insulin glulisine Side Effects
Also known as: Apidra
Analysis of 9,944 adverse event reports submitted to the FDA from 2005 to 2025.
Total Reports
9,944
Death-Related
795
8.0% of reports
Hospitalizations
4,001
40.2% 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 795 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 207 |
| RENAL FAILURE | 78 |
| GASTROINTESTINAL HAEMORRHAGE | 56 |
| PNEUMONIA | 49 |
| BALANCE DISORDER | 48 |
| BLOOD GLUCOSE FLUCTUATION | 48 |
| COGNITIVE DISORDER | 48 |
| CONTRAINDICATED PRODUCT ADMINISTERED | 47 |
| HAEMATOMA | 47 |
| URINARY INCONTINENCE | 47 |
| DIZZINESS | 45 |
| ACUTE KIDNEY INJURY | 44 |
| CARDIO-RESPIRATORY ARREST | 44 |
| DYSPNOEA | 39 |
| HYPERHIDROSIS | 39 |
| CONFUSIONAL STATE | 38 |
| DRUG INTERACTION | 36 |
| BLOOD GLUCOSE ABNORMAL | 34 |
| FALL | 34 |
| RESPIRATORY FAILURE | 34 |
Reactions in Hospitalization Reports
Top reactions in 4,001 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| BLOOD GLUCOSE INCREASED | 359 |
| HYPOGLYCAEMIA | 335 |
| HYPERGLYCAEMIA | 330 |
| DYSPNOEA | 246 |
| ACUTE KIDNEY INJURY | 225 |
| VOMITING | 218 |
| DIABETIC KETOACIDOSIS | 192 |
| PNEUMONIA | 170 |
| MALAISE | 162 |
| ASTHENIA | 160 |
| ANAEMIA | 157 |
| NAUSEA | 153 |
| FALL | 152 |
| DIARRHOEA | 148 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 144 |
| DIZZINESS | 139 |
| FATIGUE | 138 |
| PYREXIA | 138 |
| HYPOTENSION | 117 |
| OFF LABEL USE | 117 |
Nearby — Related Medications
What the FAERS Data Reveals About insulin glulisine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 9,944 voluntary reports linked to insulin glulisine and its brand equivalents (Apidra), spanning 2005 through 2025. Of those, 795 (8.0%) listed death as an outcome and 4,001 (40.2%) 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, 53% were female and 47% male; age distribution skews toward 45-64, with 2,851 reports in that bracket. The single most reported reaction is blood glucose increased with 1,526 submissions, followed by hypoglycaemia and hyperglycaemia.
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.