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TERBINAFINE HYDROCHLORIDE
At a glance
| Generic name | TERBINAFINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1992 |
Approved indications
Common side effects
- Headache
- Gastrointestinal Symptoms: Diarrhea
- Dermatological Symptoms: Rash
- Liver Enzyme Abnormalities
- Gastrointestinal Symptoms: Dyspepsia
- Gastrointestinal Symptoms: Abdominal Pain
- Gastrointestinal Symptoms: Nausea
- Dermatological Symptoms: Pruritus
- Liver Enzyme Abnormalities >= 2x the upper limit of the normal range
- Taste Disturbance
- Gastrointestinal Symptoms: Flatulence
- Dermatological Symptoms: Urticaria
Key clinical trials
- A Phase 2 Study to Assess the Effectiveness of Topical Terbinafine in Participants With Mild to Moderate Onychomycosis of the Toenails (PHASE2)
- Terbinafine for Biochemically Recurrent Prostate Cancer (TerbinaPro) (PHASE2)
- Efficacy Comparison of Itraconazole Pulse Therapy and Terbinafine Therapy in Treatment of Tinea Capitis in Children. (NA)
- Efficacy of Ultraviolet B Phototherapy in the Management of Resistant and Relapsing Tinea Corporis and Tinea Cruris (NA)
- Clinical Effect of Caffeine Consumption in Patients Taking Oral Terbinafine (NA)
- Terbinafine Hydrochloride for the Treatment of Otomycosis (NA)
- Population Pharmacokinetics of Terbinafine in Children With Tinea Capitis
- From Fungus to Virus, Investigating the Safety and Efficacy of Terbinafine in Chronic Hepatitis B Patients (PHASE1, PHASE2)
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:
- TERBINAFINE HYDROCHLORIDE CI brief — competitive landscape report
- TERBINAFINE HYDROCHLORIDE updates RSS · CI watch RSS