Active ingredient
Orlistat: FDA Status, Uses, Safety and Cost
Blocks fat absorption in the gut
What Orlistat is
Orlistat is the only FDA-approved weight-loss medication that works in the digestive tract rather than on appetite. It is sold as prescription-strength Xenical and over-the-counter Alli (a lower dose) — the only FDA-approved over-the-counter weight-loss drug.
Key facts
| Generic (active ingredient) | Orlistat |
|---|---|
| Brand names | Xenical, Alli |
| Drug class | Lipase inhibitor |
| Manufacturer | CHEPLAPHARM (Xenical); Haleon (Alli) |
| FDA status | FDA ApprovedApproved for chronic weight management |
| Administration | Oral capsule, taken with fat-containing meals |
| Frequency | Up to three times daily with meals |
| Approval date | Xenical: April 1999 (prescription). Alli: February 2007 (over the counter). |
| Prescription required | No — available over the counter |
| Official label | Prescribing information (DailyMed) |
What Orlistat is approved for
- Obesity management, including weight loss and weight maintenance, with a reduced-calorie diet (Xenical, prescription)
- Weight-loss aid in overweight adults, used with a reduced-calorie, low-fat diet (Alli, over the counter)
How Orlistat works
Orlistat inhibits lipases, the enzymes that break down dietary fat in the gut. A portion of the fat you eat passes through undigested instead of being absorbed, reducing calorie absorption from fat.
Administration
Orlistat is given by oral capsule, taken with fat-containing meals, up to three times daily with meals.
We do not publish dosing guidance
Dose selection, titration schedules, and what to do about a missed dose are individual clinical decisions. Follow the instructions from your prescriber and the official prescribing information — never a website.
Important safety information
The FDA labeling for Orlistat does not include a boxed warning. It does include warnings and precautions — read the full prescribing information, linked in Sources below.
Contraindications (who should not take it)
- Pregnancy
- Chronic malabsorption syndrome
- Cholestasis
- Known hypersensitivity to orlistat or product components
Summarized from the FDA prescribing information. This is not the complete list — see the full label.
Common adverse reactions from official labeling
- Oily spotting
- Flatus with discharge
- Fecal urgency
- Fatty or oily stool
- Increased defecation
- Fecal incontinence
The most common adverse reactions listed in the product’s FDA prescribing information. Frequency and full adverse-reaction data are in the label.
Cost and access
- Alli is available over the counter without a prescription; Xenical requires a prescription.
- Generic prescription orlistat availability varies; check with pharmacies for current options and prices.
Why we don't publish a price
List prices, savings-card amounts, and self-pay offers change frequently and vary by pharmacy, plan, and location. Any figure we printed would be wrong for many readers and stale within weeks. See our cost guide for how to get an accurate number for your own situation.
Insurance considerations
- Over-the-counter Alli is generally not covered by insurance.
- Prescription Xenical coverage varies by plan and is often excluded under weight-loss drug exclusions.
More detail: how insurance coverage works for weight-loss medication.
Frequently asked questions
- Is Alli the same as Xenical?
- Both contain orlistat. Xenical is the prescription strength (120 mg); Alli is the FDA-approved over-the-counter version at a lower strength (60 mg).
- Is orlistat a GLP-1 medication?
- No. Orlistat is a lipase inhibitor that blocks some dietary fat absorption in the gut. It does not act on appetite hormones the way GLP-1 receptor agonists do.
Sources
- Orlistat prescribing information (DailyMed, NIH) — DailyMed/NIH. Link last verified August 12, 2026.
- Drugs@FDA database — FDA. Link last verified August 12, 2026.
Not medical advice. WeightLossDrugsGuide is an independent educational publisher. We are not a pharmacy, a medical provider, or a telehealth clinic, and we do not provide personalized medical recommendations or dosing guidance. Information here summarizes official FDA labeling and other primary sources and may not reflect the most recent changes. Always talk with a licensed clinician about your own situation, and read the full prescribing information for any medication.