Orlistat
Peripherally Acting Antiobesity Products
Sold as ALLI · Xenical
- Drug class
- Peripherally Acting Antiobesity Products
- Availability
- Over-the-counter
- Routes
- Oral
- Markets covered
- 4
- Products on record
- 19
- FDA reports (12 mo)
- 199
Overview
Orlistat is an active pharmaceutical ingredient in the Peripherally Acting Antiobesity Products group (A08AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| GB United Kingdom | MHRA | 15 | May 29, 2026 |
| EU European Union | EMA | 2 | December 5, 2024 |
| US United States | FDA | 1 | March 27, 2024 |
| CA Canada | Health Canada | 1 | March 22, 2025 |
GBUnited Kingdom· MHRA
15 products
Uses
Orlistat is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m², or overweight patients (BMI ≥ 28 kg/m²) with associated risk factors.
Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
How to take
EUEuropean Union· EMA
2 products
Uses
alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
How to take
USUnited States· FDA
1 product
Uses
Use for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet
How to take
CACanada· Health Canada
1 product
Uses
XENICAL (orlistat), when used in conjunction with a mildly hypocaloric diet, is indicated for: • obesity management including weight loss and weight maintenance; • reducing the risk of weight regain in obese patients after prior weight loss.
g. hypertension, type 2 diabetes, dyslipidemia, excess visceral fat). The weight loss induced by the combination of XENICAL and a mildly hypocaloric diet results in an improvement of risk factors and comorbidities including hypercholesterolemia, impaired glucose tolerance, hyperinsulinemia, hypertension, reduction of visceral fat and waist circumference.
The weight loss induced by XENICAL improves glycemic control in diabetic patients and reduces the risk of developing type 2 diabetes in obese patients (BMI* ≥ 30 kg/m2) with impaired glucose tolerance. The effect of XENICAL on weight loss is adjunctive to that of diet and exercise.
XENICAL can be used in combination with anti-diabetic agents (sulfonylureas, metformin, insulin) to improve blood glucose control in overweight or obese type 2 diabetes patients who are inadequately controlled on diet, exercise, and one or more of a sulfonylurea, metformin, or insulin.
Drug interactions
Known interactions involving Orlistat. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 292. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]MHRA (UK) · PL204160270 · revised December 19, 2025
- [2]European Medicines Agency · EMEA/H/C/000854 · revised December 5, 2024
- [3]FDA DailyMed · 14a75092-f910-53… · revised March 27, 2024 [PDF]
- [4]Health Canada (DPD) · 02240325 · revised March 22, 2025
- [5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.