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Drug side effects

glimepiride Side Effects

The reactions most often reported to the FDA for glimepiride (also sold as Amaryl), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

37,936
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2003 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of glimepiride come from 37,936 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 37,936 reports to the FDA Adverse Event Reporting System (FAERS) for glimepiride (Amaryl): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

37,936

Reports Mentioning Death

3,187

8.4% of reports — not proof the medicine caused the death

Hospitalizations

13,533

35.7% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

BLOOD GLUCOSE INCREASED
2,970
NAUSEA
2,276
DIARRHOEA
2,169
FATIGUE
1,827
HYPOGLYCAEMIA
1,639
WEIGHT DECREASED
1,391
DIZZINESS
1,365
DYSPNOEA
1,319
VOMITING
1,287
ACUTE KIDNEY INJURY
1,214
ASTHENIA
1,196
DECREASED APPETITE
1,147
FALL
1,071
PAIN
1,049
HEADACHE
1,022
DEATH
1,008
MALAISE
995
RENAL FAILURE
966

Who Reports Side Effects

Gender Distribution

Female 17,644 (49%)
Male 18,306 (51%)
Unknown 61

Age Distribution

0-17 154 (1%)
18-44 1,070 (4%)
45-64 8,920 (35%)
65-74 8,573 (33%)
75+ 7,043 (27%)

Reporting Trend by Year

2003 2025

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

Compare glimepiride vs acarbose →

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.

How to read these numbers

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.