Dimethyl Fumarate Glenmark
Oral immunomodulatory treatment for relapsing-remitting multiple sclerosis
Quick Facts About Dimethyl Fumarate Glenmark
Key Takeaways About Dimethyl Fumarate Glenmark
- Oral MS treatment: Dimethyl fumarate Glenmark is a convenient twice-daily oral capsule for relapsing-remitting multiple sclerosis, suitable for patients aged 13 and older
- Gradual dose increase: Treatment starts at 120 mg twice daily for the first 7 days, then increases to 240 mg twice daily to help minimize initial side effects
- Common early side effects: Flushing and gastrointestinal symptoms are very common initially but typically improve over the first month of treatment
- Blood monitoring required: Regular blood tests are necessary to monitor white blood cell counts, as dimethyl fumarate can lower lymphocyte levels and increase infection risk
- Take with food: Taking the capsules with food significantly reduces the most common side effects of flushing, nausea, and stomach discomfort
What Is Dimethyl Fumarate Glenmark and What Is It Used For?
Dimethyl fumarate Glenmark is an oral immunomodulatory medication used to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged 13 years and older. It reduces the frequency of MS relapses by modulating the immune system and protecting nerve cells from inflammatory damage.
Dimethyl fumarate Glenmark contains the active substance dimethyl fumarate (DMF), a fumaric acid ester that has been extensively studied for the treatment of multiple sclerosis. This medication is a generic version manufactured by Glenmark Arzneimittel GmbH and contains the same active ingredient found in the original branded formulation that received regulatory approval based on robust clinical trial data.
Multiple sclerosis is a chronic autoimmune disease affecting the central nervous system (CNS), including the brain and spinal cord. In MS, the body's own immune system mistakenly attacks the myelin sheath, the protective covering surrounding nerve fibers. This damage disrupts the transmission of nerve signals, leading to a wide range of neurological symptoms. According to the World Health Organization, approximately 2.8 million people worldwide live with multiple sclerosis, with the majority initially diagnosed with the relapsing-remitting form of the disease.
Relapsing-remitting MS (RRMS) is characterized by recurring episodes of neurological symptoms, known as relapses or attacks, followed by periods of partial or complete recovery. During a relapse, new or worsening symptoms may include difficulties with walking, impaired balance and coordination, visual disturbances such as blurred or double vision, numbness or tingling in the limbs, fatigue, and cognitive difficulties. While many symptoms may resolve between relapses, some degree of permanent neurological damage can accumulate over time if the disease is not adequately controlled.
How Dimethyl Fumarate Works
Dimethyl fumarate exerts its therapeutic effects through multiple mechanisms of action. After oral administration, dimethyl fumarate is rapidly metabolized to its primary active metabolite, monomethyl fumarate (MMF), which is responsible for much of the drug's pharmacological activity.
The primary mechanism of action involves activation of the nuclear factor erythroid 2-related factor 2 (Nrf2) pathway, a key cellular defense system against oxidative stress. When activated, Nrf2 moves into the cell nucleus and triggers the production of antioxidant enzymes and cytoprotective proteins. This helps protect nerve cells and oligodendrocytes (the cells that produce myelin) from the oxidative damage that contributes to disease progression in multiple sclerosis.
In addition to its antioxidant properties, dimethyl fumarate modulates the immune response by shifting the balance of immune cells from pro-inflammatory to anti-inflammatory profiles. It reduces the activation and proliferation of certain immune cells that are known to attack the central nervous system in MS, while promoting regulatory immune cell populations that help maintain immune tolerance. This dual action — protecting nerve cells while calming the overactive immune response — makes dimethyl fumarate an effective disease-modifying therapy for relapsing-remitting MS.
Clinical trials, including the pivotal DEFINE and CONFIRM studies, demonstrated that dimethyl fumarate significantly reduced the annualized relapse rate by approximately 44–53% compared to placebo and slowed the progression of physical disability as measured by the Expanded Disability Status Scale (EDSS). MRI studies also showed a significant reduction in the number of new or enlarging brain lesions, confirming the drug's ability to reduce ongoing inflammatory activity in the central nervous system.
Dimethyl fumarate Glenmark is a generic formulation that contains the same active substance (dimethyl fumarate) in the same dosage forms and strengths as the original branded product. Generic medicines undergo rigorous regulatory review to ensure they meet the same standards of quality, safety, and efficacy. The active substance may also be approved for other conditions not covered in this information — always follow your doctor's instructions.
What Should You Know Before Taking Dimethyl Fumarate Glenmark?
Before starting dimethyl fumarate, your doctor will perform blood tests to check your white blood cell count, kidney function, and liver function. You must not take this medication if you are allergic to dimethyl fumarate or if you have confirmed or suspected progressive multifocal leukoencephalopathy (PML).
Dimethyl fumarate can affect several aspects of your health, including your white blood cell count, kidney function, and liver function. Careful assessment before and during treatment is essential to ensure your safety. Your doctor will conduct a thorough evaluation before prescribing this medication and will continue to monitor you throughout treatment.
Contraindications
You must not take Dimethyl fumarate Glenmark if:
- You are allergic to dimethyl fumarate or any of the other ingredients in this medicine
- You are suspected of having or have been confirmed to have progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection
PML is caused by the JC virus and can occur when the immune system is severely weakened. It is a potentially life-threatening condition that can lead to severe disability. If you have any history of or concern about PML, discuss this with your doctor before starting treatment.
Warnings and Precautions
Talk to your doctor before taking Dimethyl fumarate Glenmark if you have:
- Severe kidney disease: Dimethyl fumarate is primarily excreted through the lungs as carbon dioxide and through the kidneys; impaired kidney function may affect drug clearance
- Severe liver disease: Liver function may be affected by this medication, and pre-existing liver problems require careful monitoring
- A disease of the stomach or intestines: Gastrointestinal conditions may be worsened by the common GI side effects of dimethyl fumarate
- A serious active infection: Such as pneumonia or other significant infections that may require treatment before starting immunomodulatory therapy
PML is a rare but serious brain infection that has been reported in patients treated with dimethyl fumarate, typically occurring after 1 to 5 years of treatment. Symptoms may resemble an MS relapse and can include new or worsening weakness on one side of the body, clumsiness, changes in vision, thinking or memory problems, confusion, personality changes, and difficulty with speech or communication. Contact your doctor immediately if you notice any new or worsening neurological symptoms, as early detection of PML is critical for patient outcomes. Your doctor will continue to monitor your white blood cell counts throughout treatment.
Herpes zoster (shingles) can occur during treatment with dimethyl fumarate. In some cases, serious complications have been reported. You should immediately inform your doctor if you suspect you have symptoms of shingles, such as a painful rash with blisters typically appearing on one side of the body or face, often preceded by burning, tingling, or numbness.
A rare but serious kidney condition called Fanconi syndrome has been reported with a product containing dimethyl fumarate in combination with other fumaric acid esters used for the treatment of psoriasis. If you notice that you are urinating more than usual, feel unusually thirsty and drink more than normal, experience unexplained muscle weakness, bone fractures, or persistent pain, contact your doctor promptly so that this can be investigated further.
Children and Adolescents
Dimethyl fumarate Glenmark is approved for the treatment of RRMS in patients aged 13 years and older. It should not be given to children under 10 years of age, as no clinical data are available for this age group. For adolescents aged 10 to 12, the prescribing physician will make an individual assessment based on the expected benefits and risks.
Pregnancy and Breastfeeding
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, talk to your doctor before taking this medicine.
- Pregnancy: There is limited information about the effects of dimethyl fumarate on unborn babies. Do not use this medication during pregnancy unless your doctor has discussed it with you and determined it is absolutely necessary for your care
- Breastfeeding: It is not known whether the active substance passes into breast milk. Your doctor will help you weigh the benefits of breastfeeding against the benefits of continuing treatment, so you can make an informed decision
Driving and Operating Machinery
Dimethyl fumarate is not expected to directly affect your ability to drive or use machines. However, you are responsible for assessing whether you are fit to perform these activities, taking into account any side effects you may experience from the medication. If you feel unwell or experience side effects that could impair your concentration or coordination, avoid driving or operating machinery until these symptoms resolve.
This medicine contains less than 1 mmol sodium (23 mg) per capsule and is therefore considered essentially sodium-free. This is relevant for patients on a sodium-restricted diet.
How Does Dimethyl Fumarate Glenmark Interact with Other Drugs?
Dimethyl fumarate may interact with other fumaric acid esters, immunosuppressive medications, nephrotoxic drugs, and live vaccines. Avoid consuming strong alcoholic beverages within one hour before or after taking the medication. Tell your doctor about all medicines you are currently taking.
Drug interactions with dimethyl fumarate are an important consideration, particularly because this medication modulates the immune system and can affect kidney function. It is essential to inform your doctor about all medications you are taking, including prescription drugs, over-the-counter medicines, and dietary supplements, so that potential interactions can be identified and managed.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Other fumaric acid esters | Increased risk of adverse effects due to additive pharmacological activity | Do not use concurrently; discontinue other fumarate products before starting |
| Immunosuppressants & cytotoxic agents | Increased risk of infections due to combined immunomodulatory effects | Use with caution; close monitoring of blood counts required |
| Other MS disease-modifying therapies | Additive immunosuppression with potential for increased infection risk | Generally avoid concurrent use; discuss switching strategies with your neurologist |
| Live vaccines | Risk of infection from live attenuated organisms during immunosuppression | Avoid live vaccines during treatment; inactivated vaccines may be used with caution |
| Nephrotoxic medications | Increased risk of kidney damage, including aminoglycosides, NSAIDs (ibuprofen), diuretics, and lithium | Monitor kidney function closely; discuss alternatives with your doctor |
Alcohol Interactions
You should avoid consuming more than a small amount (more than 50 ml) of strong alcoholic beverages (more than 30% alcohol by volume, such as spirits) within one hour before or after taking dimethyl fumarate. Alcohol can interact with the medication and cause inflammation of the stomach lining (gastritis), particularly in people who are already prone to gastrointestinal problems. Moderate consumption of lower-strength alcoholic beverages such as beer or wine is generally considered less problematic, but you should discuss your individual circumstances with your doctor.
Vaccination Considerations
If you are taking dimethyl fumarate and certain types of vaccines, specifically live vaccines, there is a risk that you could develop an infection. Your doctor will determine whether it is safe to administer non-live (inactivated) vaccines during your treatment. If you need to receive a live vaccine, your doctor will advise on the appropriate timing and whether a treatment break is necessary. Always inform your vaccination provider that you are taking dimethyl fumarate.
What Is the Correct Dosage of Dimethyl Fumarate Glenmark?
The starting dose is 120 mg twice daily for the first 7 days, followed by the maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with water, taken with food, and never crushed, chewed, or dissolved. Do not take a double dose to make up for a missed one.
Always take this medicine exactly as your doctor has told you. Dimethyl fumarate uses a gradual dose-escalation approach to help minimize the gastrointestinal and flushing side effects that are most common during the first weeks of treatment. Taking the medication consistently with food can further reduce these initial side effects.
Adults
Starting Dose (Days 1–7)
120 mg twice daily — Take one 120 mg capsule in the morning and one 120 mg capsule in the evening, approximately 12 hours apart. This lower starting dose helps your body gradually adjust to the medication and reduces the likelihood of initial side effects.
Maintenance Dose (Day 8 onward)
240 mg twice daily — After the first 7 days, increase to one 240 mg capsule in the morning and one 240 mg capsule in the evening. This is the standard maintenance dose that should be continued for the duration of treatment. Do not reduce the dose unless your doctor specifically instructs you to do so.
Children and Adolescents (13 years and older)
Adolescent Dosing
The same dosing regimen as adults applies to patients aged 13 years and older: 120 mg twice daily for the first 7 days, followed by 240 mg twice daily. Dose adjustments based on body weight are not typically required. Your doctor will monitor your child closely during treatment, particularly regarding blood counts and tolerability.
How to Take
Dimethyl fumarate Glenmark gastro-resistant hard capsules must be swallowed whole with a little water. Do not split, crush, dissolve, suck, or chew the capsules, as doing so may increase the risk of certain side effects by disrupting the gastro-resistant coating designed to protect the stomach lining.
Take with food — taking your capsules during or immediately after a meal can significantly help reduce the very common side effects of flushing (skin redness, warmth, itching) and gastrointestinal discomfort (nausea, diarrhea, stomach pain) that are most noticeable during the early weeks of treatment.
Missed Dose
If you forget to take a dose, do not take a double dose to compensate for the missed one. You may take the missed dose if you allow at least 4 hours between doses. If less than 4 hours remain until your next scheduled dose, simply skip the missed dose and take your next dose at the usual time. Try to maintain a regular dosing schedule to ensure consistent therapeutic levels of the medication.
Overdose
If you take more of this medicine than you should, or if a child accidentally ingests the medication, contact your doctor or go to the nearest emergency department immediately for an assessment of the risk and medical advice. You may experience side effects similar to those described in the side effects section. There is no specific antidote for dimethyl fumarate overdose; treatment is supportive and based on the symptoms that develop.
What Are the Side Effects of Dimethyl Fumarate Glenmark?
The most common side effects are flushing (redness and warmth of the skin) and gastrointestinal symptoms including diarrhea, nausea, and abdominal pain. These are most pronounced during the first month and typically improve with continued use. The most serious risk is lymphopenia, which can increase susceptibility to infections including the rare brain infection PML.
Like all medicines, dimethyl fumarate can cause side effects, although not everyone who takes it will experience them. Understanding the possible side effects — both common and rare — helps you know what to expect and when to seek medical attention. Many of the most common side effects are temporary and tend to diminish as your body adjusts to the medication over the first several weeks.
Flushing (redness of the face or body) is a very common side effect. However, if you experience flushing together with a red rash or hives along with any of the following symptoms, it may be a severe allergic reaction (anaphylaxis): swelling of the face, lips, mouth or tongue; wheezing, difficulty breathing or shortness of breath; dizziness or loss of consciousness. Stop taking the medication and seek emergency medical attention immediately.
Side Effect Frequency Overview
Very Common (affects more than 1 in 10 patients)
- Flushing: redness of the face or body, feeling of warmth, heat, burning, or itching of the skin
- Diarrhea (loose stools)
- Nausea
- Abdominal pain or cramping
- Ketones in urine (substances naturally produced by the body, detected on urine tests)
Common (affects up to 1 in 10 patients)
- Gastroenteritis (inflammation of the intestines)
- Vomiting
- Dyspepsia (indigestion)
- Gastritis (inflammation of the stomach lining)
- Gastrointestinal disorder
- Burning sensation
- Hot flush, feeling of warmth
- Pruritus (itching of the skin)
- Rash
- Erythema (pink or red patches on the skin)
- Alopecia (hair loss)
- Lymphopenia/leukopenia: low white blood cell counts in blood tests, which may reduce the body's ability to fight infections
- Proteinuria: proteins (albumin) detected in urine
- Elevated liver enzymes (ALT, AST) detected in blood tests
Uncommon (affects up to 1 in 100 patients)
- Allergic reactions (hypersensitivity)
- Thrombocytopenia: decreased number of blood platelets
Rare (affects up to 1 in 1,000 patients)
- Hepatitis: liver inflammation with elevated liver enzymes (ALT or AST in combination with bilirubin)
Not Known (frequency cannot be estimated from available data)
- Herpes zoster (shingles): painful blistering rash, burning sensation, itching or pain in the skin, typically on one side of the upper body or face, sometimes accompanied by fever and weakness
- Rhinorrhea: runny nose
Managing Common Side Effects
The flushing and gastrointestinal side effects that are most common during the first weeks of treatment can often be managed with simple strategies. Taking dimethyl fumarate with food is the most effective way to reduce these symptoms. Your doctor may also recommend taking aspirin (or another anti-inflammatory) approximately 30 minutes before your dose to help reduce flushing. If side effects are particularly bothersome, your doctor may temporarily reduce your dose, but you should not change your dose without medical advice.
It is important to keep all scheduled blood test appointments during treatment. Regular monitoring of your complete blood count, particularly lymphocyte levels, is essential. If your white blood cell count drops significantly, your doctor may consider additional testing or may decide to discontinue treatment to protect you from the increased risk of infections.
Side Effects in Adolescents
The side effects listed above also apply to children and adolescents aged 13 years and older. However, certain side effects were reported more frequently in younger patients than in adults, including headache, abdominal pain or cramping, nausea, vomiting, sore throat, cough, and painful menstrual periods. Parents and caregivers should monitor younger patients closely and report any concerning symptoms to the treating physician.
How Should You Store Dimethyl Fumarate Glenmark?
Store this medicine out of the sight and reach of children. No special storage conditions are required. Do not use after the expiration date printed on the carton or blister pack. Dispose of unused medicines properly — do not throw them in household waste or flush them down the drain.
Proper storage of medications is important to ensure they remain effective and safe throughout their shelf life. Dimethyl fumarate Glenmark does not require any special storage conditions such as refrigeration or protection from light, making it straightforward to store at home.
Keep this medicine in the original packaging until ready to use. Check the expiration date on the carton or blister foil before each use — the date refers to the last day of the indicated month. Do not use this medicine after that date has passed.
When you have finished a course of treatment or have leftover capsules that have expired, do not dispose of them through household waste or by flushing them down the drain. Ask your pharmacist how to properly dispose of medicines you no longer need. These measures help protect the environment and prevent accidental exposure.
What Does Dimethyl Fumarate Glenmark Contain?
Dimethyl fumarate Glenmark contains the active substance dimethyl fumarate, available in 120 mg and 240 mg gastro-resistant hard capsules. The capsules contain enteric-coated mini-tablets designed to release the active ingredient in the intestine rather than the stomach, helping to reduce gastrointestinal side effects.
Active Substance
The active ingredient is dimethyl fumarate:
- 120 mg capsule: Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate
- 240 mg capsule: Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate
Excipients (Inactive Ingredients)
The other ingredients in the capsule contents (enteric-coated mini-tablets) include:
- Microcrystalline cellulose
- Croscarmellose sodium
- Talc (E553b)
- Colloidal anhydrous silicon dioxide (E551)
- Magnesium stearate (E470b)
- Triethyl citrate (E1505)
- Methacrylic acid-methyl methacrylate copolymer (1:1)
- Methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30%
- Simethicone
Appearance and Pack Sizes
Dimethyl fumarate Glenmark capsules are hard gastro-resistant capsules filled with white to off-white, round mini-tablets:
- 120 mg capsules (size 1, 20 mm): White opaque body imprinted with “307” in black ink and a blue cap imprinted with “G” in black ink. Available in blister packs of 14, 28, or 56 capsules, and perforated unit dose blister packs of 14×1, 28×1, or 56×1 capsules
- 240 mg capsules (size 0, 22 mm): Blue body imprinted with “308” in black ink and a blue cap imprinted with “G” in black ink. Available in blister packs of 56, 112, 168, or 196 capsules, and perforated unit dose blister packs of 56×1, 112×1, 168×1, or 196×1 capsules
Not all pack sizes may be available in all markets.
Marketing Authorization Holder and Manufacturer
Marketing authorization holder: Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany
Manufacturer: Glenmark Pharmaceutical s.r.o., Fibichova 143, 566 17 Vysoké Mýto, Czech Republic
Frequently Asked Questions About Dimethyl Fumarate Glenmark
Dimethyl fumarate Glenmark is used to treat relapsing-remitting multiple sclerosis (RRMS) in patients aged 13 years and older. It is an oral immunomodulatory medication that helps reduce the frequency of MS relapses and may slow the progression of physical disability caused by MS. It works by modulating the immune system and protecting nerve cells from oxidative damage.
The most common side effects are flushing (redness, warmth, burning, or itching of the skin) and gastrointestinal symptoms including diarrhea, nausea, and abdominal pain or cramping. These side effects are most pronounced during the first month of treatment and typically improve over time. Taking the medication with food can significantly help reduce these effects. Your doctor may also suggest taking aspirin before your dose to minimize flushing.
Dimethyl fumarate is taken orally twice daily. The starting dose is 120 mg twice daily for the first 7 days, then increased to the maintenance dose of 240 mg twice daily. Capsules should be swallowed whole with water and taken with food to help reduce flushing and gastrointestinal side effects. Never crush, chew, or open the capsules, as this may increase side effects by disrupting the gastro-resistant coating.
Yes. Dimethyl fumarate can lower lymphocyte counts (a type of white blood cell), which may increase the risk of infections, including a rare but serious brain infection called progressive multifocal leukoencephalopathy (PML). PML has been reported after 1 to 5 years of treatment. Regular blood tests are required to monitor lymphocyte levels throughout treatment. If lymphocyte counts drop significantly, your doctor may consider additional testing or stopping treatment.
You should avoid consuming more than a small amount of strong alcoholic beverages (more than 50 ml of drinks with over 30% alcohol content, such as spirits) within one hour before and after taking dimethyl fumarate. Alcohol can interact with the medication and increase the risk of stomach inflammation (gastritis), particularly in people who are already prone to stomach problems. Moderate consumption of lower-strength beverages is generally less problematic, but discuss your individual situation with your doctor.
There is limited information about the effects of dimethyl fumarate on unborn babies when used during pregnancy. You should not use this medication during pregnancy unless your doctor has discussed it with you and determined it is absolutely necessary. It is also unknown whether the active substance passes into breast milk. Your doctor will help you weigh the benefits and risks. If you are planning a pregnancy, discuss this with your neurologist to consider the most appropriate treatment strategy.
References
- European Medicines Agency (EMA). Dimethyl fumarate Glenmark — Summary of Product Characteristics. Available at: ema.europa.eu. Accessed December 2025.
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis (DEFINE study). N Engl J Med. 2012;367(12):1098-1107. doi:10.1056/NEJMoa1114287
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis (CONFIRM study). N Engl J Med. 2012;367(12):1087-1097. doi:10.1056/NEJMoa1206328
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN Guideline on the pharmacological treatment of people with multiple sclerosis. Mult Scler. 2018;24(2):96-120. doi:10.1177/1352458517751049
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline recommendations summary: Disease-modifying therapies for adults with multiple sclerosis. Neurology. 2018;90(17):777-788. doi:10.1212/WNL.0000000000005347
- World Health Organization (WHO). Atlas of MS 2020: Mapping Multiple Sclerosis Around the World. Geneva: WHO; 2020.
- Linker RA, Lee DH, Ryan S, et al. Fumaric acid esters exert neuroprotective effects in neuroinflammation via activation of the Nrf2 antioxidant pathway. Brain. 2011;134(3):678-692. doi:10.1093/brain/awq386
- U.S. Food and Drug Administration (FDA). Dimethyl fumarate — Prescribing Information. Updated 2024.
About the Editorial Team
This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialists in neurology, pharmacology, and clinical medicine. Our content follows the GRADE evidence framework and is based on peer-reviewed research, international clinical guidelines (EMA, FDA, AAN, ECTRIMS/EAN), and established medical standards.
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