Prescription medicine
Siponimod Brand names: Mayzent
Siponimod (Mayzent) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the siponimod FDA label on DailyMed (effective June 30, 2026, Novartis Pharmaceuticals Corporation); the NDA 209884 record on Drugs@FDA; every siponimod label on DailyMed.
Highlights of the record
FDA label of June 30, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageMAYZENT 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 adults.
Forms and strengths
- 0.25 mg
- 1 mg
- 2 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 26, 2019 Mayzent, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first April 22, 2025; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- April 23, 2036 Mayzent tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 8,869 through July 30, 2026
What is siponimod used for?
From the label: indications and usageMAYZENT 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 adults. MAYZENT is a sphingosine 1-phosphate (S1P) 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 adults.
Conditions named in the indications of siponimod's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Sphingosine 1-phosphate Receptor Modulator.
Source: FDA drug label (MAYZENT), Novartis Pharmaceuticals Corporation, effective June 30, 2026 (SPL set 44492772-5aed-4627-bd85-e8e89f308bb3), via openFDA; the full label on DailyMed
What does the patient leaflet for siponimod 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 MAYZENT?MAYZENT may cause serious side effects, including: 1. Infections. MAYZENT can increase your risk of serious infections that can be life-threatening and cause death. MAYZENT lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 to 4 weeks of stopping treatment. Your healthcare provider should review a recent blood test of your white blood cells before you start taking MAYZENT. Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with MAYZENT and for 3 to 4 weeks after your last dose of MAYZENT: fever tiredness body aches chills nausea vomiting headache with fever, neck stiffness, sensitivity to light, nausea, confusion (these may be symptoms of meningitis, an infection of the lining around your brain and spine or encephalitis, an infection of the brain) 2. Progressive multifocal leukoencephalopathy (PML). MAYZENT can increase your risk for PML, which is a rare brain infection that usually leads to death or severe disability. If PML happens, it usually happens in people with weakened immune systems, but has happened in people who do not have weakened immune systems. Symptoms of PML get worse over days to weeks. Call your healthcare provider right away if you have any new or worsening neurologic symptoms that have lasted several days, including: weakness on 1 side of your body loss of coordination in your arms and legs decreased strength problems with balance changes in your vision changes in your thinking or memory confusion changes in your personality 3. A problem with your vision called macular edema. Macular edema can cause some of the same vision symptoms as a multiple sclerosis (MS) attack (optic neuritis). […]
From the patient leaflet: How should I store MAYZENT?Unopened Containers MAYZENT 0.25 mg, 1 mg, and 2 mg tablets may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months. If you need to store MAYZENT tablets for more than 3 months, containers should remain unopened and stored in a refrigerator between 36°F to 46°F (2°C to 8°C) until use. Opened Containers Bottles MAYZENT 0.25 mg, 1 mg, and 2 mg tablets may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months. Do not refrigerate after opening. Starter Pack/Blister Card MAYZENT 0.25 mg tablets may be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 3 months. Do not refrigerate after opening. Store in original calendarized blister wallet container. Keep MAYZENT and all medicines out of the reach of children.
Source: FDA drug label (MAYZENT), Novartis Pharmaceuticals Corporation, effective June 30, 2026 (SPL set 44492772-5aed-4627-bd85-e8e89f308bb3), via openFDA; the full label on DailyMed
Is there a generic for siponimod (Mayzent)?
The FDA approved the first generic siponimod on April 22, 2025. 2 generic applications are approved; 0 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 2 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 5 patents for Mayzent tablets: the compound patent runs to August 27, 2028, and the last listed entry to April 23, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2025 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the siponimod label say about other medicines?
The siponimod label names 12 other medicines in its interaction, contraindication or warning sections. 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 |
|---|---|---|
| Alemtuzumab | drug interactions | Because of the characteristics and duration of alemtuzumab immune suppressive effects, initiating treatment with MAYZENT after alemtuzumab is not recommended. |
| Amiodarone | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Atropine | warnings and precautions | The conduction abnormalities typically were transient, asymptomatic, resolved within 24 hours, rarely required treatment with atropine, and did not require discontinuation of MAYZENT treatment. |
| Digoxin | drug interactions | … channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., ivabradine, digoxin) [see Warnings and Precautions (5.4) and Drug Interactions (7.3)]. |
| Diltiazem | drug interactions | … drugs with known arrhythmogenic properties, heart-rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., ivabradine, digoxin) [see Warnings and Precautions (5.4) and Drug Interactions (7.3)]. |
| Glatiramer | drug interactions | MAYZENT can generally be started immediately after discontinuation of beta interferon or glatiramer acetate. |
| Ivabradine | drug interactions | … calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may decrease heart rate (e.g., ivabradine, digoxin) [see Warnings and Precautions (5.4) and Drug Interactions (7.3)]. |
| Natalizumab | warnings and precautions | PML has occurred in MAYZENT-treated patients who had not been treated previously with natalizumab (which has a known association with PML), were not taking any other immunosuppressive or immunomodulatory medications concomitantly, and did not have any ongoing systemic medical conditions resulting in compromised immune … |
| Procainamide | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Quinidine | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Sotalol | drug interactions | Class Ia (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic drugs have been associated with cases of Torsades de Pointes in patients with bradycardia. |
| Verapamil | drug interactions | Because of the potential additive effects on heart rate, treatment with MAYZENT should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties, heart-rate lowering calcium channel blockers (e.g., verapamil, diltiazem), or other drugs that may … |
Source: FDA drug label (MAYZENT), Novartis Pharmaceuticals Corporation, effective June 30, 2026 (SPL set 44492772-5aed-4627-bd85-e8e89f308bb3), via openFDA; the full label on DailyMed
What do FAERS reports show for siponimod?
The FDA Adverse Event Reporting System holds 8,869 reports that list siponimod among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 1,463 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 rose sharply in 2020 (2,147, against a median of 507 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
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 siponimod?
8 other medicines are given the same way (oral) and in the same FDA class as siponimod 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 |
|---|---|---|---|---|
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to siponimod
- 8 medicines for the same use
- Other sphingosine 1-phosphate receptor modulators
- the pharmacologic class, with prices and generics
- Siponimod side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other