Is Orlistat registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Orlistat, including FATLOS 120MG CAPSULES (120 mg, Capsule, SAR 115.45); XENICAL 120MG CAPSULE (120 mg, Capsule, SAR 142.65).

Is Orlistat approved by the US FDA?

Drugs@FDA lists 2 application product lines for Orlistat, including XENICAL (Prescription); ALLI (Over-the-counter).

Is Orlistat authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Orlistat: Xenical, Alli (previously Orlistat GSK).

Are there safety signals or safety updates for Orlistat?

EMA PRAC: 4 entries; US FDA: 2 entries; MHRA: 1 entry (latest 2026-09-30).

Active substance

Orlistat

SFDA 6
US FDA 2
EMA 2
Health Canada 1
US price lines 2
NHS prices 2
Safety 7

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FATLOS 120MG CAPSULES	120 mg	Capsule · Oral use	80 Blister	SAR 115.45	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
FATLOS 120MG CAPSULES	120 mg	Capsule · Oral use	40 Blister	SAR 57.70	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
XENICAL 120MG CAPSULE	120 mg	Capsule · Oral use	84 Blister	SAR 142.65	NCE · Prescription	CHEPLAPHARM Arzneimittel GmbH	Valid
ALLI 60MG CAPSULES	60 mg	Capsule · Oral use	120 Bottle	SAR 156.55	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
ALLI 60MG CAPSULES	60 mg	Capsule · Oral use	60 Bottle	SAR 78.30	Generic · Prescription	GLAXOSMITHKLINE (GSK)	Withdrawn by MAH · Not Marketed
XENICAL 120MG CAPSULE	120 mg	Capsule · Oral use	42 Blister	SAR 122.75	NCE · Prescription	ROCHE	Withdrawn by MAH · Not Marketed

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
XENICAL	120MG	capsule · oral	CHEPLAPHARM	Prescription	23 Apr 1999
ALLI	60MG	capsule · oral	HALEON US HOLDINGS	Over-the-counter	7 Feb 2007

EMA European Union — centrally authorised medicines

Xenical CHEPLAPHARM Arzneimittel GmbH · Authorised · authorised 29 Jul 1998 · ATC A08AB01

Therapeutic indication (EMA)

Xenical 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.

Alli (previously Orlistat GSK) Haleon Ireland Dungarvan Limited · Authorised · authorised 22 Jul 2007 · ATC A08AB01

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
XENICAL	02240325	120 MG	CAPSULE · ORAL	CHEPLAPHARM ARZNEIMITTEL GMBH

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ORLISTAT 120 MG CAPSULE	$6.9989	per EA	23 Sep 2026
US NADAC	XENICAL 120 MG CAPSULE	$4.59792	per EA	23 Sep 2026
NHS Drug Tariff	Orlistat 120mg capsules	£14.24	84 capsule	1 Oct 2026
NHS Drug Tariff	Orlistat 60mg capsules	£33.77	84 capsule	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 30 Sep 2026 XENICAL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 27 Mar 2026 ALLI — safety-related labeling change
Labeling sections changed: Warnings and Precautions
MHRA 11 Dec 2014 Orlistat: theoretical interaction with antiretroviral HIV medicines
Initiate orlistat treatment only after careful consideration of the possible impact on efficacy of antiretroviral HIV medicines.
EMA PRAC 9 Jan 2014 PRAC signal: Pharmacokinetic drug interaction (at absorption) with highly active antiretroviral therapy (HAART) leading to loss of HAART efficacy
Action for MAH: update of the product information: Yes
EMA PRAC 10 Oct 2013 PRAC signal: Pharmacokinetic drug interaction (at absorption) with highly active antiretroviral therapy (HAART) leading to loss of HAART efficacy
Action for MAH: update of the product information: Yes
EMA PRAC 13 Jun 2013 PRAC signal: Inhibition of carboxylesterase-2 from an in vitro study
Action for MAH: update of the product information: No
EMA PRAC 16 May 2013 PRAC signal: Pharmacokinetic drug interaction (at absorption) with highly active antiretroviral therapy (HAART) leading to loss of HAART efficacy
Action for MAH: update of the product information: No

All safety entries for orlistat →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.