Overview
Phenylephrine is an alpha-1 adrenergic receptor agonist used to treat hypotension, dilate the pupil, and induce local vasoconstriction. The action of phenylephrine, or neo-synephrine, was first described in literature in the 1930s. Phenylephrine was granted FDA approval in 1939.
Background
Phenylephrine is an alpha-1 adrenergic receptor agonist used to treat hypotension, dilate the pupil, and induce local vasoconstriction. The action of phenylephrine, or neo-synephrine, was first described in literature in the 1930s. Phenylephrine was granted FDA approval in 1939.
Indication
Phenylephrine is available in various drug formulations, which have different indications. Phenylephrine injections are indicated to treat hypotension caused by shock or anesthesia. The ophthalmic formulation is indicated to induce mydriasis and conjunctival vasoconstriction. The intranasal formulation is used to treat congestion, and a topical formulation is used to treat hemorrhoids. Off-label uses include priapism and induction of local vasoconstriction.
Associated Conditions
- Allergic Conjunctivitis (AC)
- Allergic Rhinitis (AR)
- Allergy to Tree Pollen
- Anorectal discomfort
- Cold
- Common Cold
- Congestion of the Conjunctivas
- Cough
- Cough caused by Common Cold
- Eye allergy
- Eye redness
- Fever
- Flu caused by Influenza
- Haemorrhoids
- Headache
- Headache caused by Allergies
- Headache caused by Common Cold
- Headache caused by Pollen Allergy
- Hypotension
- Irritative cough
- Itching of the nose
- Itching of the throat
- Laryngotracheitis
- Nasal Congestion
- Nose discomfort
- Ocular Inflammation
- Ocular Irritation
- Paroxysmal Supraventricular Tachycardia (PSVT)
- Respiratory tract congestion
- Respiratory tract irritation
- Rhinopharyngitis
- Rhinorrhoea
- Seasonal Allergies
- Sinus Congestion
- Sinus pressure
- Sinusitis
- Sneezing
- Sore Throat
- Tracheobronchitis
- Upper respiratory tract hypersensitivity reaction, site unspecified
- Vasomotor Rhinitis
- Aching caused by Flu caused by Influenza
- Bronchial congestion
- Cold or flu syndrome
- Itchy throat
- Minor aches and pains
- Vascular failure
- Watery itchy eyes
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/20 | Not Applicable | Recruiting | |||
2025/01/31 | Phase 4 | Recruiting | |||
2025/01/13 | Phase 3 | Not yet recruiting | |||
2024/12/19 | N/A | Active, not recruiting | Centre of Postgraduate Medical Education | ||
2024/10/18 | Phase 3 | Not yet recruiting | |||
2024/07/18 | Not Applicable | Not yet recruiting | General Hospital of Ningxia Medical University | ||
2024/04/19 | N/A | Completed | Catharina Ziekenhuis Eindhoven | ||
2024/02/29 | Not Applicable | Recruiting | Samuel Lunenfeld Research Institute, Mount Sinai Hospital | ||
2024/02/08 | Phase 4 | Recruiting | Hassan II University | ||
2024/01/24 | N/A | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Armas Pharmaceuticals Inc. | 72485-506 | INTRAVENOUS | 100 mg in 10 mL | 6/1/2021 | |
| Lifestar Pharma LLC | 70756-623 | INTRAVENOUS | 100 mg in 10 mL | 3/29/2023 | |
| Sandoz Inc | 0781-3422 | INTRAVENOUS | 10 mg in 1 mL | 10/17/2022 | |
| Walgreen Company | 0363-8005 | ORAL | 10 mg in 20 mL | 4/25/2025 | |
| Jiangxi Hemei Pharmaceutical Co., Ltd | 84010-121 | TOPICAL | 0.25 g in 100 g | 5/23/2025 | |
| Publix Super Markets Inc | 56062-763 | ORAL | 10 mg in 30 mL | 5/19/2025 | |
| Sandoz Inc | 0781-9227 | INTRAVENOUS | 10 mg in 1 mL | 10/17/2022 | |
| Exela Phrama Sciences, LLC | 51754-4010 | INTRAVENOUS | 10 mg in 1 mL | 3/26/2021 | |
| Physicians Total Care, Inc. | 54868-0263 | ORAL | 5 mg in 5 mL | 12/9/2011 | |
| Sincerus Florida, LLC | 72934-5071 | TOPICAL | 1 g in 100 g | 5/10/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 7/28/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MAXIGESIC PE FILM-COATED TABLET | SIN16703P | TABLET, FILM COATED | 2.50mg | 2/21/2023 | |
| MINIMS PHENYLEPHRINE HYDROCHLORIDE EYE DROPS 10% w/v | SIN04319P | SOLUTION | 10% w/v | 4/20/1990 | |
| Panadol FluMax Caplets | GlaxoSmithKline Dungarvan Ltd, SmithKline Beecham, S.A (Primary and Secondary Packager) | SIN13452P | TABLET, FILM COATED | 5 mg | 5/9/2008 |
| UNIFLU COLDS & FLU TABLETS | SIN07102P | TABLET | 5 mg | 7/7/1992 | |
| PHENYLALPHA SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 50MCG/ML | SIN15668P | INJECTION, SOLUTION | 50.0mcg/ml | 4/15/2019 | |
| DECOLGEN COLD & FLU EXTRA STRENGTH CAPLET | SIN12260P | TABLET | 10 mg | 4/25/2003 | |
| PHENYLALPHA SOLUTION FOR INJECTION 50mcg/ml | SIN15896P | INJECTION, SOLUTION | 50mcg/ml | 3/3/2020 | |
| SUNFLU TABLET | SIN03038P | TABLET | 5 mg | 6/7/1989 | |
| Panadol Cold Relief PE Caplet | Aspen Pharma Pty Ltd. | SIN13878P | TABLET | 5 mg | 10/27/2010 |
| MINIMS PHENYLEPHRINE HYDROCHLORIDE EYE DROPS 2.5% w/v | SIN10139P | SOLUTION | 2.5% w/v | 10/2/1998 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Phenylephrine Hydrochloride Injection | 国药准字H20249841 | 化学药品 | 注射剂 | 12/25/2024 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20243723 | 化学药品 | 注射剂 | 5/15/2024 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20249840 | 化学药品 | 注射剂 | 12/25/2024 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20253247 | 化学药品 | 注射剂 | 1/24/2025 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20253388 | 化学药品 | 注射剂 | 2/20/2025 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20253246 | 化学药品 | 注射剂 | 1/24/2025 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20243559 | 化学药品 | 注射剂 | 4/24/2024 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20233385 | 化学药品 | 注射剂 | 3/24/2023 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20243558 | 化学药品 | 注射剂 | 4/24/2024 | |
| Phenylephrine Hydrochloride Injection | 国药准字H20243722 | 化学药品 | 注射剂 | 5/15/2024 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| RHINO-COMFORT TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 11/21/2001 |
| SURE-RELIEF COLD AND COUGH CAP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 6/30/2000 |
| FAST FLU TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 10/18/2002 |
| NEW-PRITMIN TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 7/9/2010 |
| NASAL COM TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 11/21/2001 |
| ANTI-COLD TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 9/30/2002 |
| COFENZA CAP | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 6/30/2000 |
| PANADOL COLD & FLU HOT REMEDY POWDER | N/A | N/A | N/A | 9/5/1998 | |
| THROUGH TAB | N/A | unicorn laboratories o/b american unicorn laboratories limited | N/A | N/A | 11/21/2001 |
| N2012 CAP | N/A | karen laboratories o/b karen pharmaceutical co ltd | N/A | N/A | 2/8/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DEMAZIN COLD + FLU RELIEF tablet blister pack | 286271 | Medicine | A | 3/1/2017 | |
| AVALLON COLD & FLU DAY + NIGHT RELIEF PE tablet blister pack | 300169 | Medicine | A | 3/1/2018 | |
| CHEMISTS' OWN CHILDREN'S COLD AND ALLERGY RELIEF LIQUID 6 YEARS TO ADULT oral liquid bottle | 71041 | Medicine | A | 9/14/1999 | |
| TRUST FOR KIDS DECONGESTANT & ANTIHISTAMINE ELIXIR oral liquid - solution bottle | 214691 | Medicine | A | 9/17/2013 | |
| DEMAZIN KIDS 6+ COLD RELIEF BLUE SYRUP bottle | 18813 | Medicine | A | 10/8/1991 | |
| TERRY WHITE CHEMISTS SINUS PLUS PE DUAL ACTION tablet blister pack | 199056 | Medicine | A | 7/4/2012 | |
| MEDIX SINUS + PAIN RELIEF PE tablet blister pack | 195426 | Medicine | A | 3/8/2012 | |
| MEDREICH PHENYLEPHRINE HYDROCHLORIDE 10 mg TABLETS blister pack | 175337 | Medicine | A | 9/2/2010 | |
| TERRYWHITE CHEMMART COLD & FLU RELIEF PE tablet blister pack | 295508 | Medicine | A | 10/25/2017 | |
| BLOOMS THE CHEMIST PE DAY + NIGHT COLD & FLU RELIEF tablet blister pack | 294345 | Medicine | A | 9/26/2017 |