Drug · FAERS side-effect profile with label screen
Infliximab side effects: what 217,056 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Renflexis
openFDA label
Who reports
217,056 reports · 89% serious · 13,761 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
RENFLEXIS is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease: reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.
FDA label, Indications and Usage
What it is
Infliximab-abda, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-abda is produced by a recombinant murine myeloma cell line, SP2/0.
FDA label, Description section
Boxed warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, incl.
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 — boxed warning 1Labeled adverse reaction 1Labeled (related wording) 2Reporting / coding artifact 1Lab value / disease marker 12Not in label — unassessed 23
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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). 1,262 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 |
|---|---|---|---|---|---|---|
| Human antichimeric antibody positive | 307 | 1,034.2 702.4–1,522.7ROR 1,035.6 · calibrated p 2e-16 ✓ | 86.9 EB05 79.0 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 9.5 (8.3–11.0) | Lab value / disease marker | serious n=304 · ♀ 100% (drug 63%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,687 | 403.9 380.6–428.7ROR 414.8 · calibrated p 4e-13 ✓ | 77.3 EB05 75.6 · IC025 +6.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.3–4.6) | Lab value / disease marker | serious PRR 50.4 · ♀ 99% (drug 63%) · 93% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 219 | 350.1 262.6–466.7ROR 350.5 · calibrated p 5e-12 ✓ | 74.6 EB05 66.7 · IC025 +5.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.8 (4.1–5.5) | Lab value / disease marker | serious n=219 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Swollen joint count increased | 2,226 | 246.1 227.5–266.3ROR 248.7 · calibrated p 6e-11 ✓ | 68.9 EB05 66.5 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.9–4.3) | Lab value / disease marker | serious n=2,226 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Rheumatoid factor positive | 4,102 | 242.9 229.3–257.3ROR 247.5 · calibrated p 6e-11 ✓ | 68.6 EB05 66.9 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.3–4.6) | Lab value / disease marker | serious n=4,100 · ♀ 99% (drug 63%) · 92% clinician | not reported in cached trials |
| Pemphigus | 8,799 | 239.1 229.9–248.6ROR 249.2 · calibrated p 5e-11 ✓ | 68.3 EB05 67.2 · IC025 +6.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.6 (4.5–4.7) | Not in label — unassessed | serious PRR 44.6 · ♀ 100% (drug 63%) | not reported in cached trials |
| Rheumatic fever | 3,038 | 224.9 210.7–240.1ROR 228.1 · calibrated p 1e-10 ✓ | 67.1 EB05 65.2 · IC025 +6.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (4.0–4.3) | Labeled (related wording) related wording | serious n=3,038 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 437 | 185.7 158.0–218.2ROR 186.0 · calibrated p 9e-10 ✓ | 63.0 EB05 58.2 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.4 (3.1–3.8) | Lab value / disease marker | serious n=437 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Granuloma skin | 530 | 173.6 150.4–200.3ROR 174.0 · calibrated p 2e-9 ✓ | 61.6 EB05 57.3 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.8 (6.2–7.5) | Not in label — unassessed | serious n=530 · ♀ 100% (drug 63%) | not reported in cached trials |
| Duodenal ulcer perforation | 4,679 | 171.9 163.9–180.4ROR 175.7 · calibrated p 1e-9 ✓ | 61.5 EB05 60.1 · IC025 +5.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 40.0 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,228 | 163.6 149.2–179.4ROR 164.5 · calibrated p 2e-9 ✓ | 60.4 EB05 57.6 · IC025 +5.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.7–4.1) | Not in label — unassessed | serious n=1,228 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Lupus vulgaris | 713 | 145.6 129.5–163.6ROR 146.0 · calibrated p 6e-9 ✓ | 57.8 EB05 54.3 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.6 (3.3–3.9) | Not in label — unassessed | serious n=713 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Grip strength | 136 | 137.9 106.0–179.5ROR 138.0 · calibrated p 2e-8 ✓ | 56.2 EB05 48.7 · IC025 +5.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.3 (4.3–6.4) | Not in label — unassessed | serious n=136 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 531 | 137.2 120.1–156.8ROR 137.6 · calibrated p 1e-8 ✓ | 56.4 EB05 52.5 · IC025 +5.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.4–4.2) | Lab value / disease marker | serious n=531 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Hand deformity | 7,477 | 129.7 125.3–134.3ROR 134.3 · calibrated p 1e-8 ✓ | 55.2 EB05 54.1 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 39.0 · ♀ 99% (drug 63%) · 91% clinician | not reported in cached trials |
| Facet joint syndrome | 1,773 | 124.9 116.4–134.1ROR 125.9 · calibrated p 2e-8 ✓ | 54.3 EB05 52.2 · IC025 +5.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.8–4.2) | Not in label — unassessed | serious n=1,772 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Swollen joint count | 135 | 117.9 91.5–151.8ROR 118.0 · calibrated p 5e-8 ✓ | 52.6 EB05 45.6 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.6 (4.6–6.8) | Labeled (related wording) related wording | serious n=135 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Musculoskeletal deformity | 129 | 117.0 90.4–151.5ROR 117.1 · calibrated p 5e-8 ✓ | 52.4 EB05 45.2 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 16.9 (13.1–21.7) | Not in label — unassessed | serious n=128 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Vaginal flatulence | 159 | 104.9 83.7–131.4ROR 104.9 · calibrated p 1e-7 ✓ | 49.9 EB05 43.7 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 24.6 (19.1–31.6) | Not in label — unassessed | serious n=159 · ♀ 100% (drug 63%) | not reported in cached trials |
| Drug specific antibody | 689 | 98.8 88.8–109.9ROR 99.1 · calibrated p 1e-7 ✓ | 48.7 EB05 45.7 · IC025 +5.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 36.5 (31.8–41.8) | Lab value / disease marker | serious n=544 | not reported in cached trials |
| C-reactive protein abnormal | 3,220 | 97.8 93.2–102.8ROR 99.3 · calibrated p 1e-7 ✓ | 48.5 EB05 47.1 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.3–4.6) | Lab value / disease marker | serious n=3,219 · ♀ 87% (drug 63%) | not reported in cached trials |
| Synovitis | 9,005 | 96.4 93.7–99.3ROR 100.6 · calibrated p 1e-7 ✓ | 48.2 EB05 47.4 · IC025 +5.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.5–4.6) | Not in label — unassessed | serious PRR 32.8 · ♀ 93% (drug 63%) | not reported in cached trials |
| Hepatosplenic t-cell lymphoma | 184 | 94.3 76.9–115.7ROR 94.4 · calibrated p 2e-7 ✓ | 47.4 EB05 42.0 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 68.7 (49.0–96.4) | Labeled — boxed warning exact term | serious n=184 · ♀ 0% (drug 63%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 964 | 88.6 81.2–96.8ROR 89.0 · calibrated p 3e-7 ✓ | 46.1 EB05 43.7 · IC025 +5.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.6–4.1) | Not in label — unassessed | serious n=964 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Helicobacter infection | 4,856 | 88.0 84.6–91.5ROR 90.0 · calibrated p 2e-7 ✓ | 46.0 EB05 44.9 · IC025 +5.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 31.6 · ♀ 99% (drug 63%) · 93% clinician | not reported in cached trials |
| Body height below normal | 301 | 83.3 71.3–97.2ROR 83.4 · calibrated p 5e-7 ✓ | 44.6 EB05 40.5 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 9.0 (7.8–10.4) | Reporting / coding artifact | serious n=301 · ♀ 100% (drug 63%) | not reported in cached trials |
| Dislocation of vertebra | 1,023 | 82.3 75.7–89.4ROR 82.6 · calibrated p 5e-7 ✓ | 44.4 EB05 42.1 · IC025 +5.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.8–4.4) | Not in label — unassessed | serious n=1,023 · ♀ 95% (drug 63%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 818 | 81.7 74.4–89.7ROR 82.0 · calibrated p 5e-7 ✓ | 44.2 EB05 41.7 · IC025 +5.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.8–4.4) | Lab value / disease marker | serious n=818 · ♀ 95% (drug 63%) · 93% clinician | not reported in cached trials |
| Ileocaecal resection | 139 | 69.4 55.7–86.3ROR 69.4 · calibrated p 2e-6 ✓ | 40.2 EB05 34.9 · IC025 +4.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 16.4 (12.9–20.8) | Not in label — unassessed | serious n=138 · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 2,692 | 69.3 66.0–72.8ROR 70.2 · calibrated p 1e-6 ✓ | 40.4 EB05 39.1 · IC025 +5.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–4.1) | Not in label — unassessed | serious n=2,689 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Muscle injury | 3,385 | 67.7 64.8–70.7ROR 68.8 · calibrated p 2e-6 ✓ | 39.8 EB05 38.7 · IC025 +5.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.6–3.9) | Not in label — unassessed | serious PRR 28.0 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Blood parathyroid hormone decreased | 612 | 67.1 60.5–74.4ROR 67.3 · calibrated p 2e-6 ✓ | 39.6 EB05 37.0 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.9 (6.3–7.6) | Lab value / disease marker | serious n=612 · ♀ 100% (drug 63%) | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 952 | 66.8 61.4–72.5ROR 67.1 · calibrated p 2e-6 ✓ | 39.5 EB05 37.4 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.9 (4.6–5.3) | Lab value / disease marker | serious n=949 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 219 | 64.8 54.5–76.9ROR 64.8 · calibrated p 3e-6 ✓ | 38.7 EB05 34.6 · IC025 +4.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.6–4.8) | Not in label — unassessed | serious n=219 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Folliculitis | 4,112 | 63.8 61.3–66.3ROR 65.0 · calibrated p 2e-6 ✓ | 38.4 EB05 37.5 · IC025 +5.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–4.0) | Not in label — unassessed | serious PRR 29.3 · ♀ 98% (drug 63%) · 94% clinician | not reported in cached trials |
| Retinitis | 660 | 63.0 57.1–69.5ROR 63.2 · calibrated p 3e-6 ✓ | 38.1 EB05 35.8 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.6–4.2) | Not in label — unassessed | serious n=660 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Pericarditis | 6,271 | 58.1 56.3–60.0ROR 59.8 · calibrated p 4e-6 ✓ | 36.3 EB05 35.6 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.6 (4.5–4.7) | Not in label — unassessed | serious PRR 23.8 · ♀ 96% (drug 63%) · 92% clinician | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 8,347 | 57.4 55.9–59.0ROR 59.7 · calibrated p 4e-6 ✓ | 36.1 EB05 35.4 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.5 (4.4–4.6) | Not in label — unassessed | serious PRR 33.9 · ♀ 100% (drug 63%) · 90% clinician | not reported in cached trials |
| Lupus-like syndrome | 3,336 | 56.5 54.2–59.0ROR 57.4 · calibrated p 6e-6 ✓ | 35.7 EB05 34.7 · IC025 +5.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 13.9 (13.3–14.6) | Labeled adverse reaction exact term | serious PRR 23.9 | NCT00727298: 1/4,465 (0.0%) on Infliximab (serious AE) |
| Bone erosion | 1,235 | 51.5 48.1–55.2ROR 51.8 · calibrated p 1e-5 ✓ | 33.6 EB05 32.1 · IC025 +5.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.8–4.3) | Not in label — unassessed | serious n=1,234 · ♀ 85% (drug 63%) · 92% 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 |
|---|---|---|---|
| Opportunistic infection | 6,895 | 5.15.0–5.2 | signal |
| Liver injury | 12,444 | 4.14.0–4.2 | signal |
| Interstitial lung disease | 3,631 | 3.83.6–3.9 | signal |
| Serious infection | 20,294 | 2.62.5–2.6 | signal |
| Malignancy | 9,317 | 2.42.4–2.5 | signal |
| Anaphylaxis / angioedema | 2,966 | 2.32.2–2.4 | signal |
| Pancreatitis | 1,669 | 2.01.9–2.1 | raised |
| Tendon disorder | 690 | 1.81.6–1.9 | raised |
| Gi bleeding | 2,923 | 1.61.5–1.6 | raised |
| Hyperglycaemia / diabetes | 5,206 | 1.51.4–1.5 | raised |
| Depression | 3,812 | 1.31.3–1.4 | raised |
| Venous thromboembolism | 2,671 | 1.21.1–1.2 | raised |
| Anaemia | 3,175 | 1.01.0–1.1 | no difference |
| Fall / fracture | 3,670 | 0.90.9–1.0 | lower than other drugs |
| Rhabdomyolysis / myopathy | 679 | 0.80.7–0.9 | lower than other drugs |
| Myocardial infarction | 1,506 | 0.70.7–0.7 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Infliximab 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).
- NCT00727298 — Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840) (N=4485, phase n/a; 155 AE terms posted; arms: Infliximab)
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) | 39,629 | 3.0 2.9–3.0ROR 3.4 · calibrated p 0.508 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.4–4.4) | Reporting / coding artifact | age-adj. PRR 3.2 · serious PRR 4.7 | not reported in cached trials |
| Off label use (used outside approved label) | 38,973 | 4.5 4.5–4.5ROR 5.3 · calibrated p 0.208 | 4.3 EB05 4.3 · IC025 +2.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 8.7 (8.7–8.7) | Reporting / coding artifact | age-adj. PRR 5.2 · serious PRR 5.0 | not reported in cached trials |
| Condition aggravated | 19,722 | 6.7 6.6–6.8ROR 7.3 · calibrated p 0.089 | 6.3 EB05 6.2 · IC025 +2.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.1 (6.0–6.2) | Reporting / coding artifact | age-adj. PRR 7.1 · serious PRR 6.1 | NCT00727298: 2/4,465 (0.0%) on Infliximab (serious AE) |
| Infusion related reaction (reaction during infusion) | 19,073 | 39.0 38.4–39.7ROR 42.7 · calibrated p 4e-5 ✓ | 27.9 EB05 27.6 · IC025 +4.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 11.9 (11.7–12.1) | Labeled (related wording) related wording | age-adj. PRR 32.9 · serious PRR 20.9 | NCT00727298: 28/4,465 (0.6%) on Infliximab (serious AE) |
| Pain | 18,573 | 3.0 2.9–3.0ROR 3.2 · calibrated p 0.576 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.5) | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 2.9 · ♀ 84% (drug 63%) | NCT00727298: 1/4,465 (0.0%) on Infliximab (serious AE) |
| Rheumatoid arthritis | 18,465 | 18.7 18.4–19.0ROR 20.3 · calibrated p 0.002 ✓ | 15.8 EB05 15.6 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.2 (3.2–3.3) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 16.5 · serious PRR 12.4 · ♀ 92% (drug 63%) | not reported in cached trials |
| Arthralgia (joint pain) | 17,737 | 4.3 4.2–4.3ROR 4.6 · calibrated p 0.287 | 4.1 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.5) | Labeled adverse reaction exact term | age-adj. PRR 4.6 · serious PRR 4.7 | not reported in cached trials |
| Fatigue (tiredness) | 16,695 | 2.1 2.1–2.1ROR 2.2 · calibrated p 0.956 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.9–3.9) | Labeled adverse reaction exact term | age-adj. PRR 2.1 · serious PRR 2.5 · ♀ 84% (drug 63%) | not reported in cached trials |
| Product use issue | 13,443 | 7.4 7.3–7.5ROR 7.8 · calibrated p 0.071 | 6.9 EB05 6.8 · IC025 +2.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 8.9 (8.7–9.0) | Reporting / coding artifact | age-adj. PRR 8.0 · serious PRR 9.5 | not reported in cached trials |
| Rash | 13,341 | 3.0 3.0–3.1ROR 3.2 · calibrated p 0.574 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Labeled adverse reaction exact term | age-adj. PRR 2.8 · serious PRR 4.1 · ♀ 87% (drug 63%) | NCT00727298: 1/4,465 (0.0%) on Infliximab (serious AE) |
| Intentional product use issue | 12,987 | 16.6 16.3–16.9ROR 17.6 · calibrated p 0.004 ✓ | 14.3 EB05 14.1 · IC025 +3.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 9.5 (9.3–9.7) | Reporting / coding artifact | age-adj. PRR 25.5 · serious PRR 13.5 · 92% clinician | not reported in cached trials |
| Drug intolerance | 12,434 | 14.2 13.9–14.5ROR 15.0 · calibrated p 0.007 ✓ | 12.5 EB05 12.3 · IC025 +3.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.8 (4.8–4.9) | Reporting / coding artifact | age-adj. PRR 16.5 · serious PRR 13.0 · ♀ 89% (drug 63%) | not reported in cached trials |
| Nausea | 12,307 | 1.5 1.5–1.5ROR 1.5 · calibrated p 0.671 | 1.5 EB05 1.5 · IC025 +0.6 vs other Tumor Necrosis Factor Blockers: PRR 4.9 (4.8–5.0) | Labeled adverse reaction exact term | age-adj. PRR 1.6 · serious PRR 1.8 | NCT00727298: 3/4,465 (0.1%) on Infliximab (serious AE) |
| Alopecia (hair loss) | 11,830 | 6.1 6.0–6.2ROR 6.4 · calibrated p 0.126 | 5.8 EB05 5.7 · IC025 +2.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.7 (4.6–4.8) | Not in label — unassessed | age-adj. PRR 5.1 · serious PRR 7.8 · ♀ 97% (drug 63%) | not reported in cached trials |
| Joint swelling | 11,591 | 10.2 10.0–10.4ROR 10.7 · calibrated p 0.025 ✓ | 9.3 EB05 9.2 · IC025 +3.2 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.5 (3.5–3.6) | Not in label — unassessed | age-adj. PRR 10.0 · serious PRR 10.3 · ♀ 87% (drug 63%) | NCT00727298: 1/4,465 (0.0%) on Infliximab (serious AE) |
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=8,799, PRR 239.1
- Granuloma skin — n=530, PRR 173.6
- Duodenal ulcer perforation — n=4,679, PRR 171.9
- Deep vein thrombosis postoperative — n=1,228, PRR 163.6
- Lupus vulgaris — n=713, PRR 145.6
- Grip strength — n=136, PRR 137.9
- Hand deformity — n=7,477, PRR 129.7
- Facet joint syndrome — n=1,773, PRR 124.9
- Musculoskeletal deformity — n=129, PRR 117.0
- Vaginal flatulence — n=159, PRR 104.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Infliximab (TNF inhibitors) ↔ Tuberculosis reactivation.
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 Infliximab?
In FDA FAERS, the most frequently co-reported reaction terms for Infliximab are infusion related reaction, pain, rheumatoid arthritis, arthralgia, fatigue, 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 Infliximab 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. Increased risk of serious infections leading to hospitalization or death, incl.
Do FAERS signals prove that Infliximab 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 dbf738c4-3fac-4422-a9d8-51d9c83a8789, effective 20260828; matched on
openfda.generic_name.exact:"INFLIXIMAB" 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, 1,302 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
INFLIXIMAB, 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.