Duo-medihaler, Omidria(phenylephrine)

Advil, Biorphen, Duo-medihaler, Immphentiv, Mydcombi, Omidria, Phenergan, Pherazine, Prefrin-a, Prometh, 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-1A adrenergic receptor and alpha-1B adrenergic receptor. In addition, it is known to target alpha-1D adrenergic receptor.

Download report

Favorite

Top OTC Drugs

Commercial

Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
digestive system diseases	D004066
respiratory tract diseases	D012140
otorhinolaryngologic diseases	D010038
eye diseases	D005128
cardiovascular diseases	D002318
skin and connective tissue diseases	D017437
signs and symptoms pathological conditions	D013568
operative surgical procedures	D013514

Trade Name

FDA

EMA

Biorphen, Immphentiv, Vazculep (generic drugs available since 1982-01-01)

Combinations

Advil, Mydcombi, Omidria (generic drugs available since 1982-01-01, discontinued: Duo-medihaler, Phenergan, Pherazine, Prefrin-a, Prometh)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Chlorpheniramine maleate

Ibuprofen

Phenylephrine hydrochloride

Tradename	Company	Number	Date	Products
ADVIL MULTI-SYMPTOM COLD & FLU	GSK	N-022113 OTC	2017-04-28	1 products, RLD, RS
ADVIL ALLERGY AND CONGESTION RELIEF	GSK	N-022113 OTC	2011-12-21	1 products, RLD, RS

Codeine phosphate

Phenylephrine hydrochloride

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PHENERGAN VC W/ CODEINE	ANI PHARMS	N-008306 DISCN	1984-04-02	1 products, RLD

Hide discontinued

Codeine phosphate

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PHENERGAN W/ CODEINE	ANI PHARMS	N-008306 DISCN	1984-04-02	1 products, RLD

Hide discontinued

Ibuprofen

Phenylephrine hydrochloride

Tradename	Company	Number	Date	Products
ADVIL CONGESTION RELIEF	GSK	N-022565 OTC	2010-05-27	1 products, RLD, RS

Isoproterenol hydrochloride

Phenylephrine bitartrate

Tradename	Company	Number	Date	Products
DUO-MEDIHALER	3M	N-013296 DISCN	1982-01-01	1 products

Hide discontinued

Ketorolac tromethamine

Phenylephrine hydrochloride

Tradename	Company	Number	Date	Products
OMIDRIA	Rayner Surgical	N-205388 RX	2014-05-30	1 products, RLD, RS

Phenylephrine hydrochloride

Tradename	Company	Number	Date	Products
PHENYLEPHRINE HYDROCHLORIDE	Akorn	N-207926 RX	2015-01-15	2 products, RLD, RS
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
IMMPHENTIV	Hikma Pharmaceuticals	N-203826 RX	2023-03-09	2 products, RLD, RS
PHENYLEPHRINE HYDROCHLORIDE	Hikma Pharmaceuticals	N-203826 RX	2012-12-20	3 products, RLD, RS
PHENYLEPHRINE HYDROCHLORIDE	Paragon BioTeck	N-203510 RX	2013-03-21	2 products, RLD, RS

Show 1 discontinued

Phenylephrine hydrochloride

Promethazine hydrochloride

Tradename	Company	Number	Date	Products
PHENERGAN VC	ANI PHARMS	N-008604 DISCN	1984-04-02	1 products, RLD

Hide discontinued

Phenylephrine hydrochloride

Pyrilamine maleate

Tradename	Company	Number	Date	Products
PREFRIN-A	Allergan	N-007953 DISCN	1982-01-01	1 products

Hide discontinued

Phenylephrine hydrochloride

Tropicamide

Tradename	Company	Number	Date	Products
MYDCOMBI	Eyenovia	N-215352 RX	2023-05-05	1 products, RLD, RS

Labels

FDA

EMA

Brand Name	Status	Last Update
advil dual action with acetaminophen	New Drug Application	2023-04-13
biorphen	New Drug Application	2022-09-30
cyclomydril	ANDA	2021-10-06
immphentiv phenylephrine hydrochloride	New Drug Application	2023-04-07
mydcombi	New Drug Application	2023-05-09
omidria	New Drug Application	2017-12-11
phenergan	ANDA	2022-12-01
promethazine hydrochloride	ANDA	2023-06-08
severe cold and flu relief	OTC monograph final	2023-06-19
vazculep	New Drug Application	2021-03-26

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
fissure in ano	HP_0012390	D005401	K60.2
hemorrhoids	EFO_0009552	D006484	K64
hypotension	EFO_0005251	D007022	I95
open-angle glaucoma	EFO_0004190	D005902	H40.1
pruritus ani	—	D011538	L29.0
septic shock	—	D012772	A48.3
supraventricular tachycardia	HP_0004755	D013617	I47.1
vasomotor rhinitis	EFO_0007533	D012223	J30.0

Agency Specific

FDA

EMA

Expiration	Code
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE, MANKIND PHARMA
2023-07-17	CGT
2023-04-05	CGT

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
8173707	2023-07-30		U-1518
8586633	2023-07-30	DP
9278101	2023-07-30		U-1518
9399040	2023-07-30	DP

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

1055 clinical trials

View more details

Mock data
Subscribe for the real data

Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pain	D010146	EFO_0003843	R52	13	13	27	28	16	96
Healthy volunteers/patients	—			47	—	1	4	8	60
Postoperative pain	D010149		G89.18	4	8	13	22	13	59
Patent ductus arteriosus	D004374	HP_0001643	Q25.0	2	9	10	9	12	39
Hypotension	D007022	EFO_0005251	I95	2	4	4	14	12	34
Fever	D005334	HP_0001945	R50.9	2	—	5	10	3	20
Low back pain	D017116	HP_0003419	M54.5	—	2	4	11	2	18
Acute pain	D059787		R52	3	3	5	7	1	18
Anesthesia	D000758			1	3	4	5	4	17
Osteoarthritis	D010003	EFO_0002506	M15-M19	3	3	6	2	1	15

Show 139 more

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	2	6	1	—	1	9
Breast neoplasms	D001943	EFO_0003869	C50	2	2	3	—	2	8
Respiratory tract infections	D012141		J06.9	1	—	5	—	—	6
Depression	D003863		F33.9	—	1	1	—	3	5
Lupus nephritis	D008181	EFO_0005761		—	2	2	—	—	4
Systemic lupus erythematosus	D008180	EFO_0002690	M32	—	2	3	—	—	4
Rhinitis	D012220	EFO_0008521	J31	1	1	2	—	—	4
Hiv infections	D015658	EFO_0000764	B20	—	—	1	—	2	3
Sleep initiation and maintenance disorders	D007319		F51.01	1	—	1	—	1	3
Vertigo	D014717		H81.39	—	—	2	—	1	3

Show 77 more

Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Multiple myeloma	D009101		C90.0	2	4	—	—	—	6
Precursor cell lymphoblastic leukemia-lymphoma	D054198		C91.0	3	2	—	—	—	4
Non-hodgkin lymphoma	D008228		C85.9	2	3	—	—	—	4
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	1	—	—	2	3
Atopic dermatitis	D003876	EFO_0000274	L20	1	1	—	—	1	3
Tuberculosis	D014376	EFO_0000774	A15-A19	—	2	—	—	—	2
Phimosis	D010688	EFO_1001104	N47.1	1	1	—	—	—	2
Paraphimosis	D010263	EFO_1001086	N47.2	1	1	—	—	—	2
Balanitis	D001446	EFO_1000833	N48.1	1	1	—	—	—	2
Malaria	D008288	EFO_0001068	B54	1	2	—	—	—	2

Show 82 more

Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Vasoconstriction	D014661			3	—	—	—	5	8
Therapeutic equivalency	D013810			7	—	—	—	—	7
Vasodilation	D014664			2	—	—	—	3	5
Cardiovascular diseases	D002318	EFO_0000319	I98	1	—	—	—	4	5
Autonomic nervous system diseases	D001342	EFO_0009532	G90	2	—	—	—	1	3
Postural orthostatic tachycardia syndrome	D054972		G90.A	1	—	—	—	2	3
Orthostatic hypotension	D007024		I95.1	2	—	—	—	—	2
Pharmacokinetics	D010599			1	—	—	—	1	2
Vascular diseases	D014652	EFO_0004264	I77	1	—	—	—	1	2
Surgical blood loss	D016063			1	—	—	—	1	2

Show 32 more

Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Carotid endarterectomy	D016894			—	—	—	—	3	3
Cystic fibrosis	D003550	EFO_0000390	E84	—	—	—	—	3	3
Hyperalgesia	D006930			—	—	—	—	2	2
Aging	D000375	GO_0007568	R41.81	—	—	—	—	2	2
Leg ulcer	D007871			—	—	—	—	2	2
Long-term memory	D057567			—	—	—	—	1	1
Short-term memory	D008570	EFO_0004335		—	—	—	—	1	1
Insulin resistance	D007333	EFO_0002614		—	—	—	—	1	1
Microcirculation	D008833			—	—	—	—	1	1
Colonic neoplasms	D003110		C18	—	—	—	—	1	1

Show 82 more

Epidemiology

Epidemiological information for investigational and approved indications

View more details

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	8163
ChEMBL ID	CHEMBL1215
ChEBI ID	8093
PubChem CID	6041
DrugBank	DB00388
UNII ID	1WS297W6MV (ChemIDplus, GSRS)

Target

Agency Approved

ADRA1A

ADRA1B

Organism

Homo sapiens

Gene name

ADRA1A

Gene synonyms

ADRA1C

NCBI Gene ID

148

Protein name

alpha-1A adrenergic receptor

Protein synonyms

Alpha-1A adrenoceptor, Alpha-1A adrenoreceptor, Alpha-1C adrenergic receptor, Alpha-adrenergic receptor 1c, G protein coupled receptor

Uniprot ID

Q9UD67

Mouse ortholog

Adra1a (11549)

alpha-1A adrenergic receptor (Q8BV77)

Alternate

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 (P97714)

Variants

Clinical Variant

No data

Financial

Vazculep - Avadel Pharmaceuticals

€

₣

Mock data
Subscribe for the real data

Tabular view

Trends

PubMed Central

Top Terms for Disease or Syndrome:

Mock data
Subscribe for the real data

Additional graphs summarizing 30,654 documents

View more details

Safety

Black-box Warning

Black-box warning for: Promethazine hydrochloride

Adverse Events

Top Adverse Reactions

Mock data
Subscribe for the real data

3,240 adverse events reported

View more details

Real-time Data on

Companies, Drugs, and Diseases

PharmaKB

MATERIALS

COMPANY