Hydroxyzine

Overview

Hydroxyzine is a first-generation histamine H-receptor antagonist of the dephenylmethane and piperazine classes that exhibits sedative, anxiolytic, and antiemetic properties. It was first developed in 1955, and has since remained a relatively common treatment for allergic conditions such as pruritus, urticaria, dermatoses, and histamine-mediated pruritus. The active metabolite of hydroxyzine, cetirizine, is also available as an active ingredient in allergic medications, and is responsible for much of its hydroxyzine's antihistaminic effect. Hydroxyzine is also used for generalized anxiety disorder, tension caused by psychoneurosis, and other conditions with manifestations of anxiety.

Indication

Hydroxyzine is indicated for the symptomatic relief of anxiety and tension associated with psychoneuroses, and as an adjunct in organic disease states in which anxiety is manifested. It is also indicated in the treatment of histamine-mediated pruritus and pruritus due to allergic conditions such as chronic urticaria. Canadian labeling states that hydroxyzine is also indicated in adults and children as a premedication prior to medical procedures, such as dental surgery. It is also used in the control of nausea and vomiting, excluding nausea and vomiting of pregnancy.

Associated Conditions

Anxiety
Nausea and vomiting
Pruritus

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Investigating Pre-Procedural Anxiety and Effect of Analgesia on Intrauterine Device Placement and Endometrial Biopsy	2025/06/22	NCT07031206	Phase 2	Not yet recruiting	The University of Texas Health Science Center, Houston
Efficacy of Hydroxyzine for Patients With Panic Disorder	2023/02/21	NCT05737511	Phase 4	Not yet recruiting	Sultan Qaboos University
Comparison Between Oral Melatonin and Hydroxyzine in Pediatric Patients Undergoing Adenotonsillectomy	2023/01/11	NCT05680584	Phase 1	Recruiting	Minia University
Sedation and Nursing Management in EEG Recording in Children	2022/08/09	NCT05492812	Not Applicable	Completed	Suleyman Demirel University
Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture	2022/02/04	NCT05224167	Not Applicable	UNKNOWN	Mongi Slim Hospital
Efficacy and Tolerability of Combination Varenicline With Hydroxyzine as a Potential Smoking Cessation Treatment	2019/12/05	NCT04188106	Phase 4	Completed	Rose Research Center, LLC
Preoperative Use of Alprazolam and Hydroxyzine in Anxiety	2019/12/03	NCT04184141	Phase 4	UNKNOWN	Istanbul Medeniyet University
Comparing Pediatric Dental Oral Sedation Outcomes With and Without Meperidine in Children Aged 3-7 Years	2019/08/28	NCT04068948	Phase 4	Completed	University of Washington
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms	2019/01/18	NCT03808805	Phase 3	UNKNOWN	University Hospital, Brest
Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery	2019/01/16	NCT03806270	N/A	Completed	Yeditepe University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Hydroxyzine hydrochloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-501	ORAL	25 mg in 1 1	3/9/2022
HydrOXYzine hydrochloride	Caraco Pharmaceutical Laboratories, Ltd.	57664-112	ORAL	10 mg in 1 1	2/4/2010
Hydroxyzine Hydrochloride	ATLANTIC BIOLOGICALS CORP.	17856-0507	ORAL	10 mg in 5 mL	12/1/2022
Hydroxyzine Hydrochloride	Proficient Rx LP	71205-155	ORAL	25 mg in 1 1	2/1/2023
Hydroxyzine Hydrochloride	State of Florida DOH Central Pharmacy	53808-0632	ORAL	50 mg in 1 1	9/11/2013
Hydroxyzine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	43063-943	ORAL	10 mg in 1 1	4/27/2023
Hydroxyzine Hydrochloride	Pharmaceutical Associates, Inc.	0121-4822	ORAL	10 mg in 5 mL	3/9/2015
Hydroxyzine Hydrochloride	PD-Rx Pharmaceuticals, Inc.	72789-216	ORAL	25 mg in 1 1	8/17/2023
Hydroxyzine Hydrochloride	REMEDYREPACK INC.	70518-3574	ORAL	50 mg in 1 1	1/15/2024
Hydroxyzine Hydrochloride	KVK-Tech, Inc.	10702-012	ORAL	50 mg in 1 1	1/4/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
HYDROXYZINE MEVON FILM-COATED TABLETS 10 MG	Centaur Pharmaceuticals Pvt Ltd, Medreich Limited	SIN16329P	TABLET, FILM COATED	10.000 mg	9/21/2021
HIZIN TABLET 10 mg	OLIC (THAILAND) LTD	SIN03423P	TABLET	10 mg	6/16/1989
HYDROXYZINE MEVON FILM-COATED TABLETS 25 MG	Centaur Pharmaceuticals Pvt Ltd, Medreich Limited	SIN16328P	TABLET, FILM COATED	25.000 mg	9/21/2021
HIZIN 25 TABLET 25 mg	OLIC (THAILAND) LTD	SIN03422P	TABLET	25 mg	6/16/1989
AA PHARMA HYDROXYZINE CAPSULE 10 mg	CATALENT ONTARIO LIMITED	SIN04096P	CAPSULE	10 mg	3/7/1990
AA PHARMA HYDROXYZINE CAPSULE 25 mg	CATALENT ONTARIO LIMITED	SIN04142P	CAPSULE, LIQUID FILLED	25 mg	4/20/1990
PHYMORAX TABLET 10 mg	MEDICA KOREA CO LTD	SIN09981P	TABLET	10 mg	9/8/1998
HIZIN LIQUID 10 mg/5 ml	OLIC (THAILAND) LTD	SIN03569P	SOLUTION	10 mg/5 ml	7/4/1989

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
APO-HYDROXYZINE CAP 10MG	N/A	HIND WING COMPANY LIMITED	N/A	N/A	1/3/1996

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-HYDROXYZINE	nu-pharm inc	02166321	Capsule - Oral	25 MG	12/31/1995
NU-HYDROXYZINE	nu-pharm inc	02166313	Capsule - Oral	10 MG	12/31/1995
MULTIPAX CAP 25MG	rhone-poulenc rorer canada inc.	01938835	Capsule - Oral	25 MG / CAP	12/31/1992
HYDROXYZINE	aa pharma inc	00646024	Capsule - Oral	25 MG	12/31/1986
RIVA-HYDROXYZIN 10MG CAPSULES	laboratoire riva inc.	02241192	Capsule - Oral	10 MG	11/23/1999
RIVA-HYDROXYZIN 25MG CAPSULES	laboratoire riva inc.	02241193	Capsule - Oral	25 MG	11/23/1999
RIVA-HYDROXYZIN 50MG CAPSULES	laboratoire riva inc.	02241194	Capsule - Oral	50 MG	11/23/1999
PMS HYDROXYZINE SYR 10MG/5ML	Pharmascience Inc	00741817	Syrup - Oral	10 MG / 5 ML	12/31/1988
PMS HYDROXYZINE CAP 50MG	Pharmascience Inc	00741906	Capsule - Oral	50 MG	12/31/1988
HYDROXYZINE HYDROCHLORIDE INJECTION	fresenius kabi canada ltd	02242864	Liquid - Intramuscular	50 MG / ML	4/5/2001

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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