ramipril Side Effects
Also known as: Altace
Analysis of 119,507 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
119,507
Death-Related
12,637
10.6% of reports
Hospitalizations
62,948
52.7% 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 12,637 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,198 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,724 |
| OFF LABEL USE | 1,724 |
| DIARRHOEA | 1,599 |
| VOMITING | 1,545 |
| DYSPNOEA | 1,520 |
| PNEUMONIA | 1,499 |
| NAUSEA | 1,459 |
| PAIN | 1,433 |
| CONDITION AGGRAVATED | 1,371 |
| CONFUSIONAL STATE | 1,370 |
| FATIGUE | 1,359 |
| TYPE 2 DIABETES MELLITUS | 1,333 |
| HYPERTENSION | 1,330 |
| RASH | 1,305 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,297 |
| PEMPHIGUS | 1,290 |
| ABDOMINAL DISCOMFORT | 1,268 |
| RHEUMATOID ARTHRITIS | 1,268 |
| ARTHRALGIA | 1,261 |
Reactions in Hospitalization Reports
Top reactions in 62,948 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 5,486 |
| NAUSEA | 4,617 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 4,503 |
| VOMITING | 4,485 |
| ACUTE KIDNEY INJURY | 4,406 |
| DIARRHOEA | 4,309 |
| FATIGUE | 3,997 |
| FALL | 3,942 |
| DIZZINESS | 3,897 |
| ASTHENIA | 3,631 |
| OFF LABEL USE | 3,630 |
| PNEUMONIA | 3,254 |
| CONFUSIONAL STATE | 3,229 |
| PAIN | 3,178 |
| HYPOTENSION | 3,166 |
| CONDITION AGGRAVATED | 3,054 |
| PYREXIA | 3,022 |
| HYPERTENSION | 3,009 |
| MALAISE | 2,959 |
| HEADACHE | 2,913 |
Nearby — Related Medications
What the FAERS Data Reveals About ramipril Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 119,507 voluntary reports linked to ramipril and its brand equivalents (Altace), spanning 2003 through 2025. Of those, 12,637 (10.6%) listed death as an outcome and 62,948 (52.7%) 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, 48% were female and 52% male; age distribution skews toward 75+, with 30,902 reports in that bracket. The single most reported reaction is dyspnoea with 8,083 submissions, followed by fatigue and nausea.
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.