Prescription medicine
Diroximel fumarate Brand names: Vumerity
Diroximel fumarate (Vumerity) 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 diroximel fumarate FDA label on DailyMed (effective May 29, 2025, Biogen Inc.); the NDA 211855 record on Drugs@FDA; every diroximel fumarate label on DailyMed.
Highlights of the record
FDA label of May 29, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVUMERITY 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
- 231 mg
Capsule.
On the market
- Earliest approval on file
- October 29, 2019 Vumerity, Biogen; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first November 12, 2025; 1 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
- October 29, 2033 Vumerity capsules; 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)
- 1 since 2020 0 Class I among all firms' recalls; latest December 9, 2020
- FAERS reports
- 11,848 through July 30, 2026
What is diroximel fumarate used for?
From the label: indications and usageVUMERITY 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. VUMERITY 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.
Conditions named in the indications of diroximel fumarate's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Vumerity), Biogen Inc., effective May 29, 2025 (SPL set 2d74414f-6b83-4ea2-9a95-3cecabbce774), via openFDA; the full label on DailyMed
What does the patient leaflet for diroximel fumarate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking VUMERITY?Do not drink alcohol at the time you take a VUMERITY dose.
From the patient leaflet: How should I store VUMERITY?Store VUMERITY at room temperature between 68°F to 77°F (20°C to 25°C). Keep VUMERITY and all medicines out of the reach of children. General Information about the safe and effective use of VUMERITY Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use VUMERITY for a condition for which it was not prescribed. Do not give VUMERITY to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information, talk to your doctor or pharmacist. You can ask your pharmacist or doctor for information about VUMERITY that is written for healthcare professionals.
Source: FDA drug label (Vumerity), Biogen Inc., effective May 29, 2025 (SPL set 2d74414f-6b83-4ea2-9a95-3cecabbce774), via openFDA; the full label on DailyMed
Is there a generic for diroximel fumarate (Vumerity)?
The FDA approved the first generic diroximel fumarate on November 12, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 3 patents for Vumerity capsules: the compound patent runs to October 29, 2033. 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
- 2033 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has diroximel fumarate been recalled?
The FDA's Enforcement Report lists 1 recall naming diroximel fumarate since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 9, 2020 | Class II | Biogen MA Inc. | Failed dissolution specifications: out-of-specification test results observed during the buffer stage dissolution testing. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the diroximel fumarate label say about other medicines?
The diroximel fumarate label names 4 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name diroximel fumarate. 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 |
|---|---|---|
| Aspirin | warnings and precautions | Studies with dimethyl fumarate show that administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )]. |
| Dimethyl fumarate | contraindications | CONTRAINDICATIONS VUMERITY is contraindicated in patients With known hypersensitivity to diroximel fumarate, dimethyl fumarate, or to any of the excipients of VUMERITY. |
| Monomethyl fumarate | drug interactions | DRUG INTERACTIONS 7.1 Concomitant Dimethyl Fumarate VUMERITY is contraindicated in patients currently taking dimethyl fumarate, which is also metabolized to monomethyl fumarate. |
| Natalizumab | warnings and precautions | The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. |
Source: FDA drug label (Vumerity), Biogen Inc., effective May 29, 2025 (SPL set 2d74414f-6b83-4ea2-9a95-3cecabbce774), via openFDA; the full label on DailyMed
What do FAERS reports show for diroximel fumarate?
The FDA Adverse Event Reporting System holds 11,848 reports that list diroximel fumarate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 354 are coded as a death and 2,305 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 2022 (2,568, against a median of 479 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 diroximel fumarate?
8 other medicines are given the same way (oral) and in the same FDA class as diroximel fumarate 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 |
|---|---|---|---|---|
| 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 |
| Fingolimod | Multiple sclerosis | 21 labelers | $1.58 per capsule 0.5 mg capsule | 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 |
| Siponimod | Multiple sclerosis | none listed | n/a | No current entry |
| Ponesimod | 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 diroximel fumarate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to diroximel fumarate
- 8 medicines for the same use
- Diroximel fumarate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other