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Orlistat (ALLI) is the only over-the-counter weight-loss drug approved by the Food and Drug Administration (FDA). In June 2026 the FDA approved labeling changes to warn of the risk of kidney stones and kidney injury.[1]
The agency’s action calls attention to the work of Public Citizen’s Health Research Group, which in 2006[2] and again in 2011[3] unsuccessfully petitioned the FDA to remove all orlistat products from the market. For many years, we have classified orlistat as Do Not Use.[4]
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Orlistat (ALLI) is the only over-the-counter weight-loss drug approved by the Food and Drug Administration (FDA). In June 2026 the FDA approved labeling changes to warn of the risk of kidney stones and kidney injury.[1]
The agency’s action calls attention to the work of Public Citizen’s Health Research Group, which in 2006[2] and again in 2011[3] unsuccessfully petitioned the FDA to remove all orlistat products from the market. For many years, we have classified orlistat as Do Not Use.[4]
Orlistat works by binding to enzymes known as gastrointestinal lipases that break down fats. People taking orlistat absorb less dietary fat from the digestive tract.
Approved in 2007 for nonprescription use by overweight adults in conjunction with a reduced-calorie and low-fat diet, orlistat is sold over the counter in 60-mg capsules.[5] The retail cost for 90 capsules is about $100.[6] A higher-strength orlistat product (XENICAL), approved in 1999, is available by prescription in 120-mg capsules.[7] A dose of the drug is taken with each main meal containing fat up to three times a day.
When Public Citizen petitioned the FDA to ban orlistat in 2011, we argued that both the prescription and over-the-counter versions of the drug “expose patients to serious risks that greatly outweigh their minimal clinical benefits.” The serious risks cited in the petition were severe liver injury, acute pancreatitis and “acute renal failure secondary to acute oxalate nephropathy, and calcium oxalate nephrolithiasis (kidney stones).” For efficacy, the petition cited clinical trial data for the higher-dose (120-mg) orlistat product showing that “the average weight loss (beyond placebo) for interval from 20 weeks to two years of treatment was only 6.5 lbs out of a starting weight of 212 lbs.”[8]
In 2013 the FDA denied the second petition, concluding that the criteria for market withdrawal for orlistat had not been met. The agency maintained that “orlistat’s benefits outweigh its risks for its approved indications” and the labeling “adequately addressed” the risks.[9]
The recent FDA drug safety communication followed an agency review of 12 cases of kidney complications associated with the nonprescription product and aligns the labeling for over-the-counter orlistat with the labeling for prescription orlistat products. Consumers are now advised to consult with a clinician before using the over-the-counter product if they have ever had kidney disease or kidney stones and to stop using the product “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.”[10]
The labeling changes for over-the-counter orlistat are welcome but beg the question of why the FDA allows orlistat products to remain on the market at all. We recommend that you Do Not Use orlistat, and we call on the agency to reconsider its continuing approval of a minimally effective drug with serious risks and safety concerns.
References
[1] FDA approves labeling changes for over-the-counter (OTC) weight loss drug alli (Orlistat) to warn of risk of kidney stones and kidney injury. 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. Accessed July 15, 2026.
[2] Public Citizen. Petition to the FDA to immediately remove the diet drug orlistat (Xenical) from the market. April 10, 2006. https://www.citizen.org/article/petition-to-ban-diet-drug-orlistat-xenical/. Accessed July 15, 2026.
[3] Public Citizen. Petition to ban Orlistat (Alli, Xenical), April 14, 2011. https://www.citizen.org/article/petition-to-fda-to-ban-orlistat-alli-xenical/. Accessed July 15, 2026.
[4] Review of the diet drug orlistat. Worst Pills, Best Pills News. November 2019. https://www.worstpills.org/newsletters/view/1294.
[5] Food and Drug Administration. Orlistat Drug Facts. https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021887lbl.pdf. Accessed July 15, 2026.
[6] Alli. GoodRx. https://www.goodrx.com/alli?srsltid=AfmBOor7EfCho3t-ogILZIv-BzWUTccsGt0B7Yep0DXH65zQt4jYvrIU. Accessed July 15, 2026.
[7] Xenical prescribing information. https://www.xenical.com/media/xenical/pi_xenical-brand_final.pdf. Accessed July 15, 2026.
[8] Public Citizen. Petition to ban Orlistat (Alli, Xenical), April 14, 2011. https://www.citizen.org/article/petition-to-fda-to-ban-orlistat-alli-xenical/. Accessed July 15, 2026.
[9] FDA response to petition to ban Orlistat (Alli, Xenical). December 16, 2013. https://www.citizen.org/wp-content/uploads/1942_fda_response_to_orlistat_petition_denial.pdf Accessed July 15, 2026.
[10] FDA approves labeling changes for over-the-counter (OTC) weight loss drug alli (Orlistat) to warn of risk of kidney stones and kidney injury. 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 Accessed July 15, 2026.
