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Drug ReportsPhenylephrine
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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Drug
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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
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
eye diseasesD005128
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
operative surgical proceduresD013514
Trade Name
FDA
EMA
Biorphen, Immphentiv, Phenylephrine, Vazculep (discontinued: Biorphen, Phenylephrine)
Combinations
Advil, Cyclomydril, 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)
Chlorpheniramine maleate
+
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL ALLERGY AND CONGESTION RELIEFGSKN-022113 OTC2011-12-21
1 products, RLD, RS
ADVIL MULTI-SYMPTOM COLD & FLUGSKN-022113 OTC2017-04-28
1 products, RLD, RS
Ibuprofen
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
ADVIL CONGESTION RELIEFGSKN-022565 OTC2010-05-27
1 products, RLD, RS
Isoproterenol hydrochloride
+
Phenylephrine bitartrate
Tradename
Company
Number
Date
Products
DUO-MEDIHALER3MN-013296 DISCN1982-01-01
1 products
Hide discontinued
Phenylephrine hydrochloride
+
Pyrilamine maleate
Tradename
Company
Number
Date
Products
PREFRIN-AAllerganN-007953 DISCN1982-01-01
1 products
Hide discontinued
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
PHENYLEPHRINE HYDROCHLORIDEAlcon ResearchN-207926 RX2015-01-15
2 products, RLD
BIORPHENDr Reddys LaboratoriesN-212909 RX2019-10-21
1 products, RLD, RS
VAZCULEPExela Pharma SciencesN-204300 RX2014-06-27
3 products, RLD, RS
PHENYLEPHRINE HYDROCHLORIDEHikma PharmaceuticalsN-203826 RX2012-12-20
3 products, RLD, RS
IMMPHENTIVHikma PharmaceuticalsN-203826 RX2023-03-09
2 products, RLD, RS
PHENYLEPHRINE HYDROCHLORIDEParagon BioTeckN-203510 RX2013-03-21
2 products, RLD, RS
Show 1 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
Ketorolac tromethamine
+
Phenylephrine hydrochloride
Tradename
Company
Number
Date
Products
OMIDRIARayner SurgicalN-205388 RX2014-05-30
1 products, RLD, RS
Phenylephrine hydrochloride
+
Tropicamide
Tradename
Company
Number
Date
Products
MYDCOMBIEyenoviaN-215352 DISCN2023-05-05
1 products, RLD
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
biorphenNew Drug Application2024-04-25
cyclomydrilANDA2023-12-14
dextromethorphan hydrobromide and promethazine hydrochlorideANDA2024-06-05
immphentiv phenylephrine hydrochlorideNew Drug Application2024-04-09
mydcombiNew Drug Application2023-05-09
omidriaNew Drug Application2023-07-07
phenadozANDA2021-03-01
phenerganANDA2024-08-09
phenylephrine hydrochlorideNew Drug Application2020-03-10
prometh with codeineANDA2012-01-24
Show 25 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
septic shock—D012772A48.3
hypotensionEFO_0005251D007022I95
juvenile arthritisEFO_1002007D001171M08
menorrhagiaEFO_0003945D008595N92.0
pruritus ani—D011538L29.0
ankylosing spondylitisEFO_0003898D013167M45
rheumatoid arthritisEFO_0000685D001172M06.9
fever—D005334R50.9
inflammationMP_0001845D007249—
osteoarthritisEFO_0002506D010003M15-M19
Show 33 more
Agency Specific
FDA
EMA
Expiration
Code
PHENYLEPHRINE HYDROCHLORIDE / TROPICAMIDE, MYDCOMBI, EYENOVIA
2026-05-05NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Phenylephrine Hydrochloride, Immphentiv, Hikma
112134802036-09-26DP
114714002036-08-05DP
Phenylephrine Hydrochloride, Phenylephrine Hydrochloride, Paragon Bioteck
88596232033-11-14U-1594
Ketorolac Tromethamine / Phenylephrine Hydrochloride, Omidria, Rayner Surgical
90668562033-10-23DP
94864062033-10-23DP
98552462033-10-23DP
Phenylephrine Hydrochloride / Tropicamide, Mydcombi, Eyenovia
108399602031-07-15U-3685
113983062031-07-15U-3685
118394872031-07-15U-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
HCPCS
Code
Description
J1097
Phenylephrine 10.16 mg/ml and ketorolac 2.88 mg/ml ophthalmic irrigation solution, 1 ml
J2370
Injection, phenylephrine hcl, up to 1 ml
Clinical
Clinical Trials
736 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
RosaceaD012393—L71——3——3
ErythemaD004890—L53.9——2——2
PresbyopiaD011305—H52.4——1——1
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common namePhenylephrine
INNphenylephrine
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CNC[C@H](O)c1cccc(O)c1
Identifiers
PDB—
CAS-ID59-42-7
RxCUI—
ChEMBL IDCHEMBL1215
ChEBI ID8093
PubChem CID6041
DrugBankDB00388
UNII ID1WS297W6MV (ChemIDplus, GSRS)
Target
Agency Approved
ADRA1B
ADRA1B
ADRA1A
ADRA1A
Organism
Homo sapiens
Gene name
ADRA1B
Gene synonyms
NCBI Gene ID
147
Protein name
alpha-1B adrenergic receptor
Protein synonyms
adrenergic, alpha-1B-, receptor, Alpha-1B adrenoceptor, Alpha-1B adrenoreceptor
Uniprot ID
P35368
Mouse ortholog
Adra1b (11548)
alpha-1B adrenergic receptor (P97717)
Alternate
ADRA1D
ADRA1D
Organism
Homo sapiens
Gene name
ADRA1D
Gene synonyms
ADRA1A
NCBI Gene ID
146
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
Q9NPY0
Mouse ortholog
Adra1d (11550)
alpha-1D adrenergic receptor (Q61619)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Vazculep – Avadel Pharmaceuticals
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Estimated US medical usage
Phenylephrine
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Acetaminophen
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Chlorpheniramine
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Phenylephrine
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Acetaminophen
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Diphenhydramine
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Phenylephrine
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Carbetapentane
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Brompheniramine
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Phenylephrine
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Codeine
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Brompheniramine
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Phenylephrine
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Brompheniramine
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Dihydrocodeine
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Diphenhydramine
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Brompheniramine
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Phenylephrine
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Hydrocodone
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Brompheniramine
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Phenylephrine
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Brompheniramine
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Phenylephrine
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Carbetapentane
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Chlorpheniramine
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Phenylephrine
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Carbetapentane
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Diphenhydramine
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Phenylephrine
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Carbetapentane
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Guaifenesin
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Phenylephrine
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Carbetapentane
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Phenylephrine
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Carbetapentane
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Pyrilamine
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Phenylephrine
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Dextromethorphan
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Carbinoxamine
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Phenylephrine
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Hydrocodone
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Carbinoxamine
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Carbinoxamine
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Phenylephrine
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Codeine
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Chlorpheniramine
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Phenylephrine
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Chlorpheniramine
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Dihydrocodeine
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Phenylephrine
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Guaifenesin
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Chlorpheniramine
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Phenylephrine
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Hydrocodone
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Chlorpheniramine
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Chlorpheniramine
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Phenylephrine
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Chlorpheniramine
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Pyrilamine
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Phenylephrine
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Diphenhydramine
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Codeine
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Phenylephrine
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Codeine
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Promethazine
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Phenylephrine
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Codeine
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Triprolidine
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Phenylephrine
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Cyclopentolate
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Phenylephrine
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Hydrocodone
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Dexbrompheniramine
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Phenylephrine
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Dexbrompheniramine
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Phenylephrine
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Hydrocodone
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Dexchlorpheniramine
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Phenylephrine
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Dexchlorpheniramine
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Phenylephrine
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Dextromethorphan
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Guaifenesin
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Phenylephrine
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Dextromethorphan
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Phenylephrine
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Dextromethorphan
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Pyrilamine
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Phenylephrine
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Dextromethorphan
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Triprolidine
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Phenylephrine
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Diphenhydramine
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Guaifenesin
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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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Additional graphs summarizing 33,866 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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62,342 adverse events reported
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