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Drug · FAERS side-effect profile with label screen

Adalimumab side effects: what 703,389 FDA adverse event reports show

Adalimumab · Humira · 1,298 reaction terms · 2,730,152 drug–reaction co-reports · data 2026-09-14

Drug class

Tumor necrosis factor (tnf) blocker

FDA label, Indications wording

Brand names

Humira

openFDA label

Who reports

703,389 reports · 51% serious · 30,045 with death outcome · 68% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Adalimumab is a tumor necrosis factor (TNF) blocker indicated for: Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis .

FDA label, Indications and Usage

What it is

Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.

FDA label, Description section

Boxed warning

WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

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 adverse reaction 1Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 9Not in label — unassessed 20

What the badges mean

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.
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). 1,258 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 positive	5,985	165.1 154.6–176.4ROR 166.5 · calibrated p 2e-9 ✓	25.1 EB05 24.6 · IC025 +4.6 3/3 methods agree	Lab value / disease marker	serious PRR 28.4 · ♀ 100% (drug 68%) · 92% clinician	not reported in cached trials
Anti-cyclic citrullinated peptide antibody	547	138.8 113.3–170.1ROR 138.9 · calibrated p 1e-8 ✓	24.4 EB05 22.7 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=546 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Rheumatoid factor positive	4,659	127.8 119.5–136.7ROR 128.6 · calibrated p 2e-8 ✓	24.1 EB05 23.5 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=4,650 · ♀ 98% (drug 68%) · 91% clinician	not reported in cached trials
Swollen joint count increased	2,409	102.2 93.8–111.3ROR 102.5 · calibrated p 1e-7 ✓	23.0 EB05 22.3 · IC025 +4.5 3/3 methods agree	Lab value / disease marker	serious n=2,408 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Lupus vulgaris	888	87.9 77.0–100.4ROR 88.0 · calibrated p 3e-7 ✓	22.2 EB05 21.0 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=888 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Pemphigus	9,240	86.7 83.2–90.3ROR 87.8 · calibrated p 3e-7 ✓	22.2 EB05 21.8 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · ♀ 100% (drug 68%)	not reported in cached trials
Rheumatic fever	3,220	83.8 78.2–89.7ROR 84.2 · calibrated p 4e-7 ✓	22.0 EB05 21.3 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=3,217 · ♀ 100% (drug 68%) · 94% clinician	not reported in cached trials
Deep vein thrombosis postoperative	1,428	79.9 72.2–88.4ROR 80.0 · calibrated p 6e-7 ✓	21.7 EB05 20.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious n=1,428 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Injection site burning	562	73.3 62.7–85.7ROR 73.3 · calibrated p 1e-6 ✓	21.2 EB05 19.8 · IC025 +4.2 3/3 methods agree	Labeled (related wording) related wording	♀ 100% (drug 68%) · 100% consumer	not reported in cached trials
Injection site papule	3,181	70.5 66.1–75.2ROR 70.8 · calibrated p 1e-6 ✓	21.0 EB05 20.4 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious n=378 · 92% consumer	not reported in cached trials
Cartilage atrophy	570	69.2 59.5–80.6ROR 69.3 · calibrated p 2e-6 ✓	20.8 EB05 19.4 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=556 · 100% consumer	not reported in cached trials
C-reactive protein	615	62.2 54.0–71.6ROR 62.2 · calibrated p 4e-6 ✓	20.2 EB05 18.9 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=614 · ♀ 100% (drug 68%) · 100% clinician	NCT01076959: 2/7,740 (0.0%) on Adalimumab (serious AE)
C-reactive protein abnormal	4,334	61.9 58.7–65.3ROR 62.3 · calibrated p 3e-6 ✓	20.2 EB05 19.7 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=4,317	NCT01076959: 2/7,740 (0.0%) on Adalimumab (serious AE)
Duodenal ulcer perforation	4,928	60.4 57.5–63.5ROR 60.8 · calibrated p 4e-6 ✓	20.0 EB05 19.5 · IC025 +4.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 22.6 · ♀ 100% (drug 68%) · 93% clinician	not reported in cached trials
Granuloma skin	539	54.9 47.5–63.4ROR 54.9 · calibrated p 8e-6 ✓	19.4 EB05 18.0 · IC025 +4.1 3/3 methods agree	Labeled (related wording) related wording	serious n=532 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Hand deformity	8,490	54.5 52.6–56.6ROR 55.2 · calibrated p 7e-6 ✓	19.3 EB05 19.0 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 23.4 · ♀ 98% (drug 68%)	not reported in cached trials
Synovitis	11,430	50.9 49.4–52.5ROR 51.7 · calibrated p 1e-5 ✓	18.9 EB05 18.6 · IC025 +4.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 22.2 · ♀ 92% (drug 68%)	NCT01076205: 7/7,229 (0.1%) on Adalimumab (serious AE)
Red blood cell sedimentation rate abnormal	1,441	47.8 44.0–52.1ROR 47.9 · calibrated p 2e-5 ✓	18.5 EB05 17.7 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=1,427	NCT01076205: 1/7,229 (0.0%) on Adalimumab (serious AE)
Facet joint syndrome	1,918	45.6 42.5–49.1ROR 45.8 · calibrated p 2e-5 ✓	18.1 EB05 17.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=1,915 · ♀ 100% (drug 68%) · 100% clinician	NCT01076205: 2/7,229 (0.0%) on Adalimumab (serious AE)
Adjustment disorder with depressed mood	1,172	40.7 37.2–44.5ROR 40.8 · calibrated p 5e-5 ✓	17.3 EB05 16.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=1,166 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Bone erosion	2,023	39.0 36.5–41.7ROR 39.1 · calibrated p 6e-5 ✓	17.0 EB05 16.4 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=2,000	not reported in cached trials
X-ray abnormal	1,003	37.6 34.2–41.3ROR 37.6 · calibrated p 8e-5 ✓	16.7 EB05 15.9 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=998 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Dislocation of vertebra	1,248	37.4 34.4–40.7ROR 37.5 · calibrated p 8e-5 ✓	16.7 EB05 15.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=1,242 · ♀ 100% (drug 68%)	not reported in cached trials
Hidradenitis	4,739	35.1 33.6–36.6ROR 35.3 · calibrated p 1e-4 ✓	16.2 EB05 15.9 · IC025 +4.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=2,443 · 75% consumer	NCT01076205: 1/7,229 (0.0%) on Adalimumab (serious AE)
Adverse food reaction	492	33.3 29.2–37.9ROR 33.3 · calibrated p 2e-4 ✓	15.9 EB05 14.7 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=310 · 100% consumer	not reported in cached trials
Helicobacter infection	5,291	31.5 30.3–32.8ROR 31.7 · calibrated p 2e-4 ✓	15.5 EB05 15.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 18.3 · ♀ 100% (drug 68%) · 91% clinician	not reported in cached trials
Body height below normal	322	28.6 24.5–33.4ROR 28.6 · calibrated p 4e-4 ✓	14.7 EB05 13.4 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=321 · 100% clinician	not reported in cached trials
Intestinal stenosis	2,080	28.5 26.8–30.3ROR 28.6 · calibrated p 3e-4 ✓	14.7 EB05 14.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=2,018	NCT01076205: 1/7,229 (0.0%) on Adalimumab (serious AE)
Surgical failure	572	28.4 25.3–31.9ROR 28.4 · calibrated p 4e-4 ✓	14.7 EB05 13.7 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious n=571 · 100% consumer	not reported in cached trials
Postoperative adhesion	328	27.7 23.8–32.3ROR 27.8 · calibrated p 4e-4 ✓	14.5 EB05 13.2 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=320 · 100% consumer	not reported in cached trials
Retinitis	809	27.4 24.9–30.2ROR 27.4 · calibrated p 4e-4 ✓	14.4 EB05 13.6 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=806 · ♀ 100% (drug 68%) · 100% clinician	not reported in cached trials
Small intestinal stenosis	511	26.9 23.9–30.4ROR 27.0 · calibrated p 5e-4 ✓	14.3 EB05 13.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=496	not reported in cached trials
Gastrointestinal fistula	407	25.1 22.0–28.7ROR 25.2 · calibrated p 7e-4 ✓	13.8 EB05 12.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=395 · 100% consumer	not reported in cached trials
Muscle injury	3,785	24.9 23.9–26.0ROR 25.1 · calibrated p 7e-4 ✓	13.7 EB05 13.4 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.7 · ♀ 100% (drug 68%) · 91% clinician	not reported in cached trials
Ileal stenosis	813	24.5 22.3–26.9ROR 24.6 · calibrated p 8e-4 ✓	13.6 EB05 12.8 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=802	not reported in cached trials
Drug specific antibody	621	24.3 21.8–27.1ROR 24.3 · calibrated p 8e-4 ✓	13.5 EB05 12.7 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=504	not reported in cached trials
Rheumatoid nodule	1,249	23.7 22.0–25.5ROR 23.7 · calibrated p 9e-4 ✓	13.4 EB05 12.7 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious n=1,171	NCT01076205: 6/7,229 (0.1%) on Adalimumab (serious AE)
Intestinal fistula	631	23.5 21.2–26.1ROR 23.6 · calibrated p 9e-4 ✓	13.3 EB05 12.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=613	not reported in cached trials
Folliculitis	4,615	23.5 22.6–24.4ROR 23.7 · calibrated p 9e-4 ✓	13.3 EB05 13.0 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 17.1 · ♀ 95% (drug 68%) · 91% clinician	NCT01076205: 1/7,229 (0.0%) on Adalimumab (serious AE)
Large intestinal stenosis	868	22.8 20.8–24.9ROR 22.8 · calibrated p 0.001 ✓	13.1 EB05 12.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious n=834	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
Tendon disorder	3,012	2.52.4–2.6	signal
Opportunistic infection	9,348	2.12.1–2.2	signal
Liver injury	17,718	1.81.8–1.8	raised
Serious infection	43,460	1.71.7–1.7	raised
Interstitial lung disease	5,214	1.71.6–1.7	raised
Fall / fracture	15,463	1.21.2–1.2	raised
Depression	9,884	1.01.0–1.1	raised
Gi bleeding	5,934	1.00.9–1.0	lower than other drugs
Hyperglycaemia / diabetes	10,200	0.90.9–0.9	lower than other drugs
Pancreatitis	2,304	0.80.8–0.9	lower than other drugs
Anaemia	8,466	0.80.8–0.9	lower than other drugs
Malignancy	10,272	0.80.8–0.8	lower than other drugs
Venous thromboembolism	5,686	0.80.8–0.8	lower than other drugs
Myocardial infarction	4,710	0.70.7–0.7	lower than other drugs
Anaphylaxis / angioedema	2,621	0.60.6–0.6	lower than other drugs
Stroke	5,163	0.60.6–0.6	lower than other drugs

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Adalimumab 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 (9 of 40 signal terms matched).

NCT01076959 — Drug Use Investigation for Humira® - All Patient Investigation for Rheumatoid Arthritis (N=7972, phase n/a; 287 AE terms posted; arms: Humira)
NCT01076205 — Safety and Effect on Quality of Life/Work Productivity of Humira in Patients With Rheumatoid Arthritis (N=7229, phase n/a; 882 AE terms posted; arms: Adalimumab)

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)	91,612	2.2 2.1–2.2ROR 2.3 · calibrated p 0.889	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.3 · serious PRR 4.0	NCT01076205: 8/7,229 (0.1%) on Adalimumab (serious AE)
Pain	49,673	2.5 2.5–2.6ROR 2.6 · calibrated p 0.752	2.4 EB05 2.4 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.5 · serious PRR 2.9	NCT01076959: 3/7,740 (0.0%) on Adalimumab (serious AE)
Arthralgia (joint pain)	48,590	3.8 3.8–3.9ROR 4.0 · calibrated p 0.370	3.5 EB05 3.5 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 3.3 · serious PRR 4.7	NCT01076959: 4/7,740 (0.1%) on Adalimumab (serious AE)
Injection site pain (pain where injected)	47,375	5.3 5.3–5.4ROR 5.7 · calibrated p 0.174	4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 5.4 · serious PRR 4.8 · 90% consumer	NCT01076959: 3/7,740 (0.0%) on Adalimumab (serious AE)
Fatigue (tiredness)	39,652	1.6 1.5–1.6ROR 1.6 · calibrated p 0.695	1.5 EB05 1.5 · IC025 +0.6	Labeled (related wording) related wording	age-adj. PRR 1.5 · serious PRR 2.0	NCT01076205: 4/7,229 (0.1%) on Adalimumab (serious AE)
Rheumatoid arthritis	36,065	13.6 13.4–13.7ROR 14.3 · calibrated p 0.009 ✓	9.5 EB05 9.4 · IC025 +3.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 11.0 · serious PRR 11.0	NCT01076959: 5/7,740 (0.1%) on Adalimumab (serious AE)
Headache	28,766	1.4 1.4–1.4ROR 1.4 · calibrated p 0.578	1.4 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	age-adj. PRR 1.3 · serious PRR 1.8	NCT01076205: 5/7,229 (0.1%) on Adalimumab (serious AE)
Nausea	27,486	1.0 1.0–1.1ROR 1.0 · calibrated p 0.334	1.0 EB05 1.0 · IC025 +0.0	Labeled adverse reaction exact term	age-adj. PRR 1.0 · serious PRR 1.4	NCT01076205: 5/7,229 (0.1%) on Adalimumab (serious AE)
Diarrhoea (diarrhea)	25,850	1.2 1.2–1.2ROR 1.2 · calibrated p 0.450	1.2 EB05 1.2 · IC025 +0.2	Not in label — unassessed	age-adj. PRR 1.3 · serious PRR 1.6	NCT01076959: 2/7,740 (0.0%) on Adalimumab (serious AE)
Rash	25,745	1.8 1.8–1.8ROR 1.9 · calibrated p 0.859	1.8 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	age-adj. PRR 1.8 · serious PRR 2.8	NCT01076959: 2/7,740 (0.0%) on Adalimumab (serious AE)
Psoriasis	24,917	6.8 6.7–6.9ROR 7.0 · calibrated p 0.098	5.7 EB05 5.6 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	age-adj. PRR 6.2 · serious PRR 8.1	NCT01076205: 2/7,229 (0.0%) on Adalimumab (serious AE)
Pain in extremity	24,578	2.6 2.6–2.7ROR 2.7 · calibrated p 0.741	2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	age-adj. PRR 2.4 · serious PRR 3.2	NCT01076205: 5/7,229 (0.1%) on Adalimumab (serious AE)
Joint swelling	23,657	7.1 7.0–7.2ROR 7.3 · calibrated p 0.088	5.9 EB05 5.8 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	age-adj. PRR 6.5 · serious PRR 9.1	NCT01076205: 1/7,229 (0.0%) on Adalimumab (serious AE)
Incorrect dose administered	22,383	3.2 3.1–3.2ROR 3.3 · calibrated p 0.548	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 3.6 · serious PRR 1.3 · 92% consumer	not reported in cached trials
Off label use (used outside approved label)	21,858	0.7 0.7–0.8ROR 0.7 · calibrated p 0.149	0.8 EB05 0.7 · IC025 -0.4 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.8 · serious PRR 1.3	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.

Lupus vulgaris — n=888, PRR 87.9
Pemphigus — n=9,240, PRR 86.7
Deep vein thrombosis postoperative — n=1,428, PRR 79.9
Cartilage atrophy — n=570, PRR 69.2
Hand deformity — n=8,490, PRR 54.5
Facet joint syndrome — n=1,918, PRR 45.6 (also seen in trial arm)
Adjustment disorder with depressed mood — n=1,172, PRR 40.7
Bone erosion — n=2,023, PRR 39.0
Dislocation of vertebra — n=1,248, PRR 37.4
Adverse food reaction — n=492, PRR 33.3

✓ A hand-written Bradford Hill causality assessment exists for this drug: TNF-inhibitors (adalimumab) ↔ Drug-induced lupus.

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 Adalimumab?

In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab are pain, arthralgia, injection site pain, fatigue, rheumatoid arthritis, 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 Adalimumab have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: WARNING: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Do FAERS signals prove that Adalimumab 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 608d4f0d-b19f-46d3-749a-7159aa5f933d, effective 20251223; matched on openfda.generic_name.exact:"ADALIMUMAB")
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, 1,298 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 ADALIMUMAB, 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.