HIGH-VOLUME · HOSP-HEAVY
ondansetron Side Effects
ondansetron (also sold as Zofran) is HIGH-VOLUME in this FAERS book #75 of 524 by FAERS report count. Signature opener: HOSP-HEAVY - 45.5% mention hospitalization (47,077 reports).
Data updated 2026-05-15
- 103,354
- FAERS reports
FAERS voluntary reports, 2003 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
ondansetron: 45.5% mention hospitalization (47,077 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #75 of 524 by FAERS report count.
High-report extract for ondansetron (Zofran): 103,354 FAERS rows (2003-2025). Top named reactions: NAUSEA, FATIGUE, DIARRHOEA. Outcome stamps DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2003–2025). Stamps MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
NAUSEA leads 11,554 of 103,354 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (26,693 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (13,423 reports, 13.0%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 4,848 |
| NAUSEA | 1,078 |
| 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
Hospitalization is HEAVY (47,077, 45.5% of the book). Top reactions in those rows:
| 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 |
| 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 |
How to read ondansetron FAERS figures (MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 103,354 voluntary reports linked to ondansetron (Zofran), 2003-2025. Death is listed on 13,423 (13.0%). Hospitalization appears on 47,077 (45.5%). Top co-reported indication: Product Used For Unknown Indication.
MEGA-CASE books overweight common drugs and loud reporting cultures; HOSP-HEAVY is the page opener, not a per-patient risk.
Read with ondansetron
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 103,356 FAERS cases (Δ 2 heavier vs ondansetron); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 104,378 FAERS cases (Δ 1,024 heavier vs ondansetron); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 102,306 FAERS cases (Δ 1,048 lighter vs ondansetron); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 102,095 FAERS cases (Δ 1,259 lighter vs ondansetron); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's MEGA-CASE · DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 49.1 pp vs ondansetron's DEATH-HEAVY): CASELOAD · HOSP-MID.
ondansetron stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload MEGA-CASE and the label guide.