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Gilenya Side Effects

Generic Name: fingolimod

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.

For the Consumer

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:

More common
  • Blurred vision
  • chills
  • cough
  • cough-producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • fever
  • general feeling of discomfort or illness
  • headache
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • pounding in the ears
  • runny nose
  • shivering
  • slow or fast heartbeat
  • sore throat
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common
  • Black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • cough or hoarseness
  • headache, severe and throbbing
  • lightheadedness, dizziness, or fainting
  • lower back or side pain
  • painful or difficult urination
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • unusual bleeding or bruising
Incidence not known
  • Weight loss
  • yellow skin and eyes

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:

More common
  • Back pain
  • pain or tenderness around the eyes and cheekbones
  • stuffy nose
Less common
  • Abdominal or stomach pain
  • decreased weight
  • depression
  • eye pain
  • hair loss or thinning of the hair
  • itching in the genital or other skin areas
  • itching skin
  • lack or loss of strength
  • scaling
  • skin rash, encrusted, scaly, and oozing
  • weakness

For Healthcare Professionals

Applies to fingolimod: oral capsule

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

Infections occurred at a rate similar to placebo.[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]

Nervous system

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]

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

References

1. "Product Information. Gilenya (fingolimod)." Novartis Pharmaceuticals, East Hanover, NJ.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Some side effects of Gilenya may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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