Octreotide (somatostatin analogues) and Gallstones (cholelithiasis): is the FAERS signal real?
Octreotide (somatostatin analogues) ↔ Gallstones (cholelithiasis)
Octreotide and other somatostatin analogues reduce gallbladder contractility and alter bile composition, so they promote the formation of gallstones or biliary sludge — a well-recognised effect that is usually asymptomatic but can cause biliary colic or pancreatitis. It is dose- and duration-related and is why periodic gallbladder imaging is considered during long-term therapy. The 68 co-reports (PRR 7.8) reflect the drug's use in acromegaly and neuroendocrine tumours, where treatment is often lifelong.
Regulatory basis: octreotide prescribing information (gallbladder/biliary adverse effects; periodic imaging advice). Established somatostatin-analogue cholelithiasis literature.
| Bradford Hill viewpoint | Status | Note |
|---|---|---|
| Temporality (necessary) | met | Stones/sludge form during long-term therapy |
| Strength | partial | PRR 8 on a small co-report count |
| Consistency | met | Reproduced across somatostatin analogues and in imaging studies |
| Specificity | met | A recognised somatostatin-analogue effect |
| Biological gradient | partial | Dose- and duration-related |
| Plausibility | met | Reduced gallbladder contractility and altered bile composition are the mechanisms |
| Coherence | met | Coheres with the labelled advice to monitor the gallbladder |
| Experiment | partial | Dechallenge (withdrawal) may slow progression but does not dissolve stones; no randomized trial |
| Analogy | met | Analogous to gallstones with other somatostatin analogues |
This page's own qualitative read, not an automated/citation-gated assessment.