Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to almost white powder that is freely soluble in water and dimethyl sulfoxide; practically insoluble in dichloromethane and n-Heptane. It has a molecular weight of 343.93 g/mol. Fingolimod are provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: carrageenan, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, potassium chloride and titanium dioxide. Details of the non-volatile components of the imprinting ink are as follows; iron oxide black, potassium hydroxide, propylene glycol and shellac. Structure

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.

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.

Fingolimod: uses, dosing, side effects & brands

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) sourcesHow 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
Typical price: about $144 for a 30-count supply

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)] .…

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…

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?	Typical price
1	Fingolimod Hydrochloride	70/100	Prescription	Capsule	Generic	$144	View →
2	Gilenya	68/100	Prescription	Capsule	Generic

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

Frequently asked questions

What is fingolimod?: Fingolimod is a sphingosine 1-phosphate receptor modulator. Chemically, fingolimod is 2-amino-2-[2-(4-octylphenyl)ethyl]propan-1,3-diol hydrochloride. Its structure is shown below: Fingolimod hydrochloride is a white to almost white powder that is freely soluble in water and dimethyl sulfoxide; practically insoluble in dichloromethane and n-Heptane. It has a molecular weight of 343.93 g/mol. Fingolimod are provided as 0.5 mg hard gelatin capsules for oral use. Each capsule contains 0.56 mg of fingolimod hydrochloride, equivalent to 0.5 mg of fingolimod. Each fingolimod 0.5 mg capsule contains the following inactive ingredients: carrageenan, hypromellose, iron oxide yellow, magnesium stearate, microcrystalline cellulose, potassium chloride and titanium dioxide. Details of the non-volatile components of the imprinting ink are as follows; iron oxide black, potassium hydroxide, propylene glycol and shellac. Structure
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.
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.

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.