Is Fexofenadine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 10 valid registrations of Fexofenadine, including FENADEX 120 MG F- CTABLETS (120 mg, Film-coated tablet, SAR 16.25); FENADEX 180MG F.C. TABLETS (180 mg, Film-coated tablet, SAR 15.15); FEXODINE 120MG TABLET (120 mg, Film-coated tablet, SAR 16.85); FEXODINE 180MG TABLET (180 mg, Film-coated tablet, SAR 16.85); FEXOFIN (180 mg, Film-coated tablet, SAR 32.50).

Is Fexofenadine approved by the US FDA?

Drugs@FDA lists 58 application product lines for Fexofenadine, including ALLEGRA ALLERGY (Over-the-counter); ALLEGRA HIVES (Over-the-counter); FEXOFENADINE HYDROCHLORIDE HIVES (Over-the-counter); CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY (Over-the-counter); CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES (Over-the-counter).

Is Fexofenadine on the WHO Model List of Essential Medicines?

Yes — 3. Antiallergics and medicines used in anaphylaxis (core list): Therapeutic equivalent to loratadine for Allergic or hypersensitivity conditions of unspecified type.

Are there safety signals or safety updates for Fexofenadine?

US FDA: 2 entries (latest 2021-10-13).

Active substance

Fexofenadine

SFDA 15
US FDA 58
Health Canada 3
US price lines 3
NHS prices 3
WHO EML 1
Safety 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
FENADEX 120 MG F- CTABLETS	120 mg	Film-coated tablet · Oral use	15 Blister	SAR 16.25	Generic · OTC	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
FENADEX 180MG F.C. TABLETS	180 mg	Film-coated tablet · Oral use	15 Blister	SAR 15.15	Generic · OTC	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Valid
FEXODINE 120MG TABLET	120 mg	Film-coated tablet · Oral use	14 Blister	SAR 16.85	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
FEXODINE 180MG TABLET	180 mg	Film-coated tablet · Oral use	14 Blister	SAR 16.85	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
FEXOFIN	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 32.50	Generic · OTC	Saudi Amarox	Valid
FEXOTEL 120MG TABLET	120 mg	Tablet · Oral use	14 Blister	SAR 15.15	Generic · OTC	BATTERJEE PHARMACETICAL FACTORY	Valid
TELFAST 120 MG FILM COATED TAB	120 mg	Film-coated tablet · Oral use	15 Blister	SAR 26.55	NCE · OTC	Sanofi Consumer Healthcare	Valid
TELFAST 180 MG FILM COATED TAB	180 mg	Film-coated tablet · Oral use	15 Blister	SAR 28.65	NCE · OTC	Sanofi Consumer Healthcare	Valid
Telfast	120 mg	Film-coated tablet · Oral use	30 Blister	SAR 39.70	NCE · OTC	Sanofi Consumer Healthcare	Valid
Telfast	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 43.65	NCE · OTC	Sanofi Consumer Healthcare	Valid
SARFEX 180MG F.C.TAB.(10S)	180 mg	Film-coated tablet · Oral use	10 Blister	SAR 10.85	Generic · OTC	NEOPHARMA	Suspended
SARFEX 180MG F.C.TAB.(30S)	180 mg	Film-coated tablet · Oral use	30 Blister	SAR 32.50	Generic · OTC	NEOPHARMA	Suspended
FENADEX 60 MG F-C TABLETS	60 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.25	Generic · OTC	The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM)	Withdrawn by MAH · Not Marketed
TELFAST 120 MG FILM COATED TAB	120 mg	Film-coated tablet · Oral use	15 Blister	SAR 26.55	NCE · OTC	SANOFI WINTHROP INDUSTRIE	Withdrawn by MAH · Not Marketed
TELFAST 180 MG FILM COATED TAB	180 mg	Film-coated tablet · Oral use	15 Blister	SAR 28.65	NCE · OTC	SANOFI WINTHROP INDUSTRIE	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); ALLERGIC RHINITIS; HUMAN IMMUNODEFICIENCY VIRUS; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; TUBERCULOSIS-SUPPORTIVE CARE; URTICARIA

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

Product	Strength	Form · route	Applicant	Status	First approved
ALLEGRA ALLERGY	60MG; 180MG	tablet · oral	CHATTEM SANOFI	Over-the-counter	25 Feb 2000
ALLEGRA HIVES	180MG	tablet · oral	CHATTEM SANOFI	Over-the-counter	25 Feb 2000
FEXOFENADINE HYDROCHLORIDE HIVES	180MG	tablet · oral	TEVA	Over-the-counter	1 Sep 2005
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	11 Apr 2006
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	11 Apr 2006
FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG; 180MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	11 Apr 2006
FEXOFENADINE HYDROCHLORIDE HIVES	60MG; 180MG	tablet · oral	DR REDDYS LABS LTD	Over-the-counter	11 Apr 2006
CHILDREN'S ALLEGRA ALLERGY	30MG/5ML	suspension · oral	CHATTEM SANOFI	Over-the-counter	24 Jan 2011
FEXOFENADINE HYDROCHLORIDE HIVES	180MG	tablet · oral	SUN PHARM INDS	Over-the-counter	6 Feb 2012
FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	tablet · oral	SUN PHARM INDS	Over-the-counter	6 Feb 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG	tablet · oral	PHARMAZONE	Over-the-counter	8 Feb 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	tablet · oral	PHARMAZONE	Over-the-counter	8 Feb 2012
FEXOFENADINE HYDROCHLORIDE HIVES	60MG; 180MG	tablet · oral	PHARMAZONE	Over-the-counter	8 Feb 2012
FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG; 180MG	tablet · oral	PHARMAZONE	Over-the-counter	8 Feb 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	suspension · oral	P AND L	Over-the-counter	18 Nov 2014
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	suspension · oral	P AND L	Over-the-counter	18 Nov 2014
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	tablet · oral	AUROBINDO PHARMA LTD	Over-the-counter	19 Nov 2014
FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG; 180MG	tablet · oral	AUROBINDO PHARMA LTD	Over-the-counter	19 Nov 2014
FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG; 180MG	tablet · oral	SCIEGEN PHARMS	Over-the-counter	16 Sep 2015
FEXOFENADINE HYDROCHLORIDE HIVES	60MG; 180MG	tablet · oral	SCIEGEN PHARMS	Over-the-counter	16 Sep 2015
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG	tablet · oral	HETERO LABS LTD V	Over-the-counter	19 Aug 2016
FEXOFENADINE HYDROCHLORIDE ALLERGY	60MG; 180MG	tablet · oral	HETERO LABS LTD V	Over-the-counter	19 Aug 2016
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY	30MG/5ML	suspension · oral	TARO	Over-the-counter	9 Nov 2017
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES	30MG/5ML	suspension · oral	TARO	Over-the-counter	9 Nov 2017
FEXOFENADINE HYDROCHLORIDE ALLERGY	180MG	tablet · oral	UNIQUE	Over-the-counter	13 Aug 2018

33 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALLEGRA 12 HOUR	02231462	60 MG	TABLET · ORAL	OPELLA CANADA INC.
ALLEGRA 24 HOUR	02242819	120 MG	TABLET · ORAL	OPELLA CANADA INC.
ALLEGRA HIVES	02521245	60 MG	TABLET · ORAL	OPELLA CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FEXOFENADINE HCL 180 MG TABLET	$0.2302	per EA	23 Sep 2026
US NADAC	FEXOFENADINE HCL 60 MG TABLET	$0.1529	per EA	23 Sep 2026
US NADAC	GNP FEXOFENADINE HCL 180 MG TB	$0.2302	per EA	23 Sep 2026
NHS Drug Tariff	Fexofenadine 120mg tablets	£1.17	30 tablet	1 Oct 2026
NHS Drug Tariff	Fexofenadine 180mg tablets	£2.64	30 tablet	1 Oct 2026
NHS Drug Tariff	Fexofenadine 30mg tablets	£5.46	60 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)

3. Antiallergics and medicines used in anaphylaxis · core
Therapeutic equivalent to loratadine for Allergic or hypersensitivity conditions of unspecified type

Safety signals and safety-related labeling changes

US FDA 13 Oct 2021 ALLEGRA HIVES — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 30 May 2019 ALLEGRA — safety-related labeling change
Labeling sections changed: Use in Specific Populations

All safety entries for fexofenadine →

Combinations containing Fexofenadine

Fexofenadine + pseudoephedrine

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.