Monomethyl Fumarate
Monomethyl fumarate is an oral medication used to treat relapsing forms of multiple sclerosis (MS) in adults.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Monomethyl Fumarate: Patient Information Guide
A plain-language walkthrough of Monomethyl Fumarate — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Monomethyl fumarate is used to treat relapsing forms of multiple sclerosis (MS) in adults. All current approved uses are specific to Bafiertam, the oral delayed-release capsule form.
- Bafiertam treats clinically isolated syndrome — a first episode of neurological symptoms that may indicate MS
- Bafiertam treats relapsing-remitting MS — the most common form, where symptoms flare and then partially or fully recover
- Bafiertam treats active secondary progressive MS — a later stage of MS where disability gradually worsens but relapses still occur
⚙️How it works▾
The precise way monomethyl fumarate (MMF) helps control MS is not yet fully understood. It activates a cellular pathway called Nrf2, which helps the body defend against oxidative stress — a type of internal damage that can harm nerve cells. MMF also acts on nicotinic acid receptors. These actions are believed to contribute to its benefit in MS, though the complete picture is still being studied.
💊How it's taken▾
Bafiertam is taken by mouth twice a day as delayed-release capsules. Treatment starts at a lower dose for the first 7 days to help your body adjust, then steps up to the full maintenance dose. If you have trouble tolerating the maintenance dose, a temporary reduction may be possible — your prescriber will guide you on getting back to the full dose within about 4 weeks.
- Capsules must be swallowed whole — never crushed, chewed, or opened into food
- Can be taken with or without food; skipping food may help if stomach upset is a problem
- Follow your prescriber's exact schedule and dosing instructions
🤒Side effects — in detail▾
The most commonly reported side effects with this class of medication include:
- Flushing — sudden redness, warmth, or tingling, especially in the face
- Abdominal (belly) pain
- Diarrhea
- Nausea
- Vomiting
- Itching (pruritus) or rash
- Indigestion (dyspepsia)
- Temporary rise in a type of white blood cell called eosinophils (usually in the first 2 months)
Serious reactions — including severe allergic reactions, signs of a brain infection (PML), liver injury, or serious gut problems — require immediate medical attention. Don't wait to call your doctor if something feels seriously wrong.
⚠️Warnings & precautions▾
- Anaphylaxis and angioedema (severe allergic reaction): Seek emergency care immediately. Bafiertam must be stopped permanently if this occurs.
- Progressive Multifocal Leukoencephalopathy (PML): A rare but potentially fatal brain infection caused by the JC virus. Bafiertam should be stopped at the first sign of new or worsening neurological symptoms.
- Lymphopenia (low lymphocyte counts): Bafiertam can reduce infection-fighting white blood cells. Blood counts must be checked before treatment, at 6 months, and regularly thereafter.
- Serious infections: Including herpes zoster (shingles) and other opportunistic infections. Treatment may need to be paused if a serious infection develops.
- Liver injury: Liver function tests are needed before and during treatment. Report yellowing skin or eyes, dark urine, or unusual fatigue right away.
- Serious gastrointestinal events: Post-marketing reports include acute pancreatitis, gastrointestinal perforation, ulceration, obstruction, and bleeding.
🔀What it interacts with▾
There are a few important interactions to know about with monomethyl fumarate:
- Dimethyl fumarate (Tecfidera) or diroximel fumarate (Vumerity): These drugs are converted to the same active compound as Bafiertam. Taking them together is contraindicated — it would essentially be a dangerous double dose.
- Aspirin (non-enteric coated, up to 325 mg): Taking it about 30 minutes before a Bafiertam dose may help reduce flushing. Ask your doctor before adding aspirin to your routine.
- Interferon beta-1a or glatiramer acetate: Single doses did not affect how the body handles monomethyl fumarate in studies.
- Combined oral contraceptives: No meaningful interaction was found with one tested combination (norelgestromin/ethinyl estradiol), but not all contraceptive types have been studied.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Tell your doctor if you have ever had a serious allergic reaction to monomethyl fumarate, dimethyl fumarate, or diroximel fumarate — Bafiertam is contraindicated in those cases
- You must have blood tests (CBC with lymphocyte count, and liver function tests) before starting treatment
- Tell your doctor if you are pregnant or trying to become pregnant — animal studies showed harm to developing offspring, and Bafiertam may cause fetal harm
- Tell your doctor if you are breastfeeding — it is not known whether the drug passes into breast milk
- Bafiertam has not been studied in children; safety and effectiveness in pediatric patients have not been established
- Limited data exist for adults aged 65 and older; it is not known if they respond differently than younger patients
- No dose adjustment is needed for kidney or liver problems based on current data, but tell your doctor about any organ health concerns
📡Pharmacodynamics — effects in the body▾
Studies using dimethyl fumarate (the prodrug that converts to monomethyl fumarate) showed no clinically meaningful effect on the QT interval — an electrical measurement of heart rhythm — in healthy subjects. This suggests monomethyl fumarate is unlikely to cause dangerous heart rhythm changes at therapeutic doses.
🔬Pharmacokinetics — how your body processes it▾
After you take Bafiertam by mouth, the capsule releases monomethyl fumarate (MMF) which is absorbed and reaches peak blood levels in about 4 hours when taken without food. A high-fat meal slows absorption and delays peak levels to around 11 hours, though the total amount absorbed stays roughly the same. MMF is broken down through the body's normal energy cycle (not through liver enzymes like CYP450), and most of it is eliminated by breathing out as carbon dioxide. The drug clears quickly — its half-life is only about 30 minutes — and it does not build up in the body with repeated doses.
📦How to store it▾
Store unopened bottles in refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. stored at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) permitted .
📄 Written from Monomethyl Fumarate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Monomethyl Fumarate — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly does Bafiertam do for my MS? ▾
I've heard flushing is a big problem. Will that happen to me, and is there anything I can do about it? ▾
Does it matter if I take Bafiertam with food? ▾
Are there any other MS drugs I absolutely cannot take with Bafiertam? ▾
What warning signs should make me call my doctor right away? ▾
Is Bafiertam safe to take during pregnancy? ▾
Is Monomethyl Fumarate available over the counter? ▾
When was Monomethyl Fumarate first available? ▾
Who makes Monomethyl Fumarate? ▾
💬 Answers drafted from Monomethyl Fumarate’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Monomethyl Fumarate comes
Monomethyl Fumarate is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Capsule
How this form is used
- Bafiertam is used to treat relapsing forms of multiple sclerosis in adults, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS
- Bafiertam capsules must be swallowed whole and intact — do not crush, chew, or mix the contents with food
- Bafiertam can be taken with or without food; taking it without food may help reduce stomach side effects
- Bafiertam is taken twice a day — starting at a lower dose for the first 7 days, then increasing to the maintenance dose
- Taking non-enteric coated aspirin about 30 minutes before a Bafiertam dose may reduce flushing — check with your doctor first
📊 Monomethyl Fumarate across the U.S. market
How Monomethyl Fumarate appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (3) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Monomethyl Fumarate is used
A general measure of how commonly Monomethyl Fumarate is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Monomethyl Fumarate is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Monomethyl Fumarate prescribed? Of the 1,596 medications we measure, Monomethyl Fumarate ranks #1,492 by Medicaid prescriptions — more than 7% of them.
Utilization by Monomethyl Fumarate product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
monomethyl fumarate 95 MG Delayed Release Oral Capsule
Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2393587
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Monomethyl Fumarate, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 1 listed Monomethyl Fumarate NDCs with Medicaid activity.
🔍 Compare Monomethyl Fumarate products
A representative set of FDA-listed product records for Monomethyl Fumarate — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 95 mg | Oral | Banner Life Sciences LLC × 5 listings | NDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 kg/kg | — | Curia Italy S.r.l. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Honour Lab Limited | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | MSN Life Sciences Private Limited | BULK INGREDIENT | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Monomethyl Fumarate NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Monomethyl Fumarate — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Monomethyl Fumarate in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Monomethyl Fumarate went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Monomethyl Fumarate is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Monomethyl Fumarate belongs to the Other immunosuppressants class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Banner Life Sciences LLC is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.