FDA Kidney Warning for Orlistat (Alli/Xenical): Symptoms to Know
On June 10, 2026, the FDA approved new labeling for the OTC weight-loss drug alli (orlistat 60 mg) warning about rare but serious kidney injury and kidney stones. The warning also aligns across FDA-approved orlistat products, including prescription Xenical. If you have kidney disease or a history of kidney stones, ask a clinician before using orlistat—and know the symptom checklist that should trigger prompt medical evaluation.
