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Causality: well established
Causality assessment · Causality: well established
Cyclosporine and Gingival hypertrophy: 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.
Cyclosporine ↔ Gingival hypertrophy
n=231 co-reports · PRR 34.4 · ROR 34.4
Cyclosporine commonly causes gingival hyperplasia, related to dose, duration and oral hygiene; 231 co-reports give PRR 34.4. The label lists gingival hyperplasia and advises dental care and monitoring.
Regulatory basis: cyclosporine prescribing information — gingival hyperplasia.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Months of therapy |
| Strength | met | PRR 34.4 with 231 co-reports |
| Consistency | met | Reproduced across cohorts |
| Specificity | met | Fairly specific to cyclosporine |
| Biological gradient | met | Dose/concentration-related |
| Plausibility | met | Known fibroblast-proliferation mechanism |
| Coherence | met | Fits cyclosporine's connective-tissue effect |
| Experiment | n/a | Not a short-term trial endpoint |
| Analogy | met | Analogous to phenytoin gingival overgrowth |
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 cyclosporine captured gingival hypertrophy as a tracked adverse event in a usable structure. Trials were too short and did not code gingival changes as adverse events.