Is Desloratadine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 27 valid registrations of Desloratadine, including AERIALLERG 5MG FILM COATED TABLET (5 mg, Film-coated tablet, SAR 16.75); AERIUS 2.5 MG-5ML SYRUP (0.5 mg/ml, Oral solution, SAR 23.95); AERIUS 5MG TABLETS (5 mg, Film-coated tablet, SAR 23.30); Batlor (0.5 mg/ml, Syrup, SAR 11.45); Batlor (5 mg, Film-coated tablet, SAR 28.25).

Is Desloratadine approved by the US FDA?

Drugs@FDA lists 17 application product lines for Desloratadine, including CLARINEX (Prescription); CLARINEX (Prescription); CLARINEX (Prescription); CLARINEX (Prescription); DESLORATADINE (Prescription).

Is Desloratadine authorised in the European Union?

EMA lists 7 centrally authorised medicines containing Desloratadine: Azomyr, Aerius, Neoclarityn, Desloratadine Teva, Dasselta, Desloratadine ratiopharm, Desloratadine Actavis.

Are there safety signals or safety updates for Desloratadine?

EMA PRAC: 2 entries; US FDA: 6 entries (latest 2019-03-15).

Active substance

Desloratadine

SFDA 29
US FDA 17
EMA 10
Health Canada 4
US price lines 3
NHS prices 3
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
AERIALLERG 5MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.75	Generic · OTC	Pharma International Co.	Valid
AERIUS 2.5 MG-5ML SYRUP	0.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 23.95	NCE · OTC	BAYER CONSUMER CARE AG	Valid
AERIUS 5MG TABLETS	5 mg	Film-coated tablet · Oral use	18 Blister	SAR 23.30	NCE · OTC	BAYER CONSUMER CARE AG	Valid
Batlor	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 11.45	Generic · OTC	BATTERJEE PHARMACETICAL FACTORY	Valid
Batlor	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 28.25	Generic · OTC	BATTERJEE PHARMACETICAL FACTORY	Valid
Celer	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.70	Generic · OTC	GULF PHARMACEUTICAL INDUSTIRES- JULPHAR	Valid
Celer	0.5 mg	Syrup · Oral use	1 Bottle	SAR 14.30	Generic · OTC	GULF PHARMACEUTICAL INDUSTIRES- JULPHAR	Valid
DARINE	5 mg	Tablet · Oral use	30 Blister	SAR 28.25	Generic · OTC	Med City Pharma	Valid
DESLIN 2.5mg/5ml Oral Solution	0.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 15.90	Generic · OTC	AJA PHARMACEUTICAL INDUSTRIES	Valid
DESLIN 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 28.25	Generic · OTC	AJA PHARMACEUTICAL INDUSTRIES	Valid
DESLOR 5 MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 23.30	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
DESLORATADINE/GENEPHARM 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.75	Generic · OTC	GENEPHARM S.A.	Valid
DESTAMIN 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 18.85	Generic · OTC	LABORATORIOS CINFA SA	Valid
Dorius	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 18.85	Generic · OTC	AL RAZI PHARMA INDUSTRIES	Valid
IRIS 0.5 MG/ML SYRUP	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 9.55	Generic · OTC	MS Pharma Saudi (MSPS)	Valid
LORETA 2.5 mg/5 ml Syrup	0.5 mg/ml mg/ml	Syrup · Oral use	1 Bottle	SAR 14.30	Generic · OTC	DAMMAM PHARMA	Valid
LORETA 5mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 18.85	Generic · OTC	DAMMAM PHARMA	Valid
LORINEX 0.5MG-1ML SYRUP	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 17.65	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
LORINEX 5MG FILM COATED TABLETS	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 20.95	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
Loradeel	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 18.85	Generic · OTC	Alrai Pharmaceutical industry Co. (L.L.C)	Valid
Loradin	5 mg	Film-coated tablet · Oral use	28 Blister	SAR 26.40	Generic · OTC	Middle East Pharmaceutical Industries Co Ltd Avalon Pharma	Valid
Lorinex	5 mg	Film-coated tablet · Oral use	190 Blister	SAR 177.35	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Lorius	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 16.75	Generic · OTC	Savvy Pharma	Valid
Lorius	5 mg	Film-coated tablet · Oral use	10 Blister	SAR 5.60	Generic · OTC	Savvy Pharma	Valid
NEORIN 2.5MG -5ML SYRUP	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 22.70	Generic · OTC	SPIMACO ADDWAEIH	Valid

4 more — full table

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); 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
CLARINEX	5MG	tablet · oral	ORGANON	Prescription	21 Dec 2001
CLARINEX	5MG	tablet · oral	SCHERING	Prescription	8 Feb 2002
CLARINEX	5MG	tablet · oral	SCHERING	Prescription	8 Feb 2002
CLARINEX	0.5MG/ML	syrup · oral	SCHERING	Prescription	1 Sep 2004
DESLORATADINE	5MG	tablet · oral	ORBION PHARMS	Prescription	19 Feb 2010
DESLORATADINE	2.5MG; 5MG	tablet, orally disintegrating · oral	REDDYS	Prescription	12 Jul 2010
DESLORATADINE	5MG	tablet · oral	LUPIN PHARMS	Prescription	25 Oct 2010
DESLORATADINE	5MG	tablet · oral	DR REDDYS LABS LTD	Prescription	8 Mar 2011
DESLORATADINE	5MG	tablet · oral	NATCO PHARMA USA	Prescription	10 Feb 2012
DESLORATADINE	5MG	tablet · oral	AJENAT PHARMS	Prescription	19 Apr 2012
DESLORATADINE	0.5MG/ML	solution · oral	TARO	Prescription	26 May 2016
CLARINEX	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons; 2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, orally disintegrating · oral	ORGANON	Discontinued	26 Jun 2002
CLARINEX	0.5MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	ORGANON LLC	Discontinued	1 Sep 2004
DESLORATADINE	5MG	tablet · oral	SUN PHARM INDS	Discontinued	16 Nov 2010
DESLORATADINE	5MG	tablet · oral	CHARTWELL RX	Discontinued	3 Dec 2010
DESLORATADINE	5MG	tablet · oral	PERRIGO	Discontinued	22 Dec 2011
DESLORATADINE	0.5MG/ML	solution · oral	TARO	Discontinued	30 Jun 2015

EMA European Union — centrally authorised medicines

Azomyr Organon N.V. · Authorised · authorised 15 Jan 2001 · ATC R06AX27

Therapeutic indication (EMA)

Azomyr is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)

Aerius Organon N.V. · Authorised · authorised 15 Jan 2001 · ATC R06AX27

Therapeutic indication (EMA)

Aerius is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.

Neoclarityn Organon N.V. · Authorised · authorised 15 Jan 2001 · ATC R06AX27

Therapeutic indication (EMA)

Neoclarityn is indicated for the relief of symptoms associated with: allergic rhinitis urticaria

Desloratadine Teva Teva B.V · Authorised · authorised 24 Nov 2011 · ATC R06AX27

Therapeutic indication (EMA)

Desloratadine Teva is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.

Dasselta Krka, d.d., Novo mesto · Authorised · authorised 28 Nov 2011 · ATC R06AX27

Therapeutic indication (EMA)

Dasselta is indicated for the relief of symptoms associated with: allergic rhinitis; urticaria.

Desloratadine ratiopharm Ratiopharm GmbH · Authorised · authorised 13 Jan 2012 · ATC R06AX27

Therapeutic indication (EMA)

Desloratadine ratiopharm is indicated in adults for the relief of symptoms associated with: allergic rhinitis chronic idiopathic urticaria as initially diagnosed by a physician

Desloratadine Actavis Actavis Group PTC ehf · Authorised · authorised 13 Jan 2012 · ATC R06AX27

Therapeutic indication (EMA)

Treatment of allergic rhinitis and urticaria.

Desloratadine Krka Krka, d.d., Novo mesto · Application withdrawn · ATC R06AX27

Therapeutic indication (EMA)

Relief of symptoms of allergic rhinitis and urticaria

Opulis Schering-Plough Europe · Withdrawn · authorised 15 Jan 2001 · ATC R06AX27

Therapeutic indication (EMA)

Opulis is indicated for the relief of symptoms associated with:- allergic rhinitis (see section 5.1)- urticaria (see section 5.1)

Allex Schering-Plough Europe · Withdrawn · authorised 15 Jan 2001 · ATC R06AX27

Therapeutic indication (EMA)

Aerius is indicated for the relief of symptoms associated with: allergic rhinitis (see section 5.1) urticaria (see section 5.1)

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AERIUS	02243919	5 MG	TABLET · ORAL	BAYER INC
AERIUS KIDS	02247193	0.5 MG / ML	SYRUP · ORAL	BAYER INC
DESLORATADINE	02546019	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
DESLORATADINE ALLERGY CONTROL	02298155	5 MG	TABLET · ORAL	PHARMASCIENCE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CLARINEX 5 MG TABLET	$8.84762	per EA	18 Feb 2026
US NADAC	DESLORATADINE 5 MG ODT	$4.77528	per EA	23 Sep 2026
US NADAC	DESLORATADINE 5 MG TABLET	$0.25755	per EA	23 Sep 2026
NHS Drug Tariff	Desloratadine 2.5mg/5ml oral solution sugar free	£6.77	100 ml	1 Oct 2026
NHS Drug Tariff	Desloratadine 2.5mg/5ml oral solution sugar free	£10.15	150 ml	1 Oct 2026
NHS Drug Tariff	Desloratadine 5mg tablets	£1.59	30 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 15 Mar 2019 CLARINEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 15 Mar 2019 CLARINEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 15 Mar 2019 CLARINEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 15 Mar 2019 CLARINEX — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations
US FDA 15 Mar 2019 CLARINEX D 24 HOUR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Mar 2019 CLARINEX-D 12 HOUR — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 29 Sep 2017 PRAC signal: Weight increased in children
Action for MAH: update of the product information: Yes
EMA PRAC 6 Jul 2017 PRAC signal: Weight increased in children
Action for MAH: update of the product information: No

All safety entries for desloratadine →

Combinations containing Desloratadine

Desloratadine + 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.