Drug side effects
insulin glulisine Side Effects
The reactions most often reported to the FDA for insulin glulisine (also sold as Apidra), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 9,944
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2005 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 insulin glulisine come from 9,944 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 9,944 reports to the FDA Adverse Event Reporting System (FAERS) for insulin glulisine (Apidra): 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
9,944
Reports Mentioning Death
795
8.0% of reports — not proof the medicine caused the death
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 |
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.
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to insulin glulisine's 9,944.
Read our methodology - how this data is sourced, computed, and verified.