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Sudafed (pseudoephedrine)
Pseudoephedrine (Sudafed) is the most effective OTC oral decongestant. Kept behind pharmacy counters in the US due to methamphetamine precursor regulations. Available generically.
At a glance
| Generic name | pseudoephedrine |
|---|---|
| Also known as | Sudafed |
| Sponsor | Generic (multiple manufacturers) |
| Drug class | Nasal decongestant (sympathomimetic) |
| Target | Alpha-1A adrenergic receptor, Alpha-2A adrenergic receptor, Beta-2 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
- Eustachian Tube Congestion
- Headache disorder
- Influenza-like symptoms
- Nasal congestion
- Nasal discharge
- Rhinitis
- Seasonal allergic rhinitis
- Sinus headache
- Vasomotor rhinitis
Common side effects
Key clinical trials
- A Magnetic Resonance Imaging Study of Nasal Strips in Subjects With Nasal Congestion (Phase 4)
- To Quantify the Contractile Response of the Thoracic Aorta to Vasoactive Substances and Identify Potential Predictors of This Response. (N/A)
- Preoperative Ephedrine Attenuates the Hemodynamic Responses of Propofol During Valve Surgery: A Dose Dependent Study (Phase 2)
- Evaluation of Diet and Treatment With a Combination of Ephedrine and Caffeine on Thermogenesis, Cardiac Function and on Uncoupling Proteins Expression in Adipose and Muscle Tissue of Morbid Obese Pati (Phase 3)
- To Determine if the Cardiac Output Monitoring During Cesarean Delivery Under Spinal Anesthesia Will Change Our Clinical Practice of Using Vasopressors (NA)
- A Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Intramuscular Ephedrine on the Incidence of Perioperative Nausea and Vomiting During Elective Cesarean Section (Phase 2)
- Effect of Drinking Water on the Pressor Response to Pseudoephedrine in Patients With Autonomic Failure (EARLY/Phase 1)
- An Open Label, Balanced, Randomized, Two-way, Single Dose, Crossover Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tabs of Dr. Reddy's and Allegra-D 24 hr ER Tabs of (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sudafed CI brief — competitive landscape report
- Sudafed updates RSS · CI watch RSS
- Generic (multiple manufacturers) portfolio CI