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