Inaugural briefing · 15 October 2026

Reports of tuberculosis with TNF inhibitors: what the FAERS signal does and does not show

A reporting signal is not proof a drug caused an event.

FAERS data as of 2026-07-30.

This is the first briefing, from the snapshot of 15 October 2026. There is no earlier snapshot to compare, so the lists below are the latest notices and the strongest prespecified signals in the current extract, not week-over-week changes. openFDA extract dated 2026-07-30. Myocardial Infarction and Cerebrovascular Accident cleared a reporting-odds bound only. The PRR is below 2, so those comparisons are not Evans signals and they are not the headline. PRR and ROR describe reporting. A higher ratio is a disproportionality signal. It is not an incidence rate.

There is no certainty that the reported event was actually due to the product. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.

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Latest FDA safety notices

FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
FDA Drug Safety Communications
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
FDA Drug Safety Communications
FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
FDA Drug Safety Communications

Recalls in the extract

Class I
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
D-0827-2026 · Class I · Fresenius Kabi USA, LLC · reported 20260902
Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
Class I
Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5
D-0183-2023 · Class I · Glaxosmithkline Consumer Healthcare Holdings DBA Haleon · reported 20230201
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I
Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3
D-0182-2023 · Class I · Glaxosmithkline Consumer Healthcare Holdings DBA Haleon · reported 20230201
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I
Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940
D-0181-2023 · Class I · Glaxosmithkline Consumer Healthcare Holdings DBA Haleon · reported 20230201
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

Strongest prespecified safety signals

Evans
TNF inhibitors · Tuberculosis
PRR 7.54 (95% CI 7.28–7.82) · ROR 7.56 (95% CI 7.29–7.84)
Tuberculosis was reported more often than expected with TNF inhibitors than with all other FAERS reports (PRR 7.54, 95% CI 7.28–7.82). This is a disproportionality signal. The reporting odds ratio is 7.56 (95% CI 7.29–7.84). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.
Evans
TNF inhibitors · Pulmonary Tuberculosis
PRR 6.89 (95% CI 6.46–7.34) · ROR 6.89 (95% CI 6.47–7.34)
Pulmonary tuberculosis was reported more often than expected with TNF inhibitors than with all other FAERS reports (PRR 6.89, 95% CI 6.46–7.34). This is a disproportionality signal. The reporting odds ratio is 6.89 (95% CI 6.47–7.34). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.
Evans
NSAIDs · Gastric Ulcer
PRR 6.30 (95% CI 6.05–6.55) · ROR 6.33 (95% CI 6.08–6.58)
Gastric ulcer was reported more often than expected with NSAIDs than with all other FAERS reports (PRR 6.30, 95% CI 6.05–6.55). This is a disproportionality signal. The reporting odds ratio is 6.33 (95% CI 6.08–6.58). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.
Evans
NSAIDs · Melaena
PRR 4.24 (95% CI 4.06–4.42) · ROR 4.25 (95% CI 4.07–4.44)
Melaena was reported more often than expected with NSAIDs than with all other FAERS reports (PRR 4.24, 95% CI 4.06–4.42). This is a disproportionality signal. The reporting odds ratio is 4.25 (95% CI 4.07–4.44). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.
Evans
JAK inhibitors · Deep Vein Thrombosis
PRR 2.55 (95% CI 2.38–2.73) · ROR 2.55 (95% CI 2.38–2.74)
Deep vein thrombosis was reported more often than expected with JAK inhibitors than with TNF inhibitors (PRR 2.55, 95% CI 2.38–2.73). This is a disproportionality signal. The reporting odds ratio is 2.55 (95% CI 2.38–2.74). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.
Evans
NSAIDs · Gastrointestinal Haemorrhage
PRR 2.52 (95% CI 2.46–2.59) · ROR 2.54 (95% CI 2.47–2.61)
Gastrointestinal haemorrhage was reported more often than expected with NSAIDs than with all other FAERS reports (PRR 2.52, 95% CI 2.46–2.59). This is a disproportionality signal. The reporting odds ratio is 2.54 (95% CI 2.47–2.61). This meets the Evans screen: at least 3 reports, a PRR of at least 2, and a chi-square of at least 4. The ratio is not an incidence rate.

Recent trials

Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
NCT07619547 · Recruiting · Crohn's disease · start 2026-10-19
Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
Deciphering the Genetic Architecture of Autoimmune Diseases
NCT06948110 · Recruiting · Systemic lupus erythematosus · start 2026-10-19
Autoimmune Diseases
Retinal Capillary Vessel Density and Foveal Avascular Zone Size in Patients With Psoriatic Arthritis: A Case-Control Study.
NCT07858591 · Recruiting · Psoriasis · start 2026-09-01
Arthritic Psoriasis; Psoriasis (PsO); Retinal Vessels
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
NCT07621809 · PHASE3 · Recruiting · Rheumatoid arthritis · start 2026-07-16
Sjögren´s Disease

Recent PubMed papers

Titles and links only. Abstracts are not shown. NCBI disclaimer: https://www.ncbi.nlm.nih.gov/home/about/policies/

NCBI disclaimer

For research and informational purposes only. Not medical advice. Do not stop or change any medication without talking to your doctor. FAERS is a spontaneous-report system with under-reporting, duplicate reports, and no exposure denominator. A disproportionality signal means a reaction was reported more often than expected. It is not an incidence rate. Report adverse events to FDA MedWatch.

Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). This site is not affiliated with or endorsed by the U.S. Food and Drug Administration.

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