Note: This document contains side effect information about fingolimod. Some dosage forms listed on this page may not apply to the brand name Gilenya.

Summary

Common side effects of Gilenya include: infection, back pain, diarrhea, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, and increased liver enzymes. Other side effects include: blurred vision, bradycardia, bronchitis, increased gamma-glutamyl transferase, lymphocytopenia, migraine, dizziness, dyspnea, hypertension, increased serum transaminases, and tinea. Continue reading for a comprehensive list of adverse effects.

Applies to fingolimod: oral capsules, oral tablets orally disintegrating.

Side effects include:

Adverse effects reported in ≥10% of patients receiving fingolimod (the active ingredient contained in Gilenya) and more frequently than with placebo include headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity.

For Healthcare Professionals

Applies to fingolimod: oral capsule, oral tablet disintegrating.

General

The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, first degree AV block, bradycardia

Uncommon (0.1% to 1%): Symptomatic bradycardia, second degree AV block

Rare (0.01% to 0.1%): Peripheral arterial occlusive disease

Very rare (less than 0.01%): Hemophagocytic syndrome

Frequency not reported: Heart rate decrease, Mobitz type I (Wenckebach) block, Mobitz type II block

Postmarketing reports: Third degree AV block, AV block with junctional escape, transient asystole, peripheral arterial occlusive disease^[Ref]

Hepatic

Very common (10% or more): ALT/AST increased (14%)

Common (1% to 10%): Elevation in liver transaminases, GGT increased, hepatic enzyme increased, liver function test abnormal^[Ref]

In the majority of cases, elevations in liver enzymes occurred within 6 to 9 months and returned to normal within approximately 2 months following discontinuation of fingolimod.^[Ref]

Immunologic

Very common (10% or more): Influenza viral infection (13%), sinusitis (10.9%), infections

Common (1% to 10%): Herpes viral infection, bronchitis, gastroenteritis, tinea infection

Uncommon (0.1% to 1%): Pneumonia

Frequency not reported: Fatal herpetic infection, fatal varicella zoster virus infection^[Ref]

Infections occurred at a rate similar to placebo.^[Ref]

Nervous system

Symptoms of posterior reversible encephalopathy syndrome included sudden onset of severe headache, altered mental status, visual disturbances, and seizure.^[Ref]

Very common (10% or more): Headache (25%)

Common (1% to 10%): Dizziness, paresthesia, migraine

Rare (less than 0.1%): Posterior reversible encephalopathy syndrome, ischemic and hemorrhagic stroke

Frequency not reported: Neurological atypical disorders

Postmarketing reports: Syncope^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (12%)^[Ref]

Hematologic

Common (1% to 10%): Lymphopenia, leukopenia

Uncommon (0.1% to 1%): Neutrophil count decreased^[Ref]

Ocular

Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.^[Ref]

Common (1% to 10%): Vision blurred, eye pain

Uncommon (0.1% to 1%): Macular edema^[Ref]

Respiratory

Very common (10% or more): Cough (10%)

Common (1% to 10%): Dyspnea, reduction in diffusion lung capacity, reduction in FEV1^[Ref]

Musculoskeletal

Very common (10% or more): Back pain (12%)^[Ref]

Dermatologic

Common (1% to 10%): Alopecia, eczema, pruritus^[Ref]

Metabolic

Common (1% to 10%): Weight decreased, blood triglycerides increased^[Ref]

Other

Common (1% to 10%): Asthenia

Postmarketing reports: Unexplained death^[Ref]

Psychiatric

Common (1% to 10%): Depression

Uncommon (0.1% to 1%): Depressed mood^[Ref]

Oncologic

Frequency not reported: Lymphoma^[Ref]

Hypersensitivity

Postmarketing reports: Rash, urticaria, angioedema