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
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
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
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.
Read our methodology — how this data is sourced, computed, and verified.