Ursodiol and Pruritus: is the FAERS signal real?
Ursodiol ↔ Pruritus
Ursodiol (ursodeoxycholic acid) is a bile acid used for primary biliary cholangitis and gallstones; diarrhoea and pruritus are its common effects, and pruritus carries 1,299 co-reports here (PRR 3.3) — a high count partly because pruritus is itself a symptom of the cholestatic disease being treated. The drug is otherwise well tolerated, and effects are usually dose-related.
Regulatory basis: ursodiol prescribing information — diarrhoea and gastrointestinal effects.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Pruritus and diarrhoea follow dosing |
| Strength | met | PRR 3.3, modest |
| Consistency | met | Reported across practice |
| Specificity | not established | Cannot separate drug from cholestatic disease |
| Biological gradient | met | Dose-related |
| Plausibility | met | Bile-acid effect on gut and skin |
| Coherence | met | Fits the pharmacology |
| Experiment | n/a | Not a trial endpoint |
| Analogy | partial | Analogous to other bile-acid effects |
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.
✓ Trial evidence found — ENHANCE: Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA) (NCT03602560)
| Adverse event | Seladelpar 5/10 mg (n=89) · Seladelpar 10 mg (n=89) · Placebo (n=87) | ||
|---|---|---|---|
| Pruritus | 3/89 | 10/89 | 11/87 |
| Pruritus generalised | 3/89 | 3/89 | 3/87 |
Post-marketing signal terms appear in this trial's posted adverse-event tables; per-arm counts shown as affected/at-risk. View on ClinicalTrials.gov →