nateglinide Side Effects
Also known as: Starlix
Analysis of 1,302 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,302
Death-Related
141
10.8% of reports
Hospitalizations
532
40.9% 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 141 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 47 |
| LACTIC ACIDOSIS | 19 |
| RENAL FAILURE | 16 |
| CARDIAC ARREST | 15 |
| TOXICITY TO VARIOUS AGENTS | 14 |
| COMA | 11 |
| COMPLETED SUICIDE | 11 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 11 |
| RESPIRATORY FAILURE | 9 |
| BLOOD PRESSURE DECREASED | 7 |
| DIARRHOEA | 7 |
| DYSPNOEA | 7 |
| PNEUMONIA | 7 |
| RENAL FAILURE ACUTE | 7 |
| ACUTE KIDNEY INJURY | 6 |
| RENAL IMPAIRMENT | 6 |
| HEART RATE DECREASED | 5 |
| INTENTIONAL OVERDOSE | 5 |
| INTERSTITIAL LUNG DISEASE | 5 |
| MULTI-ORGAN FAILURE | 5 |
Reactions in Hospitalization Reports
Top reactions in 532 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 34 |
| HYPOGLYCAEMIA | 30 |
| LACTIC ACIDOSIS | 30 |
| NAUSEA | 29 |
| RENAL FAILURE | 29 |
| FALL | 27 |
| PNEUMONIA | 27 |
| VOMITING | 27 |
| DECREASED APPETITE | 26 |
| DIARRHOEA | 23 |
| FATIGUE | 22 |
| PYREXIA | 22 |
| ACUTE KIDNEY INJURY | 20 |
| BLOOD GLUCOSE INCREASED | 20 |
| ASTHENIA | 17 |
| CHEST PAIN | 17 |
| DIZZINESS | 17 |
| HYPOTENSION | 17 |
| TOXICITY TO VARIOUS AGENTS | 16 |
| ABDOMINAL PAIN | 15 |
Nearby — Related Medications
What the FAERS Data Reveals About nateglinide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,302 voluntary reports linked to nateglinide and its brand equivalents (Starlix), spanning 2004 through 2025. Of those, 141 (10.8%) listed death as an outcome and 532 (40.9%) 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, 53% were female and 47% male; age distribution skews toward 75+, with 299 reports in that bracket. The single most reported reaction is blood glucose increased with 76 submissions, followed by drug ineffective 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.