FDA.reportPublic FDA data

Hydroxyzine Pamoate

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
Hydroxyzine Pamoate
Generic name
HYDROXYZINE PAMOATE
Manufacturer
Asclemed USA, Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
82187031-779e-47bc-943c-eb1a1ef30a7a
SPL ID
2e63fa75-efcf-d9ee-e063-6394a90ab2d0
Version
1
Effective date
2025-02-17
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:19:15
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS Nursing Mothers It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Side effects reported with the administration of hydroxyzine pamoate are usually mild and transitory in nature. Skin and Appendages Oral hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) and fixed drug eruptions in postmarketing reports. Anticholinergic Dry mouth. Central Nervous System Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses. Cardiac System QT prolongation, Torsade de Pointes. In postmarketing experience, the following additional undesirable effects have been reported: Body as a Whole allergic reaction. Nervous System headache. Psychiatric hallucination. Skin and Appendages pruritus, rash, urticaria. To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.