Note: This document contains side effect information about fingolimod. Some of the dosage forms listed on this page may not apply to the brand name Gilenya.
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. See below for a comprehensive list of adverse effects.
Applies to fingolimod: oral capsule
Along with its needed effects, fingolimod (the active ingredient contained in Gilenya) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking fingolimod:
Incidence not known
Some side effects of fingolimod may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Applies to fingolimod: oral capsule
The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.
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
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 (the active ingredient contained in Gilenya)
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
Infections occurred at a rate similar to placebo.
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
Symptoms of posterior reversible encephalopathy syndrome included sudden onset of severe headache, altered mental status, visual disturbances, and seizure.
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
Very common (10% or more): Diarrhea (12%)
Common (1% to 10%): Lymphopenia, leukopenia
Uncommon (0.1% to 1%): Neutrophil count decreased
Macular edema occurred at a dramatically higher rate in patients with a history of uveitis.
Common (1% to 10%): Vision blurred, eye pain
Uncommon (0.1% to 1%): Macular edema
Very common (10% or more): Cough (10%)
Common (1% to 10%): Dyspnea, reduction in diffusion lung capacity, reduction in FEV1
Very common (10% or more): Back pain (12%)
Common (1% to 10%): Alopecia, eczema, pruritus
Common (1% to 10%): Weight decreased, blood triglycerides increased
Common (1% to 10%): Asthenia
Postmarketing reports: Unexplained death
Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Depressed mood
Frequency not reported: Lymphoma
Postmarketing reports: Rash, urticaria, angioedema
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Gilenya