Is Chloroquine 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 Chloroquine, including CHLOROQUINE (150 mg, Film-coated tablet, SAR 5.25); CHLOROQUINE (10 mg/ml, Syrup, SAR 8.75).

Is Chloroquine approved by the US FDA?

Drugs@FDA lists 15 application product lines for Chloroquine, including CHLOROQUINE PHOSPHATE (Prescription); CHLOROQUINE PHOSPHATE (Prescription); CHLOROQUINE PHOSPHATE (Prescription); CHLOROQUINE PHOSPHATE (Prescription); CHLOROQUINE PHOSPHATE (Prescription).

Is Chloroquine on the WHO Model List of Essential Medicines?

Yes — 29.2. Disease-modifying anti-rheumatic drugs (DMARDs) (core list): Rheumatoid arthritis.

Are there safety signals or safety updates for Chloroquine?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2020-11-26).

Active substance

Chloroquine

SFDA 6
US FDA 15
US price lines 2
WHO EML 3
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CHLOROQUINE	150 mg	Film-coated tablet · Oral use	10 Blister	SAR 5.25	Generic · Prescription	RIYADH PHARMA	Valid
CHLOROQUINE	10 mg/ml	Syrup · Oral use	1 Bottle	SAR 8.75	Generic · Prescription	RIYADH PHARMA	Valid
CHLOROQUIN PHOSPHATE 80MG/5ML SYRUR	16 mg/ml	Syrup · Oral use	1 Bottle	SAR 3.90	Generic · Prescription	PHARCO PHARMACEUTICAL	Withdrawn by MAH · Not Marketed
MALAREX SYRUP 120MG-5ML	24 mg/ml	Syrup · Oral use	1 Bottle	SAR 8.75	NCE · Prescription	XELLIA PHARMACEUTICAL APS	Withdrawn by MAH · Not Marketed
MALAREX TABLETS 250mg	250 mg	Tablet · Oral use	10 Blister	SAR 5.25	NCE · Prescription	XELLIA PHARMACEUTICAL APS	Withdrawn by MAH · Not Marketed
RESOCHIN TAB 250MG	250 mg	Film-coated tablet · Oral use	10 Blister	SAR 5.10	Generic · Prescription	BAYER AG	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

LICHEN PLANUS; MALARIA; SYSTEMIC LUPUS ERYTHEMATOSUS

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

Product	Strength	Form · route	Applicant	Status	First approved
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	IMPAX LABS	Prescription	11 Dec 1974
CHLOROQUINE PHOSPHATE	500MG	tablet · oral	IMPAX LABS	Prescription	29 Aug 2003
CHLOROQUINE PHOSPHATE	500MG	tablet · oral	NATCO PHARMA LTD	Prescription	21 Jan 2011
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	NATCO PHARMA LTD	Prescription	21 Jan 2011
CHLOROQUINE PHOSPHATE	500MG	tablet · oral	COHANCE LIFESCIENCES	Prescription	3 Sep 2021
ARALEN	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	SANOFI AVENTIS US	Discontinued	31 Oct 1949
ARALEN HYDROCHLORIDE	EQ 40MG BASE/ML	injectable · injection	SANOFI AVENTIS US	Discontinued	31 Oct 1949
CHLOROQUINE PHOSPHATE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	HIKMA PHARMS	Discontinued	9 Jul 1975
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	TEVA	Discontinued	13 Jan 1982
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	WATSON LABS	Discontinued	21 Dec 1982
CHLOROQUINE PHOSPHATE	500MG	tablet · oral	WATSON LABS	Discontinued	21 Dec 1982
CHLOROQUINE PHOSPHATE	500MG	tablet · oral	IPCA LABS LTD	Discontinued	3 Dec 2009
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	IPCA LABS LTD	Discontinued	3 Dec 2009
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	PUREPAC PHARM	Discontinued
CHLOROQUINE PHOSPHATE	250MG	tablet · oral	MD PHARM	Discontinued

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CHLOROQUINE PH 250 MG TABLET	$2.53965	per EA	23 Sep 2026
US NADAC	CHLOROQUINE PH 500 MG TABLET	$6.65389	per EA	23 Sep 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)

29.2. Disease-modifying anti-rheumatic drugs (DMARDs) · core
Rheumatoid arthritis
Oral > Solid: 100 mg tablet (as phosphate or sulfate); 150 mg tablet (as phosphate or sulfate)
6.5.3.1. Antimalarial medicines > Medicines for curative treatment · core
Malaria due to Plasmodium vivax
Oral > Liquid: 50 mg per 5 mL (base) | Oral > Solid > tablet: 150 mg (base)
6.5.3.3. Antimalarial medicines > Medicines for chemoprophylaxis in travellers · core
Malaria due to Plasmodium vivax
Oral > Liquid: 50 mg per 5 mL (base) | Oral > Solid > tablet: 150 mg (base)

Safety signals and safety-related labeling changes

EMA PRAC 26 Nov 2020 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: Yes
EMA PRAC 3 Sep 2020 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: No
EMA PRAC 11 Jun 2020 PRAC signal: Psychiatric disorders
Action for MAH: update of the product information: No
US FDA 24 Oct 2018 ARALEN — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations
EMA PRAC 5 Sep 2013 PRAC signal: Hypoglycaemia
Action for MAH: update of the product information: Yes

All safety entries for chloroquine →

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.