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Sudafed PE (phenylephrine)
Phenylephrine is a widely sold OTC decongestant, though FDA panels found oral doses ineffective for congestion. The IV form is an important vasopressor. The nasal spray is effective topically. Available generically.
At a glance
| Generic name | phenylephrine |
|---|---|
| Also known as | Sudafed PE, Neo-Synephrine |
| Sponsor | Generic (multiple manufacturers) |
| Drug class | Alpha-1 adrenergic agonist (decongestant/vasopressor) |
| Target | Alpha-1A adrenergic receptor, Alpha-1B adrenergic receptor, Alpha-1D adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1976-01-01 (United States) |
Approved indications
- Allergic conjunctivitis
- Allergic rhinitis
- Common cold
- Cough
- Dilated pupil
- Fever
- Headache disorder
- Hemorrhoids
- Influenza-like symptoms
- Maintenance of intraoperative mydriasis
- Nasal congestion
- Nasal discharge
- Postoperative ocular pain in intraocular lens replacement surgery
- Prevention of Posterior Synechiae
- Prevention of intraoperative miosis
- Proctitis
- Pruritus ani
- Rectal pain
- Red eye
- Rhinitis
Common side effects
Key clinical trials
- A Single-Dose, Open-Label, Randomized, 4-Way Crossover Pivotal Study to Assess the Bioequivalence of the Metformin Component of the Fixed Dose Combination Tablet of Canagliflozin and Metformin Immedia (Phase 1)
- A Phase 1, Randomized, Open-Label, Single-Dose, 4-Way Crossover Study to Assess the Relative Bioavailability of Four 80 mg Febuxostat XR Formulations (Phase 1)
- A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Positive-Controlled, Four-Way Crossover Study to Investigate the Effect of BL-8040 (Motixafortide) on the QTc Interval in Healthy Subjects (Phase 1)
- Contribution of the Kinematic Theory in the Early Differential Diagnosis of the Parkinson's Disease (N/A)
- Assessing Patient Comfort, Anxiety, and Satisfaction During Cycloplegic Refraction: Comparing Conventional Drops With Rapid-Onset Cycloplegics (NA)
- What Are the Changes in Cardiac Deformation Variables and Hemodynamic Parameters Following Changes in Cardiac Loading Conditions and After Administration of Two Different Inotropic Drugs. (NA)
- An Observational Study to Test the Effect of the Vasoactive Drugs Phenylephrine and Ephedrine on the Stroke Volume and Microvascular Blood Flow of Healthy Volunteers (N/A)
- Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa: a Doubleblind, Randomized, F (Phase 1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |