Is Mercaptopurine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Mercaptopurine, including PURINETHOL 50MG TAB (50 mg, Tablet, SAR 279.45); Xaluprine (20 mg/ml, Oral suspension, SAR 1573.00).

Is Mercaptopurine approved by the US FDA?

Drugs@FDA lists 6 application product lines for Mercaptopurine, including PURINETHOL (Prescription); MERCAPTOPURINE (Prescription); MERCAPTOPURINE (Prescription); PURIXAN (Prescription); MERCAPTOPURINE (Prescription).

Is Mercaptopurine authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Mercaptopurine.

Is Mercaptopurine on the WHO Model List of Essential Medicines?

Yes — 8.2.1. Cytotoxic medicines (complementary list): Lymphoid leukaemia, not elsewhere classified; Acute myeloid leukaemia with recurrent genetic abnormalities; Langerhans cell histiocytosis.

Are there safety signals or safety updates for Mercaptopurine?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2026-07-16).

Active substance

Mercaptopurine

SFDA 4
US FDA 6
EMA 1
Health Canada 2
US price lines 1
NHS prices 2
WHO EML 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PURINETHOL 50MG TAB	50 mg	Tablet · Oral use	25 Tablet Container	SAR 279.45	NCE · Prescription	ASPEN PHARMA TRADING LIMITED (APTL)	Valid
Xaluprine	20 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 1573.00	NCE · Prescription	Nova Laboratories Limited	Valid
PURINETHOL 50MG TAB	50 mg	Tablet · Oral use	25 Blister	SAR 53.20	NCE · Prescription	GLAXOWELLCOME	Withdrawn by regulatory authority · Not Marketed
PURINETHOL 50MG TAB	50 mg	Tablet · Oral use	25 Blister	SAR 328.75	NCE · Prescription	ASPEN	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE LYMPHOCYTIC LEUKEMIA (ALL); AUTOIMMUNE HEPATITIS; CROHN'S DISEASE; PEDIATRIC ACUTE LYMPHOBLASTIC LEUKAEMIA (ALL); ULCERATIVE COLITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
PURINETHOL	50MG	tablet · oral	STASON PHARMS	Prescription	11 Sep 1953
MERCAPTOPURINE	50MG	tablet · oral	DR REDDYS LABS SA	Prescription	11 Feb 2004
MERCAPTOPURINE	50MG	tablet · oral	HIKMA PHARMS	Prescription	13 Feb 2004
PURIXAN	20MG/ML	suspension · oral	NOVA LABS LTD	Prescription	28 Apr 2014
MERCAPTOPURINE	20MG/ML	suspension · oral	HIKMA PHARMS	Prescription	26 Feb 2025
MERCAPTOPURINE	50MG	tablet · oral	MYLAN	Discontinued	1 Jul 2005

EMA European Union — centrally authorised medicines

Loulla Only For Children Pharmaceuticals · Application withdrawn · ATC L01BB02

Therapeutic indication (EMA)

Treatment of acute lymphatic leukemia

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
MERCAPTOPURINE TABLETS USP	02415275	50 MG	TABLET · ORAL	STERIMAX INC
PURINETHOL	00004723	50 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	MERCAPTOPURINE 50 MG TABLET	$1.07143	per EA	23 Sep 2026
NHS Drug Tariff	Mercaptopurine 20mg/ml oral suspension	£170.00	100 ml	1 Oct 2026
NHS Drug Tariff	Mercaptopurine 50mg tablets	£13.04	25 tablet	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.

WHO WHO Model List of Essential Medicines (2025)

8.2.1. Cytotoxic medicines · complementary
Lymphoid leukaemia, not elsewhere classified; Acute myeloid leukaemia with recurrent genetic abnormalities; Langerhans cell histiocytosis
Oral > Liquid: 20 mg per mL (EMLc) | Oral > Solid: 50 mg tablet

Safety signals and safety-related labeling changes

US FDA 16 Jul 2026 PURIXAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 9 Jul 2024 PURINETHOL — 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
EMA PRAC 17 Mar 2016 PRAC signal: Lymphoproliferative disorders
Action for MAH: update of the product information: Yes
EMA PRAC 6 Nov 2015 PRAC signal: Lymphoproliferative disorders
Action for MAH: update of the product information: No

All safety entries for mercaptopurine →

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.