Adalimumab-Afzb side effects: what 2,611 FDA adverse event reports show
Drug class
Tumor necrosis factor (tnf) blocker
Brand names
Abrilada
Who reports
2,611 reports · 86% serious · 117 with death outcome · 61% female
Used for
ABRILADA 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 .
What it is
Adalimumab-afzb is a tumor necrosis factor (TNF) blocker. Adalimumab-afzb is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.
Boxed warning
SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] .
Causality screen of the 40 strongest signals
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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 159 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Device mechanical issue | 117 | 73.5 61.5–87.8ROR 76.9 · χ² 8,220 / p <1e-300 | 72.0 EB05 61.7 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Uveitis | 77 | 46.0 36.9–57.4ROR 47.4 · χ² 3,330 / p <1e-300 | 45.3 EB05 37.4 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 32.6 | no trial data cached |
| Fistula | 64 | 45.9 36.0–58.5ROR 47.0 · χ² 2,750 / p <1e-300 | 45.0 EB05 36.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 32.3 · 94% clinician | no trial data cached |
| Abscess | 67 | 33.9 26.7–42.9ROR 34.7 · χ² 2,098 / p <1e-300 | 33.5 EB05 27.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.1 · 97% clinician | no trial data cached |
| Drug level decreased | 37 | 29.2 21.2–40.2ROR 29.6 · χ² 975 / p 3e-214 | 28.7 EB05 21.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 23.4 · 100% clinician | no trial data cached |
| Device defective | 52 | 25.9 19.8–33.9ROR 26.4 · χ² 1,216 / p 9e-267 | 25.6 EB05 20.3 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious n=11 | no trial data cached |
| Therapeutic response shortened | 79 | 20.0 16.1–24.8ROR 20.6 · χ² 1,404 / p <1e-300 | 19.8 EB05 16.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · 95% clinician | no trial data cached |
| Condition aggravated | 626 | 16.7 15.6–17.9ROR 21.6 · χ² 9,328 / p <1e-300 | 16.6 EB05 15.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 · 96% clinician | no trial data cached |
| Needle issue | 58 | 16.3 12.6–21.0ROR 16.7 · χ² 818 / p 3e-180 | 16.2 EB05 12.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Exposure via skin contact | 44 | 15.7 11.7–21.0ROR 15.9 · χ² 588 / p 3e-130 | 15.5 EB05 11.9 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious n=23 | no trial data cached |
| Device leakage | 79 | 15.0 12.1–18.7ROR 15.4 · χ² 1,019 / p 5e-224 | 14.9 EB05 12.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=27 | no trial data cached |
| Drug dose omission by device | 142 | 14.9 12.7–17.5ROR 15.7 · χ² 1,833 / p <1e-300 | 14.8 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Therapeutic product effect incomplete | 114 | 13.0 10.8–15.5ROR 13.5 · χ² 1,249 / p 6e-274 | 12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.6 · 90% clinician | no trial data cached |
| Blood iron decreased | 19 | 13.0 8.3–20.3ROR 13.0 · χ² 198 / p 3e-45 | 12.1 EB05 7.7 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 11.2 | no trial data cached |
| Intestinal obstruction | 59 | 12.7 9.8–16.3ROR 12.9 · χ² 622 / p 1e-137 | 12.4 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 95% clinician | no trial data cached |
| Haematochezia (blood in stool) | 80 | 11.7 9.4–14.5ROR 12.0 · χ² 771 / p 5e-170 | 11.5 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 96% clinician | no trial data cached |
| Device failure | 22 | 11.7 7.7–17.7ROR 11.8 · χ² 204 / p 2e-46 | 10.8 EB05 7.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Incorrect dose administered by device | 36 | 11.4 8.2–15.8ROR 11.5 · χ² 331 / p 3e-74 | 10.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=20 | no trial data cached |
| Ankylosing spondylitis | 17 | 10.5 6.5–16.9ROR 10.6 · χ² 136 / p 8e-32 | 9.3 EB05 5.8 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 8.0 | no trial data cached |
| Injection site discomfort | 13 | 10.1 5.9–17.4ROR 10.2 · χ² 98 / p 2e-23 | 8.5 EB05 4.9 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious n=9 | no trial data cached |
| Device deployment issue | 15 | 10.0 6.1–16.6ROR 10.1 · χ² 113 / p 1e-26 | 8.6 EB05 5.2 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=4 | no trial data cached |
| Hernia | 24 | 10.0 6.7–14.9ROR 10.1 · χ² 186 / p 1e-42 | 9.2 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Mouth ulceration | 26 | 9.9 6.8–14.6ROR 10.0 · χ² 200 / p 1e-45 | 9.1 EB05 6.3 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.5 · 100% clinician | no trial data cached |
| Device delivery system issue | 32 | 9.8 7.0–13.9ROR 10.0 · χ² 245 / p 1e-55 | 9.2 EB05 6.6 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=6 · ♀ 84% (drug 61%) | no trial data cached |
| Eye infection | 13 | 9.3 5.4–16.0ROR 9.4 · χ² 88 / p 3e-21 | 7.7 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious n=13 | no trial data cached |
| Frequent bowel movements | 31 | 9.3 6.5–13.1ROR 9.4 · χ² 220 / p 4e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Cyst | 14 | 9.1 5.4–15.3ROR 9.1 · χ² 92 / p 4e-22 | 7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.0 | no trial data cached |
| Haemorrhoids | 22 | 9.0 6.0–13.7ROR 9.1 · χ² 150 / p 1e-34 | 8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 · 91% clinician | no trial data cached |
| Pharyngitis | 14 | 9.0 5.4–15.2ROR 9.1 · χ² 92 / p 4e-22 | 7.6 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 | no trial data cached |
| Synovitis | 20 | 8.9 5.8–13.8ROR 9.0 · χ² 133 / p 6e-31 | 7.9 EB05 5.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · 100% clinician | no trial data cached |
| Skin infection | 12 | 8.6 4.9–15.2ROR 8.7 · χ² 74 / p 5e-18 | 7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.3 | no trial data cached |
| Nodule | 14 | 8.6 5.1–14.5ROR 8.7 · χ² 87 / p 6e-21 | 7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.3 | no trial data cached |
| Hip arthroplasty | 16 | 8.5 5.2–13.8ROR 8.5 · χ² 98 / p 2e-23 | 7.2 EB05 4.6 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Rectal haemorrhage | 45 | 8.4 6.3–11.2ROR 8.5 · χ² 286 / p 2e-64 | 7.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Device use issue | 17 | 7.9 4.9–12.7ROR 7.9 · χ² 96 / p 7e-23 | 6.8 EB05 4.4 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Off label use (used outside approved label) | 832 | 7.7 7.3–8.2ROR 10.8 · χ² 5,053 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 94% clinician | no trial data cached |
| Joint injury | 20 | 7.5 4.9–11.6ROR 7.6 · χ² 107 / p 3e-25 | 6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 100% clinician | no trial data cached |
| Skin laceration | 10 | 7.4 4.0–13.8ROR 7.5 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pharyngitis streptococcal | 10 | 7.4 4.0–13.8ROR 7.4 · χ² 49 / p 1e-12 | 5.8 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Limb injury | 25 | 7.4 5.0–11.0ROR 7.5 · χ² 133 / p 6e-31 | 6.7 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 832 | 7.7 7.3–8.2ROR 10.8 · χ² 5,053 / p <1e-300 | 7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 · 94% clinician | no trial data cached |
| Condition aggravated | 626 | 16.7 15.6–17.9ROR 21.6 · χ² 9,328 / p <1e-300 | 16.6 EB05 15.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 16.1 · 96% clinician | no trial data cached |
| Arthralgia (joint pain) | 225 | 4.4 3.9–4.9ROR 4.7 · χ² 591 / p 7e-131 | 4.3 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 94% clinician | no trial data cached |
| Injection site pain (pain where injected) | 169 | 4.5 3.9–5.2ROR 4.7 · χ² 459 / p 5e-102 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.7 | no trial data cached |
| Drug dose omission by device | 142 | 14.9 12.7–17.5ROR 15.7 · χ² 1,833 / p <1e-300 | 14.8 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Abdominal pain | 135 | 4.7 4.0–5.5ROR 4.9 · χ² 389 / p 6e-87 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 93% clinician | no trial data cached |
| Inappropriate schedule of product administration | 124 | 5.6 4.7–6.7ROR 5.9 · χ² 472 / p 6e-105 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · 91% clinician | no trial data cached |
| Device mechanical issue | 117 | 73.5 61.5–87.8ROR 76.9 · χ² 8,220 / p <1e-300 | 72.0 EB05 61.7 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Therapeutic product effect incomplete | 114 | 13.0 10.8–15.5ROR 13.5 · χ² 1,249 / p 6e-274 | 12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.6 · 90% clinician | no trial data cached |
| Covid-19 | 107 | 4.9 4.0–5.9ROR 5.0 · χ² 327 / p 3e-73 | 4.8 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Nasopharyngitis (common cold) | 102 | 4.4 3.7–5.4ROR 4.6 · χ² 270 / p 5e-61 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Haematochezia (blood in stool) | 80 | 11.7 9.4–14.5ROR 12.0 · χ² 771 / p 5e-170 | 11.5 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 96% clinician | no trial data cached |
| Illness | 79 | 6.3 5.1–7.9ROR 6.5 · χ² 350 / p 2e-78 | 6.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Device leakage | 79 | 15.0 12.1–18.7ROR 15.4 · χ² 1,019 / p 5e-224 | 14.9 EB05 12.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=27 | no trial data cached |
| Therapeutic response shortened | 79 | 20.0 16.1–24.8ROR 20.6 · χ² 1,404 / p <1e-300 | 19.8 EB05 16.4 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 37.8 · 95% clinician | no trial data cached |
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.
- Fistula — n=64, PRR 45.9
- Needle issue — n=58, PRR 16.3
- Drug dose omission by device — n=142, PRR 14.9
- Intestinal obstruction — n=59, PRR 12.7
- Haematochezia — n=80, PRR 11.7
- Hernia — n=24, PRR 10.0
- Frequent bowel movements — n=31, PRR 9.3
- Haemorrhoids — n=22, PRR 9.0
- Rectal haemorrhage — n=45, PRR 8.4
- Limb injury — n=25, PRR 7.4
✓ 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-Afzb?
In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab-Afzb are arthralgia, injection site pain, drug dose omission by device, abdominal pain, covid-19, nasopharyngitis. 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-Afzb have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS AND MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including ABRILADA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Adalimumab-Afzb 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 1602cfaf-9ddd-4eb6-b847-10a4eebcf5e5, effective 20260807; matched on
openfda.generic_name.exact:"ADALIMUMAB-AFZB") - 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, 199 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
Page generated 2026-10-08. 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.