Fingolimod Side Effects
Commonly reported side effects of fingolimod 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.
For the Consumer
Applies to fingolimod: oral capsules
Side effects include:
For Healthcare Professionals
Applies to fingolimod: oral capsule
The most common adverse events were headache, influenza, diarrhea, back pain, liver transaminase elevations, and cough.[Ref]
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]
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]
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]
Very common (10% or more): Headache (25%)
Rare (less than 0.1%): Posterior reversible encephalopathy syndrome, ischemic and hemorrhagic stroke
Frequency not reported: Neurological atypical disorders
Very common (10% or more): Diarrhea (12%)[Ref]
Common (1% to 10%): Lymphopenia, leukopenia
Uncommon (0.1% to 1%): Neutrophil count decreased[Ref]
Common (1% to 10%): Vision blurred, eye pain
Uncommon (0.1% to 1%): Macular edema[Ref]
Very common (10% or more): Cough (10%)
Very common (10% or more): Back pain (12%)[Ref]
Common (1% to 10%): Weight decreased, blood triglycerides increased[Ref]
Common (1% to 10%): Asthenia
Postmarketing reports: Unexplained death[Ref]
Common (1% to 10%): Depression
Uncommon (0.1% to 1%): Depressed mood[Ref]
Frequency not reported: Lymphoma[Ref]
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More about fingolimod
- Drug interactions
- Dosage information
- During pregnancy or Breastfeeding
- Reviews (94)
- Imprints, shape & color data
- En español
- Drug class: selective immunosuppressants
Related treatment guides
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals (2010):
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.