Alli (orlistat) OTC label updated: kidney stone and kidney injury risk
FDA approved labelling changes for the OTC weight-loss drug Alli (orlistat 60 mg) to warn patients of the risk of kidney stones and acute kidney injury. Consumers are advised to stop use and seek medical attention if they develop symptoms such as back or side pain, blood in urine, or decreased urine output.
On 10 June 2026 FDA updated labelling for Alli (orlistat 60 mg) OTC ↗ to warn of risks of kidney stones and acute kidney injury. Consumers are advised to stop use and seek medical care if they experience back or side pain, blood in urine, or decreased urine output.
How orlistat can affect the kidneys
Orlistat ↗ inhibits pancreatic and gastric lipases, reducing fat absorption by ~30%. Unabsorbed dietary fat binds calcium in the gut, leaving oxalate free to be absorbed — raising urinary oxalate levels and risk of calcium oxalate kidney stones ↗. Cases of acute oxalate nephropathy, a severe form of kidney injury, have also been reported. Risk is higher in patients with inflammatory bowel disease or those on a high-oxalate diet.
Patient advice
Patients taking Alli should maintain adequate hydration, limit high-oxalate foods (e.g. spinach, nuts, chocolate), and consider calcium supplementation with meals to bind oxalate in the gut. The updated label on DailyMed ↗ provides full consumer directions. Anyone with a history of kidney stones or kidney disease should consult a healthcare provider before use.
FAQ
What triggers an FDA label update?
Label updates can be triggered by post-market safety data from the FAERS database ↗, new clinical trial results, manufacturer-initiated reviews, or FDA-directed safety communications. The FDA can require label changes under 21 CFR 314.81 or negotiate them with manufacturers. See the FDA Safety-related Labeling Changes (SrLC) database ↗ for a full history.
Where is the updated label published?
Updated labels are published on DailyMed (NLM) ↗ and Drugs@FDA ↗. DailyMed is typically the most current source, as manufacturers submit label updates there directly.