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Causality assessment · Causality: well established

Tofacitinib and Arthralgia: is the FAERS signal real?

n=19,961 co-reports · PRR 5.7 · ROR 6.3
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

Tofacitinib ↔ Arthralgia

n=19,961 co-reports · PRR 5.7 · ROR 6.3

Methimazole is a thioamide antithyroid drug for hyperthyroidism. Co-reporting of hyperthyroidism as a reaction is a coding artifact: patients on methimazole for hyperthyroidism have the indication recorded as the AE. 28 co-reports (PRR 5.9) reflect the treated population.

Coding artifact: hyperthyroidism is the indication.

Bradford Hill viewpointStatusNote
Temporality (necessary)not establishedIndication artifact
Strengthnot establishedPRR reflects treated population
Consistencynot establishedNot reproduced
Specificitynot establishedNot specific
Biological gradientnot establishedNo gradient
Plausibilitynot establishedNo mechanism
Coherencenot establishedArtifact
Experimentnot establishedNot an endpoint
Analogynot establishedN/A

This table is this page's own qualitative read of the literature cited above, not an automated or citation-gated assessment — see the note at the bottom of this page.

✗ No ClinicalTrials.gov results-posting trial in the top search hits for Tofacitinib captured arthralgia as a tracked adverse event in a usable structure. Hyperthyroidism is the indication; trials do not track it as an AE.