FDA Approves Labeling Changes for Over-the-Counter (OTC) Weight Loss Drug alli (Orlistat) to Warn of Risk of Kidney Stones and Kidney Injury FDA Drug Safety Communication – June 10, 2026

https://www.fda.gov/drugs/drug-safety-communications/fda-approves-labeling-changes-over-counter-otc-weight-loss-drug-alli-orlistat-warn-risk-kidney?utm_medium=email&utm_source=govdelivery The Food and Drug Administration (FDA) has approved changes to the Drugs Facts Label of the over-the-counter (OTC) weight loss drug, alli (orlistat) 60 mg capsules, to warn of risks of acute kidney injury, which is a rare side effect of the medication. The labeling now advises consumers to ask a health care provider before using alli if they have ever had kidney disease or kidney stones. The labeling changes also tell consumers to stop using alli and ask a doctor if they develop symptoms of kidney injury or kidney stones, such as back or groin pain, painful urination, blood in the urine, feet and leg swelling, or less frequent urination. https://www.fda.gov/drugs/understanding-over-counter-medicines/over-counter-drug-facts-label?utm_medium=email&utm_source=govdelivery