Is Loratadine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 22 valid registrations of Loratadine, including CLARA 10MG TABLET (10 mg, Tablet, SAR 17.65); CLARA 5MG\5ML SYRUP (1 mg/ml, Syrup, SAR 17.65); CLARITINE 10MG TAB (10 mg, Tablet, SAR 19.60); CLARITINE 5MG-5ML SYRUP (1 mg/ml, Syrup, SAR 20.75); GLORA 10MG TABLETS (10 mg, Tablet, SAR 9.35).

Is Loratadine approved by the US FDA?

Drugs@FDA lists 52 application product lines for Loratadine, including CLARITIN (Over-the-counter); CLARITIN HIVES RELIEF (Over-the-counter); CLARITIN (Over-the-counter); CLARITIN REDITABS (Over-the-counter); CLARITIN HIVES RELIEF REDITAB (Over-the-counter).

Is Loratadine on the WHO Model List of Essential Medicines?

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

Are there safety signals or safety updates for Loratadine?

EMA PRAC: 4 entries (latest 2017-09-29).

Active substance

Loratadine

SFDA 33
US FDA 52
Health Canada 11
US price lines 10
NHS prices 3
WHO EML 1
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
CLARA 10MG TABLET	10 mg	Tablet · Oral use	10 Blister	SAR 17.65	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
CLARA 5MG\5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 17.65	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
CLARITINE 10MG TAB	10 mg	Tablet · Oral use	10 Blister	SAR 19.60	NCE · OTC	BAYER CONSUMER CARE AG	Valid
CLARITINE 5MG-5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 20.75	NCE · OTC	BAYER CONSUMER CARE AG	Valid
GLORA 10MG TABLETS	10 mg	Tablet · Oral use	10 Blister	SAR 9.35	Generic · OTC	GLOBAL PHARMA	Valid
LOHIST 10 MG TABLETS	10 mg	Tablet · Oral use	10 Blister	SAR 10.40	Generic · OTC	National Pharmaceutical Industries Co. (SAOG)	Valid
LOHIST 5 MG-5 ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 8.00	Generic · OTC	National Pharmaceutical Industries Co. (SAOG)	Valid
LOJOUR 5MG\5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 15.10	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
LORA FM 10 mg tablet	10 mg	Tablet · Oral use	10 Blister	SAR 15.90	Generic · OTC	DAMMAM PHARMA	Valid
LORADAD 10MG TABLETS	10 mg	Tablet · Oral use	10 Blister	SAR 9.80	Generic · OTC	DAR ALDAWA	Valid
LORADAY 5 MG - 5 ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 15.10	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Valid
LORAHIST 10 mg tablet	10 mg	Tablet · Oral use	10 Blister	SAR 16.65	Generic · OTC	RIYADH PHARMA	Valid
LORAHIST syrup	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 17.65	Generic · OTC	RIYADH PHARMA	Valid
LORAMAX 10 mg tablet	10 mg	Tablet · Oral use	10 Blister	SAR 14.30	Generic · OTC	Jazeera Pharmaceutical Industries (JPI)	Valid
LORANO 10MG TABLETS	10 mg	Tablet · Oral use	7 Blister	SAR 5.90	Generic · OTC	HEXAL	Valid
LORINE 10MG FAST MELTING TABLETS	10 mg	Tablet · Oral use	10 Blister	SAR 17.65	Generic · OTC	SPIMACO ADDWAEIH	Valid
LORINE 10MG TAB	10 mg	Tablet · Oral use	10 Blister	SAR 17.65	Generic · OTC	SPIMACO ADDWAEIH	Valid
LORINE 5MG-5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 18.65	Generic · OTC	SPIMACO ADDWAEIH	Valid
Lohist	10 mg	Tablet · Oral use	1000 Blister	SAR 910.00	Generic · OTC	National Pharmaceutical Industries Co. (SAOG)	Valid
TIDILOR	10 mg	Tablet · Oral use	30 Blister	SAR 40.75	Generic · OTC	Pharma International Co.	Valid
TIDILOR 10MG TABLET	10 mg	Tablet · Oral use	10 Blister	SAR 13.60	Generic · OTC	Pharma International Co.	Valid
TIDILOR 5 MG - 5 ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 13.15	Generic · OTC	Pharma International Co.	Valid
LORADAY 10MG TABLET	10 mg	Tablet · Oral use	10 Blister	SAR 13.00	Generic · OTC	KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES	Suspended
NEODAY 10MG TABLETS	10 mg	Tablet · Oral use	10 Blister	SAR 8.40	Generic · OTC	NEOPHARMA	Suspended
NEODAY 5MG-5ML SYRUP	1 mg/ml	Syrup · Oral use	1 Bottle	SAR 7.20	Generic · OTC	NEOPHARMA	Suspended

8 more — full table

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); ALLERGIC RHINITIS; HUMAN IMMUNODEFICIENCY VIRUS; POLYCYTHEMIA VERA - BONE PAIN; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; T-CELL LYMPHOMA; TUBERCULOSIS-SUPPORTIVE CARE; URTICARIA

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

Product	Strength	Form · route	Applicant	Status	First approved
CLARITIN	10MG	tablet · oral	BAYER HEALTHCARE LLC	Over-the-counter	12 Apr 1993
CLARITIN HIVES RELIEF	10MG	tablet · oral	BAYER HEALTHCARE LLC	Over-the-counter	12 Apr 1993
CLARITIN	1MG/ML	syrup · oral	BAYER HEALTHCARE LLC	Over-the-counter	10 Oct 1996
CLARITIN REDITABS	10MG	tablet, orally disintegrating · oral	BAYER HEALTHCARE LLC	Over-the-counter	23 Dec 1996
CLARITIN HIVES RELIEF REDITAB	10MG	tablet, orally disintegrating · oral	BAYER HEALTHCARE LLC	Over-the-counter	23 Dec 1996
ALAVERT	10MG	tablet, orally disintegrating · oral	FDN CONSUMER	Over-the-counter	19 Dec 2002
LORATADINE	10MG	tablet · oral	PLD ACQUISITIONS LLC	Over-the-counter	21 Jan 2003
LORATADINE	10MG	tablet · oral	SUN PHARM INDS LTD	Over-the-counter	18 Aug 2003
LORATADINE	10MG	tablet · oral	MYLAN	Over-the-counter	20 Aug 2003
LORATADINE	10MG	tablet, orally disintegrating · oral	PERRIGO PHARMA INTL	Over-the-counter	29 Sep 2003
LORATADINE	10MG	tablet · oral	PERRIGO	Over-the-counter	25 Jun 2004
LORATADINE	1MG/ML	syrup · oral	PERRIGO	Over-the-counter	20 Aug 2004
LORATADINE	1MG/ML	syrup · oral	WOCKHARDT BIO AG	Over-the-counter	20 Aug 2004
LORATADINE	1MG/ML	syrup · oral	TARO	Over-the-counter	20 Aug 2004
LORATADINE	5MG/5ML	syrup · oral	PHARM ASSOC	Over-the-counter	5 Oct 2004
LORATADINE	10MG	tablet · oral	APOTEX	Over-the-counter	14 Feb 2006
LORATADINE	1MG/ML	syrup · oral	LANNETT CO INC	Over-the-counter	29 Jun 2006
CHILDREN'S CLARITIN	5MG	tablet, chewable · oral	BAYER HEALTHCARE LLC	Over-the-counter	23 Aug 2006
CLARITIN	10MG	tablet, chewable · oral	BAYER HEALTHCARE LLC	Over-the-counter	23 Aug 2006
CLARITIN REDITABS	5MG	tablet, orally disintegrating · oral	BAYER HEALTHCARE LLC	Over-the-counter	12 Dec 2006
LORATADINE REDIDOSE	10MG	tablet, orally disintegrating · oral	SUN PHARM INDS LTD	Over-the-counter	11 Apr 2007
CLARITIN	10MG	capsule · oral	BAYER HEALTHCARE LLC	Over-the-counter	16 Jun 2008
LORATADINE	1MG/ML	syrup · oral	TARO	Over-the-counter	31 Jul 2015
LORATADINE	10MG	capsule · oral	MARKSANS PHARMA	Over-the-counter	23 Sep 2016
LORATADINE	10MG	tablet, orally disintegrating · oral	AUROBINDO PHARMA LTD	Over-the-counter	11 Apr 2018

27 more — full table

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
24 HOUR ALLERGY REMEDY	02280159	10 MG	TABLET · ORAL	VITA HEALTH PRODUCTS INC
ALLERGY REMEDY	02375990	10 MG	TABLET · ORAL	APOTEX INC
ALLERTIN	02390388	10 MG	CAPSULE · ORAL	APOTEX INC
APO-LORATADINE	02243880	10 MG	TABLET · ORAL	APOTEX INC
CLARITIN ALLERGY	00782696	10 MG	TABLET · ORAL	BAYER INC
CLARITIN KIDS	02241523	5 MG / 5 ML	SYRUP · ORAL	BAYER INC
CLARITIN KIDS RAPID DISSOLVE	02508761	5 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	BAYER INC
CLARITIN LIQUID CAPSULES	02404494	10 MG	CAPSULE · ORAL	BAYER INC
CLARITIN RAPID DISSOLVE	02237734	10 MG	TABLET (ORALLY-DISINTEGRATING) · ORAL	BAYER INC
LORATADINE	02366444	10 MG	TABLET · ORAL	APOTEX INC
LORATADINE SOFT GEL CAPSULES	02379481	10 MG	CAPSULE · ORAL	APOTEX INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CHILD LORATADINE 5 MG TAB CHEW	$0.52124	per EA	23 Sep 2026
US NADAC	CHILD LORATADINE 5 MG/5 ML SOL	$0.04139	per ML	23 Sep 2026
US NADAC	CHILD LORATADINE 5 MG/5 ML SOL	$0.06302	per ML	23 Sep 2026
US NADAC	GNP CHILD LORATADINE 5 MG/5 ML	$0.04139	per ML	23 Sep 2026
US NADAC	GNP LORATADINE 10 MG ODT	$0.52737	per EA	23 Sep 2026
US NADAC	GNP LORATADINE 10 MG TABLET	$0.05294	per EA	23 Sep 2026
US NADAC	LORATADINE 10 MG ODT	$0.52737	per EA	23 Sep 2026
US NADAC	LORATADINE 10 MG TABLET	$0.05294	per EA	23 Sep 2026
US NADAC	LORATADINE 5 MG/5 ML SOLUTION	$0.04139	per ML	23 Sep 2026
US NADAC	LORATADINE 5 MG/5 ML SYRUP	$0.04139	per ML	23 Sep 2026
NHS Drug Tariff	Loratadine 10mg tablets	£0.76	30 tablet	1 Oct 2026
NHS Drug Tariff	Loratadine 5mg/5ml oral solution	£4.11	100 ml	1 Oct 2026
NHS Drug Tariff	Loratadine 5mg/5ml oral solution sugar free	£3.78	100 ml	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
Allergic or hypersensitivity conditions of unspecified type
Oral > Liquid: 1 mg per mL | Oral > Solid > tablet: 10 mg; 5 mg (chewable) (EMLc); 10 mg (chewable) (EMLc)

Safety signals and safety-related labeling changes

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
EMA PRAC 17 Mar 2016 PRAC signal: QT prolongation and torsade de pointe
Action for MAH: update of the product information: No
EMA PRAC 14 Jan 2016 PRAC signal: QT prolongation and torsade de pointe
Action for MAH: update of the product information: No

All safety entries for loratadine →

Combinations containing Loratadine

Loratadine + 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.