Active substance
Hydroxyzine
- SFDA 3
- US FDA 148
- Health Canada 5
- US price lines 8
- NHS prices 2
- Safety 3
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ATARAX SYRUP | 2 mg/ml | Syrup · Oral use | 1 Bottle | SAR 13.35 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by MAH · Not Marketed |
| ATARAX TABLETS 10 MG | 10 mg | Tablet · Oral use | 25 Blister | SAR 7.80 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by MAH · Not Marketed |
| ATARAX TABLETS 25 MG | 25 mg | Tablet · Oral use | 25 Blister | SAR 10.50 | NCE · Prescription | GLAXOSMITHKLINE (GSK) | Withdrawn by MAH · Not Marketed |
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| HYDROXYZINE HYDROCHLORIDE | 25MG/ML; 50MG/ML | injectable · injection | AM REGENT | Prescription | 27 Aug 1981 |
| HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | capsule · oral | SANDOZ | Prescription | 14 Dec 1981 |
| HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | capsule · oral | SANDOZ | Prescription | 14 Dec 1981 |
| HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | syrup · oral | CHARTWELL RX | Prescription | 12 Apr 1982 |
| HYDROXYZINE HYDROCHLORIDE | 50MG; 10MG; 25MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 20 Dec 1982 |
| HYDROXYZINE PAMOATE | EQ 50MG HYDROCHLORIDE | capsule · oral | BARR LABS | Prescription | 15 Jun 1984 |
| HYDROXYZINE PAMOATE | EQ 100MG HYDROCHLORIDE | capsule · oral | BARR LABS | Prescription | 15 Jun 1984 |
| HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE | capsule · oral | BARR | Prescription | 15 Jun 1984 |
| HYDROXYZINE HYDROCHLORIDE | 10MG | tablet · oral | PLIVA | Prescription | 10 Jan 1986 |
| HYDROXYZINE HYDROCHLORIDE | 25MG | tablet · oral | PLIVA | Prescription | 10 Jan 1986 |
| HYDROXYZINE HYDROCHLORIDE | 50MG | tablet · oral | PLIVA | Prescription | 10 Jan 1986 |
| HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE; EQ 50MG HYDROCHLORIDE | capsule · oral | IMPAX LABS INC | Prescription | 15 Jul 1996 |
| HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | syrup · oral | PAI HOLDINGS PHARM | Prescription | 10 Apr 2002 |
| HYDROXYZINE HYDROCHLORIDE | 50MG; 10MG; 25MG | tablet · oral | EPIC PHARMA LLC | Prescription | 28 Dec 2004 |
| HYDROXYZINE HYDROCHLORIDE | 50MG; 25MG; 10MG | tablet · oral | PRINSTON INC | Prescription | 27 May 2005 |
| HYDROXYZINE HYDROCHLORIDE | 10MG; 25MG; 50MG | tablet · oral | KVK TECH | Prescription | 20 Mar 2007 |
| HYDROXYZINE HYDROCHLORIDE | 50MG; 10MG; 25MG | tablet · oral | NORTHSTAR HLTHCARE | Prescription | 31 Mar 2008 |
| HYDROXYZINE HYDROCHLORIDE | 10MG | tablet · oral | NORTHSTAR HLTHCARE | Prescription | 31 Mar 2008 |
| HYDROXYZINE HYDROCHLORIDE | 25MG | tablet · oral | NORTHSTAR HLTHCARE | Prescription | 31 Mar 2008 |
| HYDROXYZINE HYDROCHLORIDE | 10MG; 25MG; 50MG | tablet · oral | HETERO LABS LTD III | Prescription | 29 May 2008 |
| HYDROXYZINE HYDROCHLORIDE | 10MG; 25MG; 50MG | tablet · oral | CHARTWELL RX | Prescription | 30 Jun 2008 |
| HYDROXYZINE PAMOATE | EQ 25MG HYDROCHLORIDE; EQ 50MG HYDROCHLORIDE | capsule · oral | HERITAGE PHARMA | Prescription | 3 Jun 2013 |
| HYDROXYZINE HYDROCHLORIDE | 10MG/5ML | syrup · oral | LANNETT CO INC | Prescription | 21 Aug 2013 |
| HYDROXYZINE HYDROCHLORIDE | 10MG; 25MG; 50MG | tablet · oral | HERITAGE | Prescription | 20 Aug 2014 |
| HYDROXYZINE HYDROCHLORIDE | 25MG; 10MG; 50MG | tablet · oral | NUVO PHARMS INC | Prescription | 29 Mar 2017 |
123 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| ATARAX | 00024694 | 10 MG / 5 ML | SYRUP · ORAL | SEARCHLIGHT PHARMA INC |
| HYDROXYZINE | 00646016 | 50 MG | CAPSULE · ORAL | AA PHARMA INC |
| HYDROXYZINE | 00646024 | 25 MG | CAPSULE · ORAL | AA PHARMA INC |
| HYDROXYZINE | 00646059 | 10 MG | CAPSULE · ORAL | AA PHARMA INC |
| HYDROXYZINE HYDROCHLORIDE INJECTION USP | 00742813 | 50 MG / ML | LIQUID · INTRAMUSCULAR | SANDOZ CANADA INCORPORATED |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | HYDROXYZINE 10 MG/5 ML SOLN | $0.11321 | per ML | 23 Sep 2026 |
| US NADAC | HYDROXYZINE 10 MG/5 ML SYRUP | $0.11321 | per ML | 23 Sep 2026 |
| US NADAC | HYDROXYZINE HCL 10 MG TABLET | $0.02867 | per EA | 23 Sep 2026 |
| US NADAC | HYDROXYZINE HCL 25 MG TABLET | $0.03255 | per EA | 23 Sep 2026 |
| US NADAC | HYDROXYZINE HCL 50 MG TABLET | $0.05575 | per EA | 23 Sep 2026 |
| US NADAC | HYDROXYZINE PAM 100 MG CAP | $0.42607 | per EA | 23 Sep 2026 |
| US NADAC | HYDROXYZINE PAM 25 MG CAP | $0.06361 | per EA | 23 Sep 2026 |
| US NADAC | HYDROXYZINE PAM 50 MG CAP | $0.08196 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Hydroxyzine 10mg tablets | £3.31 | 84 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Hydroxyzine 25mg tablets | £1.07 | 28 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 8 Nov 2016 VISTARIL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions - US FDA 8 Nov 2016 VISTARIL — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions - MHRA 29 Apr 2015 Hydroxyzine (Atarax, Ucerax): risk of QT interval prolongation and Torsade de Pointes
The maximum adult daily dose of hydroxyzine is now 100 mg. Do not prescribe hydroxyzine to people with a prolonged QT interval or risk factors for QT interval prolongation.
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.