miglitol Side Effects
Also known as: Glyset
Analysis of 923 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
923
Death-Related
106
11.5% of reports
Hospitalizations
542
58.7% of reports
Top Indication
Diabetes Mellitus
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 106 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 10 |
| PNEUMONIA | 10 |
| SEPSIS | 10 |
| DECREASED APPETITE | 9 |
| DIARRHOEA | 8 |
| OFF LABEL USE | 7 |
| HEPATIC FUNCTION ABNORMAL | 6 |
| INTERSTITIAL LUNG DISEASE | 6 |
| PLATELET COUNT DECREASED | 6 |
| RESPIRATORY FAILURE | 6 |
| CARDIAC FAILURE | 5 |
| LIVER DISORDER | 5 |
| MALAISE | 5 |
| DIABETES MELLITUS | 4 |
| DISEASE PROGRESSION | 4 |
| DISSEMINATED INTRAVASCULAR COAGULATION | 4 |
| DRUG-INDUCED LIVER INJURY | 4 |
| HYPOGLYCAEMIA | 4 |
| LACTIC ACIDOSIS | 4 |
| SEPTIC SHOCK | 4 |
Reactions in Hospitalization Reports
Top reactions in 542 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HYPOGLYCAEMIA | 45 |
| DECREASED APPETITE | 27 |
| DRUG INTERACTION | 24 |
| HEPATIC FUNCTION ABNORMAL | 21 |
| RENAL IMPAIRMENT | 20 |
| DIARRHOEA | 19 |
| NAUSEA | 19 |
| CARDIAC FAILURE | 18 |
| HYPERGLYCAEMIA | 18 |
| DIABETES MELLITUS | 17 |
| DIABETES MELLITUS INADEQUATE CONTROL | 16 |
| LIVER DISORDER | 16 |
| OFF LABEL USE | 16 |
| PEMPHIGOID | 16 |
| PNEUMONIA | 16 |
| VOMITING | 16 |
| DIABETIC KETOACIDOSIS | 15 |
| PLATELET COUNT DECREASED | 14 |
| ACUTE KIDNEY INJURY | 13 |
| ALANINE AMINOTRANSFERASE INCREASED | 13 |
Nearby — Related Medications
What the FAERS Data Reveals About miglitol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 923 voluntary reports linked to miglitol and its brand equivalents (Glyset), spanning 2004 through 2025. Of those, 106 (11.5%) listed death as an outcome and 542 (58.7%) involved hospitalization. The most common indication reported alongside adverse events was Diabetes Mellitus.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 40% were female and 60% male; age distribution skews toward 75+, with 267 reports in that bracket. The single most reported reaction is hypoglycaemia with 67 submissions, followed by hepatic function abnormal and decreased appetite.
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.