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Causality: well established
Causality assessment · Causality: well established
Linezolid and Serotonin syndrome: 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.
Linezolid ↔ Serotonin syndrome
n=917 co-reports · PRR 35.6 · ROR 36.8
Linezolid is a weak monoamine-oxidase inhibitor and can precipitate serotonin syndrome when combined with serotonergic drugs; 917 co-reports give PRR 35.6. The label warns of this interaction and advises careful monitoring or avoidance of the combination.
Regulatory basis: linezolid (Zyvox) prescribing information — serotonin syndrome with serotonergic drugs.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Hours to days of combination |
| Strength | met | PRR 35.6 with 917 co-reports |
| Consistency | met | Reproduced across reports |
| Specificity | met | Fairly specific to the interaction |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Known MAO-inhibition mechanism |
| Coherence | met | Fits linezolid's interaction profile |
| Experiment | n/a | Interaction seldom studied in trials |
| Analogy | met | Analogous to MAOI serotonin syndrome |
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 linezolid captured serotonin syndrome as a tracked adverse event in a usable structure. Trials did not systematically co-administer serotonergic drugs with linezolid.