Is Olmesartan registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 19 valid registrations of Olmesartan, including NORMATEC 20 mg film-coated tablet (20 mg, Film-coated tablet, SAR 53.10); NORMATEC 40 mg film-coated tablet (40 mg, Film-coated tablet, SAR 70.65); OLMEPRESS 20 mg film-coated tablet (20 mg, Film-coated tablet, SAR 43.00); OLMEPRESS 40 mg film-coated tablet (40 mg, Film-coated tablet, SAR 57.25); OLMETEC 20MG F.C. TABLETS (20 mg, Film-coated tablet, SAR 62.45).

Is Olmesartan approved by the US FDA?

Drugs@FDA lists 26 application product lines for Olmesartan, including BENICAR (Prescription); OLMESARTAN MEDOXOMIL (Prescription); OLMESARTAN MEDOXOMIL (Prescription); OLMESARTAN MEDOXOMIL (Prescription); OLMESARTAN MEDOXOMIL (Prescription).

Are there safety signals or safety updates for Olmesartan?

EMA PRAC: 5 entries; US FDA: 4 entries (latest 2025-04-10).

Active substance

Olmesartan

SFDA 22
US FDA 26
Health Canada 22
US price lines 6
NHS prices 3
Safety 9

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NORMATEC 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 53.10	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
NORMATEC 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 70.65	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
OLMEPRESS 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 43.00	Generic · Prescription	LABORATORIOS CINFA SA	Valid
OLMEPRESS 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 57.25	Generic · Prescription	LABORATORIOS CINFA SA	Valid
OLMETEC 20MG F.C. TABLETS	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 62.45	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
OLMETEC 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 83.15	NCE · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
OLSAR 20MG F.C.TABLET	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 50.35	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
OLSAR 40MG F.C.TABLET	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 67.10	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid
Olcontro	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 67.10	Generic · Prescription	Med City Pharma	Valid
Olcontro	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 50.35	Generic · Prescription	Med City Pharma	Valid
Olimestra	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 36.93	Generic · Prescription	KRKA D D NOVO MESTO	Valid
Olimestra	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 51.97	Generic · Prescription	KRKA D D NOVO MESTO	Valid
Olmetrol	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 51.50	Generic · Prescription	RIYADH PHARMA	Valid
Olmetrol	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 38.70	Generic · Prescription	RIYADH PHARMA	Valid
Olmy	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 38.70	Generic · Prescription	Saudi Amarox	Valid
Olmy	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 51.50	Generic · Prescription	Saudi Amarox	Valid
Sarolm	40 mg	Film-coated tablet · Oral use	30 Blister	SAR 51.50	Generic · Prescription	Elixir Pharmaceutical Company LLC	Valid
Sarolm	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 38.70	Generic · Prescription	Elixir Pharmaceutical Company LLC	Valid
Sarolm	10 mg	Film-coated tablet · Oral use	30 Blister	SAR 19.35	Generic · Prescription	Elixir Pharmaceutical Company LLC	Valid
CALENDA 10 mg film-coated tablet	10 mg	Film-coated tablet · Oral use	28 Blister	SAR 23.90	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
CALENDA 20 mg film-coated tablet	20 mg	Film-coated tablet · Oral use	28 Blister	SAR 47.80	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed
CALENDA 40 mg film-coated tablet	40 mg	Film-coated tablet · Oral use	28 Blister	SAR 63.60	Generic · Prescription	DEEF PHARMACEUTICAL INDUSTRIES	Withdrawn by regulatory authority · Not Marketed

Indications — CHI Daman Drug Formulary

CHRONIC KIDNEY DISEASE; CORONARY ARTERY DISEASE; HYPERTENSION; SICKLE CELL DISEASE - ALBUMINURIA MANAGEMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
BENICAR	5MG; 20MG; 40MG	tablet · oral	COSETTE	Prescription	25 Apr 2002
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	ALEMBIC	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	AUROBINDO PHARMA	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	MACLEODS PHARMS	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	ZYDUS PHARMS	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	JUBILANT GENERICS	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	ALKEM LABS LTD	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	ACCORD HLTHCARE	Prescription	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	25 May 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	SCIEGEN PHARMS	Prescription	29 Jun 2018
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	QILU	Prescription	10 Jan 2019
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	SUNSHINE	Prescription	22 Feb 2019
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	PHARMAZONE	Prescription	18 Jul 2019
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	ADAPTIS	Prescription	18 May 2020
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	PRINSTON INC	Prescription	2 Dec 2022
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	MSN	Prescription	18 Jan 2023
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	CHARTWELL RX	Prescription	25 Jan 2024
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	HETERO LABS LTD V	Prescription	31 Oct 2024
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	CADILA PHARMS LTD	Prescription	8 Nov 2024
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	RISING	Discontinued	26 Oct 2016
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	TEVA PHARMS USA	Discontinued	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	TORRENT	Discontinued	24 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	LUPIN	Discontinued	27 Apr 2017
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	MICRO LABS	Discontinued	17 Sep 2019
OLMESARTAN MEDOXOMIL	5MG; 20MG; 40MG	tablet · oral	SANDOZ	Discontinued	13 Apr 2020

1 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-OLMESARTAN	02456311	20 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-OLMESARTAN	02456338	40 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AURO-OLMESARTAN	02443864	20 MG	TABLET · ORAL	AURO PHARMA INC
AURO-OLMESARTAN	02443872	40 MG	TABLET · ORAL	AURO PHARMA INC
GLN-OLMESARTAN	02469812	20 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
GLN-OLMESARTAN	02469820	40 MG	TABLET · ORAL	GLENMARK PHARMACEUTICALS CANADA INC.
JAMP OLMESARTAN	02461641	20 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP OLMESARTAN	02461668	40 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
NRA-OLMESARTAN	02499258	20 MG	TABLET · ORAL	NORA PHARMA INC
NRA-OLMESARTAN	02499266	40 MG	TABLET · ORAL	NORA PHARMA INC
OLMESARTAN	02481057	20 MG	TABLET · ORAL	SANIS HEALTH INC
OLMESARTAN	02481065	40 MG	TABLET · ORAL	SANIS HEALTH INC
OLMESARTAN	02488744	20 MG	TABLET · ORAL	PRO DOC LIMITEE
OLMESARTAN	02488752	40 MG	TABLET · ORAL	PRO DOC LIMITEE
OLMETEC	02318660	20 MG	TABLET · ORAL	ORGANON CANADA INC.
OLMETEC	02318679	40 MG	TABLET · ORAL	ORGANON CANADA INC.
PMS-OLMESARTAN	02461307	20 MG	TABLET · ORAL	PHARMASCIENCE INC
PMS-OLMESARTAN	02461315	40 MG	TABLET · ORAL	PHARMASCIENCE INC
SANDOZ OLMESARTAN	02443414	20 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ OLMESARTAN	02443422	40 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
TEVA-OLMESARTAN	02442191	20 MG	TABLET · ORAL	TEVA CANADA LIMITED
TEVA-OLMESARTAN	02442205	40 MG	TABLET · ORAL	TEVA CANADA LIMITED

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	BENICAR 20 MG TABLET	$12.31644	per EA	1 Jul 2026
US NADAC	BENICAR 40 MG TABLET	$17.24162	per EA	1 Jul 2026
US NADAC	BENICAR 5 MG TABLET	$10.1271	per EA	1 Jul 2026
US NADAC	OLMESARTAN MEDOXOMIL 20 MG TAB	$0.08049	per EA	23 Sep 2026
US NADAC	OLMESARTAN MEDOXOMIL 40 MG TAB	$0.11097	per EA	23 Sep 2026
US NADAC	OLMESARTAN MEDOXOMIL 5 MG TAB	$0.05748	per EA	23 Sep 2026
NHS Drug Tariff	Olmesartan medoxomil 10mg tablets	£0.93	28 tablet	1 Oct 2026
NHS Drug Tariff	Olmesartan medoxomil 20mg tablets	£1.16	28 tablet	1 Oct 2026
NHS Drug Tariff	Olmesartan medoxomil 40mg tablets	£1.34	28 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.

Safety signals and safety-related labeling changes

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
EMA PRAC 2 Dec 2021 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: Yes
EMA PRAC 28 Oct 2021 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
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 2 Oct 2020 AZOR — 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 17 Oct 2019 BENICAR — 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
EMA PRAC 29 Nov 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 12 Jul 2018 PRAC signal: Autoimmune hepatitis
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2012 PRAC signal: Increased risk of fatal cardiovascular events in patients with type 2 diabetes at increased cardiovascular risk
Action for MAH: update of the product information: Yes

All safety entries for olmesartan →

Combinations containing Olmesartan

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.