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Causality: well established
Causality assessment · Causality: well established
Carbamazepine 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.
Carbamazepine ↔ Stevens-Johnson syndrome
n=920 co-reports · PRR 13.5 · ROR 13.7
Carbamazepine is a leading cause of Stevens-Johnson syndrome and toxic epidermal necrolysis, strongly linked to the HLA-B*1502 allele in certain ancestries; 920 co-reports give PRR 13.5. The label recommends genetic screening in at-risk groups and immediate withdrawal at the first sign of rash.
Regulatory basis: carbamazepine (Tegretol) prescribing information — SJS/TEN and HLA-B*1502 screening recommendation.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Erupts within first weeks |
| Strength | met | PRR 13.5 with 920 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Strong HLA association |
| Biological gradient | not established | Not clearly dose-related |
| Plausibility | met | Immune-mediated mechanism |
| Coherence | met | Fits aromatic anticonvulsant risk |
| Experiment | n/a | Too rare for trial detection |
| Analogy | met | Analogous to phenytoin and lamotrigine SJS |
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 carbamazepine captured stevens-johnson syndrome as a tracked adverse event in a usable structure. Trials could not detect a rare, genotype-linked mucocutaneous eruption.