Fingolimod: uses, dosing, side effects & brands

Q: What is fingolimod?

Fingolimod Hydrochloride is a sphingosine 1-phosphate receptor modulator used to treat Relapsing-Remitting Multiple Sclerosis.

Q: What kind of drug is fingolimod?

The FDA classifies fingolimod as a sphingosine 1-phosphate receptor modulator. These drugs mimic the natural lipid signal S1P and bind its receptors on immune cells called lymphocytes. This traps the lymphocytes inside the lymph nodes so fewer circulate in the blood, reducing the inflammatory attack on the nervous system or gut in diseases like multiple sclerosis. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

Q: How long does fingolimod stay in your system?

The elimination half-life of fingolimod is about 6 to 9 days (average apparent terminal half-life) — that is how long the body takes to clear half of a dose. This is the terminal (elimination) half-life, not a distribution phase. Fingolimod is a prodrug-like parent: it is phosphorylated by sphingosine kinase to fingolimod-phosphate, the pharmacologically active moiety. The label says fingolimod-phosphate blood levels decline in parallel with the parent in the terminal phase, "yielding similar half-lives for both" — so the active form does not outlast the parent, but it also does not clear any faster. Because the half-life is measured in days, blood levels take 1 to 2 months of once-daily dosing to reach steady state, and lymphocyte counts typically take 1 to 2 months to return to normal after stopping. Liver impairment: the apparent elimination half-life is unchanged in mild hepatic impairment but is prolonged by about 50% in moderate or severe impairment (Child-Pugh B or C); fingolimod AUC rises 12%/44%/103% in mild/moderate/severe. Kidney impairment: in severe renal impairment there is NO change in apparent elimination half-life (though fingolimod Cmax/AUC rise 32%/43%, and two inactive metabolites, M2 and M3, accumulate 3- and 13-fold). Older adults: the label states no dose adjustment is expected based on the elimination mechanism and population PK, but does not report a separate half-life for this group and notes experience above age 65 is limited. Not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Q: Can you take fingolimod with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fingolimod against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

Q: What brand names is fingolimod sold under?

We track 3 fingolimod-containing products in the U.S.: Fingolimod Hydrochloride, Gilenya and Fingolimod. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

Q: What forms does fingolimod come in?

Across the brands we track, fingolimod is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Q: Is there a generic fingolimod?

Yes. Our catalog lists 2 generic fingolimod products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Fingolimod is a sphingosine 1-phosphate receptor modulator sold in the U.S. under 3 brand and generic names, for relapsing-remitting multiple sclerosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.

By the pharmaranks editorial teamReviewed against the FDA (openFDA label, NDC Directory & Enforcement) sourcesUpdated Jul 24, 2026How we research

Key facts

Drug class: Sphingosine 1-Phosphate Receptor Modulator
Treats: Relapsing-Remitting Multiple Sclerosis
Available as: Capsule
Sold as: 3 products — Fingolimod Hydrochloride, Gilenya and Fingolimod
Prescription?: Prescription only
Generic available?: Yes
Half-life: about 6 to 9 days (average apparent terminal half-life)
What the pharmacy pays: about $126 for a 30-count supply — not your price

How fingolimod is dosed

From the FDA label for Fingolimod Hydrochloride (application ANDA207974). Other fingolimod products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

Assessments are required prior to initiating fingolimod. ( 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 ) • First-Dose Monitoring (including reinitiation after discontinuation greater than 14 days and dose increases): o 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. ( 2.4 ) o Monitor until resolution if heart rate < 45 beats per minute (bpm) in adults, < 55 bpm in patients aged 12 years and above, or < 60 bpm in pediatric patients aged 10 to below 12 years, atrioventricular (AV) block, or if lowest postdose heart rate is at the end of the observation period. ( 2.4 ) o Monitor symptomatic bradycardia with ECG until resolved. Continue overnight if intervention is required; repeat first-dose monitoring for second dose. ( 2.4 ) o Observe patients overnight if at higher risk of symptomatic bradycardia, heart block, prolonged QTc interval, or if taking drugs with known risk of torsades de pointes. ( 2.4 , 7.1 ) 2.1 Assessment Prior to Initiating Fingolimod Cardiac Evaluation Obtain a cardiac evaluation in patients with certain preexisting conditions [see Warnings and Precautions (5.1)] . Prior to starting treatment,…

Fingolimod 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 Multiple Sclerosis [see Warnings and Precautions (5.10)] Increased Blood Pressure [see Warnings and Precautions (5.11)] Malignancies [see Warnings and Precautions (5.12)] Immune System Effects Following Fingolimod Discontinuation [see Warnings and Precautions (5.13)] Hypersensitivity Reactions [see Warnings and Precautions (5.14)] Most common adverse reactions (incidence ≥10% and greater than placebo): Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals Limited at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials…

Who shouldn’t take fingolimod

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 anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs had a hypersensitivity reaction to fingolimod or any of the excipients in fingolimod capsules. Observed reactions include rash, urticaria and angioedema upon treatment initiation [see Warnings and Precautions (5.14)] • Recent myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure with hospitalization, or Class III/IV heart failure. ( 4 ) • History of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker. ( 4 ) • Baseline QTc interval ≥500 msec. ( 4 ) • Cardiac arrhythmias requiring anti-arrhythmic treatment with Class Ia or Class III anti-arrhythmic drugs. ( 4 ) • Hypersensitivity to fingolimod or its excipients. ( 4 )

Fingolimod drug interactions

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 have 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 fingolimod 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 (2.4), Warnings and Precautions (5.1)]. 7.2 Ketoconazole The blood levels of fingolimod and fingolimod-phosphate are increased by 1.7-fold when used concomitantly with ketoconazole. Patients who use fingolimod and systemic ketoconazole concomitantly should be closely monitored, as the risk of adverse reactions is increased. 7.3 Vaccines Fingolimod reduces the immune response to vaccination. Vaccination may be less effective during and for up to 2 months after discontinuation of treatment with fingolimod [see Clinical Pharmacology (12.2)]. Avoid the use of live attenuated vaccines during and for 2 months after treatment with fingolimod because of the risk of infection. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating fingolimod therapy. 7.4 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 fingolimod. 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 fingolimod [see Warnings and Precautions (5.2)]. 7.5 Drugs That Slow Heart Rate or Atrioventricular Conduction (e.g., beta blockers or diltiazem) Experience with fingolimod in patients receiving concurrent therapy with drugs that slow the heart rate or AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers, such as diltiazem or verapamil) is limited. Because initiation of fingolimod treatment may result in an additional decrease in heart rate, concomitant use of these drugs during fingolimod initiation may be associated with severe bradycardia or heart block. Seek advice from the physician prescribing these drugs regarding the possibility to switch to drugs that do not slow the heart rate or atrioventricular conduction before initiating fingolimod. Patients who cannot switch should have overnight continuous ECG monitoring after the first dose [see Dosage and Administration (2.4), Warnings and Precautions (5.1)]. 7.6 Laboratory Test Interaction Because fingolimod 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 fingolimod. A recent CBC should be available before initiating treatment with fingolimod.

Every fingolimod product we track (3)

Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.

Fingolimod products
#	Drug	Rating	Type	Form	Generic?	Pharmacy pays
1	Fingolimod Hydrochloride	72/100	Prescription	Capsule	Generic	$126	View →
2	Gilenya	70/100	Prescription	Capsule	Generic	$126	View →
3	Fingolimod	Not yet rated	Prescription	Capsule	Generic	$126	View →

What fingolimod pills look like

Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.

Fingolimod pill imprints
Imprint	Strength	Colour	Shape	Maker
FO;0;5;mg	0.5 mg	yellow, white	capsule	—
FIG;0;5;mg	0.5 mg	white, yellow	capsule	—
A190	0.5 mg	yellow, white	capsule	—
A190	0.5 mg	yellow, white	capsule	—
Bioconlogo;F0;5	0.5 mg	white, yellow	capsule	—
FIG;0;5;mg	0.5 mg	white, yellow	capsule	—

How long fingolimod keeps

No fingolimod label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.

Does fingolimod expire? The in-use limits and storage rules from its labels

Fingolimod and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

Although fingolimod and its active metabolite are highly bound in maternal plasma and unlikely to reach the breastmilk in large amounts, it has a slow clearance and long half-life and is potentially toxic to the breastfed infant. Because there is no published experience with fingolimod during breastfeeding, expert opinion generally recommends that it should be avoided during breastfeeding, especially while nursing a newborn or preterm infant. However, the manufacturer's labeling does not recommend against its use in breastfeeding.

Full LactMed record for fingolimod: levels in milk, effects in breastfed infants, and the drugs it would consider instead

National Institute of Child Health and Human Development, record revised January 15, 2026. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about fingolimod

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 6,533 reports naming fingolimod, and the FDA flagged 74% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

multiple sclerosis relapse661 reports
fatigue527 reports
lymphopenia485 reports
multiple sclerosis348 reports
headache311 reports
dizziness249 reports
lymphocyte count decreased221 reports
hypoaesthesia218 reports

Read these as a signal, not a rate. A report does not mean fingolimod caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.

Source: openFDA drug/event (FAERS), retrieved August 25, 2026.

How long fingolimod stays in your system

The elimination half-life of fingolimod is about 6 to 9 days (average apparent terminal half-life). This is the terminal (elimination) half-life, not a distribution phase. Fingolimod is a prodrug-like parent: it is phosphorylated by sphingosine kinase to fingolimod-phosphate, the pharmacologically active moiety. The label says fingolimod-phosphate blood levels decline in parallel with the parent in the terminal phase, "yielding similar half-lives for both" — so the active form does not outlast the parent, but it also does not clear any faster. Because the half-life is measured in days, blood levels take 1 to 2 months of once-daily dosing to reach steady state, and lymphocyte counts typically take 1 to 2 months to return to normal after stopping. Liver impairment: the apparent elimination half-life is unchanged in mild hepatic impairment but is prolonged by about 50% in moderate or severe impairment (Child-Pugh B or C); fingolimod AUC rises 12%/44%/103% in mild/moderate/severe. Kidney impairment: in severe renal impairment there is NO change in apparent elimination half-life (though fingolimod Cmax/AUC rise 32%/43%, and two inactive metabolites, M2 and M3, accumulate 3- and 13-fold). Older adults: the label states no dose adjustment is expected based on the elimination mechanism and population PK, but does not report a separate half-life for this group and notes experience above age 65 is limited. Not a drug-test detection window and not dosing guidance.

DailyMed — FINGOLIMOD (fingolimod hydrochloride) capsule, §12.3 Pharmacokinetics ↗

Half-life is how long the body takes to clear half a dose. It is not the same as how long a drug test can detect it, and it varies with age, kidney and liver function.

Related calculators

How long it stays in your system →

Frequently asked questions

What is fingolimod?

Fingolimod Hydrochloride is a sphingosine 1-phosphate receptor modulator used to treat Relapsing-Remitting Multiple Sclerosis.

What kind of drug is fingolimod?

The FDA classifies fingolimod as a sphingosine 1-phosphate receptor modulator. These drugs mimic the natural lipid signal S1P and bind its receptors on immune cells called lymphocytes. This traps the lymphocytes inside the lymph nodes so fewer circulate in the blood, reducing the inflammatory attack on the nervous system or gut in diseases like multiple sclerosis. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.

How long does fingolimod stay in your system?

The elimination half-life of fingolimod is about 6 to 9 days (average apparent terminal half-life) — that is how long the body takes to clear half of a dose. This is the terminal (elimination) half-life, not a distribution phase. Fingolimod is a prodrug-like parent: it is phosphorylated by sphingosine kinase to fingolimod-phosphate, the pharmacologically active moiety. The label says fingolimod-phosphate blood levels decline in parallel with the parent in the terminal phase, "yielding similar half-lives for both" — so the active form does not outlast the parent, but it also does not clear any faster. Because the half-life is measured in days, blood levels take 1 to 2 months of once-daily dosing to reach steady state, and lymphocyte counts typically take 1 to 2 months to return to normal after stopping. Liver impairment: the apparent elimination half-life is unchanged in mild hepatic impairment but is prolonged by about 50% in moderate or severe impairment (Child-Pugh B or C); fingolimod AUC rises 12%/44%/103% in mild/moderate/severe. Kidney impairment: in severe renal impairment there is NO change in apparent elimination half-life (though fingolimod Cmax/AUC rise 32%/43%, and two inactive metabolites, M2 and M3, accumulate 3- and 13-fold). Older adults: the label states no dose adjustment is expected based on the elimination mechanism and population PK, but does not report a separate half-life for this group and notes experience above age 65 is limited. Not a drug-test detection window and not dosing guidance. Half-life is not the same as how long a drug test can detect the drug, and it varies with age, kidney and liver function.

Can you take fingolimod with other medicines?

It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run fingolimod against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.

What brand names is fingolimod sold under?

We track 3 fingolimod-containing products in the U.S.: Fingolimod Hydrochloride, Gilenya and Fingolimod. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.

What forms does fingolimod come in?

Across the brands we track, fingolimod is currently marketed as capsule, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.

Is there a generic fingolimod?

Yes. Our catalog lists 2 generic fingolimod products alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.

Cite this page

APA: pharmaranks. (2026, July 24). Fingolimod: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/fingolimod
MLA: “Fingolimod: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/fingolimod.

We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.

Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.

Read the full FDA label for fingolimod on DailyMed (NIH) ↗.