PlainMeds provides educational information only. This is not medical advice. Always consult your doctor or pharmacist.

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

BLOOD GLUCOSE INCREASED
6,220
NAUSEA
1,972
BLOOD GLUCOSE DECREASED
1,568
FATIGUE
1,534
DIARRHOEA
1,399
DRUG INEFFECTIVE
1,366
VOMITING
1,313
DYSPNOEA
1,293
MALAISE
1,203
FALL
1,189
DIZZINESS
1,161
HEADACHE
1,099
PAIN
1,077
ACUTE KIDNEY INJURY
1,067
HYPOGLYCAEMIA
1,061
ASTHENIA
1,049
WEIGHT DECREASED
975
OFF LABEL USE
941
DEATH
934
INJECTION SITE PAIN
904

Who Reports Side Effects

Gender Distribution

Female 21,204 (58%)
Male 15,400 (42%)
Unknown 79

Age Distribution

0-17 406 (2%)
18-44 2,551 (11%)
45-64 9,204 (39%)
65-74 6,999 (29%)
75+ 4,725 (20%)

Reporting Trend by Year

2004 2025

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

Compare insulin detemir vs acarbose →

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.