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Causality assessment · Causality: well established

Metronidazole and Drug Hypersensitivity: is the FAERS signal real?

n=3,150 co-reports · PRR 5.4 · ROR 5.7
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

Metronidazole ↔ Drug Hypersensitivity

n=3,150 co-reports · PRR 5.4 · ROR 5.7

Ropeginterferon alfa-2b is a pegylated interferon for myelofibrosis. Myelosuppression is the expected on-target pharmacological effect: interferons inhibit haematopoietic cell proliferation. 434 co-reports (PRR 68.1) reflect both therapeutic effect and overlapping toxicity.

Label: ropeginterferon PI (myelosuppression).

Bradford Hill viewpointStatusNote
Temporality (necessary)metDocumented in label
StrengthmetPRR 68.1 with 434 co-reports
ConsistencymetReproduced across interferon class
SpecificitypartialSpecific to type I interferons
Biological gradientmetCorrelates with dose and duration
PlausibilitymetKnown interferon mechanism
CoherencemetCoherent with pharmacology
ExperimentmetRCTs confirm
AnalogymetSimilar to other peginterferons

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 Metronidazole captured drug hypersensitivity as a tracked adverse event in a usable structure. Myelosuppression is routinely monitored as a haematological AE in interferon trials.