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 (discontinued: Biorphen, Phenylephrine, Vazculep)
CombinationsCyclomydril, Ibuprofen phenylephrine, Ketorolac tromethamine phenylephrine, Omidria, Phenylephrine promethazine, Prometh hydrochloride,phenylephrine w/codeine, Promethazine hydrochloride,phenylephrine w/codeine, Promethazine phenylephrine (discontinued: Duo-medihaler, Mydcombi, 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)
Isoproterenol hydrochloride
+
Phenylephrine bitartrate
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 |
| PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE | Dr Reddys Laboratories | N-216830 RX | 2025-05-30 | 1 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 2 discontinued
Phenylephrine hydrochloride
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Pyrilamine maleate
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 |
Phenylephrine hydrochloride
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Tropicamide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MYDCOMBI | Hyperion DeFi | N-215352 DISCN | 2023-05-05 | 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
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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| biorphen | New Drug Application | 2024-04-25 |
| cyclomydril | ANDA | 2025-05-15 |
| dextromethorphan hydrobromide and promethazine hydrochloride | ANDA | 2024-06-05 |
| immphentiv phenylephrine hydrochloride | New Drug Application | 2024-04-09 |
| mydcombi | New Drug Application | 2023-05-09 |
| omidria | New Drug Application | 2023-07-07 |
| phenadoz | ANDA | 2021-03-01 |
| phenergan | ANDA | 2024-08-09 |
| phenylephrine hydrochloride | New Drug Application | 2020-03-10 |
| prometh with codeine | ANDA | 2012-01-24 |
Show 21 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
735 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 | — | — | — | 133 | 1 | — | 2 | 10 | 145 |
| Hypotension | D007022 | EFO_0005251 | I95 | 5 | 8 | 7 | 25 | 38 | 79 |
| Asthma | D001249 | EFO_0000270 | J45 | 16 | 8 | 2 | 1 | 1 | 28 |
| Mydriasis | D015878 | — | H57.04 | 2 | 2 | 5 | 9 | 6 | 23 |
| Anesthesia | D000758 | — | — | 1 | 4 | 4 | 7 | 7 | 23 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 9 | 6 | 4 | 1 | 1 | 21 |
| Spinal anesthesia | D000775 | — | — | — | 2 | 1 | 8 | 6 | 17 |
| Rhinitis | D012220 | EFO_0008521 | J31 | 1 | 5 | 6 | 2 | 3 | 17 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 2 | 1 | 4 | 5 | 6 | 17 |
| Cesarean section | D002585 | — | — | — | — | — | 5 | 9 | 14 |
Show 91 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | 1 | — | 7 | 8 |
| Nasal obstruction | D015508 | — | — | 2 | 2 | 2 | — | 1 | 7 |
| Obstructive lung diseases | D008173 | — | — | 1 | — | 3 | — | 1 | 5 |
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | — | 1 | — | 2 | 5 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | 1 | — | 4 | 5 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 2 | 1 | — | 2 | 4 |
| Cold temperature | D003080 | — | — | — | — | 3 | — | — | 3 |
| Infections | D007239 | EFO_0000544 | — | — | — | 3 | — | — | 3 |
| Intraocular lens implantation | D019654 | — | — | — | — | 3 | — | — | 3 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | — | 2 | — | 1 | 3 |
Show 25 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Parkinson disease | D010300 | EFO_0002508 | G20 | 6 | 2 | — | — | 1 | 9 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 1 | — | — | 2 | 5 |
| Fasting | D005215 | EFO_0002756 | — | 2 | 1 | — | — | — | 3 |
| Dental caries | D003731 | EFO_0003819 | K02 | — | 3 | — | — | — | 3 |
| Periapical periodontitis | D010485 | EFO_1001391 | K04.5 | — | 3 | — | — | — | 3 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | — | — | 1 | 2 |
| Traumatic stress disorders | D040921 | — | — | — | 1 | — | — | 1 | 2 |
| Microcirculation | D008833 | — | — | — | 1 | — | — | 1 | 2 |
| Hypertriglyceridemia | D015228 | EFO_0004211 | — | 1 | 1 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | 1 | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 3 | — | — | — | 8 | 11 |
| Therapeutic equivalency | D013810 | — | — | 9 | — | — | — | — | 9 |
| Pharmacokinetics | D010599 | — | — | 8 | — | — | — | — | 8 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | 4 | — | — | — | 2 | 6 |
| Biological availability | D001682 | — | — | 5 | — | — | — | — | 5 |
| Hypoxia | D000860 | — | R09.02 | 1 | — | — | — | 4 | 5 |
| Orthostatic hypotension | D007024 | — | I95.1 | 2 | — | — | — | 2 | 4 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | 1 | — | — | — | 3 | 4 |
| Essential hypertension | D000075222 | — | I10 | 3 | — | — | — | — | 3 |
| Surgical blood loss | D016063 | — | — | 1 | — | — | — | 2 | 3 |
Show 69 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carotid endarterectomy | D016894 | — | — | — | — | — | — | 4 | 4 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 3 | 3 |
| Autonomic dysreflexia | D020211 | EFO_1001762 | G90.4 | — | — | — | — | 3 | 3 |
| Brain injuries | D001930 | — | S06.9 | — | — | — | — | 2 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 2 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | — | — | 2 | 2 |
| Blood circulation | D001775 | — | — | — | — | — | — | 2 | 2 |
| Nausea | D009325 | — | R11.0 | — | — | — | — | 2 | 2 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 2 | 2 |
| Femoral fractures | D005264 | — | S72 | — | — | — | — | 2 | 2 |
Show 127 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 | α1-adrenergic receptor agonist; vasopressor |
| 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
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Vazculep – Avadel Pharmaceuticals
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Promethazine
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Cyclopentolate
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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 with codeine, Promethazine with codeine cough, Promethazine/codeine, Promethegan
Adverse Events
Top Adverse Reactions
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11,392 adverse events reported
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