Overview
- The FDA on June 10, 2026 approved updated labeling for all orlistat products that warns of risks including kidney stones, acute kidney injury, and oxalate nephropathy.
- The agency’s review found 12 reported cases from its adverse event system and medical literature with a median patient age of 61 and a median exposure of about 2.5 months before injury.
- Reported outcomes were often severe: eight people were hospitalized and five required dialysis, and some cases involved crystal deposits in kidney tubules that can cause lasting damage.
- The FDA said available data do not clearly show a dose effect, meaning the risk applies to the 60 mg OTC product (Alli) and the 120 mg prescription product (Xenical), and it advised users to stop and seek care for symptoms such as back or groin pain, blood in urine, painful urination, leg swelling, or reduced urine output.
- Orlistat is the only FDA‑approved OTC weight‑loss drug and has been used by millions since 2007, so the agency warned true case counts may be higher because side effects are often underreported and urged clinicians and consumers to report problems to MedWatch.