Drug · FAERS side-effect profile with label screen
Etanercept side effects: what 595,118 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Enbrel
openFDA label
Who reports
595,118 reports · 36% serious · 17,154 with death outcome · 75% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Enbrel is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with: Rheumatoid Arthritis (RA) ( 1.1 ) Psoriatic Arthritis (PsA) ( 1.3 ) Ankylosing Spondylitis (AS) ( 1.4 ) Plaque Psoriasis (PsO) ( 1.5 ) Pediatric patien.
FDA label, Indications and Usage
What it is
Etanercept, a tumor necrosis factor (TNF) blocker, is a dimeric fusion protein consisting of the extracellular ligand-binding portion of the human 75 kilodalton (p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human IgG1.
FDA label, Description section
Boxed warning
SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospita.
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) 6Likely indication confounding 3Reporting / coding artifact 2Lab value / disease marker 12Not in label — unassessed 17
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). 1,244 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 |
|---|---|---|---|---|---|---|
| Injection site recall reaction | 486 | 911.8 569.6–1,459.5ROR 912.5 · calibrated p 2e-15 ✓ | 33.5 EB05 31.1 · IC025 +4.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Labeled (related wording) related wording | – | not reported in cached trials |
| Human antichimeric antibody positive | 307 | 370.3 251.5–545.2ROR 370.5 · calibrated p 7e-12 ✓ | 31.8 EB05 28.9 · IC025 +4.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 9.5 (8.3–11.0) | Lab value / disease marker | serious n=307 · ♀ 100% (drug 75%) | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 5,504 | 123.0 116.2–130.2ROR 124.2 · calibrated p 2e-8 ✓ | 27.3 EB05 26.7 · IC025 +4.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Lab value / disease marker | serious PRR 43.6 · ♀ 98% (drug 75%) · 92% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 218 | 122.7 92.2–163.3ROR 122.7 · calibrated p 4e-8 ✓ | 27.2 EB05 24.3 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.7 (4.1–5.5) | Lab value / disease marker | serious n=217 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Red blood cell sedimentation rate abnormal | 1,747 | 107.3 97.5–118.1ROR 107.6 · calibrated p 7e-8 ✓ | 26.4 EB05 25.4 · IC025 +4.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 12.4 (11.7–13.2) | Lab value / disease marker | serious n=1,700 | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 501 | 107.1 89.5–128.0ROR 107.2 · calibrated p 8e-8 ✓ | 26.4 EB05 24.5 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.0 (3.6–4.4) | Lab value / disease marker | serious n=496 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 4,306 | 104.7 98.6–111.2ROR 105.4 · calibrated p 8e-8 ✓ | 26.3 EB05 25.6 · IC025 +4.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.7 (4.6–4.9) | Lab value / disease marker | serious n=4,296 · ♀ 99% (drug 75%) · 91% clinician | not reported in cached trials |
| Swollen joint count increased | 2,151 | 78.3 72.5–84.5ROR 78.6 · calibrated p 7e-7 ✓ | 24.3 EB05 23.4 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.8–4.1) | Lab value / disease marker | serious n=2,149 · ♀ 100% (drug 75%) · 95% clinician | not reported in cached trials |
| Injection site macule | 470 | 74.5 63.4–87.6ROR 74.6 · calibrated p 1e-6 ✓ | 23.9 EB05 22.1 · IC025 +4.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: only this drug | Labeled (related wording) related wording | – | not reported in cached trials |
| Pemphigus | 8,412 | 73.6 70.9–76.5ROR 74.7 · calibrated p 9e-7 ✓ | 23.8 EB05 23.4 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 38.1 · ♀ 100% (drug 75%) | not reported in cached trials |
| C-reactive protein abnormal | 4,313 | 72.4 68.7–76.4ROR 72.9 · calibrated p 1e-6 ✓ | 23.7 EB05 23.1 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.6 (6.4–6.8) | Lab value / disease marker | serious n=4,285 | not reported in cached trials |
| Rheumatic fever | 2,908 | 69.9 65.6–74.5ROR 70.3 · calibrated p 1e-6 ✓ | 23.4 EB05 22.7 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.7–4.0) | Likely indication confounding shares a disease stem with the indications wording | serious n=2,906 · ♀ 100% (drug 75%) · 93% clinician | not reported in cached trials |
| Hand deformity | 8,536 | 65.9 63.5–68.3ROR 66.8 · calibrated p 2e-6 ✓ | 23.0 EB05 22.6 · IC025 +4.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.1 (5.0–5.2) | Not in label — unassessed | serious PRR 37.7 · ♀ 95% (drug 75%) | not reported in cached trials |
| C-reactive protein | 589 | 64.8 56.4–74.4ROR 64.9 · calibrated p 3e-6 ✓ | 22.8 EB05 21.3 · IC025 +4.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (3.9–4.7) | Lab value / disease marker | serious n=589 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Synovitis | 11,207 | 57.3 55.6–59.1ROR 58.4 · calibrated p 5e-6 ✓ | 21.9 EB05 21.5 · IC025 +4.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.1 (6.0–6.2) | Not in label — unassessed | serious PRR 36.0 | not reported in cached trials |
| Granuloma skin | 513 | 56.8 49.3–65.4ROR 56.8 · calibrated p 7e-6 ✓ | 21.8 EB05 20.3 · IC025 +4.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.5 (5.9–7.2) | Labeled (related wording) related wording | serious n=511 · ♀ 100% (drug 75%) | not reported in cached trials |
| Duodenal ulcer perforation | 4,537 | 56.6 53.9–59.3ROR 57.0 · calibrated p 6e-6 ✓ | 21.8 EB05 21.2 · IC025 +4.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (4.0–4.3) | Not in label — unassessed | serious PRR 34.7 · ♀ 100% (drug 75%) · 93% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,212 | 56.5 51.6–62.0ROR 56.6 · calibrated p 6e-6 ✓ | 21.8 EB05 20.8 · IC025 +4.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.8 (3.6–4.1) | Not in label — unassessed | serious n=1,212 · ♀ 100% (drug 75%) · 93% clinician | not reported in cached trials |
| Lupus vulgaris | 662 | 43.6 38.8–48.9ROR 43.6 · calibrated p 3e-5 ✓ | 19.6 EB05 18.4 · IC025 +4.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.3 (3.0–3.6) | Not in label — unassessed | serious n=662 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Facet joint syndrome | 1,651 | 38.2 35.6–40.9ROR 38.3 · calibrated p 7e-5 ✓ | 18.4 EB05 17.7 · IC025 +4.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.7 (3.5–3.9) | Not in label — unassessed | serious n=1,648 · ♀ 100% (drug 75%) · 94% clinician | not reported in cached trials |
| Joint destruction | 811 | 37.4 33.8–41.3ROR 37.4 · calibrated p 8e-5 ✓ | 18.3 EB05 17.2 · IC025 +4.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 10.6 (9.7–11.6) | Not in label — unassessed | serious n=699 | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 3,315 | 36.8 35.1–38.7ROR 37.0 · calibrated p 8e-5 ✓ | 18.1 EB05 17.6 · IC025 +4.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 5.1 (4.9–5.3) | Not in label — unassessed | serious n=3,211 · ♀ 95% (drug 75%) · 91% clinician | not reported in cached trials |
| Injection site warmth | 10,385 | 35.3 34.3–36.3ROR 35.9 · calibrated p 1e-4 ✓ | 17.8 EB05 17.5 · IC025 +4.1 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 591.0 (524.0–666.6) | Labeled (related wording) related wording | serious n=791 | not reported in cached trials |
| Body height below normal | 322 | 34.0 29.1–39.7ROR 34.0 · calibrated p 1e-4 ✓ | 17.4 EB05 15.9 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 10.0 (8.7–11.5) | Reporting / coding artifact | serious n=322 · ♀ 100% (drug 75%) | not reported in cached trials |
| Bone erosion | 1,731 | 33.1 31.0–35.4ROR 33.2 · calibrated p 2e-4 ✓ | 17.2 EB05 16.5 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.3 (5.9–6.6) | Not in label — unassessed | serious n=1,697 | not reported in cached trials |
| Adjustment disorder with depressed mood | 976 | 32.5 29.8–35.5ROR 32.6 · calibrated p 2e-4 ✓ | 17.0 EB05 16.2 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 3.9 (3.6–4.2) | Not in label — unassessed | serious n=974 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Helicobacter infection | 4,820 | 31.1 29.9–32.3ROR 31.3 · calibrated p 2e-4 ✓ | 16.7 EB05 16.3 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.2–4.4) | Not in label — unassessed | serious PRR 27.9 · ♀ 100% (drug 75%) · 93% clinician | not reported in cached trials |
| Muscle injury | 3,852 | 30.6 29.3–32.0ROR 30.8 · calibrated p 2e-4 ✓ | 16.5 EB05 16.1 · IC025 +4.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.4 (4.3–4.5) | Not in label — unassessed | serious PRR 28.3 · ♀ 100% (drug 75%) · 92% clinician | not reported in cached trials |
| Rheumatoid nodule | 1,295 | 30.1 27.9–32.4ROR 30.1 · calibrated p 3e-4 ✓ | 16.4 EB05 15.6 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 10.4 (9.7–11.1) | Labeled (related wording) related wording | serious n=1,116 | not reported in cached trials |
| X-ray abnormal | 830 | 30.1 27.4–33.0ROR 30.1 · calibrated p 3e-4 ✓ | 16.4 EB05 15.5 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.2 (3.9–4.5) | Lab value / disease marker | serious n=825 · ♀ 100% (drug 75%) · 100% clinician | not reported in cached trials |
| Dislocation of vertebra | 1,027 | 29.7 27.3–32.3ROR 29.7 · calibrated p 3e-4 ✓ | 16.3 EB05 15.4 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.1 (3.8–4.4) | Not in label — unassessed | serious n=1,025 · 93% clinician | not reported in cached trials |
| Contraindicated product administered | 12,897 | 25.8 25.2–26.4ROR 26.4 · calibrated p 5e-4 ✓ | 15.1 EB05 14.8 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.5 (6.4–6.6) | Reporting / coding artifact | age-adj. PRR 18.9 · serious PRR 29.1 | not reported in cached trials |
| Folliculitis | 4,400 | 25.6 24.7–26.7ROR 25.8 · calibrated p 6e-4 ✓ | 15.0 EB05 14.6 · IC025 +3.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.3 (4.1–4.4) | Not in label — unassessed | serious PRR 27.6 · ♀ 99% (drug 75%) · 93% clinician | not reported in cached trials |
| Injection site haematoma | 6,063 | 24.4 23.6–25.2ROR 24.6 · calibrated p 7e-4 ✓ | 14.6 EB05 14.3 · IC025 +3.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 450.6 (392.4–517.4) | Labeled (related wording) related wording | serious n=500 · 72% consumer | not reported in cached trials |
| Rheumatoid arthritis | 46,770 | 24.4 24.1–24.7ROR 26.4 · calibrated p 5e-4 ✓ | 14.6 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 12.1 (12.1–12.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 19.5 · serious PRR 23.5 | not reported in cached trials |
| Blood parathyroid hormone decreased | 605 | 23.6 21.2–26.1ROR 23.6 · calibrated p 9e-4 ✓ | 14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 6.8 (6.2–7.4) | Lab value / disease marker | serious n=605 · ♀ 100% (drug 75%) | not reported in cached trials |
| Wrist deformity | 250 | 23.3 19.9–27.4ROR 23.3 · calibrated p 0.001 ✓ | 14.2 EB05 12.8 · IC025 +3.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 103.4 (73.3–146.1) | Not in label — unassessed | serious n=203 | not reported in cached trials |
| Seronegative arthritis | 444 | 22.6 20.0–25.5ROR 22.6 · calibrated p 0.001 ✓ | 13.9 EB05 12.9 · IC025 +3.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 4.9 (4.4–5.5) | Likely indication confounding shares a disease stem with the indications wording | serious n=439 · 100% clinician | not reported in cached trials |
| Finger deformity | 1,882 | 21.9 20.7–23.2ROR 22.0 · calibrated p 0.001 ✓ | 13.7 EB05 13.2 · IC025 +3.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 13.4 (12.6–14.2) | Not in label — unassessed | serious n=1,336 | not reported in cached trials |
| Blood iron abnormal | 369 | 20.8 18.2–23.6ROR 20.8 · calibrated p 0.002 ✓ | 13.2 EB05 12.1 · IC025 +3.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 7.1 (6.3–8.0) | Lab value / disease marker | serious n=364 · ♀ 100% (drug 75%) | 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 | 7,898 | 2.12.1–2.2 | signal |
| Interstitial lung disease | 4,970 | 1.91.8–1.9 | raised |
| Liver injury | 15,236 | 1.81.8–1.9 | raised |
| Tendon disorder | 1,761 | 1.71.6–1.7 | raised |
| Serious infection | 35,491 | 1.61.6–1.7 | raised |
| Fall / fracture | 10,427 | 1.00.9–1.0 | lower than other drugs |
| Malignancy | 9,406 | 0.90.9–0.9 | lower than other drugs |
| Hyperglycaemia / diabetes | 7,811 | 0.80.8–0.8 | lower than other drugs |
| Depression | 6,017 | 0.70.7–0.8 | lower than other drugs |
| Anaphylaxis / angioedema | 2,007 | 0.60.5–0.6 | lower than other drugs |
| Myocardial infarction | 2,926 | 0.50.5–0.5 | lower than other drugs |
| Venous thromboembolism | 2,902 | 0.50.4–0.5 | lower than other drugs |
| Pancreatitis | 1,017 | 0.40.4–0.5 | lower than other drugs |
| Stroke | 3,051 | 0.40.4–0.4 | lower than other drugs |
| Heart failure | 2,046 | 0.40.4–0.4 | lower than other drugs |
| Anaemia | 3,413 | 0.40.4–0.4 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Etanercept 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 (0 of 40 signal terms matched).
- NCT01646385 — Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Cli (N=6393, phase n/a; 24 AE terms posted; arms: Etanercept; nbDMARDs)
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) | 75,450 | 2.1 2.1–2.1ROR 2.2 · calibrated p 0.932 | 2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 11.2 (11.2–11.2) | Reporting / coding artifact | age-adj. PRR 2.2 · serious PRR 5.3 | not reported in cached trials |
| Injection site pain (pain where injected) | 56,795 | 7.9 7.8–8.0ROR 8.6 · calibrated p 0.052 | 6.6 EB05 6.5 · IC025 +2.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 186.9 (181.9–192.0) | Labeled (related wording) related wording | age-adj. PRR 6.5 · serious PRR 8.0 | not reported in cached trials |
| Rheumatoid arthritis | 46,770 | 24.4 24.1–24.7ROR 26.4 · calibrated p 5e-4 ✓ | 14.6 EB05 14.5 · IC025 +3.8 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 12.1 (12.1–12.1) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 19.5 · serious PRR 23.5 | not reported in cached trials |
| Arthralgia (joint pain) | 45,369 | 4.2 4.2–4.3ROR 4.5 · calibrated p 0.299 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 14.0 (14.0–14.0) | Not in label — unassessed | age-adj. PRR 3.8 · serious PRR 5.7 | not reported in cached trials |
| Pain | 43,458 | 2.6 2.6–2.6ROR 2.7 · calibrated p 0.721 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 11.7 (11.7–11.7) | Labeled adverse reaction exact term | age-adj. PRR 2.6 · serious PRR 3.8 | not reported in cached trials |
| Injection site erythema (redness where injected) | 41,049 | 17.2 17.0–17.4ROR 18.4 · calibrated p 0.003 ✓ | 11.7 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 376.8 (359.4–395.0) | Labeled (related wording) related wording | age-adj. PRR 14.7 · serious PRR 10.2 | not reported in cached trials |
| Fatigue (tiredness) | 30,610 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.593 | 1.4 EB05 1.4 · IC025 +0.5 vs other Tumor Necrosis Factor Blockers: PRR 9.1 (9.0–9.1) | Not in label — unassessed | age-adj. PRR 1.2 · serious PRR 2.5 | not reported in cached trials |
| Joint swelling | 25,709 | 9.3 9.2–9.4ROR 9.7 · calibrated p 0.036 ✓ | 7.5 EB05 7.4 · IC025 +2.9 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 10.8 (10.7–10.9) | Not in label — unassessed | age-adj. PRR 7.8 · serious PRR 14.7 | not reported in cached trials |
| Pain in extremity | 25,636 | 3.3 3.2–3.3ROR 3.4 · calibrated p 0.520 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 21.5 (21.2–21.8) | Not in label — unassessed | age-adj. PRR 3.2 · serious PRR 3.7 | not reported in cached trials |
| Psoriasis | 25,095 | 8.2 8.0–8.3ROR 8.5 · calibrated p 0.056 | 6.8 EB05 6.7 · IC025 +2.7 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 29.2 (28.8–29.7) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 7.9 · serious PRR 9.1 | not reported in cached trials |
| Headache | 24,919 | 1.4 1.4–1.4ROR 1.4 · calibrated p 0.600 | 1.4 EB05 1.4 · IC025 +0.5 vs other Tumor Necrosis Factor Blockers: PRR 12.1 (12.0–12.2) | Labeled adverse reaction exact term | age-adj. PRR 1.2 · serious PRR 2.2 | not reported in cached trials |
| Injection site swelling | 23,283 | 15.3 15.0–15.5ROR 15.9 · calibrated p 0.006 ✓ | 10.8 EB05 10.7 · IC025 +3.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 256.1 (243.0–269.9) | Labeled (related wording) related wording | age-adj. PRR 12.8 · serious PRR 10.2 | not reported in cached trials |
| Off label use (used outside approved label) | 22,534 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.249 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Tumor Necrosis Factor Blockers: PRR 4.0 (4.0–4.1) | Reporting / coding artifact | age-adj. PRR 0.9 · serious PRR 1.7 | not reported in cached trials |
| Injection site pruritus | 22,115 | 17.1 16.9–17.4ROR 17.8 · calibrated p 0.003 ✓ | 11.7 EB05 11.6 · IC025 +3.5 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 388.7 (363.7–415.4) | Labeled (related wording) related wording | age-adj. PRR 14.7 · serious PRR 13.0 | not reported in cached trials |
| Injection site reaction | 20,927 | 15.1 14.9–15.3ROR 15.6 · calibrated p 0.006 ✓ | 10.7 EB05 10.6 · IC025 +3.4 3/3 methods agree vs other Tumor Necrosis Factor Blockers: PRR 71.1 (69.1–73.3) | Labeled adverse reaction exact term | age-adj. PRR 13.9 · serious PRR 13.5 | 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=8,412, PRR 73.6
- Hand deformity — n=8,536, PRR 65.9
- Synovitis — n=11,207, PRR 57.3
- Duodenal ulcer perforation — n=4,537, PRR 56.6
- Deep vein thrombosis postoperative — n=1,212, PRR 56.5
- Lupus vulgaris — n=662, PRR 43.6
- Facet joint syndrome — n=1,651, PRR 38.2
- Joint destruction — n=811, PRR 37.4
- Sleep disorder due to general medical condition, insomnia type — n=3,315, PRR 36.8
- Bone erosion — n=1,731, PRR 33.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Etanercept ↔ 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 Etanercept?
In FDA FAERS, the most frequently co-reported reaction terms for Etanercept are injection site pain, rheumatoid arthritis, arthralgia, pain, injection site erythema, fatigue. 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 Etanercept have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS and MALIGNANCIES WARNING: SERIOUS INFECTIONS and MALIGNANCIES See full prescribing information for complete boxed warning. SERIOUS INFECTIONS Increased risk of serious infections leading to hospita.
Do FAERS signals prove that Etanercept 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 a002b40c-097d-47a5-957f-7a7b1807af7f, effective 20260511; matched on
openfda.generic_name.exact:"ETANERCEPT" 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, 1,284 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
ETANERCEPT, 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.