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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 (discontinued: Mepergan, Phenergan, Phenylephrine promethazine, Pherazine, Prometh, Promethazine, Promethazine codeine, Promethazine dextromethorphan, Promethazine hydrochloride, phenylephrine w/codeine, Promethazine with 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
phenerganANDA2025-06-30
prometh with codeineANDA2012-01-24
promethazineANDA2022-10-08
promethazine and codeineANDA2009-08-21
promethazine dmANDA2025-05-31
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
vomiting—D014839R11.1
nausea—D009325R11.0
anaphylaxis—D000707T78.2
allergic conjunctivitisEFO_0007141D003233H10.44
allergic rhinitis perennialEFO_1001417D012221J30.89
urticariaEFO_0005531D014581L50
motion sickness—D009041T75.3
cough—D003371R05
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
1198 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HypertensionD006973EFO_0000537I1026289510763313
Healthy volunteers/patients———731121591
Essential hypertensionD000075222—I10442113749
Kidney diseasesD007674EFO_0003086N08371213336
Type 2 diabetes mellitusD003924EFO_0001360E1141812630
Covid-19D000086382—U07.151293227
Diabetic nephropathiesD003928EFO_0000401—23512727
ProteinuriaD011507—R801467724
NauseaD009325—R11.0—357823
Diabetes mellitusD003920EFO_0000400E08-E1323410321
Show 167 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223—C85.912151—127
NeoplasmsD009369—C809141—225
Multiple myelomaD009101—C90.08123—122
Plasma cell neoplasmsD054219——6103—119
Non-hodgkin lymphomaD008228—C85.97101—117
Breast neoplasmsD001943EFO_0003869C50582—215
HyperlipidemiasD006949EFO_0003774E78.5815——14
Non-small-cell lung carcinomaD002289——355—113
Lung neoplasmsD008175—C34.90472—111
InfectionsD007239EFO_0000544—342—210
Show 112 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938—C951211——223
Precursor cell lymphoblastic leukemia-lymphomaD054198—C91.086——114
Pancreatic neoplasmsD010190EFO_0003860C2545——110
B-cell lymphomaD016393——73———10
Hematologic neoplasmsD019337——26——19
Myelodysplastic syndromesD009190—D4637———8
B-cell chronic lymphocytic leukemiaD015451—C91.162———8
Hepatitis bD006509——15——28
FibrosisD005355——36———7
Myeloid leukemia acuteD015470—C92.053———7
Show 192 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug interactionsD004347——5———16
ArthritisD001168EFO_0005856M05-M143———25
MalnutritionD044342EFO_0008572E40-E463———14
Therapeutic equivalencyD013810——3————3
Pure autonomic failureD054970——3————3
Pre-eclampsiaD011225EFO_0000668O141———12
Peripheral arterial diseaseD058729EFO_0004265—1———12
Autonomic nervous system diseasesD001342EFO_0009532G902————2
B-cell lymphoma marginal zoneD018442—C88.42————2
Alcohol-related disordersD019973—F101———12
Show 51 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
ParasomniasD020447—G47.5————44
DyssomniasD020920——————33
Chronic painD059350——————33
Morbid obesityD009767EFO_0001074—————22
Inferior wall myocardial infarctionD056989EFO_1000983—————22
Suicidal ideationD059020EFO_0004320R45.851————22
Rotator cuff injuriesD000070636—M75.1————22
Skin diseasesD012871—L00-L99————22
Systolic heart failureD054143EFO_1001207I50.20————11
Drug-related side effects and adverse reactionsD064420—T88.7————11
Show 57 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
Total medical expenditures per year (USD, in millions)
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Promethazine
+
Dextromethorphan
Total medical expenditures per year (USD, in millions)
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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
Total medical expenditures per year (USD, in millions)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,614 documents
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Safety
Black-box Warning
Black-box warning for: Phenergan, 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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17,062 adverse events reported
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