Monomethyl: uses, dosing, side effects & brands
Monomethyl is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Capsule
- Sold as
- Bafiertam
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How monomethyl is dosed
From the FDA label for Bafiertam (application NDA210296). Other monomethyl products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Blood tests are required prior to initiation of BAFIERTAM. ( 2.1 ) Starting dose: 95 mg twice a day, orally, for 7 days ( 2.2 ) Maintenance dose after 7 days: 190 mg (administered as two 95 mg capsules) twice a day, orally ( 2.2 ) Swallow BAFIERTAM capsules whole and intact. Do not crush, chew, or mix contents with food. ( 2.3 ) Take BAFIERTAM with or without food. ( 2.3 ) 2.1 Blood Tests Prior to Initiation of BAFIERTAM Obtain the following prior to treatment with BAFIERTAM: A complete blood cell count (CBC), including lymphocyte count [see Warnings and Precautions ( 5.4 )] . Serum aminotransferase, alkaline phosphatase, and total bilirubin levels [see Warnings and Precautions ( 5.5 )] . 2.2 Dosing Information The starting dosage for BAFIERTAM is 95 mg twice a day orally for 7 days. After 7 days, the dosage should be increased to the maintenance dosage of 190 mg (administered as two 95 mg capsules) twice a day orally. Temporary dosage reductions to 95 mg twice a day may be considered for individuals who do not tolerate the maintenance dosage. Within 4 weeks, the recommended dosage of 190 mg twice a day should be resumed. Discontinuation of BAFIERTAM should be considered for patients unable to tolerate return to the maintenance dosage. Administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to BAFIERTAM dosing may reduce the incidence or severity…
Monomethyl side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis and Angioedema [see Warnings and Precautions ( 5.1 )] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions ( 5.2 ) ] Herpes Zoster and Other Serious Opportunistic Infections [see Warnings and Precautions ( 5.3 ) ] Lymphopenia [see Warnings and Precautions ( 5.4 )] Liver Injury [see Warnings and Precautions ( 5.5 )] Flushing [see Warnings and Precautions ( 5.6 )] Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence for dimethyl fumarate [the prodrug of BAFIERTAM] ≥10% and ≥2% more than placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Banner Life Sciences at toll-free phone: 1-866-MMF- 95MG or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the following sections were obtained using dimethyl fumarate delayed-release capsules (the prodrug of BAFIERTAM). Adverse Reactions in Placebo-Controlled Trials with Dimethyl…
Who shouldn’t take monomethyl
BAFIERTAM is contraindicated in patients: with known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or to any of the excipients of BAFIERTAM. Reactions may include anaphylaxis or angioedema [see Warnings and Precautions ( 5.1 )]. taking dimethyl fumarate or diroximel fumarate [see Drug Interactions ( 7.1 )]. Known hypersensitivity to monomethyl fumarate, dimethyl fumarate, diroximel fumarate, or any of the excipients of BAFIERTAM Co-administration with dimethyl fumarate or diroximel fumarate ( 4 )
Monomethyl drug interactions
7.1 Concomitant Dimethyl Fumarate or Diroximel Fumarates Both dimethyl fumarate and diroximel fumarate are metabolized to monomethyl fumarate. Therefore, BAFIERTAM is contraindicated in patients currently taking dimethyl fumarate or diroximel fumarate. BAFIERTAM may be initiated the day following discontinuation of either of these drugs.
Every monomethyl product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Bafiertam.
What monomethyl pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 95 | 95 mg | white | oval | — |
Can you crush or split monomethyl?
At least one monomethylproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each monomethyl label says about crushing, splitting and chewingWhat people report to the FDA about monomethyl
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 4 reports naming monomethyl, and the FDA flagged 50% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- bradycardia1 reports
- chest discomfort1 reports
- covid-191 reports
- dizziness1 reports
- dyspnoea1 reports
- heart rate increased1 reports
- hypotension1 reports
- infection1 reports
Read these as a signal, not a rate. A report does not mean monomethyl caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is monomethyl?
Bafiertam (Monomethyl Fumarate) is a medication supplied as a capsule.
Can you take monomethyl 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 monomethyl against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does monomethyl come in?
Across the brands we track, monomethyl 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 monomethyl?
We do not currently list a generic-labelled monomethyl product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Monomethyl: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/monomethyl
- MLA
- “Monomethyl: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/monomethyl.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
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.
Read the full FDA label for monomethyl on DailyMed (NIH) ↗.