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AboutPricing
Drug ReportsPromethazine
Promethazine
/ Promethazine, Codeine / Phenylephrine / Promethazine, Codeine / Promethazine, Mepergan, Phenylephrine / Promethazine, Promethazine, Promethegan (promethazine) is a small molecule pharmaceutical. Promethazine was first approved as Mepergan on 1982-01-01. It is used to treat allergic conjunctivitis, allergic rhinitis perennial, anaphylaxis, motion sickness, and nausea amongst others in the USA. The pharmaceutical is active against histamine H1 receptor.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Promethazine, Promethegan (discontinued: Phenergan, Prometh, Prometh fortis, Promethacon, Promethazine, Remsed, Zipan)
Combinations
Phenylephrine promethazine, Prometh hydrochloride,phenylephrine w/codeine, Promethazine, Promethazine codeine, Promethazine dextromethorphan, Promethazine hydrochloride,phenylephrine w/codeine, Promethazine phenylephrine, Promethazine w/ dextromethorphan, Promethazine with codeine (discontinued: Mepergan, Phenergan, Phenylephrine promethazine, Pherazine, Prometh, Promethazine, Promethazine codeine, Promethazine dextromethorphan, Promethazine hydrochloride, phenylephrine w/codeine)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE PLAINANI PharmaceuticalsN-008381 DISCN1982-01-01
2 products, RLD
PHENERGANDelcor AssetN-007935 DISCN1982-01-01
3 products, RLD
PHENERGANMylanN-010926 DISCN1982-01-01
2 products, RLD
PHENERGANMylanN-011689 DISCN1982-01-01
1 products, RLD
PHENERGANWyethN-008857 DISCN1982-01-01
2 products
Hide discontinued
Codeine phosphate
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Codeine phosphate
+
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VC W/ CODEINEANI PharmaceuticalsN-008306 DISCN1984-04-02
1 products, RLD
Hide discontinued
Phenylephrine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PHENERGAN VCANI PharmaceuticalsN-008604 DISCN1984-04-02
1 products, RLD
Hide discontinued
Dextromethorphan hydrobromide
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEANI PharmaceuticalsN-011265 RX1984-04-02
1 products, RLD
Meperidine hydrochloride
+
Promethazine hydrochloride
Tradename
Company
Number
Date
Products
MEPERGANHikma PharmaceuticalsN-011730 DISCN1982-01-01
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
dextromethorphan hydrobromide and promethazine hydrochlorideANDA2024-06-05
phenadozANDA2021-03-01
phenerganANDA2024-08-09
prometh with codeineANDA2012-01-24
promethazineANDA2022-10-08
promethazine and codeineANDA2009-08-21
promethazine dmANDA2020-12-16
promethazine hciANDA2024-02-22
promethazine hclANDA2019-11-26
promethazine hcl promethazine hydrochloride2006-11-27
Show 18 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
postoperative complications—D011183—
painEFO_0003843D010146R52
vomitingHP_0002013D014839R11.1
nauseaHP_0002018D009325R11.0
anaphylaxis—D000707T88.6
allergic conjunctivitisEFO_0007141D003233H10.44
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
motion sickness—D009041T75.3
coughHP_0012735D003371R05
Show 8 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA10: Promethazine
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AD: Phenothiazine derivatives, systemic antihistamines
— R06AD02: Promethazine
— R06AD52: Promethazine, combinations
V: Various drug classes in atc
— V03: All other therapeutic products
— V03A: All other therapeutic products
— V03AB: Antidotes
— V03AB05: Prednisolone and promethazine
HCPCS
Code
Description
J2180
Injection, meperidine and promethazine hcl, up to 50 mg
J2550
Injection, promethazine hcl, up to 50 mg
Q0169
Promethazine hydrochloride, 12.5 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at the time of chemotherapy treatment, not to exceed a 48 hour dosage regimen
Clinical
Clinical Trials
434 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NauseaD009325HP_0002018R11.0—256720
HeadacheD006261HP_0002315R512447419
VomitingD014839HP_0002013R11.1—254617
Migraine disordersD008881EFO_0003821G431345416
Sleep initiation and maintenance disordersD007319—F51.011232412
PruritusD011537HP_0000989L292412310
Chronic hepatitis bD019694EFO_0004239B18.115—118
HepatitisD006505HP_0012115K75.915—118
DepressionD003863—F33.9111148
Kidney transplantationD016030——26—1—7
Show 63 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.98151—124
Multiple myelomaD009101—C90.06113—120
NeoplasmsD009369—C805131——19
Plasma cell neoplasmsD054219——5103—118
PainD010146EFO_0003843R52325—414
Healthy volunteers/patients———10—1—314
Non-hodgkin lymphomaD008228—C85.9491—114
Lung neoplasmsD008175HP_0100526C34.90365——12
SyndromeD013577——162—311
Breast neoplasmsD001943EFO_0003869C50362—211
Show 68 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951112——224
Precursor cell lymphoblastic leukemia-lymphomaD054198——56——111
Lymphoid leukemiaD007945—C9146——111
Hematologic neoplasmsD019337——16——18
Hepatitis bD006509——15——28
Hepatitis aD006506EFO_0007305B1515——17
B-cell lymphomaD016393——43———7
Alzheimer diseaseD000544EFO_0000249F0334———7
Myeloid leukemia acuteD015470—C92.043———6
Myeloid leukemiaD007951—C9242———6
Show 127 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Covid-19D000086382——3———14
MalnutritionD044342EFO_0008572E40-E463————3
FeverD005334HP_0001945R50.92————2
Alcohol-related disordersD019973—F101———12
HypotensionD007022EFO_0005251I951————1
Pure autonomic failureD054970——1————1
Orthostatic hypotensionD007024—I95.11————1
Systemic mastocytosisD034721—C96.211————1
Oral lichen planusD017676——1————1
Lichen planusD008010—L431————1
Show 33 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Sleep wake disordersD012893—G47————55
Wounds and injuriesD014947—T14.8————33
DyssomniasD020920——————33
ParasomniasD020447—G47.5————33
DeliriumD003693—R41.0————22
InfectionsD007239EFO_0000544—————22
Communicable diseasesD003141——————22
Chronic painD059350HP_0012532—————22
Suicidal ideationD059020EFO_0004320R45.851————22
Rotator cuff injuriesD000070636—M75.1————22
Show 44 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePromethazine
INNpromethazine
Description
Promethazine is a tertiary amine that is a substituted phenothiazine in which the ring nitrogen at position 10 is attached to C-3 of an N,N-dimethylpropan-2-amine moiety. It has a role as a H1-receptor antagonist, a sedative, an antiemetic, a local anaesthetic, an antipruritic drug, an anti-allergic agent and an anticoronaviral agent. It is a member of phenothiazines and a tertiary amine. It is a conjugate base of a promethazine(1+).
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(CN1c2ccccc2Sc2ccccc21)N(C)C
Identifiers
PDB—
CAS-ID60-87-7
RxCUI—
ChEMBL IDCHEMBL643
ChEBI ID8461
PubChem CID4927
DrugBankDB01069
UNII IDFF28EJQ494 (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
No data
Estimated US medical usage
Promethazine
+
Phenylephrine
+
Codeine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Price per prescription (USD)
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Promethazine
+
Codeine
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Promethazine
+
Dextromethorphan
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Promethazine
+
Meperidine
Total medical expenditures per year (USD, in millions)
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Promethazine
+
Phenylephrine
Total medical expenditures per year (USD, in millions)
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Promethazine
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,141 documents
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Safety
Black-box Warning
Black-box warning for: Promethazine hci, Promethazine hcl, phenylephrine hcl, codeine phosphate, Promethazine hydrochloride and codeine phosphate, Promethazine hydrochloride and dextomethorphan hydrobromide, Promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate, Promethazine hydrochloride, phenylephrine hydrochloride, and codeine phosphate, Promethazine vc with codeine oral solution, Promethazine with codeine, Promethazine with codeine cough, Promethazine/codeine, Promethegan
Adverse Events
Top Adverse Reactions
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16,098 adverse events reported
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