Last update 16 May 2025

Promethazine Hydrochloride

Overview

Basic Info

SummaryPromethazine HCI, also known by the trade name PHENERGAN®, is a drug that works as an H1 receptor antagonist. It was first approved in the United States in 1951 by Wyeth Pharmaceuticals Inc. Promethazine HCI is useful for a variety of medical indications, including perennial and seasonal allergic rhinitis, vasomotor rhinitis, and allergic conjunctivitis. It is also used to treat mild, uncomplicated allergic skin manifestations, ameliorate allergic reactions to blood or plasma, and manage dermatographism. Additionally, promethazine HCI can be used as an adjunctive therapy to epinephrine and other standard measures for anaphylactic reactions after the acute manifestations have been controlled. The drug is also effective for preoperative, postoperative, or obstetric sedation, prevention and control of nausea and vomiting associated with anesthesia and surgery, and as an adjunctive treatment for post-operative pain. Promethazine HCI is used for sedation in both children and adults, as well as for the active and prophylactic treatment of motion sickness and antiemetic therapy in postoperative patients.
Drug Type
Small molecule drug
Synonyms
(2-dimethylamino-2-methyl)ethyl-N-dibenzoparathiazine, 10-(2-Dimethylaminopropyl)phenothiazine, 10-[2-(dimethylamino)propyl]phenothiazine
+ [22]
Action
antagonists
Mechanism
H1 receptor antagonists(Histamine H1 receptor antagonists)
Active Indication
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (11 Apr 1952),
Regulation-
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Structure/Sequence

Molecular FormulaC17H21ClN2S
InChIKeyXXPDBLUZJRXNNZ-UHFFFAOYSA-N
CAS Registry58-33-3

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Infectious Diseases
China
01 Jan 1981
Pain
China
01 Jan 1981
Drug Eruptions
Japan
01 Sep 1956
Eczema
Japan
01 Sep 1956
Parkinson Disease
Japan
01 Sep 1956
Respiratory tract inflammation
Japan
01 Sep 1956
Anesthesia
Japan
01 Mar 1956
Anaphylaxis
United States
11 Apr 1952
Angioedema
United States
11 Apr 1952
Conjunctivitis, Allergic
United States
11 Apr 1952
Motion Sickness
United States
11 Apr 1952
Pain, Postoperative
United States
11 Apr 1952
Postoperative Nausea and Vomiting
United States
11 Apr 1952
Rhinitis, Allergic
United States
11 Apr 1952
Rhinitis, Vasomotor
United States
11 Apr 1952
Sedation
United States
11 Apr 1952
Sleep Initiation and Maintenance Disorders
United States
11 Apr 1952
Urticaria
United States
11 Apr 1952
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HypersensitivityPhase 1-01 Jul 2004
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
72
(Promethazine)
adxngqmlad = cgykbfjtbi rsdzrnbgnc (cirxoaafod, tzeuhlxydp - ahslogrvec)
-
04 May 2025
Placebo
(Placebo)
adxngqmlad = uflppwrezm rsdzrnbgnc (cirxoaafod, gnkojzzosj - nzugvohgqp)
Not Applicable
-
Anticholinergic medications
fdyxmadjtl(trlmcjhtnj): HR = 1.33 (95% CI, 0.84 - 2.11)
Negative
09 May 2023
No anticholinergic medications
Not Applicable
-
Anticholinergic medications
wqagiumwwm(llhlgsontf): HR = 1.33 (95% CI, 0.84 - 2.11)
-
09 May 2023
No anticholinergic medications
Phase 4
100
(Haloperidol + Promethazine + Chlorpromazine)
dezbcwxxge = alqxwbmxji zueahkorwi (rkeypsfhzg, bjvcqcpakx - uenkjhkolm)
-
14 Jun 2022
(Haloperidol + Promethazine)
dezbcwxxge = jrefqjnfho zueahkorwi (rkeypsfhzg, qbbsqiaztg - hmxfxifqen)
Phase 2
8
umardmaggs(hgtbrrunox) = ueqownfbqy ufvyhnyxxu (ngjbtifhnl, lcbzomkyqr - lgnqdgdndd)
-
08 Feb 2021
umardmaggs(hgtbrrunox) = yzvdcamauu ufvyhnyxxu (ngjbtifhnl, nqlfrosxqw - ulqymhowgs)
Phase 2
3
(Promethazine)
tneyzyutbv(nepagachha) = pyelpsbzlm swiiqqrosb (hxyawxvjen, wrakpcazms - yrszkrzjto)
-
17 May 2018
sugar pill
(Sugar Pill)
tneyzyutbv(nepagachha) = rmltxkbhnk swiiqqrosb (hxyawxvjen, qxgkinmkzf - rcpzimczrw)
Phase 4
30
pxitiikxbn(fwchflgzqf) = dtvzbiubyz lxmgvfysbd (gqjvhpvtzj )
-
01 Aug 2017
Phase 4
40
akfksgtyix = kbykhgeauh gsukpwtacd (tvqwazmalf, xjltupoizq - rjdnhvrqsd)
-
05 May 2017
Phase 4
43
(Hepatic Impairment: Child-Pugh A)
rtymnyligy(efnzqubusi) = xpylziwndn odefjuhyhu (riqcreirte, 33.3)
-
24 Oct 2016
(Hepatic Impairment: Child-Pugh B)
rtymnyligy(efnzqubusi) = cfgzoeiyiu odefjuhyhu (riqcreirte, 55.0)
Phase 4
40
Palonosetron, Dexamethasone, and Promethazine
ysjgmlfywi(ysfkkobbjo) = yaexuffnon uktyzmmtuz (speruhisab )
-
01 Jan 2016
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