FDA Warns Alli—An Over-The-Counter Weight Loss Pill—Could Cause Fatal Kidney Problems

BreakingBusinessFDA Warns Alli—An Over-The-Counter Weight Loss Pill—Could Cause Fatal Kidney ProblemsByMary Whitfill Roeloffs,Forbes Staff. Mary Roeloffs is a Forbes breaking news reporter covering pop culture.Follow AuthorJun 10, 2026, 03:22pm EDTToplineThe Food and Drug Administration is warning against new side effects of Haleon's over-the-counter weight loss drug Alli, the only such medication currently available in the U.S. without a prescription, and has approved a new label for the drug that highlights potential kidney problems. A pack of Alli at a pharmacy in London.PA Images via Getty ImagesKey FactsThe agency approved changes to the drug facts label of Alli’s 60 mg capsules to warn of rare risks on Wednesday, including acute kidney injury, kidney stones and oxalate nephropathy, a deposit of calcium oxalate crystals into the kidney tubule that can cause kidney injury and potential fibrosis.The updated label now instructs consumers with a history of kidney disease or kidney stones to consult a doctor before use, and directs all users to stop taking Alli if they develop back or groin pain, blood in the urine, painful urination or leg swelling.The FDA warned severe untreated cases of acute kidney injury—defined as a kidney’s sudden inability to filter waste products from the blood—can be fatal. Alli’s drug facts label already warned against taking the medication for those who've had an organ transplant and advises those with gallbladder problems, pancreatitis or who take certain medications for diabetes, clotting or thyroid disease consult a doctor before use. if (!window.cnxel) { window.cnxel = {}; window.cnxel.cmd = []; var iframe = document.createElement('iframe'); iframe.style.display = 'none'; iframe.onload = function() { var iframeDoc = iframe.contentWindow.document; var script = iframeDoc.createElement('script'); script.src = '//cd.elements.video/player.js?cid=62cec241-7d09-4462-afc2-f72f8d8ef40a'; script.setAttribute('defer', '1'); script.set...