Drug · FAERS side-effect profile with label screen
Golimumab side effects: what 12,299 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Simponi Aria
openFDA label
Who reports
12,299 reports · 76% serious · 2,587 with death outcome · 82% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate ( 1.1 ) Active Psoriatic Arthritis (PsA) in patients 2 ye.
FDA label, Indications and Usage
What it is
Golimumab is a human IgG1қ monoclonal antibody specific for human tumor necrosis factor alpha (TNFα) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons.
FDA label, Description section
Boxed warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis .
FDA 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) 4Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 8Not in label — unassessed 24
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.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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). 1,196 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody positive | 5,397 | 806.2 763.0–851.9ROR 860.6 · calibrated p 1e-16 ✓ | 186.6 EB05 182.5 · IC025 +7.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.1–4.3) | Lab value / disease marker | serious PRR 335.2 · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 486 | 679.0 570.9–807.5ROR 682.9 · calibrated p 3e-15 ✓ | 177.7 EB05 164.9 · IC025 +7.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.5–4.3) | Lab value / disease marker | serious n=331 · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 2,220 | 624.6 577.5–675.6ROR 641.3 · calibrated p 4e-15 ✓ | 174.7 EB05 168.7 · IC025 +7.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.9–4.3) | Lab value / disease marker | serious n=1,004 · 96% clinician | not reported in cached trials |
| Rheumatic fever | 3,014 | 561.2 526.1–598.8ROR 581.8 · calibrated p 1e-14 ✓ | 169.5 EB05 164.4 · IC025 +7.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.9–4.2) | Likely indication confounding shares a disease stem with the indications wording | serious n=1,443 · 95% clinician | not reported in cached trials |
| Pemphigus | 8,315 | 508.1 489.6–527.4ROR 563.0 · calibrated p 2e-14 ✓ | 164.4 EB05 161.5 · IC025 +7.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.2–4.3) | Not in label — unassessed | serious PRR 254.1 · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 3,792 | 481.6 456.0–508.7ROR 504.0 · calibrated p 5e-14 ✓ | 161.5 EB05 157.2 · IC025 +7.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.2) | Lab value / disease marker | serious n=1,492 · 94% clinician | not reported in cached trials |
| Hepatic enzyme | 91 | 468.0 329.1–665.4ROR 468.5 · calibrated p 5e-13 ✓ | 154.9 EB05 130.0 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 7.7 (6.0–9.9) | Labeled (related wording) related wording | serious n=17 | not reported in cached trials |
| Lupus vulgaris | 743 | 415.7 369.3–467.9ROR 419.3 · calibrated p 4e-13 ✓ | 152.9 EB05 143.9 · IC025 +7.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.5–4.1) | Not in label — unassessed | serious n=465 · 95% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 4,452 | 385.1 367.5–403.6ROR 406.3 · calibrated p 5e-13 ✓ | 149.0 EB05 145.4 · IC025 +7.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.2) | Not in label — unassessed | serious PRR 246.9 · 94% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,186 | 382.2 348.9–418.7ROR 387.6 · calibrated p 8e-13 ✓ | 148.3 EB05 141.4 · IC025 +7.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.5–4.0) | Not in label — unassessed | serious n=603 · 96% clinician | not reported in cached trials |
| C-reactive protein | 509 | 317.9 278.6–362.8ROR 319.8 · calibrated p 6e-12 ✓ | 137.2 EB05 127.5 · IC025 +6.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.6 (3.3–3.9) | Lab value / disease marker | serious n=153 · 95% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 157 | 313.6 247.4–397.5ROR 314.2 · calibrated p 1e-11 ✓ | 134.8 EB05 118.1 · IC025 +6.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.1 (2.6–3.7) | Lab value / disease marker | serious n=82 · ♀ 58% (drug 82%) · 96% clinician | not reported in cached trials |
| Hand deformity | 7,128 | 297.8 287.8–308.1ROR 324.9 · calibrated p 4e-12 ✓ | 133.9 EB05 131.3 · IC025 +7.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.1) | Not in label — unassessed | serious PRR 251.5 · 95% clinician | not reported in cached trials |
| Swollen joint count | 130 | 278.1 216.1–357.7ROR 278.5 · calibrated p 4e-11 ✓ | 127.4 EB05 110.1 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.3 (4.4–6.5) | Not in label — unassessed | serious n=42 · 95% clinician | not reported in cached trials |
| Malignant mediastinal neoplasm | 56 | 265.4 181.6–387.8ROR 265.6 · calibrated p 1e-10 ✓ | 121.8 EB05 97.3 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Labeled (related wording) related wording | – | not reported in cached trials |
| Facet joint syndrome | 1,618 | 261.8 244.1–280.7ROR 266.8 · calibrated p 3e-11 ✓ | 126.0 EB05 120.9 · IC025 +6.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.6 (3.4–3.8) | Not in label — unassessed | serious n=593 · 94% clinician | not reported in cached trials |
| Grip strength | 115 | 243.8 188.2–315.9ROR 244.1 · calibrated p 1e-10 ✓ | 119.5 EB05 102.3 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (3.4–5.2) | Not in label — unassessed | serious n=23 · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 978 | 233.6 214.0–255.0ROR 236.3 · calibrated p 9e-11 ✓ | 119.0 EB05 112.9 · IC025 +6.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.6–4.2) | Not in label — unassessed | serious n=418 · 95% clinician | not reported in cached trials |
| Muscle injury | 3,841 | 217.9 208.7–227.5ROR 228.2 · calibrated p 1e-10 ✓ | 115.0 EB05 112.0 · IC025 +6.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.2–4.5) | Not in label — unassessed | serious PRR 163.8 · 97% clinician | not reported in cached trials |
| Helicobacter infection | 4,593 | 203.0 195.3–211.0ROR 214.5 · calibrated p 2e-10 ✓ | 110.7 EB05 108.1 · IC025 +6.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.9–4.1) | Not in label — unassessed | serious PRR 197.4 · 95% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,885 | 201.0 191.4–211.0ROR 208.0 · calibrated p 3e-10 ✓ | 110.1 EB05 106.8 · IC025 +6.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.1–4.4) | Not in label — unassessed | serious n=564 · 96% clinician | not reported in cached trials |
| Dislocation of vertebra | 981 | 195.1 179.5–212.2ROR 197.4 · calibrated p 5e-10 ✓ | 108.2 EB05 102.6 · IC025 +6.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.6–4.1) | Not in label — unassessed | serious n=425 · 93% clinician | not reported in cached trials |
| X-ray abnormal | 762 | 184.2 167.6–202.3ROR 185.8 · calibrated p 8e-10 ✓ | 104.7 EB05 98.6 · IC025 +6.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.5–4.1) | Lab value / disease marker | serious n=347 · 97% clinician | not reported in cached trials |
| Synovial fluid analysis | 37 | 182.5 119.1–279.7ROR 182.6 · calibrated p 4e-9 ✓ | 99.2 EB05 75.2 · IC025 +4.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.6 (4.5–9.7) | Reporting / coding artifact | – | not reported in cached trials |
| Folliculitis | 4,315 | 177.4 170.6–184.4ROR 186.8 · calibrated p 7e-10 ✓ | 102.7 EB05 100.1 · IC025 +6.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.0–4.3) | Not in label — unassessed | serious PRR 158.0 · 96% clinician | not reported in cached trials |
| Synovitis | 7,401 | 171.8 166.9–176.9ROR 188.1 · calibrated p 7e-10 ✓ | 100.8 EB05 98.9 · IC025 +6.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.6) | Not in label — unassessed | serious PRR 169.5 · 94% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 212 | 157.2 132.2–186.8ROR 157.6 · calibrated p 4e-9 ✓ | 94.8 EB05 84.6 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.4–4.6) | Not in label — unassessed | serious n=44 · 95% clinician | not reported in cached trials |
| C-reactive protein abnormal | 2,449 | 152.8 145.3–160.6ROR 157.2 · calibrated p 3e-9 ✓ | 93.9 EB05 90.8 · IC025 +6.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.2 (3.0–3.3) | Lab value / disease marker | serious n=767 · 95% clinician | not reported in cached trials |
| Retinitis | 617 | 144.6 130.9–159.8ROR 145.7 · calibrated p 6e-9 ✓ | 90.6 EB05 84.8 · IC025 +6.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.6 (3.3–3.9) | Not in label — unassessed | serious n=397 · 95% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,146 | 141.5 137.8–145.3ROR 156.3 · calibrated p 3e-9 ✓ | 89.6 EB05 88.0 · IC025 +6.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.3–4.5) | Not in label — unassessed | serious PRR 201.2 · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 393 | 132.8 117.5–150.2ROR 133.5 · calibrated p 1e-8 ✓ | 85.7 EB05 78.9 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (3.8–4.7) | Likely indication confounding shares a disease stem with the indications wording | serious n=162 · 94% clinician | NCT00488631: 1/405 (0.2%) on Golimumab (serious AE) |
| Granuloma skin | 288 | 131.3 113.8–151.6ROR 131.8 · calibrated p 2e-8 ✓ | 85.0 EB05 77.1 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.1 (2.7–3.5) | Labeled (related wording) related wording | serious n=66 · ♀ 48% (drug 82%) · 95% clinician | not reported in cached trials |
| Pericarditis | 5,772 | 130.7 126.7–134.8ROR 140.1 · calibrated p 8e-9 ✓ | 85.2 EB05 83.3 · IC025 +6.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.1–4.3) | Not in label — unassessed | serious PRR 173.7 · 94% clinician | NCT00488631: 1/469 (0.2%) on Golimumab (serious AE) |
| Peripheral venous disease | 1,317 | 121.3 113.5–129.5ROR 123.2 · calibrated p 2e-8 ✓ | 81.0 EB05 77.4 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.7–4.1) | Labeled (related wording) related wording | serious n=509 · 95% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 33 | 120.8 79.6–183.5ROR 120.9 · calibrated p 9e-8 ✓ | 77.4 EB05 57.7 · IC025 +4.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Hypocholesterolaemia | 100 | 118.5 93.3–150.5ROR 118.6 · calibrated p 5e-8 ✓ | 78.7 EB05 66.6 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.9 (5.4–8.7) | Not in label — unassessed | serious n=29 · 93% clinician | not reported in cached trials |
| Bone erosion | 1,080 | 108.0 100.6–116.0ROR 109.4 · calibrated p 6e-8 ✓ | 74.9 EB05 71.2 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.4 (3.2–3.6) | Not in label — unassessed | serious n=507 · 94% clinician | not reported in cached trials |
| Ankle arthroplasty | 102 | 97.8 77.7–123.1ROR 97.9 · calibrated p 2e-7 ✓ | 69.1 EB05 58.5 · IC025 +5.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 9.3 (7.3–11.9) | Not in label — unassessed | serious n=4 | not reported in cached trials |
| Contraindicated product administered | 8,444 | 95.7 93.4–98.1ROR 106.1 · calibrated p 7e-8 ✓ | 68.8 EB05 67.6 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.6–3.8) | Reporting / coding artifact | age-adj. PRR 134.7 · serious PRR 113.4 · 93% clinician | not reported in cached trials |
| Wound | 6,884 | 80.9 78.8–83.1ROR 88.0 · calibrated p 3e-7 ✓ | 60.9 EB05 59.7 · IC025 +5.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.1–4.3) | Not in label — unassessed | age-adj. PRR 144.9 · serious PRR 126.0 · 94% clinician | NCT00975130: 1/3,357 (0.0%) on Golimumab (serious AE) |
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 | 2,802 | 16.015.5–16.5 | signal |
| Interstitial lung disease | 738 | 13.212.3–14.2 | signal |
| Hyperglycaemia / diabetes | 1,584 | 7.87.5–8.2 | signal |
| Serious infection | 2,378 | 5.35.1–5.5 | signal |
| Tendon disorder | 106 | 4.73.9–5.7 | signal |
| Depression | 635 | 3.93.6–4.2 | signal |
| Opportunistic infection | 229 | 2.92.5–3.3 | signal |
| Pancreatitis | 108 | 2.31.9–2.8 | raised |
| Gi bleeding | 178 | 1.71.4–1.9 | raised |
| Anaphylaxis / angioedema | 119 | 1.61.4–1.9 | raised |
| Malignancy | 335 | 1.51.4–1.7 | raised |
| Rhabdomyolysis / myopathy | 61 | 1.31.0–1.6 | no difference |
| Fall / fracture | 278 | 1.21.1–1.4 | raised |
| Osteonecrosis | 35 | 1.00.7–1.4 | no difference |
| Venous thromboembolism | 121 | 1.00.8–1.1 | no difference |
| Thrombocytopenia | 105 | 0.80.7–1.0 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Golimumab 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 (3 of 40 signal terms matched).
- NCT00975130 — Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM St (N=3366, PHASE3; 204 AE terms posted; arms: Golimumab 50 mg Subcutaneous (GLM50-SC); Intravenous GLM (IV-GLM) 2 mg/kg + SC GL; SC-GLM50)
- NCT00488631 — An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcera (N=1228, PHASE3; 301 AE terms posted; arms: Golimumab Induction Responders (GLM-I-Rs; GLM-I-Rsp-Golimumab 50 mg Maintenance; GLM-I-Rsp-Golimumab 100 mg Maintenance; GLM-I-Rsp-Placebo Maintenance-Golimumab )
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) | 21,381 | 4.0 4.0–4.1ROR 5.1 · calibrated p 0.228 | 4.0 EB05 3.9 · IC025 +2.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.1 (2.1–2.1) | Reporting / coding artifact | age-adj. PRR 5.9 · serious PRR 9.1 | not reported in cached trials |
| Rheumatoid arthritis | 14,419 | 35.9 35.3–36.5ROR 43.0 · calibrated p 3e-5 ✓ | 31.4 EB05 30.9 · IC025 +4.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.4 (2.4–2.4) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 41.4 · serious PRR 39.8 | NCT00975130: 9/3,357 (0.3%) on Golimumab (serious AE) |
| Pain | 13,680 | 5.6 5.5–5.7ROR 6.4 · calibrated p 0.124 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.4 (2.4–2.5) | Not in label — unassessed | age-adj. PRR 8.0 · serious PRR 9.1 | NCT00975130: 4/3,357 (0.1%) on Golimumab (serious AE) |
| Fatigue (tiredness) | 11,523 | 3.7 3.6–3.8ROR 4.1 · calibrated p 0.358 | 3.6 EB05 3.6 · IC025 +1.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.5 (2.5–2.5) | Not in label — unassessed | age-adj. PRR 5.6 · serious PRR 8.3 | NCT00488631: 1/7 (14.3%) on Golimumab; 4/156 (2.6%) control |
| Off label use (used outside approved label) | 10,354 | 3.0 2.9–3.0ROR 3.2 · calibrated p 0.556 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 1.6 (1.6–1.7) | Reporting / coding artifact | age-adj. PRR 6.4 · serious PRR 7.6 · 91% clinician | not reported in cached trials |
| Joint swelling | 9,953 | 22.1 21.7–22.5ROR 24.9 · calibrated p 7e-4 ✓ | 20.3 EB05 20.0 · IC025 +4.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.9 (2.9–3.0) | Not in label — unassessed | age-adj. PRR 30.0 · serious PRR 41.5 · 92% clinician | not reported in cached trials |
| Arthralgia (joint pain) | 9,928 | 6.0 5.9–6.1ROR 6.7 · calibrated p 0.113 | 5.9 EB05 5.8 · IC025 +2.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 1.8 (1.8–1.8) | Not in label — unassessed | age-adj. PRR 8.1 · serious PRR 11.0 | NCT00975130: 3/3,357 (0.1%) on Golimumab (serious AE) |
| Rash | 9,578 | 5.5 5.4–5.6ROR 6.1 · calibrated p 0.143 | 5.4 EB05 5.3 · IC025 +2.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 2.9 (2.8–2.9) | Labeled adverse reaction exact term | age-adj. PRR 9.7 · serious PRR 15.8 · 93% clinician | NCT00975130: 1/3,357 (0.0%) on Golimumab (serious AE) |
| Alopecia (hair loss) | 9,462 | 12.4 12.1–12.6ROR 13.8 · calibrated p 0.010 ✓ | 11.8 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 21.3 · serious PRR 35.3 · 92% clinician | NCT00488631: 2/28 (7.1%) on Golimumab; 3/156 (1.9%) control |
| Drug intolerance | 8,986 | 25.3 24.7–25.8ROR 28.1 · calibrated p 4e-4 ✓ | 23.0 EB05 22.6 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.2 (3.2–3.3) | Reporting / coding artifact | age-adj. PRR 50.8 · serious PRR 50.0 · 93% clinician | not reported in cached trials |
| Abdominal discomfort | 8,857 | 13.7 13.4–14.0ROR 15.2 · calibrated p 0.007 ✓ | 13.0 EB05 12.8 · IC025 +3.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.6 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 25.0 · serious PRR 42.1 · 93% clinician | NCT00488631: 1/19 (5.3%) on Golimumab; 2/76 (2.6%) control |
| Swelling | 8,669 | 25.1 24.6–25.6ROR 27.8 · calibrated p 4e-4 ✓ | 22.8 EB05 22.4 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.7–3.9) | Not in label — unassessed | age-adj. PRR 38.2 · serious PRR 48.3 · 92% clinician | not reported in cached trials |
| Systemic lupus erythematosus | 8,576 | 78.7 76.9–80.6ROR 87.4 · calibrated p 3e-7 ✓ | 59.6 EB05 58.6 · IC025 +5.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.7–3.9) | Labeled (related wording) related wording | age-adj. PRR 125.8 · serious PRR 92.6 · 93% clinician | not reported in cached trials |
| Contraindicated product administered | 8,444 | 95.7 93.4–98.1ROR 106.1 · calibrated p 7e-8 ✓ | 68.8 EB05 67.6 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.6–3.8) | Reporting / coding artifact | age-adj. PRR 134.7 · serious PRR 113.4 · 93% clinician | not reported in cached trials |
| Pemphigus | 8,315 | 508.1 489.6–527.4ROR 563.0 · calibrated p 2e-14 ✓ | 164.4 EB05 161.5 · IC025 +7.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (4.2–4.3) | Not in label — unassessed | serious PRR 254.1 · 94% clinician | not reported in cached trials |
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.
- Pemphigus — n=8,315, PRR 508.1
- Lupus vulgaris — n=743, PRR 415.7
- Duodenal ulcer perforation — n=4,452, PRR 385.1
- Deep vein thrombosis postoperative — n=1,186, PRR 382.2
- Hand deformity — n=7,128, PRR 297.8
- Swollen joint count — n=130, PRR 278.1
- Facet joint syndrome — n=1,618, PRR 261.8
- Grip strength — n=115, PRR 243.8
- Adjustment disorder with depressed mood — n=978, PRR 233.6
- Muscle injury — n=3,841, PRR 217.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Golimumab ↔ Rheumatoid Arthritis.
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 Golimumab?
In FDA FAERS, the most frequently co-reported reaction terms for Golimumab are rheumatoid arthritis, pain, fatigue, joint swelling, arthralgia, rash. 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 Golimumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis .
Do FAERS signals prove that Golimumab 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 9e260a47-55af-4c92-8d88-a86ccc767fff, effective 20250909; matched on
openfda.generic_name.exact:"GOLIMUMAB" 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, fieldpatient.drug.openfda.generic_name.exact, 1,236 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
GOLIMUMAB, 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.