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Causality: well established
Causality assessment · Causality: well established
Nevirapine and Stevens-Johnson 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.
Nevirapine ↔ Stevens-Johnson syndrome
n=192 co-reports · PRR 20.3 · ROR 20.7
Nevirapine is a recognised cause of severe cutaneous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis; 192 co-reports give PRR 20.3. These reactions cluster in the first weeks, so the label advises stopping the drug and seeking care at the first sign of rash.
Regulatory basis: nevirapine (Viramune) prescribing information — severe cutaneous reactions including SJS/TEN.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | First weeks of therapy |
| Strength | met | PRR 20.3 with 192 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Associated with HLA alleles |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Immune-mediated mechanism |
| Coherence | met | Fits nevirapine hypersensitivity syndrome |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to carbamazepine SJS/TEN |
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 nevirapine captured stevens-johnson syndrome as a tracked adverse event in a usable structure. A rare mucocutaneous reaction cannot be resolved by randomised trials.