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# Kidney Risk in OTC Weight Loss Drug Alli
- URL: https://www.fdaweb.com/kidney-risk-in-otc-weight-loss-drug-alli/
- Published: 2026-06-10T12:00:00.000Z
- Updated: 2026-09-14T13:40:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161285

FDA has approved changes to the Drug Facts label of Haleon’s over-the-counter weight loss drug alli (orlistat) to warn of the risk of acute kidney injury, which the agency says is a rare side effect of the drug. An FDA [statement](https://www.fda.gov/drugs/drug-safety-communications/fda-approves-labeling-changes-over-counter-otc-weight-loss-drug-alli-orlistat-warn-risk-kidney?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the new labeling advises consumers to ask a healthcare provider before using alli if they have ever had kidney disease or kidney stones. Consumers are also cautioned to stop using alli and ask a doctor if they develop symptoms of kidney injury or kidney stones. FDA says the risk of kidney injury is now described consistently across the labeling for both over-the-counter and prescription orlistat products.

The notice says FDA received periodic safety reports of acute kidney injury associated with alli, which led to a reevaluation of the safety signal for the OTC product. It says a search of the FDA Adverse Event Monitoring System and the medical literature identified 12 cases of kidney complications associated with alli use from its 2/9/2007 approval through 12/21/2023\. The agency says the severity of the cases was “substantial,” with eight patients requiring hospitalization and five needing dialysis.