Dimethyl fumarate Reddy: Uses, Dosage & Side Effects
An oral immunomodulatory agent for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults, activating the Nrf2 antioxidant pathway to reduce inflammation and protect the nervous system
Dimethyl fumarate Reddy is a generic oral medication used for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adult patients. It contains the active substance dimethyl fumarate, which belongs to the class of immunomodulatory agents. The medication works by activating the Nrf2 antioxidant pathway and modulating the immune response to reduce the frequency of MS relapses and slow disability progression. Available as gastro-resistant hard capsules in 120 mg and 240 mg strengths, it is taken twice daily by mouth. Dimethyl fumarate Reddy is bioequivalent to the original brand Tecfidera and requires a prescription initiated by a specialist experienced in treating multiple sclerosis.
Quick Facts: Dimethyl fumarate Reddy
Key Takeaways
- Dimethyl fumarate Reddy is a generic oral medication approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults, offering the same efficacy and safety profile as the original brand Tecfidera at a potentially lower cost.
- The medication works through activation of the Nrf2 antioxidant pathway and immunomodulatory effects, reducing the frequency of MS relapses by approximately 44–53% compared with placebo in pivotal clinical trials (DEFINE and CONFIRM).
- Regular blood monitoring is essential: complete blood counts including lymphocyte counts must be checked before treatment, every 3 months during treatment, and after discontinuation to detect lymphopenia that may increase the risk of progressive multifocal leukoencephalopathy (PML).
- The most common side effects – flushing and gastrointestinal symptoms – typically improve after the first month of treatment and can be minimized by taking capsules with food and by using the starter dose of 120 mg twice daily for the first 7 days.
- Dimethyl fumarate should not be used during pregnancy unless clearly necessary; women of childbearing potential should use effective contraception, and treatment should be discontinued if a patient becomes pregnant unless the benefits clearly outweigh the risks.
What Is Dimethyl fumarate Reddy and What Is It Used For?
Dimethyl fumarate Reddy contains the active substance dimethyl fumarate (DMF), a fumaric acid ester that has been extensively studied and used in the treatment of multiple sclerosis since the original brand product (Tecfidera) received regulatory approval from the European Medicines Agency (EMA) in 2014 and the U.S. Food and Drug Administration (FDA) in 2013. As a generic medication, Dimethyl fumarate Reddy has been demonstrated to be bioequivalent to the originator product, meaning it delivers the same amount of active drug to the body at the same rate, ensuring equivalent therapeutic effects.
Multiple sclerosis (MS) is a chronic autoimmune disease of the central nervous system (CNS) in which the immune system mistakenly attacks the myelin sheath – the protective coating around nerve fibers in the brain and spinal cord. This process, known as demyelination, disrupts the ability of nerves to transmit electrical signals efficiently, leading to a wide range of neurological symptoms including vision problems, muscle weakness, coordination difficulties, fatigue, numbness, and cognitive impairment. In relapsing-remitting MS, the most common form of the disease affecting approximately 85% of patients at initial diagnosis, patients experience clearly defined episodes of worsening neurological function (relapses) followed by periods of partial or complete recovery (remissions).
Dimethyl fumarate exerts its therapeutic effects through a dual mechanism of action that addresses both the inflammatory and neurodegenerative components of MS. The primary mechanism involves activation of the nuclear factor erythroid 2-related factor 2 (Nrf2) transcriptional pathway, a master regulator of the cellular antioxidant response. When dimethyl fumarate is absorbed and converted to its active metabolite monomethyl fumarate (MMF), MMF modifies the Keap1 protein, which normally keeps Nrf2 sequestered in the cytoplasm. This modification allows Nrf2 to translocate to the cell nucleus, where it binds to antioxidant response elements (AREs) and upregulates the expression of cytoprotective genes. These include NAD(P)H dehydrogenase [quinone] 1 (NQO1), heme oxygenase-1 (HO-1), and glutamate-cysteine ligase, all of which play important roles in protecting cells from oxidative damage.
The second major component of dimethyl fumarate’s mechanism involves direct immunomodulatory effects. The drug promotes a shift in the balance of T helper (Th) cell responses away from the pro-inflammatory Th1 and Th17 phenotypes – which drive the autoimmune attack on myelin – and toward the anti-inflammatory Th2 phenotype. This is accompanied by a reduction in the production of pro-inflammatory cytokines such as interleukin-6 (IL-6), interleukin-17 (IL-17), interferon-gamma (IFN-γ), and tumor necrosis factor-alpha (TNF-α). Over the course of treatment, dimethyl fumarate also produces a sustained reduction in absolute lymphocyte counts, with a preferential decrease in CD8+ T cells and memory T cells while relatively preserving naive T cells and regulatory T cell populations. This selective immunological profile contributes to its efficacy while maintaining a favorable safety profile.
The clinical efficacy of dimethyl fumarate in RRMS was established in two large, Phase III, randomized, double-blind, placebo-controlled clinical trials:
- DEFINE trial: In this study of 1,234 patients, dimethyl fumarate 240 mg twice daily reduced the annualized relapse rate by 53% compared with placebo over 2 years (p < 0.001). The risk of confirmed disability progression sustained for 12 weeks was reduced by 38% (p = 0.01), and the number of new or enlarging T2 hyperintense lesions on MRI was reduced by 85% (p < 0.001).
- CONFIRM trial: This study of 1,417 patients included glatiramer acetate as an active reference comparator. Dimethyl fumarate 240 mg twice daily reduced the annualized relapse rate by 44% compared with placebo over 2 years (p < 0.001), and reduced new or enlarging T2 lesions by 71% (p < 0.001).
Long-term extension studies (ENDORSE) have demonstrated sustained efficacy and a consistent safety profile over more than 10 years of continuous treatment, making dimethyl fumarate one of the most extensively studied oral disease-modifying therapies for MS. Current international guidelines from the American Academy of Neurology (AAN) and the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) recommend dimethyl fumarate as one of several first-line treatment options for adults with RRMS.
Dimethyl fumarate Reddy is a generic version of Tecfidera. Generic medicines must meet strict regulatory standards for pharmaceutical quality and bioequivalence, demonstrating that they deliver the same therapeutic benefit as the reference product. The active ingredient, dose strengths (120 mg and 240 mg), dosage form (gastro-resistant hard capsules), and route of administration (oral) are identical. Minor differences may exist in inactive ingredients (excipients), but these do not affect the clinical efficacy or safety of the medication.
What Should You Know Before Taking Dimethyl fumarate Reddy?
Before initiating treatment with Dimethyl fumarate Reddy, your prescribing physician – who should be a neurologist or specialist experienced in managing multiple sclerosis – will perform a thorough clinical evaluation. This assessment is designed to identify any conditions that may make the medication unsuitable for you or require special monitoring. Understanding the precautions, contraindications, and potential risks is essential for safe and effective use of the medication.
Contraindications
Dimethyl fumarate Reddy must not be used in certain situations due to unacceptable safety risks. These absolute contraindications include:
- Hypersensitivity: Do not take this medication if you have a known allergy to dimethyl fumarate or any of the excipients (inactive ingredients) listed in the product information. Allergic reactions can range from mild skin reactions to serious anaphylaxis.
- Suspected or confirmed progressive multifocal leukoencephalopathy (PML): Dimethyl fumarate must not be initiated in patients with suspected or confirmed PML, a serious opportunistic brain infection caused by the JC virus.
Warnings and Precautions
Cases of PML have been reported in patients taking dimethyl fumarate, primarily in those with prolonged moderate to severe lymphopenia (lymphocyte counts below 0.5 × 109/L for more than 6 months). PML is a rare but serious brain infection that can cause severe disability or death. Symptoms may include progressive weakness on one side of the body, clumsiness, visual disturbances, changes in thinking, memory, and orientation, and personality changes. If PML is suspected, treatment must be withheld until PML has been excluded. Report any new or worsening neurological symptoms to your doctor immediately.
Your doctor will discuss the following important warnings and precautions with you before and during treatment:
- Lymphopenia and immune monitoring: Dimethyl fumarate causes a dose-dependent reduction in lymphocyte counts. Before starting treatment, a recent (within 6 months) complete blood count (CBC) with differential including lymphocyte count must be available. CBCs must be repeated every 3 months during treatment and continued after discontinuation until lymphocyte recovery. If lymphocyte counts fall below 0.5 × 109/L and remain at this level for more than 6 months, treatment should be discontinued due to the increased risk of PML and other opportunistic infections.
- Infections: Dimethyl fumarate may increase susceptibility to infections, including serious and opportunistic infections. Cases of herpes zoster (shingles), herpes simplex, and other viral reactivations have been reported. Patients with active serious infections should not start treatment until the infection has resolved. If a patient develops a serious infection during treatment, temporary discontinuation should be considered.
- Liver injury: Clinically significant liver damage, including elevated liver enzymes and cases of drug-induced liver injury, has been reported. Liver function tests (serum aminotransferases and total bilirubin) should be obtained before starting treatment and during treatment as clinically indicated. Discontinue treatment if clinically significant liver injury is suspected.
- Flushing: Flushing is a very common side effect that occurs in approximately 40% of patients. It is typically described as warmth, redness, itching, or a burning sensation of the skin, often affecting the face, neck, and upper body. While generally not dangerous, severe flushing may include systemic symptoms. Taking dimethyl fumarate with food and temporarily taking aspirin (325 mg, 30 minutes before the dose) may help reduce flushing. Flushing episodes typically decrease in frequency and severity after the first month of treatment.
- Gastrointestinal events: Nausea, vomiting, diarrhea, abdominal pain, and dyspepsia are common, particularly during the first month of treatment. Taking capsules with food can significantly reduce these effects. Starting with the lower 120 mg dose for the first week allows the body to adjust before increasing to the full maintenance dose.
- Renal function: Cases of Fanconi syndrome (a disorder of kidney tubule function) and proteinuria have been reported in patients treated with dimethyl fumarate. Monitoring of kidney function, including urinalysis, is recommended periodically during treatment.
- Severe prolonged lymphopenia: Cases of severe, prolonged lymphopenia have been associated with opportunistic infections beyond PML, including cryptococcal meningitis, disseminated herpes simplex, and serious herpes zoster infections. If lymphocyte counts are persistently low, consideration should be given to additional diagnostic evaluation and treatment modification.
Pregnancy and Breastfeeding
Dimethyl fumarate should not be used during pregnancy unless clearly necessary and the potential benefit to the mother justifies the potential risk to the fetus. Data from animal studies have shown adverse effects on fertility and embryo-fetal development at doses producing systemic exposures comparable to or higher than those achieved in humans at the recommended therapeutic dose. These findings included reduced fetal weight, delayed ossification, and increased fetal variations. However, comprehensive human pregnancy registry data and observational studies conducted to date have not identified a clear pattern of birth defects or adverse pregnancy outcomes specifically attributable to dimethyl fumarate exposure.
Women of childbearing potential should use effective contraception during treatment with dimethyl fumarate. If a patient becomes pregnant while taking the medication, the treating physician should be contacted promptly to discuss whether treatment should be continued or discontinued, weighing the individual benefits of ongoing MS disease control against the potential risks to the developing fetus. Given the relatively short half-life of the active metabolite (approximately 1 hour), discontinuation results in rapid drug elimination.
It is not known whether dimethyl fumarate or its metabolites are excreted in human breast milk. A risk to the breastfed infant cannot be excluded. The decision to discontinue breastfeeding or to discontinue the medication should be made on an individual basis, taking into account the benefit of breastfeeding for the child and the benefit of ongoing MS therapy for the mother.
Animal studies have shown effects on male fertility (testicular atrophy and reduced fertility at high doses) and female fertility (irregular estrous cycles). While the relevance to human fertility at clinical doses is not fully established, patients planning to have children should discuss this with their neurologist before starting or continuing treatment.
Driving and Operating Machinery
No specific studies on the effect of dimethyl fumarate on driving or operating machinery have been conducted. However, given that dizziness and fatigue are recognized side effects, patients should exercise caution if they experience these symptoms. Multiple sclerosis itself can also affect a person’s ability to drive or operate machinery, so patients should be guided by their overall clinical condition and any side effects they experience.
How Does Dimethyl fumarate Reddy Interact with Other Drugs?
Dimethyl fumarate has a distinct metabolic profile that limits its potential for pharmacokinetic drug interactions. After oral administration, dimethyl fumarate undergoes rapid presystemic hydrolysis by esterases – not by the cytochrome P450 (CYP450) enzyme system – to its primary active metabolite, monomethyl fumarate (MMF). MMF is subsequently metabolized via the tricarboxylic acid (TCA) cycle, with carbon dioxide as the major elimination pathway. Because the CYP450 system is not meaningfully involved in the metabolism of dimethyl fumarate or MMF, the drug has a low potential for pharmacokinetic interactions with medications metabolized by CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4/5. In vitro studies have confirmed that therapeutic concentrations of MMF do not inhibit or induce these CYP enzymes.
However, there are important pharmacodynamic interactions and clinical considerations that must be taken into account when dimethyl fumarate is used alongside other medications:
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Other MS disease-modifying therapies (e.g., fingolimod, natalizumab, teriflunomide, ocrelizumab) | Additive immunosuppression, significantly increased risk of infections including PML | Do not combine; allow adequate washout period when switching between MS therapies |
| Immunosuppressive agents (e.g., azathioprine, methotrexate, cyclophosphamide, ciclosporin) | Additive immunosuppression, increased risk of serious infections and lymphopenia | Avoid concurrent use; consider immune status before initiating dimethyl fumarate |
| Live and live-attenuated vaccines (e.g., MMR, varicella, BCG, yellow fever) | Risk of vaccine-strain infection due to reduced immune competence | Avoid during treatment; complete vaccinations before starting therapy if possible |
| Nephrotoxic medications (e.g., aminoglycosides, NSAIDs in high doses, certain antivirals) | Potential additive risk of renal tubular injury, including Fanconi syndrome | Use with caution; monitor kidney function more frequently |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Aspirin (acetylsalicylic acid, low-dose) | May reduce flushing episodes when taken 30 minutes before dimethyl fumarate | Beneficial co-administration; commonly recommended during initiation phase |
| Oral contraceptives | No clinically relevant pharmacokinetic interaction observed in studies | Can be safely co-administered; no dose adjustment required |
| Inactivated vaccines (e.g., influenza, COVID-19 mRNA vaccines) | Immune response may be slightly reduced due to immunomodulation | Can be given during treatment; response should be monitored if clinically relevant |
| Interferon beta (if switching from prior therapy) | No direct pharmacological interaction; consideration of immune status required | Washout not typically needed; check blood counts before switching |
When switching between MS disease-modifying therapies, the duration and mechanism of immunosuppression of the prior therapy must be considered. For example, patients switching from fingolimod or natalizumab should have adequate immune reconstitution (including lymphocyte recovery) confirmed before starting dimethyl fumarate. Conversely, when switching from dimethyl fumarate to another therapy, the current lymphocyte count should be assessed to ensure it is within an acceptable range for the new treatment. Your neurologist will manage these transitions carefully to minimize the period of unprotected disease activity while avoiding overlapping immunosuppression.
Concurrent use of dimethyl fumarate with short courses of systemic corticosteroids (e.g., for treating acute MS relapses with intravenous methylprednisolone) is generally considered acceptable, as corticosteroid courses for relapses are typically brief and do not produce the same sustained immunosuppression as chronic immunosuppressive therapy. Your neurologist will make this decision based on your individual clinical circumstances.
What Is the Correct Dosage of Dimethyl fumarate Reddy?
Dimethyl fumarate Reddy is taken orally as gastro-resistant hard capsules. The capsules are designed with a special enteric coating that prevents the drug from being released in the stomach and instead allows release in the small intestine, which helps reduce gastrointestinal side effects. It is critically important that capsules are swallowed whole and not crushed, chewed, broken, or opened, as this would destroy the protective coating and potentially increase side effects and alter drug absorption.
Adults
Starting Dose (Titration Phase)
Dose: 120 mg twice daily (one 120 mg capsule morning and evening)
Duration: First 7 days of treatment
This lower starting dose allows the body to adjust to the medication and helps reduce the severity of flushing and gastrointestinal side effects during the initial treatment period. Always take capsules with food (a substantial meal or snack) to further minimize these effects.
Maintenance Dose
Dose: 240 mg twice daily (one 240 mg capsule morning and evening)
Duration: Ongoing, for as long as the treating physician determines the medication is providing benefit
After the 7-day titration period, the dose is increased to the full maintenance dose. Continue to take capsules with food. If patients have difficulty tolerating the maintenance dose due to flushing or gastrointestinal symptoms, a temporary dose reduction to 120 mg twice daily may be considered, but the full dose of 240 mg twice daily should be resumed within 4 weeks. Sustained use of the lower dose beyond 4 weeks is not recommended.
Children and Adolescents
The safety and efficacy of dimethyl fumarate in children and adolescents below the age of 18 years have not been established. There are currently no approved pediatric dosing recommendations. While some off-label use has been reported in pediatric MS, this should only be considered on a case-by-case basis by specialized pediatric neurologists and is not supported by the licensed product information.
Elderly Patients
Clinical trials of dimethyl fumarate did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients. Dimethyl fumarate is primarily used for RRMS, which typically affects younger adults. No specific dose adjustment is recommended for elderly patients, but the general precautions regarding immune monitoring and renal function should be followed, with awareness that older patients may have reduced kidney function and a greater susceptibility to infections.
Missed Dose
If you miss a dose, do not take a double dose to make up for the missed one. Simply take the next scheduled dose at your regular time. Missing occasional doses may temporarily reduce the therapeutic benefit, so try to maintain a consistent dosing schedule. If you frequently forget to take your medication, discuss strategies with your neurologist or pharmacist to improve adherence.
Overdose
There is limited experience with overdose of dimethyl fumarate. In clinical trials, the highest reported accidental overdoses were up to approximately 720 mg as a single dose. The expected symptoms of overdose are an exaggeration of the known side effects, particularly flushing and gastrointestinal disturbances. There is no specific antidote for dimethyl fumarate overdose. Treatment should be symptomatic and supportive. Given the short half-life of the active metabolite (approximately 1 hour), symptoms are expected to resolve relatively quickly after the overdose. Contact your local poison control center or emergency medical services if you suspect an overdose.
Several strategies can help minimize the common side effects of dimethyl fumarate: (1) Always take capsules with food – a meal containing some fat is particularly helpful; (2) During the first month, taking a non-enteric-coated aspirin (325 mg) 30 minutes before the dose may reduce flushing; (3) The 7-day titration period at 120 mg allows gradual adjustment; (4) Side effects typically decrease significantly after the first 2–4 weeks of treatment. Do not stop taking your medication due to these initial side effects without first discussing with your doctor.
What Are the Side Effects of Dimethyl fumarate Reddy?
Like all medicines, dimethyl fumarate can cause side effects, although not everybody gets them. The side effect profile of dimethyl fumarate has been well characterized through extensive clinical trial experience (involving more than 2,600 patients in placebo-controlled studies) and post-marketing surveillance over more than a decade. Understanding the frequency and nature of potential side effects helps patients and their healthcare providers make informed treatment decisions and recognize problems early.
Side effects are classified by frequency according to standard medical conventions. The categories below represent the best available evidence from clinical trials and post-marketing experience:
Very Common
- Flushing – warmth, redness, itching, or burning sensation of the skin, typically affecting the face, neck, and chest; usually begins within the first month and decreases over time
- Diarrhea – loose or frequent bowel movements, most common during the first few weeks
- Nausea – feeling sick to the stomach, often related to dosing without food
- Abdominal pain – stomach cramps or discomfort, particularly in the upper abdomen
Common
- Vomiting – particularly in the first weeks of treatment
- Dyspepsia – indigestion, heartburn, or upper abdominal discomfort
- Gastritis – inflammation of the stomach lining
- Gastrointestinal disorder – general stomach and bowel complaints
- Pruritus – itching of the skin, which may occur independently of flushing
- Rash – skin eruptions of various types
- Erythema – redness of the skin
- Hot flush – sudden feeling of warmth, distinct from cutaneous flushing
- Burning sensation – feeling of heat on the skin or internally
- Proteinuria – protein in the urine, detected on laboratory tests
- Feeling hot – generalized sensation of increased body warmth
- Lymphopenia – reduced lymphocyte counts in the blood
- Leukopenia – reduced overall white blood cell counts
- Elevated liver enzymes (AST, ALT) – detected on blood tests
- Ketones in urine – detected on urinalysis
- Albumin in urine – detected on urinalysis
Uncommon
- Gastroenteritis – stomach and bowel infection or inflammation
- Herpes zoster (shingles) – reactivation of the varicella-zoster virus
- Lymphocyte count decreased below normal range on monitoring
- White blood cell count decreased significantly
- Anaphylaxis – severe, potentially life-threatening allergic reaction
- Angioedema – swelling of the face, lips, tongue, or throat
Rare
- Progressive multifocal leukoencephalopathy (PML) – a serious brain infection caused by JC virus, primarily in patients with prolonged severe lymphopenia
- Fanconi syndrome – a disorder of kidney tubule function causing loss of essential substances in the urine
- Drug-induced liver injury – clinically significant hepatotoxicity
- Herpes simplex reactivation – including disseminated herpes simplex in severely immunocompromised patients
- Cryptococcal infections – opportunistic fungal infections in the context of severe lymphopenia
Flushing and gastrointestinal adverse events are the most frequently cited reasons for treatment discontinuation during clinical trials. However, it is important to note that these side effects are most prominent during the first 2–4 weeks of treatment and diminish considerably with continued use. In the DEFINE and CONFIRM trials, flushing led to treatment discontinuation in approximately 3% of patients receiving the 240 mg twice-daily dose, and gastrointestinal events led to discontinuation in approximately 4%. The vast majority of patients who experience these side effects find them manageable, particularly when employing the dose titration strategy and taking capsules with food.
Lymphocyte count reductions occur in a significant proportion of patients, with a mean decrease of approximately 30% from baseline during the first year of treatment, after which counts typically stabilize. About 6% of patients experience grade 3 lymphopenia (lymphocyte counts below 0.5 × 109/L). These patients require careful monitoring, as prolonged severe lymphopenia is the primary risk factor for PML. The risk of PML is considered very low in patients with lymphocyte counts maintained above 0.8 × 109/L.
Contact your doctor or seek emergency medical care immediately if you experience: (1) Signs of a severe allergic reaction including difficulty breathing, swelling of the face, lips, or tongue, severe rash, or dizziness; (2) New or worsening neurological symptoms such as progressive weakness, visual changes, confusion, or personality changes (possible PML); (3) Signs of serious infection such as prolonged fever, severe headache with stiff neck, unusual skin lesions, or persistent cough; (4) Symptoms of liver injury such as yellowing of the skin or eyes (jaundice), dark urine, severe nausea, or right-sided abdominal pain.
How Should You Store Dimethyl fumarate Reddy?
Proper storage of Dimethyl fumarate Reddy is essential to maintain the medication’s effectiveness and safety throughout its shelf life. The gastro-resistant coating of the capsules can be sensitive to environmental conditions, and exposure to excessive heat, moisture, or light may compromise the integrity of the coating and alter drug release characteristics.
Follow these storage guidelines carefully:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze. Avoid leaving the medication in hot environments such as a car during summer or near a heat source.
- Light protection: Keep the capsules in the original blister packaging or bottle to protect them from light. Do not transfer capsules to a different container unless instructed by your pharmacist.
- Moisture: Protect from moisture. Do not store in the bathroom or other humid environments.
- Children: Keep out of the sight and reach of children. Store in a secure location. Consider using a child-resistant container if available.
- Expiry date: Do not use the medication after the expiry date printed on the packaging (month/year). The expiry date refers to the last day of that month. If capsules appear discolored, damaged, or have an unusual odor, do not take them.
- Disposal: Do not dispose of unused medication via household waste or wastewater. Return unused or expired capsules to your pharmacy for safe disposal in accordance with local environmental regulations. This helps protect the environment.
If you travel, keep your medication in its original packaging and carry it in your hand luggage rather than checked baggage. Checked luggage in aircraft cargo holds can be exposed to extreme temperatures. If you are traveling to a hot climate, consider using an insulated medication pouch. Ensure you have enough medication for the duration of your trip, plus a few extra days in case of travel delays.
What Does Dimethyl fumarate Reddy Contain?
Each medication contains both active ingredients (the substances that provide the therapeutic effect) and excipients (inactive ingredients that are necessary for the formulation, manufacture, stability, and proper delivery of the drug). Understanding the full composition is important, particularly for patients with known allergies or intolerances to specific pharmaceutical excipients.
Active Ingredient
- Dimethyl fumarate 120 mg: Each gastro-resistant hard capsule contains 120 mg of dimethyl fumarate as the active substance.
- Dimethyl fumarate 240 mg: Each gastro-resistant hard capsule contains 240 mg of dimethyl fumarate as the active substance.
Dimethyl fumarate (chemical name: dimethyl (E)-butenedioate; molecular formula: C6H8O4; molecular weight: 144.13 g/mol) is the methyl ester of fumaric acid. It is a white to off-white crystalline powder. After oral administration, dimethyl fumarate is rapidly hydrolyzed by esterases to its primary active metabolite, monomethyl fumarate (MMF), before reaching the systemic circulation in significant amounts. Therefore, dimethyl fumarate is essentially a prodrug, and the therapeutic activity is primarily mediated by MMF.
Excipients (Inactive Ingredients)
The excipients used in the formulation serve specific pharmaceutical purposes:
- Capsule contents: Microcrystalline cellulose (filler/binder), croscarmellose sodium (disintegrant to help the capsule contents break apart in the intestine), talc (glidant), silica colloidal anhydrous (flow agent), magnesium stearate (lubricant), triethyl citrate (plasticizer for the coating), methacrylic acid – methyl methacrylate copolymer (1:1) (the gastro-resistant coating that prevents release in the stomach), methacrylic acid – ethyl acrylate copolymer (1:1) dispersion 30% (additional enteric coating component), simethicone (anti-foaming agent), sodium laurilsulfate (wetting agent), polysorbate 80 (surfactant).
- Capsule shell: The hard capsule shell is made of gelatin with colorants including titanium dioxide (E171) and may contain iron oxide yellow (E172) and/or iron oxide red (E172) depending on the capsule strength, as well as brilliant blue FCF (E133). The different strengths may be distinguished by capsule color and size.
- Printing ink: The capsules may bear printing that includes shellac, iron oxide black (E172), propylene glycol, and potassium hydroxide.
Dimethyl fumarate Reddy gastro-resistant capsules contain less than 1 mmol sodium (23 mg) per capsule, and are therefore essentially “sodium-free.” This is relevant for patients on sodium-restricted diets or those monitoring their sodium intake.
If you have any known allergies to specific excipients (for example, gelatin intolerance), inform your doctor or pharmacist before starting treatment. The formulation differences between generic products and the original brand are limited to excipients and do not affect the clinical efficacy or safety of the active substance.
Frequently Asked Questions About Dimethyl fumarate Reddy
References
- European Medicines Agency (EMA). Tecfidera (dimethyl fumarate) – Summary of Product Characteristics. Last updated 2025.
- U.S. Food and Drug Administration (FDA). Tecfidera (dimethyl fumarate) Prescribing Information. Biogen Inc. Revised 2024.
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis (DEFINE study). New England Journal of Medicine. 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). New England Journal of Medicine. 2012;367(12):1087–1097. doi:10.1056/NEJMoa1206328
- Gold R, Arnold DL, Bar-Or A, et al. Long-term effects of delayed-release dimethyl fumarate in multiple sclerosis: interim analysis of ENDORSE, a randomized extension study. Multiple Sclerosis Journal. 2017;23(2):253–265. doi:10.1177/1352458516649037
- 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(Pt 3):678–692. doi:10.1093/brain/awq386
- 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
- Montalban X, Gold R, Thompson AJ, et al. ECTRIMS/EAN guideline on the pharmacological treatment of people with relapsing multiple sclerosis. Multiple Sclerosis Journal. 2018;24(2):96–120. doi:10.1177/1352458517751049
- World Health Organization (WHO). Model List of Essential Medicines – 23rd List (2023). Geneva: WHO; 2023.
- British National Formulary (BNF). Dimethyl fumarate. National Institute for Health and Care Excellence (NICE). Accessed 2025.
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