Ustekinumab side effects: what 101,629 FDA adverse event reports show

Ustekinumab · 1,265 reaction terms · 574,565 drug–reaction co-reports · data 2026-09-14

Drug class

Interleukin-12 Antagonist, Interleukin-23 Antagonist

FDA label (Established Pharmacologic Class)

Who reports

101,629 reports · 59% serious · 5,950 with death outcome · 60% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Ustekinumab is a human interleukin-12 and -23 antagonist indicated for the treatment of: Moderate to severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for phototherapy or systemic therapy. ( 1.1 ) Active psoriatic arthritis in adults and pediatric patients 6 years of age and older.

FDA label, Indications and Usage

What it is

Ustekinumab, a human IgG1κ monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 2Likely indication confounding 1Lab value / disease marker 8Not in label — unassessed 29

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,225 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Anti-cyclic citrullinated peptide antibody	408	328.9 281.1–384.9ROR 330.3 · calibrated p 5e-12 ✓	125.2 EB05 115.3 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=408 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Swollen joint count increased	1,892	322.6 300.1–346.8ROR 328.7 · calibrated p 4e-12 ✓	124.8 EB05 120.2 · IC025 +6.8 3/3 methods agree	Lab value / disease marker	serious n=1,891 · ♀ 100% (drug 60%) · 96% clinician	not reported in cached trials
Rheumatic fever	2,495	277.9 261.7–295.1ROR 284.8 · calibrated p 2e-11 ✓	117.6 EB05 113.7 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=2,494 · ♀ 100% (drug 60%) · 94% clinician	not reported in cached trials
Lupus vulgaris	661	260.2 231.9–292.0ROR 261.9 · calibrated p 4e-11 ✓	114.0 EB05 106.9 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=661 · ♀ 100% (drug 60%) · 96% clinician	not reported in cached trials
C-reactive protein	487	241.0 211.3–274.8ROR 242.1 · calibrated p 8e-11 ✓	110.1 EB05 102.1 · IC025 +6.5 3/3 methods agree	Lab value / disease marker	serious n=487 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Deep vein thrombosis postoperative	1,039	234.4 214.4–256.3ROR 236.8 · calibrated p 9e-11 ✓	108.9 EB05 103.5 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=1,039 · ♀ 100% (drug 60%) · 94% clinician	not reported in cached trials
Rheumatoid factor positive	2,939	215.8 205.0–227.2ROR 222.2 · calibrated p 2e-10 ✓	104.9 EB05 101.7 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=2,936 · ♀ 100% (drug 60%) · 94% clinician	not reported in cached trials
Swollen joint count	125	214.4 166.7–275.7ROR 214.6 · calibrated p 4e-10 ✓	103.0 EB05 88.7 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=125 · ♀ 100% (drug 60%) · 100% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody positive	3,572	210.0 200.4–219.9ROR 217.6 · calibrated p 2e-10 ✓	103.5 EB05 100.7 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious PRR 100.7 · ♀ 99% (drug 60%) · 93% clinician	not reported in cached trials
Grip strength	114	200.6 154.8–259.9ROR 200.8 · calibrated p 7e-10 ✓	99.6 EB05 85.2 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=114 · ♀ 100% (drug 60%) · 100% clinician	not reported in cached trials
Red blood cell sedimentation rate	127	170.2 134.4–215.5ROR 170.4 · calibrated p 3e-9 ✓	91.7 EB05 79.0 · IC025 +5.8 3/3 methods agree	Lab value / disease marker	serious n=127 · 92% clinician	not reported in cached trials
Facet joint syndrome	1,380	161.2 150.3–173.0ROR 163.4 · calibrated p 2e-9 ✓	90.1 EB05 86.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=1,380 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Duodenal ulcer perforation	3,088	150.3 143.5–157.4ROR 155.0 · calibrated p 3e-9 ✓	86.6 EB05 84.1 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 84.0 · ♀ 100% (drug 60%) · 93% clinician	not reported in cached trials
Adjustment disorder with depressed mood	846	149.7 137.0–163.5ROR 150.9 · calibrated p 5e-9 ✓	86.3 EB05 81.5 · IC025 +6.2 3/3 methods agree	Not in label — unassessed	serious n=845 · ♀ 100% (drug 60%) · 96% clinician	not reported in cached trials
X-ray abnormal	725	141.5 128.7–155.5ROR 142.5 · calibrated p 7e-9 ✓	83.5 EB05 78.5 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=725 · ♀ 100% (drug 60%) · 97% clinician	not reported in cached trials
Subcutaneous drug absorption impaired	215	134.7 113.4–160.0ROR 135.0 · calibrated p 1e-8 ✓	80.7 EB05 72.1 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious n=215 · ♀ 100% (drug 60%) · 100% clinician	not reported in cached trials
Retinitis	637	127.5 115.5–140.8ROR 128.3 · calibrated p 2e-8 ✓	78.4 EB05 73.4 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=637 · ♀ 100% (drug 60%) · 93% clinician	not reported in cached trials
Ileocaecal resection	121	118.3 94.5–148.0ROR 118.4 · calibrated p 4e-8 ✓	74.2 EB05 63.7 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=121 · 100% clinician	not reported in cached trials
Dislocation of vertebra	798	115.5 105.9–126.0ROR 116.4 · calibrated p 4e-8 ✓	73.8 EB05 69.6 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=798 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Sleep disorder due to general medical condition, hypersomnia type	32	96.7 63.4–147.3ROR 96.7 · calibrated p 5e-7 ✓	63.4 EB05 47.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=32 · ♀ 100% (drug 60%) · 100% clinician	not reported in cached trials
Neurologic neglect syndrome	175	93.7 78.3–112.1ROR 93.8 · calibrated p 2e-7 ✓	63.9 EB05 56.4 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=175 · ♀ 100% (drug 60%) · 93% clinician	not reported in cached trials
Helicobacter infection	3,183	93.6 89.8–97.6ROR 96.6 · calibrated p 1e-7 ✓	64.3 EB05 62.5 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 65.9 · ♀ 99% (drug 60%) · 93% clinician	not reported in cached trials
Pemphigus	3,867	93.1 89.7–96.7ROR 96.8 · calibrated p 1e-7 ✓	64.1 EB05 62.4 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 62.3 · ♀ 100% (drug 60%) · 92% clinician	not reported in cached trials
Hand deformity	3,970	89.8 86.6–93.2ROR 93.4 · calibrated p 2e-7 ✓	62.5 EB05 60.9 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 65.9 · ♀ 99% (drug 60%) · 93% clinician	not reported in cached trials
C-reactive protein abnormal	1,765	78.3 74.2–82.7ROR 79.7 · calibrated p 6e-7 ✓	56.7 EB05 54.5 · IC025 +5.7 3/3 methods agree	Lab value / disease marker	serious n=1,765 · ♀ 91% (drug 60%) · 94% clinician	not reported in cached trials
Peripheral venous disease	1,058	74.2 69.2–79.6ROR 75.0 · calibrated p 9e-7 ✓	54.5 EB05 51.8 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious n=1,057 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Muscle injury	2,157	73.4 69.9–77.1ROR 75.0 · calibrated p 9e-7 ✓	54.1 EB05 52.2 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 56.8 · ♀ 99% (drug 60%) · 94% clinician	not reported in cached trials
Sleep disorder due to general medical condition, insomnia type	1,632	69.9 66.1–74.0ROR 71.1 · calibrated p 1e-6 ✓	52.2 EB05 50.1 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=1,632 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Synovitis	4,564	69.7 67.4–72.1ROR 72.9 · calibrated p 1e-6 ✓	52.1 EB05 50.8 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 52.9 · ♀ 94% (drug 60%) · 92% clinician	not reported in cached trials
Seronegative arthritis	279	68.1 59.5–78.0ROR 68.3 · calibrated p 2e-6 ✓	51.0 EB05 46.2 · IC025 +5.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=279 · ♀ 100% (drug 60%) · 95% clinician	not reported in cached trials
Folliculitis	2,544	67.3 64.4–70.3ROR 69.0 · calibrated p 2e-6 ✓	50.7 EB05 49.1 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 57.4 · ♀ 99% (drug 60%) · 94% clinician	NCT01708603: 1/300 (0.3%) on Ustekinumab
Pericarditis	3,805	60.9 58.8–63.1ROR 63.2 · calibrated p 3e-6 ✓	47.0 EB05 45.8 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 46.0 · ♀ 99% (drug 60%) · 93% clinician	not reported in cached trials
Contraindication to vaccination	42	57.8 41.0–81.5ROR 57.8 · calibrated p 9e-6 ✓	44.3 EB05 34.2 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	100% consumer	not reported in cached trials
Bone erosion	767	56.9 52.5–61.6ROR 57.3 · calibrated p 6e-6 ✓	44.6 EB05 42.0 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=767 · ♀ 96% (drug 60%) · 93% clinician	not reported in cached trials
Ileectomy	72	55.6 42.8–72.2ROR 55.7 · calibrated p 1e-5 ✓	43.4 EB05 35.6 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=72	not reported in cached trials
Carotid artery thrombosis	177	53.8 45.6–63.5ROR 53.9 · calibrated p 1e-5 ✓	42.5 EB05 37.5 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=177 · ♀ 100% (drug 60%) · 93% clinician	not reported in cached trials
Hypocholesterolaemia	57	46.7 35.0–62.3ROR 46.7 · calibrated p 3e-5 ✓	37.7 EB05 30.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=57 · ♀ 100% (drug 60%) · 100% clinician	not reported in cached trials
Proctocolectomy	54	44.6 33.2–59.9ROR 44.6 · calibrated p 4e-5 ✓	36.3 EB05 28.9 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=54	not reported in cached trials
Glossodynia (burning tongue/mouth pain)	3,974	44.5 43.0–46.0ROR 46.2 · calibrated p 2e-5 ✓	36.6 EB05 35.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 51.4 · ♀ 100% (drug 60%) · 93% clinician	not reported in cached trials
Granuloma skin	143	42.9 35.8–51.3ROR 42.9 · calibrated p 4e-5 ✓	35.4 EB05 30.8 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=143 · 91% clinician	not reported in cached trials

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Liver injury	6,083	4.24.1–4.3	signal
Interstitial lung disease	1,410	3.12.9–3.2	signal
Serious infection	9,360	2.52.5–2.6	signal
Tendon disorder	388	2.11.9–2.3	raised
Hyperglycaemia / diabetes	3,351	2.01.9–2.1	raised
Opportunistic infection	1,062	1.61.5–1.7	raised
Pancreatitis	593	1.51.4–1.6	raised
Malignancy	2,584	1.41.4–1.5	raised
Depression	1,852	1.41.3–1.4	raised
Stroke	1,054	0.90.8–0.9	lower than other drugs
Anaphylaxis / angioedema	517	0.80.8–0.9	lower than other drugs
Rhabdomyolysis / myopathy	320	0.80.7–0.9	lower than other drugs
Gi bleeding	719	0.80.8–0.9	lower than other drugs
Fall / fracture	1,392	0.80.7–0.8	lower than other drugs
Myocardial infarction	651	0.70.6–0.7	lower than other drugs
Venous thromboembolism	603	0.60.5–0.6	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Ustekinumab as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).

NCT01708629 — Efficacy and Safety of Brodalumab Compared With Placebo and Ustekinumab in Moderate to Severe Plaque Psoriasis (N=1881, PHASE3; 58 AE terms posted; arms: 210 mg Brodalumab; 140 mg Brodalumab; Placebo; Ustekinumab)
NCT01708603 — P3 Study Brodalumab in Treatment of Moderate to Severe Plaque Psoriasis (N=1831, PHASE3; 97 AE terms posted; arms: 210 mg Brodalumab; 140 mg Brodalumab; Ustekinumab; Placebo)

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug ineffective (drug did not work)	14,782	2.3 2.3–2.4ROR 2.6 · calibrated p 0.790	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.4 · serious PRR 4.1	not reported in cached trials
Off label use (used outside approved label)	12,685	3.0 3.0–3.1ROR 3.3 · calibrated p 0.527	3.0 EB05 3.0 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.4 · serious PRR 3.7	not reported in cached trials
Product dose omission issue	10,083	7.5 7.4–7.7ROR 8.3 · calibrated p 0.060	7.3 EB05 7.2 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 7.9 · serious PRR 2.6	not reported in cached trials
Fatigue (tiredness)	6,838	1.8 1.8–1.9ROR 1.9 · calibrated p 0.877	1.8 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 2.9 · ♀ 87% (drug 60%)	NCT01708629: 4/313 (1.3%) on Ustekinumab; 6/315 (1.9%) control
Psoriasis	6,573	10.9 10.6–11.1ROR 11.5 · calibrated p 0.019 ✓	10.4 EB05 10.1 · IC025 +3.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 10.2 · serious PRR 16.9	NCT01708629: 1/315 (0.3%) control (serious AE)
Pain	6,223	2.1 2.0–2.1ROR 2.2 · calibrated p 0.968	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.1 · serious PRR 2.8 · ♀ 87% (drug 60%)	NCT01708629: 6/313 (1.9%) on Ustekinumab; 3/315 (1.0%) control
Arthralgia (joint pain)	5,825	2.9 2.9–3.0ROR 3.0 · calibrated p 0.613	2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.7 · serious PRR 4.3 · ♀ 82% (drug 60%)	NCT01708629: 10/313 (3.2%) on Ustekinumab; 6/315 (1.9%) control
Rash	5,627	2.7 2.6–2.8ROR 2.8 · calibrated p 0.696	2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.6 · serious PRR 5.1 · ♀ 90% (drug 60%)	NCT01708629: 1/629 (0.2%) on Ustekinumab (serious AE)
Product use issue	5,422	6.1 6.0–6.3ROR 6.4 · calibrated p 0.126	6.0 EB05 5.8 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 7.4 · serious PRR 11.1	not reported in cached trials
Headache	5,281	1.7 1.7–1.8ROR 1.8 · calibrated p 0.821	1.7 EB05 1.7 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.6 · serious PRR 2.9 · ♀ 82% (drug 60%)	NCT01708629: 11/313 (3.5%) on Ustekinumab; 14/315 (4.4%) control
Condition aggravated	5,223	3.6 3.5–3.7ROR 3.8 · calibrated p 0.427	3.6 EB05 3.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.8 · serious PRR 4.2 · ♀ 84% (drug 60%)	not reported in cached trials
Infusion related reaction (reaction during infusion)	5,145	17.3 16.9–17.8ROR 18.2 · calibrated p 0.003 ✓	16.1 EB05 15.7 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 14.3 · serious PRR 18.6 · ♀ 93% (drug 60%)	not reported in cached trials
Rheumatoid arthritis	4,834	9.2 8.9–9.4ROR 9.6 · calibrated p 0.037 ✓	8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	age-adj. PRR 8.8 · serious PRR 10.4 · ♀ 97% (drug 60%)	not reported in cached trials
Joint swelling	4,725	8.4 8.1–8.6ROR 8.7 · calibrated p 0.050	8.1 EB05 7.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	age-adj. PRR 7.5 · serious PRR 13.3 · ♀ 94% (drug 60%)	NCT01708603: 1/612 (0.2%) on Ustekinumab; 1/309 (0.3%) control
Diarrhoea (diarrhea)	4,675	1.5 1.5–1.5ROR 1.5 · calibrated p 0.658	1.5 EB05 1.5 · IC025 +0.5	Labeled adverse reaction exact term	age-adj. PRR 1.7 · serious PRR 2.2	NCT01708629: 3/313 (1.0%) on Ustekinumab; 4/315 (1.3%) control

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Rheumatic fever — n=2,495, PRR 277.9
Lupus vulgaris — n=661, PRR 260.2
Deep vein thrombosis postoperative — n=1,039, PRR 234.4
Swollen joint count — n=125, PRR 214.4
Grip strength — n=114, PRR 200.6
Facet joint syndrome — n=1,380, PRR 161.2
Duodenal ulcer perforation — n=3,088, PRR 150.3
Adjustment disorder with depressed mood — n=846, PRR 149.7
Subcutaneous drug absorption impaired — n=215, PRR 134.7
Retinitis — n=637, PRR 127.5

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Ustekinumab?

In FDA FAERS, the most frequently co-reported reaction terms for Ustekinumab are fatigue, psoriasis, pain, arthralgia, rash, headache. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Ustekinumab have an FDA boxed warning?

No. The FDA label retrieved for Ustekinumab has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Ustekinumab causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 23b486eb-f48d-47d4-815e-1313d4ebfbfa, effective 20260831; matched on openfda.generic_name.exact:"USTEKINUMAB" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,265 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query USTEKINUMAB, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.