Adalimumab-Aacf side effects: what 300 FDA adverse event reports show

Adalimumab-Aacf · Idacio · 6 reaction terms · 66 drug–reaction co-reports · data 2026-09-14

Drug class

Tumor necrosis factor (tnf) blocker

FDA label, Indications wording

Brand names

Idacio

openFDA label

Who reports

300 reports · 81% serious · 2 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

IDACIO is a tumor necrosis factor (TNF) blocker indicated for: • Rheumatoid Arthritis (RA) ( 1.1 ): 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 RA .

FDA label, Indications and Usage

What it is

Adalimumab-aacf is a tumor necrosis factor blocker. Adalimumab-aacf 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

SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products including IDACIO are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] .

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 5 strongest signals

Likely indication confounding 3Not in label — unassessed 2

What the badges mean

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.
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. 1 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
Psoriatic arthropathy	26	45.2 31.3–65.3ROR 49.4 · χ² 1,082 / p 2e-237	43.8 EB05 31.4 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.7 · ♀ 100% (drug 59%) · 96% clinician	no trial data cached
Uveitis	8	41.4 20.9–82.1ROR 42.5 · χ² 276 / p 2e-62	37.9 EB05 20.5 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.2	no trial data cached
Rotator cuff syndrome	6	32.5 14.7–71.9ROR 33.2 · χ² 153 / p 2e-35	29.1 EB05 13.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.7	no trial data cached
Frequent bowel movements	12	31.2 17.9–54.3ROR 32.4 · χ² 321 / p 4e-72	29.8 EB05 18.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Colitis ulcerative	11	17.2 9.7–30.8ROR 17.9 · χ² 153 / p 2e-35	16.0 EB05 8.6 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 11.9	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
Psoriatic arthropathy	26	45.2 31.3–65.3ROR 49.4 · χ² 1,082 / p 2e-237	43.8 EB05 31.4 · IC025 +4.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 38.7 · ♀ 100% (drug 59%) · 96% clinician	no trial data cached
Frequent bowel movements	12	31.2 17.9–54.3ROR 32.4 · χ² 321 / p 4e-72	29.8 EB05 18.1 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 34.0	no trial data cached
Colitis ulcerative	11	17.2 9.7–30.8ROR 17.9 · χ² 153 / p 2e-35	16.0 EB05 8.6 · IC025 +2.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 11.9	no trial data cached
Uveitis	8	41.4 20.9–82.1ROR 42.5 · χ² 276 / p 2e-62	37.9 EB05 20.5 · IC025 +2.4 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 31.2	no trial data cached
Rotator cuff syndrome	6	32.5 14.7–71.9ROR 33.2 · χ² 153 / p 2e-35	29.1 EB05 13.5 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 26.7	no trial data cached
Ankylosing spondylitis	3	16.1 5.2–49.6ROR 16.2 · χ² 29 / p 4e-8	8.5 EB05 2.3 · IC025 +0.3 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 13.0	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

✓ 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-Aacf?

In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab-Aacf are psoriatic arthropathy, frequent bowel movements, colitis ulcerative, uveitis, rotator cuff syndrome, ankylosing spondylitis. 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-Aacf 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 IDACIO 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-Aacf 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 08dbaffe-9d05-43cf-b24b-b44ade8685fc, effective 20241015; matched on openfda.generic_name.exact:"ADALIMUMAB-AACF")
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, 6 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.