Is Thalidomide approved by the US FDA?

Drugs@FDA lists 4 application product lines for Thalidomide, including THALOMID (Prescription); THALOMID (Prescription); THALIDOMIDE (Prescription); THALIDOMIDE (Discontinued).

Is Thalidomide authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Thalidomide: Thalidomide BMS (previously Thalidomide Celgene), Thalidomide Lipomed.

Is Thalidomide on the WHO Model List of Essential Medicines?

Yes — 8.2.3. Immunomodulators (complementary list): Plasma cell myeloma.

Are there safety signals or safety updates for Thalidomide?

EMA PRAC: 1 entry; US FDA: 1 entry; MHRA: 3 entries (latest 2026-09-02).

Active substance

Thalidomide

US FDA 4
EMA 2
Health Canada 2
WHO EML 1
Safety 5

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
THALOMID	50MG; 100MG; 200MG; 150MG	capsule · oral	BRISTOL-MYERS	Prescription	16 Jul 1998
THALOMID	50MG; 100MG; 200MG	capsule · oral	CELGENE	Prescription	25 May 2006
THALIDOMIDE	50MG; 100MG; 200MG	capsule · oral	NATCO	Prescription	27 Apr 2023
THALIDOMIDE	150MG	capsule · oral	NATCO	Discontinued	27 Apr 2023

EMA European Union — centrally authorised medicines

Thalidomide BMS (previously Thalidomide Celgene) Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 16 Apr 2008 · ATC L04AX02

Therapeutic indication (EMA)

Thalidomide BMS in combination with melphalan and prednisone as first line treatment of patients with untreated multiple myeloma, aged >/= 65 years or ineligible for high dose chemotherapy. Thalidomide BMS is prescribed and dispensed according to the Thalidomide Celgene Pregnancy Prevention Programme (see section 4.4).

Thalidomide Lipomed Lipomed GmbH · Authorised · authorised 19 Sep 2022 · ATC L04AX02

Therapeutic indication (EMA)

Thalidomide Lipomed in combination with melphalan and prednisone is indicated as first line treatment of patients with untreated multiple myeloma, aged ? 65 years or ineligible for high dose chemotherapy. Thalidomide Lipomed is prescribed and dispensed in accordance with the Thalidomide Lipomed Pregnancy Prevention Programme (see section 4.4).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
THALOMID	02355191	50 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA
THALOMID	02355205	100 MG	CAPSULE · ORAL	BRISTOL-MYERS SQUIBB CANADA

WHO WHO Model List of Essential Medicines (2025)

8.2.3. Immunomodulators · complementary
Plasma cell myeloma
Oral > Solid: 50 mg

Safety signals and safety-related labeling changes

US FDA 2 Sep 2026 THALOMID — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
MHRA 14 Dec 2015 Thalidomide: reduced starting dose in patients older than age 75 years
Use a lower starting dose of thalidomide in patients with untreated multiple myeloma who are older than age 75 years.
MHRA 11 Dec 2014 Thalidomide: risk of second primary malignancies
Healthcare professionals should consider this risk when deciding whether to treat patients with thalidomide monitor for the occurrence of these conditions.
MHRA 11 Dec 2014 Thalidomide: risk of arterial and venous thromboembolism
Increased risk of arterial thromboembolism, including myocardial infarction and cerebrovascular events for patients treated with thalidomide.
EMA PRAC 10 Jan 2013 PRAC signal: Posterior reversible encephalopathy syndrome
Action for MAH: update of the product information: No

All safety entries for thalidomide →

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.