February 9, 2016
Recommended Topic Related To:


"The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

Sandoz has received FDA approval to market "...



Gilenya Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/12/2015

Gilenya (fingolimod) is a sphingosine 1-phosphate receptor modulator used to treat patients with relapsing forms of multiple sclerosis (MS) to reduce the frequency of exacerbations and to delay physical disability. Common side effects of Gilenya are headache, tired feeling, influenza, stuffy nose, sinus pain, diarrhea, back pain, liver transaminase elevations, and cough.

The recommended dose for Gilenya is 0.5 mg orally once daily, with or without food. Gilenya may interact with beta-blockers, calcium channel blockers, citalopram, chlorpromazine, digoxin, erythromycin, haloperidol, ketoconazole, medications to control the immune system, medications for cancer, heart problems, or high blood pressure, and methadone. Tell your doctor all medications and supplements you use. Gilenya may cause fetal harm. It takes approximately 2 months for Gilenya to be eliminated from the body. Women should avoid pregnancy during treatment with Gilenya and for 2 months after treatment. It is not known if Gilenya passes into breast milk. Women and their doctors should decide whether to take Gilenya or breastfeed. Women should not do both.

Our Gilenya (fingolimod) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Gilenya in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Gilenya (Fingolimod Capsules)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Gilenya Overview - Patient Information: Side Effects

SIDE EFFECTS: Cough, headache, back pain, or diarrhea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

This medication can affect your immune system's ability to fight an infection while you are taking the medication and for 2 months after your last dose. You may be more likely to get a serious infection (such as bronchitis, pneumonia). Tell your doctor right away if you develop any signs of an infection such as persistent cough/sore throat, difficulty breathing, fever/chills, or cold/flu symptoms. Do not start fingolimod if you have a current infection.

Get medical help right away if you have any very serious side effects, including: shortness of breath, chest pain, severe dizziness/fainting, slow/irregular/fast heartbeat, unusual tiredness/weakness, eye pain/sensitivity to light, vision changes (such as blurred vision, blind spot/shadows in the center of your vision, color changes), clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating, memory loss), difficulty moving muscles, seizure, sudden/severe headache, problems with speech.

This medication may rarely cause serious liver problems. Tell your doctor right away if you experience: yellowing eyes/skin, dark urine, stomach/abdominal pain, persistent nausea.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Gilenya (Fingolimod Capsules)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Gilenya FDA Prescribing Information: Side Effects
(Adverse Reactions)


The following serious adverse reactions are described elsewhere in labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials (Studies 1, 2, and 3), a total of 1212 patients with relapsing forms of multiple sclerosis received GILENYA 0.5 mg. This included 783 patients who received GILENYA 0.5 mg in the 2-year placebo-controlled trials (Studies 1 and 3) and 429 patients who received GILENYA 0.5 mg in the 1 year active-controlled trial (Study 2). The overall exposure in the controlled trials was equivalent to 1716 person-years. Approximately 1000 patients received at least 2 years of treatment with GILENYA 0.5 mg. In all clinical studies, including uncontrolled extension studies, the exposure to GILENYA 0.5 mg was approximately 4119 person-years.

In placebo-controlled trials, the most frequent adverse reactions (incidence ≥ 10% and > placebo) for GILENYA 0.5 mg were headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. Adverse events that led to treatment discontinuation and occurred in more than 1% of patients taking GILENYA 0.5 mg were serum transaminase elevations (4.7% compared to 1% on placebo) and basal cell carcinoma (1% compared to 0.5% on placebo).

Table 1 lists adverse reactions that occurred in ≥ 1% of GILENYA-treated patients and ≥ 1% higher rate than for placebo.

Table 1 : Adverse Reactions Reported in Studies 1 and 3 (Occurring in ≥ 1% of Patients and Reported for GILENYA 0.5 mg at ≥ 1% Higher Rate than for Placebo)

Primary System Organ Class Preferred Term GILENYA 0.5 mg
N=783 %
N=773 %
  Influenza 11 8
  Sinusitis 11 8
  Bronchitis 8 5
  Herpes zoster 2 1
  Tinea versicolor 2 < 1
Cardiac Disorders
  Bradycardia 3 1
Nervous system disorders
  Headache 25 24
Migraine 6 4
Gastrointestinal disorders
Nausea 13 12
Diarrhea 13 10
Abdominal pain 11 10
General disorders and administration site conditions
Asthenia 2 1
Musculoskeletal and connective tissue disorders
Back pain 10 9
Pain in extremity 10 7
Skin and subcutaneous tissue disorders
Alopecia 3 2
Actinic keratosis 2 1
Liver transaminase elevations (ALT/GGT/AST) 15 4
Blood triglycerides increased 3 1
Respiratory, thoracic, and mediastinal disorders
Cough 12 11
Dyspnea 9 7
Eye disorders
Vision blurred 4 2
Vascular disorders
Hypertension 8 4
Blood and lymphatic system disorders
Lymphopenia 7 < 1
Leukopenia 2 < 1
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Skin papilloma 3 2
Basal cell carcinoma 2 1

Adverse reactions of dizziness, pneumonia, eczema and pruritus were also reported in Studies 1 and 3 but did not meet the reporting rate criteria for inclusion in Table 1 (difference was less than 1%).

Adverse reactions with GILENYA 0.5 mg in Study 2, the 1-year active-controlled (versus interferon beta-1a) study were generally similar to those in Studies 1 and 3.

Vascular Events

Vascular events, including ischemic and hemorrhagic strokes, and peripheral arterial occlusive disease were reported in premarketing clinical trials in patients who received GILENYA doses (1.25-5 mg) higher than recommended for use in MS. Similar events have been reported with GILENYA 0.5 mg in the postmarketing setting although a causal relationship has not been established.


Cases of lymphoma have occurred in premarketing clinical trials and in the postmarketing setting. The relationship to GILENYA remains uncertain.


QT Prolonging Drugs

GILENYA has not been studied in patients treated with drugs that prolong the QT interval. Drugs that prolong the QT interval have been associated with cases of torsades de pointes in patients with bradycardia. Since initiation of GILENYA treatment results in decreased heart rate and may prolong the QT interval, patients on QT prolonging drugs with a known risk of torsades de pointes (e.g., citalopram, chlorpromazine, haloperidol, methadone, erythromycin) should be monitored overnight with continuous ECG in a medical facility [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].


The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use GILENYA and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is greater.


GILENYA reduces the immune response to vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with GILENYA [see CLINICAL PHARMACOLOGY]. Avoid the use of live attenuated vaccines during and for 2 months after treatment with GILENYA because of the risk of infection.

Antineoplastic, Immunosuppressive, or Immune-Modulating Therapies

Antineoplastic, immune-modulating, or immunosuppressive therapies, (including corticosteroids) are expected to increase the risk of immunosuppression, and the risk of additive immune system effects must be considered if these therapies are coadministered with GILENYA. When switching from drugs with prolonged immune effects, such as natalizumab, teriflunomide or mitoxantrone, the duration and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects when initiating GILENYA [see WARNINGS AND PRECAUTIONS].

Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem)

Experience with GILENYA in patients receiving concurrent therapy with drugs that slow the heart rate or atrioventricular conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers such as diltiazem or verapamil) is limited. Because initiation of GILENYA treatment may result in an additional decrease in heart rate, concomitant use of these drugs during GILENYA initiation may be associated with severe bradycardia or heart block. Seek advice from the prescribing physician regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating GILENYA. Patients who cannot switch, should have overnight continuous ECG monitoring after the first dose [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Laboratory Test Interaction

Because GILENYA reduces blood lymphocyte counts via redistribution in secondary lymphoid organs, peripheral blood lymphocyte counts cannot be utilized to evaluate the lymphocyte subset status of a patient treated with GILENYA. A recent CBC should be available before initiating treatment with GILENYA.

Read the entire FDA prescribing information for Gilenya (Fingolimod Capsules)

Gilenya - User Reviews

Gilenya User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Gilenya sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Multiple Sclerosis

Get the latest treatment options.