Infliximab-Axxq side effects: what 1,002 FDA adverse event reports show

Infliximab-Axxq · Avsola · 34 reaction terms · 733 drug–reaction co-reports · data 2026-09-14

Drug class

Tumor Necrosis Factor Blocker

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Avsola

openFDA label

Who reports

1,002 reports · 52% serious · 26 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

AVSOLA is a tumor necrosis factor (TNF) blocker indicated for: Crohn's Disease : reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

FDA label, Indications and Usage

What it is

Infliximab-axxq, a tumor necrosis factor (TNF) blocker, is a chimeric IgG1κ monoclonal antibody (composed of human constant and murine variable regions). It has a molecular weight of approximately 149.1 kilodaltons. Infliximab-axxq is produced in a recombinant Chinese Hamster Ovary (CHO) cell line.

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Increased risk of serious infections leading to hospitalization or death, incl.

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 22 strongest signals

Labeled adverse reaction 1Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 5Not in label — unassessed 12

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. 12 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	99	61.9 51.4–74.7ROR 68.6 · χ² 5,866 / p <1e-300	61.1 EB05 51.6 · IC025 +5.2 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Folliculitis	19	38.6 24.7–60.2ROR 39.3 · χ² 657 / p 3e-145	37.2 EB05 25.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 49.8	no trial data cached
Helicobacter infection	17	34.9 21.8–56.0ROR 35.5 · χ² 527 / p 8e-117	33.7 EB05 22.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 40.6	no trial data cached
Product storage error	144	34.9 30.0–40.6ROR 40.6 · χ² 4,717 / p <1e-300	34.7 EB05 30.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
Pemphigus	18	30.3 19.2–48.0ROR 30.9 · χ² 481 / p 5e-107	29.5 EB05 19.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 33.5	no trial data cached
Hand deformity	17	27.2 17.0–43.6ROR 27.7 · χ² 403 / p 5e-90	26.5 EB05 17.5 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 32.5	no trial data cached
Pericarditis	17	21.4 13.3–34.2ROR 21.7 · χ² 310 / p 1e-69	20.8 EB05 13.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	no trial data cached
Infusion related reaction (reaction during infusion)	55	17.4 13.5–22.5ROR 18.4 · χ² 838 / p 2e-184	17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.4 · 91% clinician	no trial data cached
Synovitis	15	17.4 10.5–28.8ROR 17.7 · χ² 216 / p 4e-49	16.7 EB05 10.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.1	no trial data cached
Glossodynia (burning tongue/mouth pain)	17	15.9 9.9–25.5ROR 16.2 · χ² 223 / p 9e-51	15.3 EB05 9.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.4	no trial data cached
Wound	20	15.1 9.8–23.2ROR 15.3 · χ² 249 / p 2e-56	14.5 EB05 9.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 90% clinician	no trial data cached
Irritable bowel syndrome	15	14.7 8.9–24.3ROR 14.9 · χ² 178 / p 6e-41	13.8 EB05 8.2 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.5	no trial data cached
Colitis ulcerative	30	14.1 9.9–20.0ROR 14.5 · χ² 352 / p 7e-79	13.7 EB05 9.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.7	no trial data cached
Therapeutic product effect decreased	27	12.7 8.8–18.5ROR 13.1 · χ² 281 / p 2e-63	12.2 EB05 8.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6	no trial data cached
Haematochezia (blood in stool)	33	12.5 9.0–17.5ROR 12.9 · χ² 340 / p 4e-76	12.1 EB05 8.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.2 · ♀ 33% (drug 58%)	no trial data cached
Product preparation error	12	12.1 6.9–21.3ROR 12.3 · χ² 112 / p 2e-26	10.5 EB05 5.7 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Frequent bowel movements	15	11.7 7.1–19.3ROR 11.8 · χ² 136 / p 1e-31	10.4 EB05 6.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 19.8	no trial data cached
Systemic lupus erythematosus	19	11.2 7.2–17.6ROR 11.4 · χ² 167 / p 1e-38	10.2 EB05 6.5 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.7	no trial data cached
Impaired healing	16	10.2 6.3–16.6ROR 10.3 · χ² 124 / p 5e-29	8.9 EB05 5.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 13.6	no trial data cached
Lower respiratory tract infection	21	9.7 6.4–14.8ROR 9.9 · χ² 156 / p 5e-36	8.7 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.3 · 100% clinician	no trial data cached
Ill-defined disorder	27	9.3 6.4–13.5ROR 9.5 · χ² 192 / p 5e-44	8.5 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · 93% clinician	no trial data cached
Accidental exposure to product	18	3.8 2.4–6.0ROR 3.8 · χ² 34 / p 3e-9	3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	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
Product storage error	144	34.9 30.0–40.6ROR 40.6 · χ² 4,717 / p <1e-300	34.7 EB05 30.2 · IC025 +4.7 3/3 methods agree	Reporting / coding artifact	serious PRR 2.9	no trial data cached
Circumstance or information capable of leading to medication error	99	61.9 51.4–74.7ROR 68.6 · χ² 5,866 / p <1e-300	61.1 EB05 51.6 · IC025 +5.2 3/3 methods agree	Labeled (related wording) related wording	serious n=1	no trial data cached
Infusion related reaction (reaction during infusion)	55	17.4 13.5–22.5ROR 18.4 · χ² 838 / p 2e-184	17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 19.4 · 91% clinician	no trial data cached
Haematochezia (blood in stool)	33	12.5 9.0–17.5ROR 12.9 · χ² 340 / p 4e-76	12.1 EB05 8.8 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.2 · ♀ 33% (drug 58%)	no trial data cached
Colitis ulcerative	30	14.1 9.9–20.0ROR 14.5 · χ² 352 / p 7e-79	13.7 EB05 9.8 · IC025 +2.9 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 16.7	no trial data cached
Ill-defined disorder	27	9.3 6.4–13.5ROR 9.5 · χ² 192 / p 5e-44	8.5 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 14.9 · 93% clinician	no trial data cached
Therapeutic product effect decreased	27	12.7 8.8–18.5ROR 13.1 · χ² 281 / p 2e-63	12.2 EB05 8.5 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 24.6	no trial data cached
Lower respiratory tract infection	21	9.7 6.4–14.8ROR 9.9 · χ² 156 / p 5e-36	8.7 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.3 · 100% clinician	no trial data cached
Wound	20	15.1 9.8–23.2ROR 15.3 · χ² 249 / p 2e-56	14.5 EB05 9.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 19.7 · 90% clinician	no trial data cached
Systemic lupus erythematosus	19	11.2 7.2–17.6ROR 11.4 · χ² 167 / p 1e-38	10.2 EB05 6.5 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.7	no trial data cached
Folliculitis	19	38.6 24.7–60.2ROR 39.3 · χ² 657 / p 3e-145	37.2 EB05 25.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 49.8	no trial data cached
Accidental exposure to product	18	3.8 2.4–6.0ROR 3.8 · χ² 34 / p 3e-9	3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Pemphigus	18	30.3 19.2–48.0ROR 30.9 · χ² 481 / p 5e-107	29.5 EB05 19.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 33.5	no trial data cached
Glossodynia (burning tongue/mouth pain)	17	15.9 9.9–25.5ROR 16.2 · χ² 223 / p 9e-51	15.3 EB05 9.6 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.4	no trial data cached
Pericarditis	17	21.4 13.3–34.2ROR 21.7 · χ² 310 / p 1e-69	20.8 EB05 13.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.7	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.

Wound — n=20, PRR 15.1
Haematochezia — n=33, PRR 12.5
Ill-defined disorder — n=27, PRR 9.3

✓ A hand-written Bradford Hill causality assessment exists for this drug: Infliximab (TNF inhibitors) ↔ Tuberculosis reactivation.

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 Infliximab-Axxq?

In FDA FAERS, the most frequently co-reported reaction terms for Infliximab-Axxq are circumstance or information capable of leading to medication error, infusion related reaction, haematochezia, colitis ulcerative, ill-defined disorder, lower respiratory tract infection. 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 Infliximab-Axxq 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. Increased risk of serious infections leading to hospitalization or death, incl.

Do FAERS signals prove that Infliximab-Axxq 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 de34bcb7-b524-45c8-9181-61c6f48d540e, effective 20260722; matched on openfda.generic_name.exact:"INFLIXIMAB-AXXQ")
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, 34 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.