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.

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.

For the Consumer

Applies to fingolimod: oral capsule

Get emergency medical help if you have any of these signs of an allergic reaction while taking fingolimod (the active ingredient contained in Gilenya) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• slow heart rate, dizziness, feeling very weak or tired;

• chest pain, pounding heartbeats or fluttering in your chest;

• sudden numbness or weakness, severe headache, problems with speech or walking;

• wheezing, chest tightness, trouble breathing, cough with yellow or green mucus;

• fever, chills, body aches, flu symptoms, nausea and vomiting, sores in your mouth and throat;

• swelling, warmth, redness, oozing, itchy rash, or other signs of skin infection;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• vision problems, blurred vision, eye pain, increased sensitivity to light, or having a blind spot or shadows in the center of your vision (vision problems may occur 3 to 4 months after you start taking fingolimod).

Less serious side effects of fingolimod may include:

• headache, tired feeling;

• back pain;

• diarrhea; or

• stuffy nose, sinus pain, or cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to fingolimod: oral capsule

General

In general, the most frequently reported side effects (incidence greater than 10%) have included headache, influenza, diarrhea, back pain, increased liver enzymes, and cough. Increased liver enzymes were the only adverse effect which lead to treatment interruption (3.8%).

Cardiovascular

Cardiovascular side effects have included hypertension (6%) and bradycardia (4%).

Dermatologic

Dermatologic side effects have included alopecia (4%), eczema (3%), and pruritus (3%).

Gastrointestinal

Gastrointestinal side effects have included diarrhea (12%) and gastroenteritis (5%).

Hematologic

Hematologic side effects have included lymphopenia (4%) and leucopenia (3%).

Hepatic

Hepatic side effects have included increased aspartate/alanine (AST/ALT) aminotransferases (14%) and increased gamma glutamyl transpeptidase (GGT; 5%).

Immunologic

Immunologic side effects have included influenza viral infection (13%), herpes viral infection (9%), and tinea infections (4%).

Metabolic

Metabolic side effects have included weight loss (5%) and increased serum triglycerides (3%).

Musculoskeletal

Musculoskeletal side effects have included back pain (12%).

Nervous system

Nervous system side effects have included headache (25%), dizziness (7%), paresthesia (5%), and migraine (5%).

Ocular

Ocular side effects have included blurred vision (4%), eye pain (3%), and macular edema.

Other

Other side effects have included asthenia (3%).

Psychiatric

Psychiatric side effects have included depression (8%).

Respiratory

Respiratory side effects have included cough (10%), dyspnea (8%), bronchitis (8%), and sinusitis (7%).

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.