Is Hydrochlorothiazide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Hydrochlorothiazide, including ESIDREX TAB. 25 MG (25 mg, Tablet, SAR 17.25); MONOZIDE 12.5MG TAB (12.5 mg, Tablet, SAR 8.40); MONOZIDE 25MG TAB (25 mg, Tablet, SAR 14.20); Monozide (12.5 mg, Tablet, SAR 256.00).

Is Hydrochlorothiazide approved by the US FDA?

Drugs@FDA lists 103 application product lines for Hydrochlorothiazide, including HYDROCHLOROTHIAZIDE (Prescription); HYDROCHLOROTHIAZIDE (Prescription); HYDROCHLOROTHIAZIDE (Prescription); HYDROCHLOROTHIAZIDE (Prescription); MICROZIDE (Prescription).

Is Hydrochlorothiazide on the WHO Model List of Essential Medicines?

Yes — 12.3. Antihypertensive medicines (core list): Essential hypertension.

Are there safety signals or safety updates for Hydrochlorothiazide?

EMA PRAC: 4 entries; US FDA: 22 entries; MHRA: 1 entry (latest 2026-07-24).

Active substance

Hydrochlorothiazide

SFDA 5
US FDA 103
Health Canada 12
US price lines 5
WHO EML 3
Safety 27

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ESIDREX TAB. 25 MG	25 mg	Tablet · Oral use	20 Blister	SAR 17.25	NCE · Prescription	Laboratoires Juvisé Pharmaceuticals	Valid
MONOZIDE 12.5MG TAB	12.5 mg	Tablet · Oral use	30 Blister	SAR 8.40	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
MONOZIDE 25MG TAB	25 mg	Tablet · Oral use	30 Blister	SAR 14.20	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
MONOZIDE 25MG TAB	25 mg	Tablet · Oral use	1000 Blister	SAR 327.05	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
Monozide	12.5 mg	Tablet · Oral use	1005 Blister	SAR 256.00	Generic · Prescription	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid

Indications — CHI Daman Drug Formulary

CENTRAL DIABETES INSIPIDUS; CONGESTIVE HEART FAILURE; HYPERKALEMIA; HYPERTENSION; HYPOPARATHYROIDISM; PRE-ECLAMPSIA; PULMONARY ARTERIAL HYPERTENSION; RENAL AND URETERIC STONES; VERTIGO - MENIERE'S DISEASE

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

Product	Strength	Form · route	Applicant	Status	First approved
HYDROCHLOROTHIAZIDE	25MG; 50MG; 12.5MG	tablet · oral	IVAX SUB TEVA PHARMS	Prescription	12 Jan 1973
HYDROCHLOROTHIAZIDE	50MG; 25MG; 12.5MG	tablet · oral	HERITAGE	Prescription	20 Jan 1978
HYDROCHLOROTHIAZIDE	25MG	tablet · oral	OXFORD PHARMS	Prescription	5 Nov 1980
HYDROCHLOROTHIAZIDE	50MG	tablet · oral	OXFORD PHARMS	Prescription	5 Nov 1980
MICROZIDE	12.5MG	capsule · oral	TEVA BRANDED PHARM	Prescription	27 Dec 1996
HYDROCHLOROTHIAZIDE	12.5MG	capsule · oral	PRINSTON INC	Prescription	17 Sep 2002
HYDROCHLOROTHIAZIDE	12.5MG	tablet · oral	ACTAVIS ELIZABETH	Prescription	27 Feb 2007
HYDROCHLOROTHIAZIDE	25MG; 50MG; 12.5MG	tablet · oral	LEADING	Prescription	16 Mar 2007
HYDROCHLOROTHIAZIDE	25MG; 50MG	tablet · oral	AUROBINDO PHARMA	Prescription	20 Jul 2007
HYDROCHLOROTHIAZIDE	12.5MG	capsule · oral	AUROBINDO PHARMA	Prescription	19 Sep 2007
HYDROCHLOROTHIAZIDE	12.5MG	capsule · oral	JUBILANT CADISTA	Prescription	11 Feb 2008
HYDROCHLOROTHIAZIDE	25MG; 50MG; 12.5MG	tablet · oral	UNICHEM	Prescription	15 Aug 2008
HYDROCHLOROTHIAZIDE	12.5MG	capsule · oral	UNICHEM	Prescription	19 Jan 2010
HYDROCHLOROTHIAZIDE	12.5MG; 25MG; 50MG	tablet · oral	ACCORD HLTHCARE	Prescription	24 Sep 2012
HYDROCHLOROTHIAZIDE	25MG; 50MG	tablet · oral	SCIEGEN PHARMS	Prescription	23 Jul 2014
HYDROCHLOROTHIAZIDE	12.5MG	capsule · oral	SCIEGEN PHARMS	Prescription	14 Jan 2019
INZIRQO	10MG/ML	for suspension · oral	NOVITIUM PHARMA	Prescription	28 Jan 2025
ESIDRIX	25MG; 50MG; 100MG	tablet · oral	NOVARTIS	Discontinued	12 Feb 1959
HYDRODIURIL	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	MERCK	Discontinued	24 Feb 1959
ORETIC	25MG; 50MG	tablet · oral	ABBVIE	Discontinued	6 Jul 1959
HYDROCHLOROTHIAZIDE	50MG; 25MG	tablet · oral	WHITEWORTH TOWN PLSN	Discontinued	2 Jul 1974
HYDROCHLOROTHIAZIDE	25MG; 50MG; 100MG	tablet · oral	SUN PHARM INDUSTRIES	Discontinued	3 Oct 1974
HYDROCHLOROTHIAZIDE	50MG	tablet · oral	WATSON LABS TEVA	Discontinued	24 Jan 1975
HYDROCHLOROTHIAZIDE	50MG	tablet · oral	IVAX SUB TEVA PHARMS	Discontinued	24 Sep 1975
HYDROCHLOROTHIAZIDE	50MG	tablet · oral	LANNETT CO INC	Discontinued	24 Jun 1976

78 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
APO-HYDROCHLOROTHIAZIDE	00312800	50 MG	TABLET · ORAL	APOTEX INC
APO-HYDROCHLOROTHIAZIDE	00326844	25 MG	TABLET · ORAL	APOTEX INC
APO-HYDROCHLOROTHIAZIDE	02327856	12.5 MG	TABLET · ORAL	APOTEX INC
HYDROCHLOROTHIAZIDE	02360594	25 MG	TABLET · ORAL	SANIS HEALTH INC
HYDROCHLOROTHIAZIDE	02486962	25 MG	TABLET · ORAL	PRO DOC LIMITEE
MINT-HYDROCHLOROTHIAZIDE	02425947	12.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-HYDROCHLOROTHIAZIDE	02426196	25 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
PMS-HYDROCHLOROTHIAZIDE	02247386	25 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-HYDROCHLOROTHIAZIDE	02247387	50 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-HYDROCHLOROTHIAZIDE	02274086	12.5 MG	TABLET · ORAL	PHARMASCIENCE INC
TEVA-HYDROCHLOROTHIAZIDE	00021474	25 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-HYDROCHLOROTHIAZIDE	00021482	50 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	HYDROCHLOROTHIAZIDE 12.5 MG CP	$0.02754	per EA	23 Sep 2026
US NADAC	HYDROCHLOROTHIAZIDE 12.5 MG TB	$0.03397	per EA	23 Sep 2026
US NADAC	HYDROCHLOROTHIAZIDE 25 MG TAB	$0.01153	per EA	23 Sep 2026
US NADAC	HYDROCHLOROTHIAZIDE 50 MG TAB	$0.03165	per EA	23 Sep 2026
US NADAC	INZIRQO 10 MG/ML ORAL SUSP	$4.46172	per ML	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)

12.3. Antihypertensive medicines · core
Essential hypertension
Oral > Liquid: 50 mg per 5 mL | Oral > Solid: 25 mg; 12.5 mg
16. Diuretics · core (EML); complementary (EMLc)
Oedema
Oral > Solid > dosage form: 25 mg; 12.5 mg (EMLc)
12.4. Medicines used in heart failure · core
Heart failure
Oral > Liquid: 50 mg per 5 mL | Oral > Solid: 25 mg

Safety signals and safety-related labeling changes

US FDA 24 Jul 2026 ZIAC — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Nov 2025 ALDACTAZIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions
US FDA 1 Aug 2025 AVALIDE — 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 20 Jun 2025 HYZAAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 10 Apr 2025 BENICAR HCT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 22 Dec 2023 LOPRESSOR HCT — 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 19 Dec 2022 MICARDIS HCT — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 14 Jan 2022 DUTOPROL — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 19 Feb 2021 ACCURETIC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 2 Oct 2020 TRIBENZOR — 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 28 Sep 2020 TEKTURNA HCT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 20 Aug 2020 LOTENSIN HCT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 20 Aug 2020 VASERETIC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 20 Aug 2020 ZESTORETIC — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions
US FDA 20 Aug 2020 ATACAND HCT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions

All safety entries for hydrochlorothiazide →

Combinations containing Hydrochlorothiazide

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.