glimepiride Side Effects
Also known as: Amaryl
Analysis of 37,936 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
37,936
Death-Related
3,187
8.4% of reports
Hospitalizations
13,533
35.7% 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 3,187 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,007 |
| COMPLETED SUICIDE | 188 |
| RENAL FAILURE | 176 |
| ACUTE KIDNEY INJURY | 166 |
| PNEUMONIA | 163 |
| DYSPNOEA | 133 |
| CARDIAC ARREST | 130 |
| DIARRHOEA | 118 |
| CHRONIC KIDNEY DISEASE | 116 |
| HYPOGLYCAEMIA | 109 |
| ANAEMIA | 102 |
| NAUSEA | 102 |
| MYOCARDIAL INFARCTION | 101 |
| TOXICITY TO VARIOUS AGENTS | 98 |
| RESPIRATORY FAILURE | 95 |
| SEPSIS | 95 |
| CARDIAC FAILURE | 89 |
| LACTIC ACIDOSIS | 87 |
| FALL | 85 |
| FATIGUE | 84 |
Reactions in Hospitalization Reports
Top reactions in 13,533 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HYPOGLYCAEMIA | 1,108 |
| ACUTE KIDNEY INJURY | 752 |
| PNEUMONIA | 725 |
| DIARRHOEA | 724 |
| NAUSEA | 720 |
| FALL | 695 |
| DYSPNOEA | 673 |
| VOMITING | 647 |
| ASTHENIA | 550 |
| BLOOD GLUCOSE INCREASED | 539 |
| FATIGUE | 512 |
| RENAL FAILURE | 503 |
| DEHYDRATION | 494 |
| LACTIC ACIDOSIS | 482 |
| ANAEMIA | 463 |
| DECREASED APPETITE | 458 |
| DIZZINESS | 425 |
| WEIGHT DECREASED | 419 |
| HYPOTENSION | 412 |
| MALAISE | 401 |
Nearby — Related Medications
What the FAERS Data Reveals About glimepiride Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 37,936 voluntary reports linked to glimepiride and its brand equivalents (Amaryl), spanning 2003 through 2025. Of those, 3,187 (8.4%) listed death as an outcome and 13,533 (35.7%) 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, 49% were female and 51% male; age distribution skews toward 45-64, with 8,920 reports in that bracket. The single most reported reaction is blood glucose increased with 2,970 submissions, followed by nausea and diarrhoea.
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.