Last reviewed 2026-04-20 · How we verify

Gilenya

At a glance

Approved indications

• Relapsing remitting multiple sclerosis

Common side effects

• Headache
• Liver transaminase elevation
• Diarrhea
• Cough
• Influenza
• Sinusitis
• Back pain
• Abdominal pain
• Pain in extremity
• Serum transaminase elevations
• Basal cell carcinoma

Serious adverse events

• Seizure
• Ischemic stroke
• Hemorrhagic stroke
• Peripheral arterial occlusive disease
• Status epilepticus
• Hemolytic anemia
• Thrombocytopenia

Key clinical trials

• A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS) (PHASE3)
• Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis (PHASE4)
• Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (PHASE2, PHASE3)
• Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis (PHASE3)
• Study of the Mechanisms of Action of Cladribine in Multiple Sclerosis (NA)
• Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis (PHASE3)
• A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS) (PHASE3)
• Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients (PHASE4)

Primary sources

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