Adalimumab-Atto side effects: what 1,469 FDA adverse event reports show

Adalimumab-Atto · Amjevita · 39 reaction terms · 1,815 drug–reaction co-reports · data 2026-09-14

Drug class

Tumor Necrosis Factor Blocker

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Amjevita

openFDA label

Who reports

1,469 reports · 24% serious · 15 with death outcome · 72% female

openFDA FAERS counts, all years, deduplication not applied

Used for

AMJEVITA 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-atto is a tumor necrosis factor blocker. Adalimumab-atto is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading.

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 21 strongest signals

Labeled adverse reaction 2Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 10Not in label — unassessed 1

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.
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. 18 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
Circumstance or information capable of leading to medication error	194	82.9 72.7–94.6ROR 95.3 · χ² 15,549 / p <1e-300	81.8 EB05 72.6 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Device difficult to use	362	78.5 71.8–85.9ROR 103.8 · χ² 27,560 / p <1e-300	77.8 EB05 71.3 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious PRR 104.6 · 76% consumer	no trial data cached
Product storage error	280	46.3 41.6–51.4ROR 56.9 · χ² 12,368 / p <1e-300	46.0 EB05 41.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug dose omission by device	237	44.2 39.4–49.7ROR 52.5 · χ² 9,978 / p <1e-300	44.0 EB05 39.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=20 · 78% consumer	no trial data cached
Accidental exposure to product	147	21.0 18.0–24.5ROR 23.2 · χ² 2,790 / p <1e-300	20.9 EB05 18.2 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 11.6 · 78% consumer	no trial data cached
Injury associated with device	25	17.7 12.0–26.2ROR 18.0 · χ² 378 / p 2e-84	17.4 EB05 12.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 92% consumer	no trial data cached
Incorrect dose administered by device	27	15.2 10.4–22.0ROR 15.4 · χ² 343 / p 6e-77	14.8 EB05 10.4 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=1 · 81% consumer	no trial data cached
Device use error	36	15.1 10.9–20.8ROR 15.4 · χ² 459 / p 3e-102	14.8 EB05 11.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=2 · 86% consumer	no trial data cached
Exposure via skin contact	18	11.4 7.2–18.0ROR 11.5 · χ² 160 / p 6e-37	10.3 EB05 6.4 · IC025 +2.4 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product administration error	12	8.6 4.9–15.1ROR 8.6 · χ² 73 / p 7e-18	7.0 EB05 4.1 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Product preparation error	12	8.3 4.7–14.5ROR 8.3 · χ² 70 / p 4e-17	6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious n=2	no trial data cached
Injection site urticaria	11	6.5 3.6–11.7ROR 6.5 · χ² 46 / p 7e-12	5.2 EB05 3.1 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Wrong technique in product usage process	83	5.9 4.8–7.2ROR 6.2 · χ² 333 / p 1e-74	5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1 · 82% consumer	no trial data cached
Rheumatoid arthritis	46	5.8 4.4–7.7ROR 6.0 · χ² 179 / p 4e-41	5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.3 · ♀ 97% (drug 72%)	no trial data cached
Injection site pain (pain where injected)	118	5.5 4.7–6.6ROR 5.9 · χ² 441 / p 3e-98	5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Psoriatic arthropathy	15	5.3 3.2–8.8ROR 5.4 · χ² 48 / p 2e-12	4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 16.1	no trial data cached
Therapy interrupted	24	5.0 3.3–7.4ROR 5.0 · χ² 72 / p 1e-17	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 19.2	no trial data cached
Injection site rash	10	4.7 2.5–8.7ROR 4.7 · χ² 26 / p 2e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Labeled (related wording) related wording	serious n=2	no trial data cached
Injection site reaction	22	4.6 3.0–6.9ROR 4.6 · χ² 58 / p 1e-14	4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.0	no trial data cached
Injection site haemorrhage	25	4.5 3.0–6.6ROR 4.6 · χ² 65 / p 4e-16	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4 · 80% consumer	no trial data cached
Injection site bruising	22	4.0 2.6–6.0ROR 4.0 · χ² 46 / p 5e-12	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.3 · 86% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Device difficult to use	362	78.5 71.8–85.9ROR 103.8 · χ² 27,560 / p <1e-300	77.8 EB05 71.3 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious PRR 104.6 · 76% consumer	no trial data cached
Product storage error	280	46.3 41.6–51.4ROR 56.9 · χ² 12,368 / p <1e-300	46.0 EB05 41.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Drug dose omission by device	237	44.2 39.4–49.7ROR 52.5 · χ² 9,978 / p <1e-300	44.0 EB05 39.5 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=20 · 78% consumer	no trial data cached
Circumstance or information capable of leading to medication error	194	82.9 72.7–94.6ROR 95.3 · χ² 15,549 / p <1e-300	81.8 EB05 72.6 · IC025 +5.9 3/3 methods agree	Labeled (related wording) related wording	–	no trial data cached
Accidental exposure to product	147	21.0 18.0–24.5ROR 23.2 · χ² 2,790 / p <1e-300	20.9 EB05 18.2 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 11.6 · 78% consumer	no trial data cached
Injection site pain (pain where injected)	118	5.5 4.7–6.6ROR 5.9 · χ² 441 / p 3e-98	5.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.3	no trial data cached
Wrong technique in product usage process	83	5.9 4.8–7.2ROR 6.2 · χ² 333 / p 1e-74	5.7 EB05 4.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 3.1 · 82% consumer	no trial data cached
Rheumatoid arthritis	46	5.8 4.4–7.7ROR 6.0 · χ² 179 / p 4e-41	5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.3 · ♀ 97% (drug 72%)	no trial data cached
Device use error	36	15.1 10.9–20.8ROR 15.4 · χ² 459 / p 3e-102	14.8 EB05 11.0 · IC025 +3.1 3/3 methods agree	Reporting / coding artifact	serious n=2 · 86% consumer	no trial data cached
Incorrect dose administered by device	27	15.2 10.4–22.0ROR 15.4 · χ² 343 / p 6e-77	14.8 EB05 10.4 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious n=1 · 81% consumer	no trial data cached
Injection site haemorrhage	25	4.5 3.0–6.6ROR 4.6 · χ² 65 / p 4e-16	4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.4 · 80% consumer	no trial data cached
Injury associated with device	25	17.7 12.0–26.2ROR 18.0 · χ² 378 / p 2e-84	17.4 EB05 12.2 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious n=1 · 92% consumer	no trial data cached
Therapy interrupted	24	5.0 3.3–7.4ROR 5.0 · χ² 72 / p 1e-17	4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 19.2	no trial data cached
Injection site bruising	22	4.0 2.6–6.0ROR 4.0 · χ² 46 / p 5e-12	3.7 EB05 2.6 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.3 · 86% consumer	no trial data cached
Injection site reaction	22	4.6 3.0–6.9ROR 4.6 · χ² 58 / p 1e-14	4.2 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.0	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.

Drug dose omission by device — n=237, PRR 44.2

✓ 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-Atto?

In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab-Atto are drug dose omission by device, circumstance or information capable of leading to medication error, injection site pain, rheumatoid arthritis, injection site haemorrhage, injury associated with device. 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-Atto have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS AND MALIGNANCY WARNING: SERIOUS INFECTIONS AND MALIGNANCY See full prescribing information for complete boxed warning. SERIOUS INFECTIONS ( 5.1 , 6.1 ): Increased risk of serious infections leading.

Do FAERS signals prove that Adalimumab-Atto 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 b7178e36-6787-45ab-8fee-be59bc6a4aa4, effective 20260713; matched on openfda.generic_name.exact:"ADALIMUMAB-ATTO")
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, 39 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.