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Fingolimod

Fingolimod is a brand of Fingolimod.

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-.

Checked against the official label · Updated

Prescription medicine Oral

Fingolimod: quick answers

Used for
Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Usual adult dose
Adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food.
Children
Recommended dosage for pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: 0.25 mg orally once-daily, with or without food.
With food?
Adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food.
Prescription
Prescription medicine in the United States; rules differ by country.

From the official label (Jan 2026). Your prescription and pharmacist come first.

How to use Fingolimod

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. ( 1 )

How to take it and how often
  • Assessments are required prior to initiating fingolimod capsules Recommended dosage for adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food
  • Recommended dosage for pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: 0.25 mg orally once-daily, with or without food
  • First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): Observe all patients for bradycardia for at least 6 hours; monitor pulse and blood pressure hourly
  • Electrocardiograms (ECGs) prior to dosing and at end of observation period required
  • Monitor until resolution if heart rate
Strengths it comes in

Fingolimod capsules are available as: 0.5 mg hard gelatin capsule with a yellow cap and white opaque body, imprinted with “TV” (over) “7820” in black ink on both the cap and body. The capsule is filled with white to off-white powder, with small agglomerates. 0.5 mg hard gelatin capsules ( 3 )

Children
  • Safety and effectiveness of fingolimod
  • For the treatment of relapsing forms of multiple sclerosis
  • In pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod n=107; intramuscular interferon (IFN) beta-1a n=108) [see Clinical Studies ]
  • In the controlled pediatric study, the safety profile
  • In pediatric patients (10 to less than 18 years of age) receiving fingolimod 0.25 mg or 0.5 mg daily was similar to that seen in adult patients. …
Older adults

Clinical MS studies of fingolimod did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Fingolimod should be used with caution in patients aged 65 years and over, reflecting the greater frequency of decreased hepatic, or renal, function and of concomitant disease or other drug therapy.

While you are taking it
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide)
  • Tell patients not to discontinue fingolimod capsules without first discussing this with the prescribing physician
  • Advise patients to contact their physician if they accidently take more fingolimod capsules than prescribed
  • Cardiac Effects Advise patients that initiation of fingolimod capsules treatment results in a transient decrease in heart rate. …
Talk to a doctor first if

Fingolimod is contraindicated in patients who have: in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization or Class III/IV heart failure a history or presence of Mobitz Type II second-degree or third-degree AV block or sick sinus syndrome, unless patient has a functioning pacemaker [see Warnings and Precautions ( 5.1 )] a baseline QTc interval ≥500 msec cardiac arrhythmias requiring a …

Medicines it may not mix with

Systemic Ketoconazole: Monitor during concomitant use. ( 7.2 , 12.3 ) Vaccines : Avoid live attenuated vaccines during, and for 2 months after stopping fingolimod treatment. ( 5.2 , 7.3 ) 7.1 QT Prolonging Drugs Fingolimod 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. …

Warnings

Infections: Fingolimod may increase the risk. Obtain a complete blood count (CBC) before initiating treatment. Monitor for infection during treatment and for 2 months after discontinuation. Do not start in patients with active infections. ( 5.2 ) Progressive Multifocal Leukoencephalopathy (PML): Withhold fingolimod at the first sign or symptom suggestive of PML. ( 5.3 ) Macular Edema: Examine the fundus before and 3 to 4 months after treatment start. Diabetes mellitus and uveitis increase the risk. ( 5.4 ) Liver Injury: Obtain liver enzyme results before initiation and periodically during treatment. Closely monitor patients with severe hepatic impairment. …

Possible side effects

The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] Macular Edema [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.5 )] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.6 )] Respiratory Effects [see Warnings and Precautions ( 5.7 )] Fetal Risk [see Warnings and Precautions ( 5.8 )] Severe Increase in Disability After Stopping Fingolimod [see Warnings and Precautions ( 5.9 )] Tumefactive Mul …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. …

If you take too much

Fingolimod can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients [see Warnings and Precautions ( 5.1 )] . In case of fingolimod overdosage, observe patients overnight with continuous ECG monitoring in a medical facility, and obtain regular measurements of blood pressure [see Dosage and Administration ( 2.4 )] . Neither dialysis nor plasma exchange results in removal of fingolimod from the body.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2026-01-13.

How much Fingolimod costs

In other countries

Prices in other countries are not what you will pay where you live; they show how prices compare.

Same medicine, other brands

Products with Fingolimod as the active ingredient. Names differ between countries.

Check your pack of Fingolimod

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Fingolimod

What is in Fingolimod?

Fingolimod contains Fingolimod. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.

What is Fingolimod used for?

Fingolimod capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older. Fingolimod capsules are a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isol (From the official U.S. FDA label.)

How do I take Fingolimod?

Follow your prescription or the leaflet in your pack. The official label says: Assessments are required prior to initiating fingolimod capsules ( 2.1 ) Recommended dosage for adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food. ( 2.2 , 2.3 ) Recommended dosage for pediatric patients (10 years of age and above) weighing less than or equal to 40 kg: 0.25 mg orally once-daily, wit…

Should I take Fingolimod with food?

Adults and pediatric patients (10 years of age and older) weighing more than 40 kg: 0.5 mg orally once-daily, with or without food.

Do I need a prescription for Fingolimod?

Usually yes. Fingolimod is a prescription medicine in most countries. Rules differ by country.

What brands contain Fingolimod?

Fingolimod is sold under names such as Gilenya, Tascenso. Brand names differ between countries.

What are the side effects of Fingolimod?

The official label lists: The following serious adverse reactions are described elsewhere in labeling: Bradyarrhythmia and Atrioventricular Blocks [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.3 )] Macular Edema [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Prec… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Fingolimod?

Safety and effectiveness of fingolimod for the treatment of relapsing forms of multiple sclerosis in pediatric patients 10 to less than 18 years of age were established in one randomized, double-blind clinical study in 215 patients (fingolimod n=107; intramuscular interferon (IFN) beta-1a n=108) [see Clinical Studies ( 14.2 )] . In the controlled pediatric study, the safety pro… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Fingolimod when pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Based on findings from animal studies, fingolimod may cause fetal harm when administered to a pregnant woman. In oral studies conducted in rats and rabbits, fingolimod demonstrated developmental toxicity, including an increase in malformations (rats) and embryolethality, when given to pregnant animals. … Ask your doctor or midwife first.

What medicines interact with Fingolimod?

Systemic Ketoconazole: Monitor during concomitant use. ( 7.2 , 12.3 ) Vaccines : Avoid live attenuated vaccines during, and for 2 months after stopping fingolimod treatment. ( 5.2 , 7.3 ) 7.1 QT Prolonging Drugs Fingolimod 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 torsa… Use the free interaction checker before combining medicines.

What happens if I take too much Fingolimod?

Fingolimod can induce bradycardia as well as AV conduction blocks (including complete AV block). The decline in heart rate usually starts within 1 hour of the first dose and is maximal within 6 hours in most patients [see Warnings and Precautions ( 5.1 )] . In case of fingolimod overdosage, observe… Get medical help right away.

How can I check that my Fingolimod is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.