MID-VOLUME · SEX-BALANCED
guselkumab Side Effects
guselkumab (also sold as Tremfya) sits MID-VOLUME #184 of 524 by FAERS report count. Lead signal: SEX-BALANCED - 59% of sex-coded reports are female (14,702 F / 10,393 M). Demographics and serious-outcome tables follow.
Data updated 2026-05-15
- 31,164
- FAERS reports
FDA Adverse Event Reporting System extract for guselkumab. Stamp set CASELOAD · DEATH-MARKED · HOSP-LIGHT. How figures are compiled.
guselkumab reporting skew - 59% of sex-coded reports are female (14,702 F / 10,393 M). Volume band MID-VOLUME #184 of 524 by FAERS report count; caseload CASELOAD.
Mid-book FAERS page for guselkumab (Tremfya) (31,164 reports). Signature SEX-BALANCED. Dominant age band on file: 45-64. Educational reference only.
Counts from the openFDA FAERS extract (2016–2025). Stamps CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ACCIDENTAL EXPOSURE TO PRODUCT leads 3,138 of 31,164 reports
Who reports · age peak 45-64 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 45-64 (7,645 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 404 reports (1.3% - MARKED). Reactions below co-occur in those rows only.
| Reaction | Reports |
|---|---|
| DEATH | 256 |
| PNEUMONIA | 22 |
| COVID-19 | 19 |
| SEPSIS | 15 |
| SEPTIC SHOCK | 14 |
| HEPATIC CIRRHOSIS | 13 |
| INFECTION | 12 |
| DYSPNOEA | 11 |
| MYOCARDIAL INFARCTION | 8 |
| CARDIAC ARREST | 7 |
| CIRCULATORY COLLAPSE | 7 |
| DEPRESSION | 7 |
| PAIN | 7 |
| FALL | 6 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 6 |
| HYPONATRAEMIA | 6 |
| KETOACIDOSIS | 6 |
| MEGACOLON | 6 |
Reactions in Hospitalization Reports
Hospitalization is lighter here (2,350). Reactions in that subset:
| Reaction | Reports |
|---|---|
| PNEUMONIA | 277 |
| PSORIASIS | 146 |
| HOSPITALISATION | 106 |
| COVID-19 | 104 |
| PSORIATIC ARTHROPATHY | 76 |
| DYSPNOEA | 69 |
| PYREXIA | 67 |
| FALL | 62 |
| INFECTION | 60 |
| SEPSIS | 59 |
| CELLULITIS | 54 |
| URINARY TRACT INFECTION | 52 |
| ARTHRALGIA | 51 |
| INFLUENZA | 48 |
| DIARRHOEA | 46 |
| FATIGUE | 46 |
| MYOCARDIAL INFARCTION | 46 |
How to read guselkumab FAERS figures (CASELOAD · DEATH-MARKED · HOSP-LIGHT)
FAERS holds 31,164 voluntary reports linked to guselkumab (Tremfya), 2016-2025. Death is listed on 404 (1.3%). Hospitalization appears on 2,350 (7.5%). Top co-reported indication: Product Used For Unknown Indication.
Mid-volume extract - treat DEATH-MARKED · HOSP-LIGHT as signal-detection rates next to 59% of sex-coded reports are female (14,702 F / 10,393 M).
Read with guselkumab
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-LIGHT stamps.
ABS(total_reports) peer at 31,122 FAERS cases (Δ 42 lighter vs guselkumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 31,083 FAERS cases (Δ 81 lighter vs guselkumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 31,340 FAERS cases (Δ 176 heavier vs guselkumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(total_reports) peer at 31,347 FAERS cases (Δ 183 heavier vs guselkumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-MARKED · HOSP-LIGHT · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 60.8 pp vs guselkumab's DEATH-MARKED): CASELOAD · HOSP-MID.
guselkumab sits in CASELOAD; high report volume tracks exposure and reporting culture more than per-patient risk. Methodology states the de-dup rules.