LOW-VOLUME · HOSP-MID
baloxavir marboxil Side Effects
baloxavir marboxil (also sold as Xofluza) is a LOW-VOLUME FAERS extract #454 of 524 by FAERS report count. Still opens on HOSP-MID: 19.3% mention hospitalization (417 reports).
Data updated 2026-05-15
- 2,164
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
baloxavir marboxil: 19.3% mention hospitalization (417 reports). Death stamp DEATH-HEAVY; volume band LOW-VOLUME #454 of 524 by FAERS report count.
Thinner FAERS extract for baloxavir marboxil (Xofluza) (2,164 reports #454 of 524 by FAERS report count). 19.3% mention hospitalization (417 reports). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2017–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
DIARRHOEA leads 129 of 2,164 reports
Who reports · age peak 0-17 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 0-17 (619 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (130 reports, 6.0%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 32 |
| PNEUMONIA | 18 |
| INFLUENZA | 10 |
| RESPIRATORY FAILURE | 9 |
| CARDIO-RESPIRATORY ARREST | 7 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 7 |
| ACUTE KIDNEY INJURY | 6 |
| ACUTE RESPIRATORY DISTRESS SYNDROME | 5 |
| DISSEMINATED INTRAVASCULAR COAGULATION | 5 |
| INFECTION | 5 |
| SEPSIS | 5 |
| CARDIAC FAILURE | 4 |
| DECREASED APPETITE | 4 |
| PNEUMONIA INFLUENZAL | 4 |
| ACUTE RESPIRATORY FAILURE | 3 |
| ALANINE AMINOTRANSFERASE INCREASED | 3 |
| BRAIN HERNIATION | 3 |
| CIRCULATORY COLLAPSE | 3 |
Reactions in Hospitalization Reports
Hospitalization mid-share (417, 19.3%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| PNEUMONIA | 52 |
| DIARRHOEA | 29 |
| COLITIS ISCHAEMIC | 25 |
| VOMITING | 24 |
| RHABDOMYOLYSIS | 17 |
| ANAPHYLACTIC REACTION | 14 |
| PYREXIA | 13 |
| ABDOMINAL PAIN | 12 |
| DRUG ERUPTION | 12 |
| ABNORMAL BEHAVIOUR | 11 |
| ACUTE KIDNEY INJURY | 11 |
| DECREASED APPETITE | 11 |
| HEPATIC FUNCTION ABNORMAL | 11 |
| RASH | 11 |
| SEIZURE | 11 |
| DYSPNOEA | 10 |
| SEPSIS | 10 |
| HAEMATOCHEZIA | 9 |
How to read baloxavir marboxil FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-MID)
FAERS holds 2,164 voluntary reports linked to baloxavir marboxil (Xofluza), 2017-2025. Death is listed on 130 (6.0%). Hospitalization appears on 417 (19.3%). Top co-reported indication: Influenza.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with baloxavir marboxil
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-MID stamps.
ABS(total_reports) peer at 2,157 FAERS cases (Δ 7 lighter vs baloxavir marboxil); DEATH-RARE · HOSP-LIGHT · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,179 FAERS cases (Δ 15 heavier vs baloxavir marboxil); DEATH-MARKED · HOSP-MID · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,222 FAERS cases (Δ 58 heavier vs baloxavir marboxil); DEATH-HEAVY · HOSP-HEAVY · MALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 2,104 FAERS cases (Δ 60 lighter vs baloxavir marboxil); DEATH-MARKED · HOSP-HEAVY · FEMALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.1 pp vs baloxavir marboxil's DEATH-HEAVY): CASELOAD · HOSP-MID.
baloxavir marboxil stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.