Loratadine

Generic Name: Loratadine

Brand Names: Alavert, Alavert D, Allerclear, Claritin, Claritin-D, Diphen, Loradamed, Wal-itin, Wal-itin D

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₃ClN_₂O_₂

CAS Number: 79794-75-5

Unique Ingredient Identifier: 7AJO3BO7QN

Overview

Loratadine is a second generation antihistamine used to manage symptoms of allergic rhinitis. A lack of sedative and CNS adverse effects make loratadine, along with other second generation antihistamines, preferable over their 1st generation counterparts in many clinical situations.

Background

Indication

Loratadine is a 2nd generation antihistamine and is used to manage symptoms of allergic rhinitis, wheal formation, urticaria, and other allergic dermatologic conditions.

Associated Conditions

Allergic Dermatologic Disorders
Allergic Reaction
Allergic Rhinitis (AR)
Allergy to Tree Pollen
Chronic Urticaria
Common Cold
Epiphora
Eye pruritus
Fever
Nasal Congestion
Nasal Itching
Pain
Perennial Allergic Rhinitis (PAR)
Pruritus
Rhinitis Perennial
Rhinorrhoea
Seasonal Allergic Rhinitis
Sneezing
Sensation of burning in the eyes
Watery itchy eyes

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Drug Levels, Tolerability and Absolute Biological Availability of Single-dose of BMS-986446 in Healthy Participants	2025/05/02	NCT06955741	Phase 1	Recruiting	Bristol-Myers Squibb
Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine	2024/08/01	NCT06531707	Phase 3	Recruiting	Laboratorios Silanes S.A. de C.V.
Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)	2024/02/09	NCT06250400	Phase 4	Not yet recruiting	Hangzhou Grand Biologic Pharmaceutical, Inc.
Over-the-Counter Antihistamines & Heat Stress	2024/01/22	NCT06217367	Phase 4	Recruiting	Lakehead University
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme	2023/08/31	NCT06019728	Phase 4	Completed	Sanofi
Gabapentin Versus Loratadine in Uremic Pruritus	2023/03/02	NCT05750875	Phase 4	Completed	King Edward Medical University
Loratadine for the Prevention of G-CSF-related Bone Pain	2022/06/16	NCT05421416	Phase 2	Recruiting	AHS Cancer Control Alberta
A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Claritin® Tablets 24-Hour in Subjects With Allergic Conjunctivitis	2022/03/04	NCT05265910	Phase 4	Completed	Andover Research Eye Institute
Evaluation of The Effect of Loratadine Versus Diosmin/Hesperidin Combination on Vinca Alkaloids Induced Neuropathy	2022/02/17	NCT05243706	Phase 3	UNKNOWN	Ain Shams University
Effect of Loratadine in Lymphangioleiomyomatosis	2022/01/13	NCT05190627	Phase 2	UNKNOWN	Institut d'Investigació Biomèdica de Bellvitge

FDA Approved Products

Product Name	Manufacturer	Route	Strength	Approved	NDC Code
Loratadine	Northwind Pharmaceuticals, LLC	ORAL	10 mg in 1 1	2014/10/31	51655-027
Loratadineantihistamine antihistamine	REMEDYREPACK INC.	ORAL	10 mg in 1 1	2013/05/20	49349-218
Allergy Relief	WinCo Foods, LLC	ORAL	10 mg in 1 1	2025/04/08	67091-350
non drowsy allergy relief	Meijer Distribution Inc	ORAL	10 mg in 1 1	2025/05/08	41250-890
dg health childrens allergy	Dolgencorp, LLC	ORAL	5 mg in 5 mL	2025/05/07	55910-611
Loratadine	CVS Pharmacy, Inc.	ORAL	10 mg in 1 1	2025/05/13	69842-242
basic care childrens allergy relief	Amazon.com Services LLC	ORAL	5 mg in 5 mL	2025/05/12	72288-511
good sense childrens allergy relief	L. Perrigo Company	ORAL	5 mg in 5 mL	2025/05/06	0113-1719
childrens allergy relief	Rite Aid Corporation	ORAL	5 mg in 5 mL	2025/05/05	11822-0620
Loratadine	Granules Pharmaceuticals Inc.	ORAL	10 mg in 1 1	2025/05/05	70010-162

EMA Approved Products

Product Name	EMA Number	Auth. Holder	Country	Drug Type	Status	Issued	Opinion	Revision

No EMA products found

No EMA products found for this drug

HSA Approved Products

Product Name	Manufacturer	Dosage Form	Strength	Approved	Approval Number
RINITYN TABLET 10 mg	HOVID BHD, HOVID Bhd.	TABLET	10.00 mg	2002/09/12	SIN12067P
SUNADINE TABLET 10MG	Sunward Pharmaceutical Sdn Bhd	TABLET, FILM COATED	10mg	2014/01/15	SIN14482P
LORIDIN RAPITAB 10 mg	CADILA HEALTHCARE LTD	TABLET	10 mg	2002/07/19	SIN12029P
CLARITYN-D 24HOUR EXTENDED RELEASE TABLET	SAG Manufacturing S.L.U.	TABLET, SUGAR COATED	10 mg	2003/04/01	SIN12246P
LORFAST TABLET 10 mg	CADILA PHARMACEUTICALS LTD	TABLET	10 mg	2001/09/24	SIN11679P
CLARITYNE TABLET 10mg	Schering-Plough Labo NV, PT. BAYER INDONESIA	TABLET, FILM COATED	10mg	2012/01/12	SIN14077P
CLARITYNE SYRUP 5 MG/5 ML (GRAPE FLAVOR)	Delpharm Montréal Inc.	SYRUP	5 mg/ 5mL	2021/01/29	SIN16091P
HALODIN TABLETS 10 mg	T O CHEMICALS (1979) LTD	TABLET	10 mg	1998/11/04	SIN10351P
Loradine Tablet 10 mg	Y.S.P. Industries (M) Sdn Bhd	TABLET	10.0 mg	2007/08/27	SIN13341P
EZEDE' TABLET 10 mg	XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD	TABLET	10 mg	2002/05/14	SIN11932P

NMPA Approved Products

Product Name	Approval Number	Manufacturer	Dosage Form	Trade Name	Strength	Type	Status	Date	Import
Loratadine Granales	国药准字H20041708	洋浦新世通制药有限公司	颗粒剂	N/A	5mg	Chemical Drug	Approved	2020/06/15	Domestic
Loratadine Granules	国药准字H20041015	苏中药业集团股份有限公司	颗粒剂	伊利欣	5mg	Chemical Drug	Approved	2020/07/28	Domestic
Loratadine Granules	国药准字H20040439	南京亿华药业有限公司	颗粒剂	华畅	5mg	Chemical Drug	Approved	2020/06/05	Domestic
Loratadine Granules	国药准字H20060719	鲁南贝特制药有限公司	颗粒剂	N/A	10mg	Chemical Drug	Approved	2020/05/20	Domestic
Loratadine Orally Disintegrating Tablets	国药准字H20080294	重庆康刻尔制药股份有限公司	片剂	伉尔纾坦	10mg	Chemical Drug	Approved	2023/01/03	Domestic
Loratadine Orally Disintegrating Tablets	国药准字H20080190	陕西量子高科药业有限公司	片剂	N/A	10mg	Chemical Drug	Approved	2022/11/10	Domestic
Loratadine Orally Disintegrating Tablets	国药准字H20080527	四川新斯顿制药股份有限公司	片剂	N/A	0.01g	Chemical Drug	Approved	2023/07/07	Domestic
Loratadine Orally Disintegrating Tablets	国药准字H20080305	西安太极药业有限公司	片剂	N/A	10mg	Chemical Drug	Approved	2023/05/08	Domestic
Loratadine Orally Disintegrating Tablets	国药准字H20070300	浙江金华康恩贝生物制药有限公司	片剂	N/A	10mg	Chemical Drug	Approved	2022/07/26	Domestic
Loratadine Capsules	国药准字H20163238	河北东风药业有限公司	胶囊剂	N/A	5mg	Chemical Drug	Approved	2020/04/30	Domestic

PPB Approved Products

Product Name	Registration Code	Company	Category	Sale Type	Registration Date
ROTIFAR TAB 10MG	HK-52476	wings pharmaceutical ltd	Part 1 Poison	Pharmacy only Medicines	2004/08/09
LORSEDIN TABLETS 10MG	HK-60926	TOP HARVEST PHARMACEUTICALS COMPANY LIMITED	Part 1 Poison	Pharmacy only Medicines	2011/12/08
LORATADINE NON-DROWSY TAB 10MG	HK-60292	ADVANCE PHARMACEUTICAL COMPANY LIMITED	Part 2 Poison	OTC	2010/12/24
CLARIN TAB 10MG	HK-53519	unicorn laboratories o/b american unicorn laboratories limited	Part 2 Poison	OTC	2005/07/14
ALLERGONE CAP 10MG	HK-53624	neochem pharmaceutical laboratories ltd.	Part 1 Poison	Pharmacy only Medicines	2005/09/10

TGA Approved Products

Product Name	ARTG ID	Sponsor	Status	Registration Date	Ingredient
AMCAL LORATADINE 10 mg tablets blister pack	226844	Sigma Company Limited	Active	2014/08/12	loratadine
TRUST LORATADINE ANTIHISTAMINE loratadine 10 mg tablets bottle pack	312388	Pharmacor Pty Ltd	Active	2018/12/11	loratadine
APOHEALTH LORATADINE HAYFEVER & ALLERGY RELIEF loratadine 10 mg tablets blister pack	227277	Arrotex Pharmaceuticals Pty Ltd	Active	2014/08/26	loratadine
CLARATYNE-D WITH DECONGESTANT tablets blister pack	53516	Bayer Australia Ltd	Active	1995/09/21	loratadine
CLARATYNE loratadine 10mg tablet blister pack (general sale)	200430	Bayer Australia Ltd	Active	2012/08/28	loratadine
CHILDREN'S CLARATYNE loratadine 1 mg/mL grape flavour oral liquid solution bottle (reformulation 2)	384266	Bayer Australia Ltd	Active	2022/02/18	loratadine
Allervic Chewables - Bubblegum Flavour	396098	Pharmacor Pty Ltd	Active	2022/09/19	loratadine
CLARATYNE REDITABS loratadine 10 mg orally disintegrating tablet blister pack (general sale)	279809	Bayer Australia Ltd	Active	2016/08/31	loratadine
TRUST LORATADINE 10 mg tablet blister pack	161830	Pharmacor Pty Ltd	Active	2009/05/15	loratadine
PHARMACY CHOICE LORATADINE TABLETS loratadine 10 mg tablet blister pack	379604	NOUMED PHARMACEUTICALS PTY LTD	Active	2021/11/30	loratadine