HIGH-VOLUME · HOSP-MID
ustekinumab Side Effects
ustekinumab (also sold as Stelara) is HIGH-VOLUME in this FAERS book #78 of 524 by FAERS report count. Signature opener: HOSP-MID - 21.7% mention hospitalization (21,428 reports).
Data updated 2026-05-15
- 98,899
- FAERS reports
FAERS voluntary reports, 2009 to 2025. High volume tracks exposure and reporting culture; see methodology for de-dup rules.
ustekinumab: 21.7% mention hospitalization (21,428 reports). Death stamp DEATH-HEAVY; volume band HIGH-VOLUME #78 of 524 by FAERS report count.
High-report extract for ustekinumab (Stelara): 98,899 FAERS rows (2009-2025). Top named reactions: FATIGUE, PSORIASIS, PAIN. Outcome stamps DEATH-HEAVY · HOSP-MID · SEX-BALANCED. FAERS is voluntary signal detection, not incidence.
Counts from the openFDA FAERS extract (2009–2025). Stamps CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
FATIGUE leads 6,589 of 98,899 reports
Who reports · age peak 18-44 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 18-44 (21,364 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (5,465 reports, 5.5%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| TYPE 2 DIABETES MELLITUS | 1,672 |
| WOUND | 1,660 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 1,649 |
| GLOSSODYNIA | 1,642 |
| HAND DEFORMITY | 1,629 |
| JOINT SWELLING | 1,626 |
| INFUSION RELATED REACTION | 1,624 |
| SYNOVITIS | 1,618 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 1,616 |
| RASH | 1,591 |
| RHEUMATOID ARTHRITIS | 1,591 |
| FATIGUE | 1,585 |
| HEPATIC ENZYME INCREASED | 1,585 |
| HYPOAESTHESIA | 1,583 |
| FIBROMYALGIA | 1,573 |
| HYPERTENSION | 1,565 |
| HELICOBACTER INFECTION | 1,551 |
| SWELLING | 1,550 |
| PSORIATIC ARTHROPATHY | 1,549 |
| DUODENAL ULCER PERFORATION | 1,532 |
Reactions in Hospitalization Reports
Hospitalization mid-share (21,428, 21.7%). Co-reported reactions:
| Reaction | Reports |
|---|---|
| FATIGUE | 2,702 |
| PAIN | 2,508 |
| RHEUMATOID ARTHRITIS | 2,459 |
| ARTHRALGIA | 2,412 |
| RASH | 2,403 |
| INFUSION RELATED REACTION | 2,313 |
| SYNOVITIS | 2,297 |
| JOINT SWELLING | 2,251 |
| PNEUMONIA | 2,223 |
| HEADACHE | 2,217 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 2,212 |
| HEPATIC ENZYME INCREASED | 2,196 |
| DIARRHOEA | 2,194 |
| CONDITION AGGRAVATED | 2,192 |
| HYPERSENSITIVITY | 2,144 |
| CROHN^S DISEASE | 2,132 |
| VOMITING | 2,118 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 2,108 |
How to read ustekinumab FAERS figures (CASELOAD · DEATH-HEAVY · HOSP-MID)
FAERS holds 98,899 voluntary reports linked to ustekinumab (Stelara), 2009-2025. Death is listed on 5,465 (5.5%). Hospitalization appears on 21,428 (21.7%). Top co-reported indication: Psoriasis.
CASELOAD books overweight common drugs and loud reporting cultures; HOSP-MID is the page opener, not a per-patient risk.
Read with ustekinumab
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 98,033 FAERS cases (Δ 866 lighter vs ustekinumab); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 96,629 FAERS cases (Δ 2,270 lighter vs ustekinumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 102,095 FAERS cases (Δ 3,196 heavier vs ustekinumab); DEATH-HEAVY · HOSP-MID · FEMALE-LED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(total_reports) peer at 102,306 FAERS cases (Δ 3,407 heavier vs ustekinumab); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's CASELOAD · DEATH-HEAVY · HOSP-MID · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 56.6 pp vs ustekinumab's DEATH-HEAVY): CASELOAD · HOSP-MID.
ustekinumab stamps DEATH-HEAVY · HOSP-MID; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload CASELOAD and the label guide.