insulin detemir Side Effects
Also known as: Levemir
Analysis of 38,664 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
38,664
Death-Related
2,535
6.6% of reports
Hospitalizations
12,948
33.5% 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 2,535 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 929 |
| ACUTE KIDNEY INJURY | 180 |
| RENAL FAILURE | 152 |
| CHRONIC KIDNEY DISEASE | 140 |
| CARDIAC ARREST | 116 |
| DYSPNOEA | 100 |
| END STAGE RENAL DISEASE | 100 |
| PNEUMONIA | 100 |
| MYOCARDIAL INFARCTION | 98 |
| SEPSIS | 78 |
| OFF LABEL USE | 76 |
| DIARRHOEA | 74 |
| NAUSEA | 73 |
| RESPIRATORY FAILURE | 70 |
| CEREBROVASCULAR ACCIDENT | 66 |
| ASTHENIA | 64 |
| CARDIAC FAILURE CONGESTIVE | 63 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 63 |
| FATIGUE | 62 |
| CARDIO-RESPIRATORY ARREST | 61 |
Reactions in Hospitalization Reports
Top reactions in 12,948 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| BLOOD GLUCOSE INCREASED | 1,208 |
| NAUSEA | 849 |
| PNEUMONIA | 792 |
| FALL | 791 |
| VOMITING | 758 |
| DYSPNOEA | 730 |
| ACUTE KIDNEY INJURY | 663 |
| FATIGUE | 617 |
| HYPOGLYCAEMIA | 580 |
| ASTHENIA | 570 |
| DIABETIC KETOACIDOSIS | 569 |
| CEREBROVASCULAR ACCIDENT | 565 |
| DIARRHOEA | 532 |
| MALAISE | 498 |
| PYREXIA | 468 |
| PAIN | 457 |
| ANAEMIA | 441 |
| DEHYDRATION | 440 |
| RENAL FAILURE | 432 |
| BLOOD GLUCOSE DECREASED | 415 |
Nearby — Related Medications
What the FAERS Data Reveals About insulin detemir Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 38,664 voluntary reports linked to insulin detemir and its brand equivalents (Levemir), spanning 2004 through 2025. Of those, 2,535 (6.6%) listed death as an outcome and 12,948 (33.5%) 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, 58% were female and 42% male; age distribution skews toward 45-64, with 9,204 reports in that bracket. The single most reported reaction is blood glucose increased with 6,220 submissions, followed by nausea and blood glucose decreased.
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.