Prescription medicine
Fingolimod Brand names: Tascenso, Gilenya
Fingolimod (Gilenya) is a prescription medicine with an FDA approval on record since 2010. FDA's NDC Directory lists it from 21 generic labelers, and pharmacies paid $1.58 per fingolimod 0.5 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the fingolimod FDA label on DailyMed (effective July 22, 2026, Novartis Pharmaceuticals Corporation); the NDA 22527 record on Drugs@FDA; every fingolimod label on DailyMed.
Highlights of the record
FDA label of July 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageGILENYA is 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.
Forms and strengths
- 0.25 mg
- 0.5 mg
Capsule; orally disintegrating tablet.
On the market
- Earliest approval on file
- September 21, 2010 Gilenya, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 19 first December 4, 2019; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 23 of which 21 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- September 30, 2032 Gilenya capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $1.58 per capsule Fingolimod 0.5 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest July 11, 2023
- FAERS reports
- 86,658 through July 30, 2026
What is fingolimod used for?
From the label: indications and usageGILENYA is 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. GILENYA is 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.
Conditions named in the indications of fingolimod's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sphingosine 1-phosphate Receptor Modulator.
Source: FDA drug label (Gilenya), Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set cc9e1c8c-0e2b-44e2-878b-27057f786be9), via openFDA; the full label on DailyMed
What does the patient leaflet for fingolimod say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about GILENYA?GILENYA may cause serious side effects, including: 1. Slow heart rate (bradycardia or bradyarrhythmia) when you start taking GILENYA. GILENYA can cause your heart rate to slow down, especially after you take your first dose. You will have a test, called an electrocardiogram (ECG), to check the electrical activity of your heart before you take your first dose of GILENYA. All adults and children will be observed by a healthcare professional for at least 6 hours after taking their first dose of GILENYA. Children should also be observed by a healthcare professional for at least 6 hours after taking their first dose of 0.5 mg of GILENYA when switching from the 0.25 mg dose. After you take your first dose of GILENYA, and after a child takes their first dose of 0.5 mg of GILENYA when switching from the 0.25 mg dose: Your pulse and blood pressure should be checked every hour. You should be observed by a healthcare professional to see if you have any serious side effects. If your heart rate slows down too much, you may have symptoms, such as: dizziness tiredness feeling like your heart is beating slowly or skipping beats chest pain If you have any of the symptoms of slow heart rate, they will usually happen during the first 6 hours after your first dose of GILENYA. Symptoms can happen up to 24 hours after you take your first GILENYA dose. 6 hours after you take your first dose of GILENYA you will have another ECG. If your ECG shows any heart problems or if your heart rate is still too low or continues to decrease, you will continue to be observed. If you have any serious side effects after your first dose of GILENYA, especially those that require treatment with other medicines, you will stay in the medical facility to be observed overnight. […]
From the patient leaflet: How should I store GILENYA?Store GILENYA in the original bottle or blister pack in a dry place. Store GILENYA at room temperature between 68°F to 77°F (20°C to 25°C). Keep GILENYA and all medicines out of the reach of children.
Source: FDA drug label (Gilenya), Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set cc9e1c8c-0e2b-44e2-878b-27057f786be9), via openFDA; the full label on DailyMed
Is there a generic for fingolimod (Gilenya)?
The FDA approved the first generic fingolimod on December 4, 2019. 19 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 3 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists fingolimod from 21 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Gilenya capsules, the last expiring on September 30, 2032; a patent listed only for Tascenso ODT tablets runs to January 19, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2019 first generic approved
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for fingolimod (Gilenya)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $1.58 per Fingolimod 0.5 mg capsule, down 72% from $5.56 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Fingolimod 0.5 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Fingolimod 0.5 mg capsule | Generic | $1.58 per capsule | $47.37 | -72% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has fingolimod been recalled?
The FDA's Enforcement Report lists 1 recall naming fingolimod since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 11, 2023 | Class II | Ascend Laboratories, LLC | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the fingolimod label say about other medicines?
The fingolimod label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name fingolimod. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atropine | warnings and precautions | The conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hours on treatment, but they occasionally required treatment with atropine or isoproterenol. |
| Chlorpromazine | drug interactions | 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 … |
| Citalopram | drug interactions | 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 … |
| Digoxin | drug interactions | 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 AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers, such as diltiazem or verapamil) is limited. |
| Diltiazem | drug interactions | 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 AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers, such as diltiazem or verapamil) is limited. |
| Erythromycin | drug interactions | 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 … |
| Haloperidol | drug interactions | 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 … |
| Isoproterenol | warnings and precautions | The conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hours on treatment, but they occasionally required treatment with atropine or isoproterenol. |
| Ketoconazole | drug interactions | DRUG INTERACTIONS Systemic Ketoconazole: Monitor during concomitant use. |
| Methadone | drug interactions | 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 … |
| Mitoxantrone | drug interactions | 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 (5.2)]. |
| Natalizumab | drug interactions | 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 (5.2)]. |
| Teriflunomide | drug interactions | 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 (5.2)]. |
| Verapamil | drug interactions | 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 AV conduction (e.g., beta blockers, digoxin, or heart rate-slowing calcium channel blockers, such as diltiazem or verapamil) is limited. |
Other labels that name fingolimod
Source: FDA drug label (Gilenya), Novartis Pharmaceuticals Corporation, effective July 22, 2026 (SPL set cc9e1c8c-0e2b-44e2-878b-27057f786be9), via openFDA; the full label on DailyMed
What do FAERS reports show for fingolimod?
The FDA Adverse Event Reporting System holds 86,658 reports that list fingolimod among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,262 are coded as a death and 11,941 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as fingolimod?
8 other medicines are given the same way (oral) and in the same FDA class as fingolimod or labeled mainly for the same use (multiple sclerosis), the same class first. Multiple sclerosis lists all 23 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | Multiple sclerosis | none listed | n/a | No current entry |
| Dimethyl fumarate | Multiple sclerosis | 19 labelers | $0.467 per capsule 240 mg capsule | No current entry |
| Teriflunomide | Multiple sclerosis | 15 labelers | $0.233 per tablet 14 mg tablet | No current entry |
| Dalfampridine | Multiple sclerosis | 9 labelers | $0.399 per tablet 10 mg tablet | No current entry |
| Cladribine | Multiple sclerosis | 3 labelers | n/a | No current entry |
| Diroximel fumarate | Multiple sclerosis | none listed | n/a | No current entry |
| Monomethyl fumarate | Multiple sclerosis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as fingolimod
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does fingolimod compare with medicines for the same use?
1 side-by-side page set fingolimod beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to fingolimod
- 8 medicines for the same use
- Other sphingosine 1-phosphate receptor modulators
- the pharmacologic class, with prices and generics
- Fingolimod side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other