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repaglinide Side Effects

Also known as: Prandin

Analysis of 7,180 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

7,180

Death-Related

688

9.6% of reports

Hospitalizations

4,308

60.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

HYPOGLYCAEMIA
765
ACUTE KIDNEY INJURY
548
DRUG INTERACTION
418
DIARRHOEA
365
LACTIC ACIDOSIS
364
DYSPNOEA
277
NAUSEA
259
ASTHENIA
251
ANAEMIA
237
VOMITING
235
FALL
229
OFF LABEL USE
225
FATIGUE
212
BLOOD GLUCOSE INCREASED
206
HYPERKALAEMIA
195
DRUG INEFFECTIVE
191
MALAISE
185
HYPOTENSION
178
CONFUSIONAL STATE
175
PYREXIA
170

Who Reports Side Effects

Gender Distribution

Female 3,029 (46%)
Male 3,589 (54%)
Unknown 5

Age Distribution

0-17 52 (1%)
18-44 149 (3%)
45-64 1,310 (22%)
65-74 1,803 (31%)
75+ 2,547 (43%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 688 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 116
LACTIC ACIDOSIS 78
ACUTE KIDNEY INJURY 48
HYPOGLYCAEMIA 44
DYSPNOEA 42
HYPOTENSION 41
SEPTIC SHOCK 40
PNEUMONIA 37
GENERAL PHYSICAL HEALTH DETERIORATION 34
ASTHENIA 32
COMA 30
DIARRHOEA 28
RESPIRATORY FAILURE 28
DRUG INTERACTION 27
OFF LABEL USE 26
SHOCK HAEMORRHAGIC 26
RENAL FAILURE 25
CARDIAC ARREST 24
CONDITION AGGRAVATED 24
VOMITING 24

Reactions in Hospitalization Reports

Top reactions in 4,308 reports where hospitalization was an outcome.

Reaction Reports
HYPOGLYCAEMIA 460
ACUTE KIDNEY INJURY 372
DRUG INTERACTION 308
DIARRHOEA 251
DYSPNOEA 202
LACTIC ACIDOSIS 200
ANAEMIA 187
FALL 183
ASTHENIA 182
VOMITING 160
CONFUSIONAL STATE 141
PYREXIA 141
PNEUMONIA 139
NAUSEA 131
HYPOTENSION 123
DEHYDRATION 121
RENAL FAILURE 120
CARDIAC FAILURE 118
MALAISE 118
OFF LABEL USE 115

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What the FAERS Data Reveals About repaglinide Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 7,180 voluntary reports linked to repaglinide and its brand equivalents (Prandin), spanning 2004 through 2025. Of those, 688 (9.6%) listed death as an outcome and 4,308 (60.0%) 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, 46% were female and 54% male; age distribution skews toward 75+, with 2,547 reports in that bracket. The single most reported reaction is hypoglycaemia with 765 submissions, followed by acute kidney injury and drug interaction.

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.