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insulin aspart Side Effects

Also known as: NovoLog, Fiasp

Analysis of 63,536 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

63,536

Death-Related

4,425

7.0% of reports

Hospitalizations

20,996

33.0% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

BLOOD GLUCOSE INCREASED
10,424
NAUSEA
3,724
BLOOD GLUCOSE DECREASED
3,344
DRUG INEFFECTIVE
3,286
FATIGUE
2,664
DYSPNOEA
2,553
DIARRHOEA
2,542
VOMITING
2,387
DIZZINESS
2,013
OFF LABEL USE
1,971
WEIGHT DECREASED
1,843
FALL
1,828
HEADACHE
1,813
MALAISE
1,789
PAIN
1,768
DEATH
1,758
ACUTE KIDNEY INJURY
1,708
ASTHENIA
1,680
CHRONIC KIDNEY DISEASE
1,619
RENAL FAILURE
1,594

Who Reports Side Effects

Gender Distribution

Female 33,246 (55%)
Male 26,957 (45%)
Unknown 98

Age Distribution

0-17 905 (2%)
18-44 4,738 (12%)
45-64 16,053 (40%)
65-74 11,250 (28%)
75+ 7,192 (18%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 4,425 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 1,748
SEPSIS 432
NAUSEA 364
VOMITING 345
DYSPNOEA 344
OFF LABEL USE 342
RENAL FAILURE 342
ABDOMINAL PAIN 310
GENERAL PHYSICAL HEALTH DETERIORATION 296
ASCITES 277
MULTIPLE ORGAN DYSFUNCTION SYNDROME 274
ACUTE KIDNEY INJURY 271
CONSTIPATION 269
CHRONIC KIDNEY DISEASE 268
END STAGE RENAL DISEASE 268
HYPONATRAEMIA 262
ABDOMINAL DISTENSION 261
CONDITION AGGRAVATED 260
ANAEMIA 254
PNEUMONIA 249

Reactions in Hospitalization Reports

Top reactions in 20,996 reports where hospitalization was an outcome.

Reaction Reports
BLOOD GLUCOSE INCREASED 2,457
DYSPNOEA 1,367
NAUSEA 1,342
PNEUMONIA 1,258
VOMITING 1,177
DIABETIC KETOACIDOSIS 1,120
FALL 1,059
ACUTE KIDNEY INJURY 1,019
DIARRHOEA 1,012
FATIGUE 892
ASTHENIA 871
DEHYDRATION 843
BLOOD GLUCOSE DECREASED 815
OFF LABEL USE 808
HYPOGLYCAEMIA 793
HOSPITALISATION 786
RENAL FAILURE 751
ANAEMIA 729
DRUG INEFFECTIVE 722
PAIN 671

Nearby — Related Medications

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What the FAERS Data Reveals About insulin aspart Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 63,536 voluntary reports linked to insulin aspart and its brand equivalents (NovoLog, Fiasp), spanning 2004 through 2025. Of those, 4,425 (7.0%) listed death as an outcome and 20,996 (33.0%) 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, 55% were female and 45% male; age distribution skews toward 45-64, with 16,053 reports in that bracket. The single most reported reaction is blood glucose increased with 10,424 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.