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Fexofenadine HCL and pseudoephedrine HCL
Fexofenadine blocks histamine H1 receptors to reduce allergy symptoms, while pseudoephedrine acts as a nasal decongestant by stimulating alpha-adrenergic receptors.
Fexofenadine blocks histamine H1 receptors to reduce allergy symptoms, while pseudoephedrine acts as a nasal decongestant by stimulating alpha-adrenergic receptors. Used for Allergic rhinitis with nasal congestion, Seasonal and perennial allergic rhinitis.
At a glance
| Generic name | Fexofenadine HCL and pseudoephedrine HCL |
|---|---|
| Also known as | ALLEGRA® D |
| Sponsor | Sanofi |
| Drug class | Antihistamine and decongestant combination |
| Target | H1 receptor (fexofenadine); alpha-1 and alpha-2 adrenergic receptors (pseudoephedrine) |
| Modality | Small molecule |
| Therapeutic area | Allergy/Immunology |
| Phase | FDA-approved |
Mechanism of action
Fexofenadine is a selective peripheral H1-receptor antagonist that prevents histamine-mediated allergic responses without significant central nervous system penetration. Pseudoephedrine is a sympathomimetic amine that causes vasoconstriction in nasal blood vessels, reducing nasal congestion. Together, they provide combined antihistamine and decongestant effects for allergic rhinitis symptoms.
Approved indications
- Allergic rhinitis with nasal congestion
- Seasonal and perennial allergic rhinitis
Common side effects
- Headache
- Nervousness or insomnia
- Dry mouth
- Tachycardia
- Dizziness
Key clinical trials
- Study to Assess Safety and Efficacy of Fexofenadine Hydrochloride (HCL) + Pseudoephedrine HCL Fixed Dose Combination in Indian Male and Female Participants With Allergic Rhinitis (AR) Who Are 12 Years and Above (PHASE4)
- Fexofenadine HCL - Pseudoephedrine HCL Combination Versus Allegra in Patients With Seasonal Allergic Rhinitis (PHASE3)
- Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr.Reddy's Under Fed Conditions (PHASE1)
- Bioequivalence Study of Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's and Allegra D 24 Hour ER Tablets Under Fasting Conditions (PHASE1)
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 |
|---|---|
| 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:
- Fexofenadine HCL and pseudoephedrine HCL CI brief — competitive landscape report
- Fexofenadine HCL and pseudoephedrine HCL updates RSS · CI watch RSS
- Sanofi portfolio CI