to fosinopril and its brand equivalents (Monopril), spanning 2004 through 2025. Of those, 398 (9.4%) listed death as an outcome and 1,936 (46.0%) involved hospitalization. The most common indication reported alongside adverse events was Hypertension.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 41% were female and 59% male; age distribution skews toward 45-64, with 1,035 reports in that bracket. The single most reported reaction is fatigue with 239 submissions, followed by diarrhoea and dyspnoea.
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.