Duo-medihaler, Omidria(phenylephrine)
/ Phenylephrine, / Phenylephrine / Promethazine, Advil, Biorphen, Cyclomydril, Duo-medihaler, Immphentiv, Mydcombi, Omidria, Phenergan, Phenylephrine, Phenylephrine / Promethazine, Prefrin-a, Vazculep (phenylephrine) is a small molecule pharmaceutical. Phenylephrine was first approved as Cyclomydril on 1982-01-01. It is used to treat fissure in ano, hemorrhoids, hypotension, open-angle glaucoma, and pruritus ani amongst others in the USA. It has been approved in Europe to treat intraocular lens implantation and postoperative pain. The pharmaceutical is active against alpha-1B adrenergic receptor and alpha-1A adrenergic receptor. In addition, it is known to target alpha-1D adrenergic receptor.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Biorphen, Immphentiv, Phenylephrine, Vazculep (discontinued: Biorphen, Phenylephrine)
CombinationsAdvil, Cyclomydril, Ibuprofen phenylephrine, Ketorolac tromethamine phenylephrine, Mydcombi, Omidria, Phenylephrine promethazine, Prometh hydrochloride,phenylephrine w/codeine, Promethazine hydrochloride,phenylephrine w/codeine, Promethazine phenylephrine (discontinued: Duo-medihaler, Phenergan, Phenylephrine promethazine, Pherazine, Prefrin-a, Prometh, Promethazine, 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)
Chlorpheniramine maleate
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Ibuprofen
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Phenylephrine hydrochloride
Ibuprofen
+
Phenylephrine hydrochloride
Isoproterenol hydrochloride
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Phenylephrine bitartrate
Phenylephrine hydrochloride
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Pyrilamine maleate
Phenylephrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | Alcon Research | N-207926 RX | 2015-01-15 | 2 products, RLD |
| BIORPHEN | Dr Reddys Laboratories | N-212909 RX | 2019-10-21 | 1 products, RLD, RS |
| VAZCULEP | Exela Pharma Sciences | N-204300 RX | 2014-06-27 | 3 products, RLD, RS |
| PHENYLEPHRINE HYDROCHLORIDE | Hikma Pharmaceuticals | N-203826 RX | 2012-12-20 | 3 products, RLD, RS |
| IMMPHENTIV | Hikma Pharmaceuticals | N-203826 RX | 2023-03-09 | 2 products, RLD, RS |
| PHENYLEPHRINE HYDROCHLORIDE | Paragon BioTeck | N-203510 RX | 2013-03-21 | 2 products, RLD, RS |
Show 1 discontinued
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 |
Hide discontinued
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 |
Hide discontinued
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 |
Hide discontinued
Ketorolac tromethamine
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Phenylephrine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OMIDRIA | Rayner Surgical | N-205388 RX | 2014-05-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| advil | New Drug Application | 2024-07-19 |
| advil allergy and congestion relief | New Drug Application | 2024-06-20 |
| advil allergy congestion relief | OTC monograph not final | 2022-03-23 |
| advil allergy sinus | New Drug Application | 2024-06-20 |
| advil cold and sinus | New Drug Application | 2024-06-21 |
| advil dual action with acetaminophen | New Drug Application | 2024-07-17 |
| advil liqui-gels | New Drug Application | 2024-03-27 |
| advil liquigels | New Drug Application | 2023-03-15 |
| advil menstrual pain | New Drug Application | 2024-01-31 |
| advil migraine | New Drug Application | 2024-06-24 |
Show 47 more
Indications
FDA
EMA
Show 33 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PHENYLEPHRINE HYDROCHLORIDE / TROPICAMIDE, MYDCOMBI, EYENOVIA | |||
| 2026-05-05 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Phenylephrine Hydrochloride, Immphentiv, Hikma | |||
| 11213480 | 2036-09-26 | DP | |
| 11471400 | 2036-08-05 | DP | |
| Phenylephrine Hydrochloride, Phenylephrine Hydrochloride, Paragon Bioteck | |||
| 8859623 | 2033-11-14 | U-1594 | |
| Ketorolac Tromethamine / Phenylephrine Hydrochloride, Omidria, Rayner Surgical | |||
| 9066856 | 2033-10-23 | DP | |
| 9486406 | 2033-10-23 | DP | |
| 9855246 | 2033-10-23 | DP | |
| Phenylephrine Hydrochloride / Tropicamide, Mydcombi, Eyenovia | |||
| 10839960 | 2031-07-15 | U-3685 | |
| 11398306 | 2031-07-15 | U-3685 | |
| 11839487 | 2031-07-15 | U-3685 | |
ATC Codes
C: Cardiovascular system drugs
— C01: Cardiac therapy drugs
— C01C: Cardiac stimulants excl. cardiac glycosides
— C01CA: Adrenergic and dopaminergic cardiac stimulants
— C01CA06: Phenylephrine
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AA: Sympathomimetics, plain
— R01AA04: Phenylephrine
— R01AB: Sympathomimetics, combinations excl. corticosteroids
— R01AB01: Phenylephrine
— R01B: Nasal decongestants for systemic use
— R01BA: Sympathomimetics
— R01BA03: Phenylephrine
— R01BA53: Phenylephrine, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01F: Mydriatics and cycloplegics
— S01FB: Sympathomimetics excl. antiglaucoma preparations
— S01FB01: Phenylephrine
— S01FB51: Phenylephrine and ketorolac
— S01G: Decongestants and antiallergics
— S01GA: Sympathomimetics used as decongestants
— S01GA05: Phenylephrine
— S01GA55: Phenylephrine, combinations
Clinical
Clinical Trials
2109 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 175 | 1 | 1 | 5 | 14 | 195 |
| Postoperative pain | D010149 | — | G89.18 | 9 | 17 | 27 | 48 | 62 | 159 |
| Pain | D010146 | EFO_0003843 | R52 | 18 | 18 | 30 | 36 | 30 | 131 |
| Hypotension | D007022 | EFO_0005251 | I95 | 5 | 9 | 7 | 24 | 37 | 78 |
| Patent ductus arteriosus | D004374 | HP_0001643 | Q25.0 | 2 | 15 | 13 | 9 | 19 | 54 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 6 | 6 | 8 | 14 | 13 | 46 |
| Acute pain | D059787 | — | R52 | 6 | 7 | 9 | 14 | 12 | 45 |
| Headache | D006261 | HP_0002315 | R51 | 4 | 6 | 9 | 12 | 10 | 38 |
| Back pain | D001416 | HP_0003418 | M54 | 2 | 3 | 4 | 17 | 11 | 36 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 5 | 7 | 8 | 7 | 6 | 33 |
Show 309 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 17 | 3 | — | 2 | 27 |
| Lymphoma | D008223 | — | C85.9 | 8 | 15 | 1 | — | 1 | 24 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 6 | 6 | 3 | — | 8 | 21 |
| Multiple myeloma | D009101 | — | C90.0 | 6 | 11 | 3 | — | 1 | 20 |
| Plasma cell neoplasms | D054219 | — | — | 5 | 10 | 3 | — | 1 | 18 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 9 | 1 | — | 1 | 14 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 1 | 7 | 1 | — | 3 | 11 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 3 | 4 | — | — | 9 |
| Carcinoma | D002277 | — | C80.0 | 1 | 6 | 1 | — | — | 8 |
| Colorectal neoplasms | D015179 | — | — | 1 | 4 | 1 | — | 2 | 7 |
Show 125 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 11 | 12 | — | — | 2 | 24 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 5 | 6 | — | — | 1 | 11 |
| Lymphoid leukemia | D007945 | — | C91 | 4 | 6 | — | — | 1 | 11 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 6 | 2 | — | — | 2 | 10 |
| Hematologic neoplasms | D019337 | — | — | 1 | 6 | — | — | 2 | 9 |
| Hepatitis b | D006509 | — | — | 2 | 5 | — | — | 2 | 9 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 2 | 5 | — | — | 1 | 8 |
| Hypoxia | D000860 | HP_0012418 | R09.02 | 2 | 1 | — | — | 5 | 8 |
| B-cell lymphoma | D016393 | — | — | 4 | 3 | — | — | — | 7 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 4 | 3 | — | — | — | 6 |
Show 210 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | — | — | 14 | — | — | — | — | 14 |
| Pharmacokinetics | D010599 | — | — | 9 | — | — | — | 1 | 10 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | 3 | — | — | — | 7 | 10 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 6 | — | — | — | 1 | 7 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 4 | — | — | — | 3 | 7 |
| Biological availability | D001682 | — | — | 5 | — | — | — | — | 5 |
| Essential hypertension | D000075222 | — | I10 | 4 | — | — | — | — | 4 |
| Orthostatic hypotension | D007024 | — | I95.1 | 2 | — | — | — | 2 | 4 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | — | — | — | 3 | 4 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | 1 | — | — | — | 3 | 4 |
Show 74 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 |
| Shoulder impingement syndrome | D019534 | EFO_1001178 | M75.4 | — | — | — | — | 4 | 4 |
| Carotid endarterectomy | D016894 | — | — | — | — | — | — | 4 | 4 |
| Dyssomnias | D020920 | — | — | — | — | — | — | 3 | 3 |
| Parasomnias | D020447 | — | G47.5 | — | — | — | — | 3 | 3 |
| Coronavirus infections | D018352 | EFO_0007224 | B34.2 | — | — | — | — | 3 | 3 |
| Trismus | D014313 | — | — | — | — | — | — | 3 | 3 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
| Spondylarthritis | D025241 | — | — | — | — | — | — | 2 | 2 |
| Spondylitis | D013166 | — | M46.9 | — | — | — | — | 2 | 2 |
Show 224 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Phenylephrine |
| INN | phenylephrine |
| Description | Phenylephrine is a member of the class of the class of phenylethanolamines that is (1R)-2-(methylamino)-1-phenylethan-1-ol carrying an additional hydroxy substituent at position 3 on the phenyl ring. It has a role as an alpha-adrenergic agonist, a cardiotonic drug, a mydriatic agent, a protective agent, a vasoconstrictor agent, a sympathomimetic agent and a nasal decongestant. It is a member of phenylethanolamines, a secondary amino compound and a member of phenols. It is a conjugate base of a phenylephrine(1+). |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CNC[C@H](O)c1cccc(O)c1 |
Identifiers
| PDB | — |
| CAS-ID | 59-42-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1215 |
| ChEBI ID | 8093 |
| PubChem CID | 6041 |
| DrugBank | DB00388 |
| UNII ID | 1WS297W6MV (ChemIDplus, GSRS) |
Target
Agency Approved
ADRA1B
ADRA1B
ADRA1A
ADRA1A
Alternate
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRA1D
Gene synonyms
ADRA1A
NCBI Gene ID
Protein name
alpha-1D adrenergic receptor
Protein synonyms
adrenergic, alpha -1D-, receptor, adrenergic, alpha-1A-, receptor, Alpha-1A adrenergic receptor, Alpha-1D adrenoceptor, Alpha-1D adrenoreceptor, Alpha-adrenergic receptor 1a
Uniprot ID
Mouse ortholog
Adra1d (11550)
alpha-1D adrenergic receptor (Q61619)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Vazculep – Avadel Pharmaceuticals
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Chlorpheniramine
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Codeine
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Promethazine
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Codeine
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Triprolidine
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Cyclopentolate
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Hydrocodone
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Dexbrompheniramine
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Dexchlorpheniramine
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Dexchlorpheniramine
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Guaifenesin
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Dextromethorphan
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Pyrilamine
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Triprolidine
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Hydrocodone
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Diphenhydramine
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Doxylamine
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Hydrocodone
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Pyrilamine
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Promethazine
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Trends
PubMed Central
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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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59,232 adverse events reported
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