Causality assessment · Causality: well established

Infliximab (TNF inhibitors) and Tuberculosis reactivation: is the FAERS signal real?

n=2,003 co-reports · PRR 17.7 · ROR 17.8

Infliximab (TNF inhibitors) side-effect profile All assessments See in the full list

A written Bradford Hill assessment of one drug–event pair. The grade is a judgement about the signal, not a statement that this drug causes this event in any one person; FAERS counts are reports, not rates.

Causality: well established

Infliximab (TNF inhibitors) ↔ Tuberculosis reactivation

n=2,003 co-reports · PRR 17.7 · ROR 17.8

TNF inhibitors such as infliximab suppress a cytokine that is essential for containing tuberculosis, so they can reactivate latent TB — a serious, sometimes disseminated infection that is why patients are screened and treated for latent TB before starting therapy. The risk is a genuine, mechanism-based consequence of the drug's immunology and is the subject of a boxed warning. The very high FAERS count (2,003 co-reports, PRR 17.7) reflects both the real effect and the drug's wide use in inflammatory disease.

Regulatory basis: infliximab prescribing information (boxed warning for serious infections including TB; latent-TB screening before therapy).

Bradford Hill viewpoint	Status	Note
Temporality (necessary)	met	Reactivation occurs during therapy, often early, and requires stopping the drug and treating TB
Strength	met	PRR 18 on a large co-report count
Consistency	met	Reproduced across the TNF-inhibitor class and registries
Specificity	met	A class effect of TNF inhibitors
Biological gradient	partial	Related to the degree of immunosuppression rather than a simple dose gradient
Plausibility	met	TNF blockade impairs granuloma formation needed to contain TB
Coherence	met	Coheres with the boxed warning and mandatory screening
Experiment	partial	A randomized trial recorded TB on infliximab and not on the comparator arms
Analogy	met	Analogous to TB risk with adalimumab and other TNF inhibitors

This page's own qualitative read, not an automated/citation-gated assessment.

✓ Trial evidence found — Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis (NCT00095147), N=803

Term (as recorded)	ABA (DB) (n=156)	ABA + MTX [OL] (n=372)	INF + MTX [DB] (n=165)	PLA + MTX [DB] (n=110)
PULMONARY TUBERCULOSIS — Infections and infestations	0	0	1	0
PERITONEAL TUBERCULOSIS — Infections and infestations	0	0	1	0

Serious pulmonary and peritoneal tuberculosis each occurred once in the infliximab arm and in none of the other arms of this randomized trial — a rare event, but exactly the reactivation pattern behind the TNF-inhibitor tuberculosis boxed warning and mandated screening. View on ClinicalTrials.gov →