ondansetron Side Effects
Also known as: Zofran
Analysis of 103,354 adverse event reports submitted to the FDA from 2003 to 2025.
Total Reports
103,354
Death-Related
13,423
13.0% of reports
Hospitalizations
47,077
45.5% 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 13,423 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 4,848 |
| NAUSEA | 1,078 |
| OFF LABEL USE | 1,056 |
| VOMITING | 969 |
| SEPSIS | 864 |
| PNEUMONIA | 818 |
| DIARRHOEA | 761 |
| DYSPNOEA | 706 |
| FATIGUE | 680 |
| CARDIAC ARREST | 630 |
| DISEASE PROGRESSION | 610 |
| CONSTIPATION | 586 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 563 |
| ANAEMIA | 557 |
| PYREXIA | 555 |
| ABDOMINAL PAIN | 549 |
| ASTHENIA | 511 |
| ACUTE KIDNEY INJURY | 507 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 491 |
| THROMBOCYTOPENIA | 489 |
Reactions in Hospitalization Reports
Top reactions in 47,077 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 4,892 |
| VOMITING | 4,248 |
| FEBRILE NEUTROPENIA | 3,885 |
| DIARRHOEA | 3,779 |
| PYREXIA | 3,440 |
| FATIGUE | 2,922 |
| PNEUMONIA | 2,832 |
| DYSPNOEA | 2,676 |
| OFF LABEL USE | 2,455 |
| ACUTE KIDNEY INJURY | 2,139 |
| ASTHENIA | 2,027 |
| ABDOMINAL PAIN | 1,981 |
| ANAEMIA | 1,908 |
| DEHYDRATION | 1,861 |
| PAIN | 1,856 |
| HEADACHE | 1,748 |
| SEPSIS | 1,636 |
| HYPOTENSION | 1,628 |
| CONSTIPATION | 1,612 |
| DECREASED APPETITE | 1,596 |
Nearby — Related Medications
What the FAERS Data Reveals About ondansetron Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 103,354 voluntary reports linked to ondansetron and its brand equivalents (Zofran), spanning 2003 through 2025. Of those, 13,423 (13.0%) listed death as an outcome and 47,077 (45.5%) 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, 61% were female and 39% male; age distribution skews toward 45-64, with 26,693 reports in that bracket. The single most reported reaction is nausea with 11,554 submissions, followed by fatigue and diarrhoea.
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.