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Causality: well established
Causality assessment · Causality: well established
Infliximab and Infusion Related Reaction: is the FAERS signal real?
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.
Infliximab ↔ Infusion Related Reaction
n=19,073 co-reports · PRR 39.0 · ROR 42.7
Cytarabine is a nucleoside analogue for leukaemia. Myelosuppression is the expected on-target toxicity: DNA polymerase inhibition kills rapidly dividing cells. 4,667 co-reports (PRR 8.3) reflect real myelotoxicity. The label carries a boxed warning for myelosuppression.
Boxed warning: cytarabine label (myelosuppression). Chemotherapy literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Documented in label |
| Strength | met | PRR 8.3 with 4,667 co-reports |
| Consistency | met | Reproduced across nucleoside analogue class |
| Specificity | partial | Specific to antimetabolite chemotherapy |
| Biological gradient | met | Correlates with dose |
| Plausibility | met | Known DNA polymerase inhibition |
| Coherence | met | Coherent with pharmacology |
| Experiment | met | RCTs confirm |
| Analogy | met | Analogous to other nucleoside analogues |
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 Infliximab captured infusion related reaction as a tracked adverse event in a usable structure. Myelosuppression is a standard haematological endpoint in all chemotherapy registration trials.