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
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Codeine phosphate
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Phenylephrine hydrochloride
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENERGAN VC W/ CODEINE | ANI Pharmaceuticals | N-008306 DISCN | 1984-04-02 | 1 products, RLD |
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Codeine phosphate
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENERGAN W/ CODEINE | ANI Pharmaceuticals | N-008306 DISCN | 1984-04-02 | 1 products, RLD |
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Dextromethorphan hydrobromide
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | ANI Pharmaceuticals | N-011265 DISCN | 1984-04-02 | 1 products, RLD |
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Meperidine hydrochloride
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MEPERGAN | Hikma Pharmaceuticals | N-011730 DISCN | 1982-01-01 | 1 products |
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Phenylephrine hydrochloride
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENERGAN VC | ANI Pharmaceuticals | N-008604 DISCN | 1984-04-02 | 1 products, RLD |
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Promethazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE PLAIN | ANI Pharmaceuticals | N-008381 DISCN | 1982-01-01 | 2 products, RLD |
| PHENERGAN | Delcor Asset | N-007935 DISCN | 1982-01-01 | 3 products, RLD |
| PHENERGAN | Mylan | N-010926 DISCN | 1982-01-01 | 2 products, RLD |
| PHENERGAN | Mylan | N-011689 DISCN | 1982-01-01 | 1 products, RLD |
| PHENERGAN | Wyeth | N-008857 DISCN | 1982-01-01 | 2 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| dextromethorphan hydrobromide and promethazine hydrochloride | ANDA | 2024-06-05 |
| phenadoz | ANDA | 2021-03-01 |
| phenergan | ANDA | 2024-08-09 |
| prometh with codeine | ANDA | 2012-01-24 |
| promethazine | ANDA | 2022-10-08 |
| promethazine and codeine | ANDA | 2009-08-21 |
| promethazine dm | ANDA | 2020-12-16 |
| promethazine hci | ANDA | 2024-02-22 |
| promethazine hcl | ANDA | 2019-11-26 |
| promethazine hcl promethazine hydrochloride | 2006-11-27 |
Show 18 more
Indications
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Agency Specific
FDA
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Patent Expiration
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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
431 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nausea | D009325 | HP_0002018 | R11.0 | — | 2 | 5 | 6 | 7 | 20 |
| Headache | D006261 | HP_0002315 | R51 | 2 | 4 | 4 | 7 | 4 | 19 |
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 2 | 5 | 4 | 6 | 17 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | 1 | 3 | 4 | 5 | 4 | 16 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 2 | 3 | 2 | 4 | 12 |
| Pruritus | D011537 | HP_0000989 | L29 | 2 | 4 | 1 | 2 | 3 | 10 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | 5 | — | 1 | 1 | 8 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | 5 | — | 1 | 1 | 8 |
| Depression | D003863 | — | F33.9 | 1 | 1 | 1 | 1 | 4 | 8 |
| Kidney transplantation | D016030 | — | — | 2 | 6 | — | 1 | — | 7 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 8 | 15 | 1 | — | 1 | 24 |
| Multiple myeloma | D009101 | — | C90.0 | 5 | 10 | 3 | — | 1 | 19 |
| Neoplasms | D009369 | — | C80 | 5 | 13 | 1 | — | — | 19 |
| Plasma cell neoplasms | D054219 | — | — | 4 | 9 | 3 | — | 1 | 17 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 2 | 5 | — | 4 | 14 |
| Healthy volunteers/patients | — | — | — | 10 | — | 1 | — | 3 | 14 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 9 | 1 | — | 1 | 14 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 3 | 6 | 5 | — | — | 12 |
| Syndrome | D013577 | — | — | 1 | 6 | 2 | — | 3 | 11 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 6 | 2 | — | 2 | 11 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 10 | 12 | — | — | 2 | 23 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 5 | 6 | — | — | 1 | 11 |
| Lymphoid leukemia | D007945 | — | C91 | 4 | 6 | — | — | 1 | 11 |
| Hematologic neoplasms | D019337 | — | — | 1 | 6 | — | — | 1 | 8 |
| Hepatitis b | D006509 | — | — | 1 | 5 | — | — | 2 | 8 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | 5 | — | — | 1 | 7 |
| B-cell lymphoma | D016393 | — | — | 4 | 3 | — | — | — | 7 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | 4 | — | — | — | 7 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 6 | — | — | — | 6 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 3 | 3 | — | — | — | 5 |
Show 127 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | — | 3 | — | — | — | 1 | 4 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 3 |
| Fever | D005334 | HP_0001945 | R50.9 | 2 | — | — | — | — | 2 |
| Alcohol-related disorders | D019973 | — | F10 | 1 | — | — | — | 1 | 2 |
| Hypotension | D007022 | EFO_0005251 | I95 | 1 | — | — | — | — | 1 |
| Pure autonomic failure | D054970 | — | — | 1 | — | — | — | — | 1 |
| Orthostatic hypotension | D007024 | — | I95.1 | 1 | — | — | — | — | 1 |
| Systemic mastocytosis | D034721 | — | C96.21 | 1 | — | — | — | — | 1 |
| Oral lichen planus | D017676 | — | — | 1 | — | — | — | — | 1 |
| Lichen planus | D008010 | — | L43 | 1 | — | — | — | — | 1 |
Show 33 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep wake disorders | D012893 | — | G47 | — | — | — | — | 5 | 5 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 3 | 3 |
| Dyssomnias | D020920 | — | — | — | — | — | — | 3 | 3 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | — | 3 | 3 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 2 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 2 | 2 |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 2 | 2 |
| Rotator cuff injuries | D000070636 | — | M75.1 | — | — | — | — | 2 | 2 |
Show 44 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Promethazine |
| INN | promethazine |
| 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) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(CN1c2ccccc2Sc2ccccc21)N(C)C |
Identifiers
| PDB | — |
| CAS-ID | 60-87-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL643 |
| ChEBI ID | 8461 |
| PubChem CID | 4927 |
| DrugBank | DB01069 |
| UNII ID | FF28EJQ494 (ChemIDplus, GSRS) |
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Estimated US medical usage
Promethazine
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Phenylephrine
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Codeine
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Promethazine
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Codeine
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Promethazine
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Dextromethorphan
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Promethazine
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Meperidine
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Promethazine
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Phenylephrine
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Promethazine
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PubMed Central
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Additional graphs summarizing 7,088 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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