Last reviewed · How we verify
EPINASTINE HYDROCHLORIDE
At a glance
| Generic name | EPINASTINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2003 |
Approved indications
Common side effects
- Infection (cold symptoms and upper respiratory infections)
- Burning sensation in the eye
- Folliculosis
- Hyperemia
- Pruritus
- Headache
- Rhinitis
- Sinusitis
- Increased cough
- Pharyngitis
Serious adverse events
- Lacrimation increased
Key clinical trials
- A Study to Evaluate the Efficacy and Safety of Epinastine Hydrochloride Eye Drops in the Treatment of Chinese Seasonal Allergic Conjunctivitis Patients (PHASE3)
- Non-Pharmaceutical Treatment of Seasonal Allergic Conjunctivitis (PHASE4)
- Effectiveness of Olopatadine HCl Ophthalmic Solution for the Treatment of Allergic Conjunctivitis in Japan (PHASE4)
- Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis (PHASE4)
- Study of DE-114 Ophthalmic Solution in Patients With Allergic Conjunctivitis (PHASE3)
- Postmarketing Surveillance to Investigate the Safety and Efficacy Information of Alesion® Tablet
- Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus
- Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria
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:
- EPINASTINE HYDROCHLORIDE CI brief — competitive landscape report
- EPINASTINE HYDROCHLORIDE updates RSS · CI watch RSS