Dimethyl fumarate Accord: Uses, Dosage & Side Effects
An oral immunomodulatory agent for the treatment of relapsing-remitting multiple sclerosis in adult patients
Dimethyl fumarate Accord is a prescription immunomodulatory medication used for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). It contains dimethyl fumarate, the same active substance found in Tecfidera, and is available as gastro-resistant hard capsules in 120 mg and 240 mg strengths. The medication works by activating the Nrf2 antioxidant pathway and modulating immune responses, reducing both the frequency of relapses and the progression of disability in MS patients. It is taken orally twice daily and has been shown in large clinical trials to significantly reduce annualized relapse rates and new brain lesions on MRI compared with placebo.
Quick Facts: Dimethyl fumarate Accord
Key Takeaways
- Dimethyl fumarate Accord is a generic version of Tecfidera, approved for the treatment of relapsing-remitting multiple sclerosis (RRMS) in adults, with the same active ingredient, dosing, and clinical efficacy as the originator product.
- In the pivotal DEFINE and CONFIRM clinical trials, dimethyl fumarate reduced annualized relapse rates by approximately 44–53% compared with placebo and significantly reduced the number of new or enlarging brain lesions on MRI.
- The most common side effects are flushing and gastrointestinal symptoms (diarrhoea, nausea, abdominal pain), which typically diminish significantly after the first 1–2 months of treatment and can be mitigated by taking the capsules with food.
- Regular blood monitoring is essential: a complete blood count must be obtained before starting treatment and every 6–12 months thereafter, as dimethyl fumarate can reduce lymphocyte counts, and prolonged severe lymphopenia is a risk factor for the rare but serious infection PML.
- The standard dosing regimen involves an initial titration phase of 120 mg twice daily for the first 7 days, followed by the maintenance dose of 240 mg twice daily, taken with food to reduce gastrointestinal side effects.
What Is Dimethyl fumarate Accord and What Is It Used For?
Dimethyl fumarate Accord contains the active substance dimethyl fumarate (DMF), an immunomodulatory agent belonging to the fumaric acid ester class of compounds. It is approved for the treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS), the most common form of MS, which is characterized by episodes of neurological dysfunction (relapses) followed by periods of partial or complete recovery. Dimethyl fumarate Accord is a generic medicine, meaning it has been developed to be equivalent to the originator product Tecfidera, which was first approved by the European Medicines Agency (EMA) in January 2014 and by the U.S. Food and Drug Administration (FDA) in March 2013.
Multiple sclerosis is a chronic autoimmune disease of the central nervous system (CNS) in which the immune system mistakenly attacks the protective myelin sheath that surrounds nerve fibers in the brain and spinal cord. This demyelination disrupts the transmission of nerve signals, leading to a wide range of symptoms including visual disturbances, muscle weakness, fatigue, balance problems, numbness and tingling, cognitive difficulties, and pain. Over time, repeated inflammatory attacks can lead to permanent nerve damage (neurodegeneration) and progressive disability. RRMS accounts for approximately 85% of initial MS diagnoses worldwide, affecting an estimated 2.8 million people globally according to the Multiple Sclerosis International Federation (MSIF).
The precise mechanism by which dimethyl fumarate exerts its therapeutic effects in MS is not fully elucidated, but it is understood to involve multiple complementary pathways. After oral administration, dimethyl fumarate is rapidly hydrolyzed by esterases in the gastrointestinal tract to its primary active metabolite, monomethyl fumarate (MMF). The key mechanisms of action include activation of the nuclear factor erythroid 2-related factor 2 (Nrf2) transcriptional pathway, which upregulates the expression of antioxidant and cytoprotective genes, thereby protecting neurons and oligodendrocytes from oxidative stress-mediated damage. Additionally, dimethyl fumarate modulates the immune response by shifting the balance from pro-inflammatory T-helper 1 (Th1) and Th17 cell responses toward anti-inflammatory Th2 responses, reducing the production of inflammatory cytokines such as TNF-alpha, IL-6, and IL-17, and decreasing the infiltration of activated immune cells into the CNS.
The efficacy of dimethyl fumarate in RRMS was established in two pivotal phase III randomized, double-blind, placebo-controlled clinical trials:
- DEFINE (Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS): This trial enrolled 1,234 patients and demonstrated that dimethyl fumarate 240 mg twice daily reduced the annualized relapse rate (ARR) by 53% compared with placebo (ARR 0.17 vs. 0.36; p < 0.001). It also significantly reduced the risk of 12-week confirmed disability progression by 38% and the number of new or enlarging T2-hyperintense lesions on MRI by 85%.
- CONFIRM (Comparator and an Oral Fumarate in Relapsing-Remitting Multiple Sclerosis): This trial enrolled 1,417 patients and included glatiramer acetate as an active reference comparator. Dimethyl fumarate 240 mg twice daily reduced the ARR by 44% compared with placebo (ARR 0.22 vs. 0.40; p < 0.001) and reduced new or enlarging T2 lesions by 71%. Dimethyl fumarate showed comparable efficacy to glatiramer acetate across all MRI endpoints.
Long-term extension studies (ENDORSE) have demonstrated sustained efficacy over up to 13 years of treatment, with persistent reductions in relapse rates and MRI disease activity. The proportion of patients achieving no evidence of disease activity (NEDA-3, defined as no relapses, no disability progression, and no new MRI activity) was significantly higher in the dimethyl fumarate group. The clinical experience with dimethyl fumarate now encompasses more than 670,000 patient-years of exposure worldwide, making it one of the most extensively studied oral disease-modifying therapies for MS.
Dimethyl fumarate Accord is a generic version of Tecfidera. Generic medicines must demonstrate bioequivalence to the reference product and meet the same quality, safety, and manufacturing standards. The European Medicines Agency (EMA) and other regulatory authorities require generic manufacturers to demonstrate that their product delivers the same amount of active substance to the body in the same timeframe as the originator. Patients can expect the same clinical effects from Dimethyl fumarate Accord as from Tecfidera.
What Should You Know Before Taking Dimethyl fumarate Accord?
Contraindications
Dimethyl fumarate Accord is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients listed in the product information. It is also contraindicated in patients with suspected or confirmed progressive multifocal leukoencephalopathy (PML), a rare and serious viral brain infection. Patients should not take this medication if they have a severe active infection that has not been resolved, or if they have severely reduced immune function (severe immunodeficiency).
Before starting treatment, your doctor must conduct a thorough assessment including a recent complete blood count (CBC) with differential and lymphocyte count. This is essential because dimethyl fumarate is known to reduce lymphocyte counts, and treatment should not be initiated in patients who already have significantly low lymphocyte levels. Liver function tests and renal function tests should also be obtained at baseline, as the medication has the potential to affect both hepatic and renal function in some patients.
Warnings and Precautions
Cases of PML have been reported in patients taking dimethyl fumarate who developed prolonged moderate to severe lymphopenia (lymphocyte counts below 0.5 × 10⁹/L for more than 6 months). PML is caused by the JC virus and can be fatal or result in severe disability. Your doctor must monitor your lymphocyte counts every 6–12 months. If your lymphocyte count falls below 0.5 × 10⁹/L and remains at that level for more than 6 months, your doctor should consider stopping treatment. Seek medical attention immediately if you notice new or worsening neurological symptoms such as progressive weakness on one side of the body, clumsiness, vision changes, confusion, or personality changes.
The following additional warnings and precautions apply to the use of Dimethyl fumarate Accord:
- Lymphopenia: Dimethyl fumarate may decrease lymphocyte counts. In clinical trials, mean lymphocyte counts decreased by approximately 30% during the first year, then plateaued. Approximately 6% of patients experienced lymphocyte counts below 0.5 × 10⁹/L. Complete blood counts must be monitored every 6–12 months during treatment. If lymphocytes fall below 0.5 × 10⁹/L for more than 6 months, the benefit-risk balance should be reassessed.
- Flushing: Flushing occurs in approximately 34% of patients and is thought to be mediated by prostaglandin pathways. Pre-treatment with aspirin (325 mg, taken 30 minutes before dosing) may reduce flushing severity. Flushing typically diminishes after the first month of treatment.
- Gastrointestinal events: Diarrhoea, nausea, abdominal pain, and vomiting are common, particularly during the first month. Taking capsules with food (especially food containing fat) significantly reduces these symptoms. A slow dose titration (starting at 120 mg twice daily for 7 days before increasing to the maintenance dose) also helps.
- Hepatotoxicity: Clinically significant cases of liver injury, including elevated serum transaminases (≥3 times the upper limit of normal) and elevated total bilirubin (≥2 times the upper limit of normal), have been reported. Liver function tests should be obtained before starting treatment and monitored during treatment as clinically indicated. Discontinue treatment if clinically significant liver injury is suspected.
- Herpes zoster: An increased incidence of herpes zoster (shingles) has been observed in patients taking dimethyl fumarate, particularly in those with low lymphocyte counts. Patients should be aware of the symptoms of shingles and seek prompt medical attention if they develop a painful, blistering rash.
- Infections: Patients should be monitored for signs and symptoms of infections during and after treatment. Treatment should be interrupted if a patient develops a serious infection until the infection has resolved.
Pregnancy and Breastfeeding
Dimethyl fumarate Accord is not recommended during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the fetus. Animal studies have shown adverse effects on embryonic and fetal development at high doses, including reduced fetal weight, delayed ossification, and increased incidence of skeletal variations. Although these effects were observed at doses exceeding the recommended human dose, there are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after stopping Dimethyl fumarate Accord.
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 breastfeed during treatment should be made in consultation with your doctor, weighing the benefit of breastfeeding to the child against the benefit of therapy for the mother. If breastfeeding is chosen, the infant should be monitored for potential adverse effects.
Pregnancy registries exist in several countries to collect data on outcomes of pregnancies exposed to dimethyl fumarate. Women who become pregnant while taking this medication should contact their healthcare provider immediately. Preliminary data from pregnancy registries have not identified a clear pattern of major birth defects, but the data remain limited and ongoing monitoring is essential.
Driving and Operating Machinery
Dimethyl fumarate Accord has no or negligible influence on the ability to drive and use machines. However, flushing and gastrointestinal symptoms may temporarily affect concentration in some patients, particularly during the early weeks of treatment. If you experience symptoms that affect your alertness, refrain from driving or operating machinery until the symptoms resolve.
How Does Dimethyl fumarate Accord Interact with Other Drugs?
Dimethyl fumarate is rapidly metabolized to monomethyl fumarate (MMF) by esterases, and MMF is further metabolized via the tricarboxylic acid (TCA) cycle without involvement of the cytochrome P450 (CYP) enzyme system. This metabolic profile means that dimethyl fumarate has a low potential for traditional pharmacokinetic drug interactions. No formal drug interaction studies have identified clinically significant interactions with commonly prescribed medications.
However, pharmacodynamic interactions (where two drugs have additive or synergistic effects on the same physiological system) are an important consideration, particularly regarding immune function. The following table summarizes key drug interaction considerations:
| Drug / Category | Interaction Type | Clinical Significance | Recommendation |
|---|---|---|---|
| Other MS disease-modifying therapies | Pharmacodynamic (additive immunosuppression) | High | Do not combine; adequate washout period required when switching |
| Live vaccines | Pharmacodynamic (reduced vaccine efficacy, risk of infection) | High | Avoid live vaccines during treatment; inactivated vaccines are acceptable |
| Immunosuppressants (azathioprine, methotrexate, ciclosporin) | Pharmacodynamic (additive immunosuppression) | High | Concomitant use not recommended; increased infection risk |
| Nephrotoxic agents (aminoglycosides, NSAIDs, lithium) | Pharmacodynamic (additive renal effects) | Moderate | Use with caution; monitor renal function |
| Aspirin (low-dose) | Pharmacodynamic (reduces flushing) | Beneficial | 325 mg aspirin 30 minutes before dose may reduce flushing |
| Oral contraceptives | None identified | Low | No dose adjustment required |
| Interferon beta | Pharmacodynamic (additive immunomodulation) | Moderate to High | Do not combine; sequential use requires appropriate washout |
When switching from another MS disease-modifying therapy to dimethyl fumarate, an appropriate washout period must be observed to allow the immune system to recover. The duration of the washout depends on the previous therapy: for interferon beta or glatiramer acetate, no washout is typically needed; for teriflunomide, an accelerated elimination procedure or a washout of at least 3.5 months is required; for fingolimod, a washout of at least 6 weeks is recommended to allow lymphocyte recovery; and for natalizumab, a washout of at least 6–8 weeks is generally advised. Your neurologist will determine the appropriate timing based on your individual clinical situation and blood test results.
It is important to note that dimethyl fumarate may reduce the immune response to vaccinations. Inactivated (killed) vaccines can be administered during treatment, but their effectiveness may be reduced. Live attenuated vaccines (such as measles, mumps, rubella, varicella, yellow fever, and oral polio) should not be given during treatment or within an appropriate interval after stopping treatment, as there is a theoretical risk of infection from the live vaccine strain in immunocompromised patients.
If you are switching to Dimethyl fumarate Accord from another MS medication, your neurologist will plan the transition carefully to minimize the risk of both disease reactivation and excessive immunosuppression. A recent blood count showing adequate lymphocyte levels is typically required before starting dimethyl fumarate. Never stop or start an MS therapy without guidance from your treating neurologist.
What Is the Correct Dosage of Dimethyl fumarate Accord?
Dimethyl fumarate Accord should be used exactly as prescribed by your doctor. The medication is available as gastro-resistant hard capsules in two strengths: 120 mg (used during the initial titration phase) and 240 mg (the maintenance dose). The gastro-resistant formulation is designed to protect the active ingredient from the acidic environment of the stomach and release it in the small intestine, which both improves absorption and reduces gastrointestinal irritation.
Adults
| Phase | Dose | Frequency | Duration |
|---|---|---|---|
| Titration (Week 1) | 120 mg | Twice daily (morning and evening) | First 7 days |
| Maintenance (Week 2 onwards) | 240 mg | Twice daily (morning and evening) | Ongoing (long-term treatment) |
The initial 7-day titration period at the lower dose is designed to help your body adjust to the medication and minimize the gastrointestinal side effects and flushing that are most common at the start of treatment. Some doctors may extend the titration period (for example, using 120 mg twice daily for 2–4 weeks) if a patient experiences significant gastrointestinal symptoms, although this is an off-label approach. Discuss with your doctor if you are having difficulty tolerating the medication.
The capsules should be swallowed whole with liquid, preferably with a meal. Do not crush, chew, dissolve, or open the capsules, as this will destroy the gastro-resistant coating and may result in increased gastrointestinal irritation and altered drug absorption. Taking the capsules with food, particularly food that contains some fat (such as a sandwich with butter, yogurt, or a meal with olive oil), has been shown in clinical practice to significantly reduce the incidence and severity of both flushing and gastrointestinal side effects.
A temporary dose reduction to 120 mg twice daily may be considered for patients who experience persistent flushing or gastrointestinal symptoms. However, the full maintenance dose of 240 mg twice daily should be resumed within 4 weeks if possible, as the lower dose has not been fully validated for long-term efficacy in clinical trials.
Children and Adolescents
Dimethyl fumarate Accord is not currently approved for use in patients under 18 years of age. The safety and efficacy of dimethyl fumarate in pediatric patients have not been established through controlled clinical trials. Pediatric MS is a distinct clinical entity with unique considerations, and treatment decisions should be made by specialist paediatric neurologists. Clinical studies evaluating dimethyl fumarate in adolescents with MS are ongoing, and dosing recommendations for this population may become available in the future.
Elderly Patients
Clinical trials of dimethyl fumarate included limited numbers of patients aged 55 years and older, and there were too few patients aged 65 or older to determine whether they respond differently from younger patients. No dose adjustment is recommended for elderly patients based on available data. However, given the age-related decline in immune function (immunosenescence), elderly patients may be at increased risk of lymphopenia and infections, and more frequent monitoring of blood counts may be warranted.
Missed Dose
If you miss a dose, do not take a double dose to compensate. If you remember the missed dose and there is still sufficient time before the next scheduled dose, take the missed dose with food. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Try to maintain approximately 12 hours between doses for optimal drug levels, but small variations in timing are unlikely to significantly affect efficacy. Setting a daily reminder on your phone or using a pill organizer can help maintain adherence to the twice-daily dosing schedule.
Overdose
No cases of overdose have been reported in the clinical trial program. The maximum single dose tested in clinical studies was 480 mg (twice the standard single dose). There is no specific antidote for dimethyl fumarate overdose. In the event of an overdose, treatment should be symptomatic and supportive. Haemodialysis is unlikely to be effective in removing dimethyl fumarate or its metabolites from the circulation, as MMF has a very short half-life (approximately 1 hour) and is rapidly metabolized. If you suspect an overdose, contact your doctor or local poison control center immediately.
What Are the Side Effects of Dimethyl fumarate Accord?
Like all medicines, Dimethyl fumarate Accord can cause side effects, although not everyone will experience them. The side effects listed below are based on extensive data from the pivotal clinical trials (DEFINE and CONFIRM), long-term extension studies (ENDORSE), and post-marketing surveillance of the originator product Tecfidera, encompassing more than 670,000 patient-years of real-world experience. It is important to understand that the side effect profile of Dimethyl fumarate Accord is expected to be identical to that of Tecfidera, as both contain the same active substance.
The most characteristic side effects of dimethyl fumarate are flushing and gastrointestinal events, both of which are typically most prominent during the first 1–2 months of treatment and tend to diminish significantly with continued use. In clinical trials, the discontinuation rate due to adverse events was approximately 16% over 2 years, compared with 13% for placebo, indicating that the majority of patients tolerate the medication well with appropriate management strategies.
Very Common
May affect more than 1 in 10 people
- Flushing (warmth, redness, itching, or burning sensation of the skin, typically of the face, neck, and upper body)
- Diarrhoea
- Nausea
- Abdominal pain or discomfort (upper abdominal pain)
Common
May affect up to 1 in 10 people
- Vomiting
- Dyspepsia (indigestion)
- Gastritis (stomach inflammation)
- Gastrointestinal disorder
- Hot flush
- Burning sensation
- Pruritus (itching)
- Rash or erythema (skin redness)
- Proteinuria (protein in urine)
- Feeling of warmth
- Lymphopenia (decreased lymphocyte count)
- Leukopenia (decreased white blood cell count)
- Elevated liver transaminases (ALT, AST)
- Albumin in urine
Uncommon
May affect up to 1 in 100 people
- Severe lymphopenia (lymphocytes below 0.5 × 10⁹/L)
- Hypersensitivity reactions
- Herpes zoster (shingles)
Rare
May affect up to 1 in 1,000 people
- Progressive multifocal leukoencephalopathy (PML) – in the setting of prolonged severe lymphopenia
- Anaphylaxis and angioedema (severe allergic reactions with swelling)
- Liver injury (hepatotoxicity with significantly elevated transaminases and bilirubin)
Not Known
Frequency cannot be estimated from available data
- Herpes simplex encephalitis and meningitis (very rare, reported in post-marketing)
- Opportunistic infections in severely lymphopenic patients
Flushing is the most characteristic side effect and occurs in approximately 34% of patients. It typically manifests as a warm, red, and sometimes itchy or burning sensation affecting the face, neck, chest, and upper body. Flushing usually begins within 30–60 minutes of taking a dose and lasts for 30–90 minutes. In clinical trials, flushing was most common during the first month of treatment and decreased substantially thereafter; by month 6, only about 6% of patients still experienced flushing. Pre-treatment with aspirin (325 mg, taken approximately 30 minutes before the dose) can significantly reduce the severity and frequency of flushing episodes. Taking the medication with food also helps. If flushing is severe or persistent, your doctor may temporarily reduce the dose to 120 mg twice daily.
Gastrointestinal side effects are the other major category of adverse events. Diarrhoea, nausea, upper abdominal pain, and vomiting were reported in approximately 14%, 12%, 10%, and 9% of patients, respectively, in clinical trials. Like flushing, these symptoms are most prominent during the first month and typically decrease with continued treatment. Taking capsules with food is the single most effective strategy for reducing GI symptoms. Gradual dose titration (starting at 120 mg twice daily for the first week) also helps, and some clinicians extend the titration period for patients who are particularly sensitive.
Lymphopenia deserves particular attention. Dimethyl fumarate reduces lymphocyte counts in most patients, with a mean decrease of approximately 30% during the first year. The lymphocyte count then typically stabilizes at a lower level. Approximately 6% of patients develop Grade 3 lymphopenia (lymphocytes below 0.5 × 10⁹/L). The clinical significance of lymphopenia is the associated risk of infections, including the rare but serious PML. Regular monitoring of complete blood counts every 6–12 months is therefore mandatory throughout the duration of treatment.
Contact your doctor immediately if you experience: new or worsening neurological symptoms (which could indicate PML), persistent severe abdominal pain, signs of liver injury (unexplained nausea, vomiting, yellowing of the skin or eyes, dark urine), signs of a serious infection (persistent fever, severe sore throat), or symptoms of a severe allergic reaction (difficulty breathing, swelling of the face or throat, severe rash). If you develop a painful, blistering rash in a band on one side of your body (possible shingles), seek prompt medical attention.
How Should You Store Dimethyl fumarate Accord?
Proper storage of Dimethyl fumarate Accord is important to ensure that the medication retains its quality and effectiveness throughout its shelf life. The gastro-resistant capsules contain a sensitive formulation that can be affected by exposure to excessive heat, moisture, and light.
Follow these storage guidelines:
- Temperature: Store below 30 °C (86 °F). Do not refrigerate or freeze the capsules. Avoid storing the medication near radiators, in direct sunlight, or in the glove compartment of a car, particularly during hot weather.
- Moisture and light protection: Keep the capsules in the original blister packaging until you are ready to take them. The blister packaging protects the capsules from moisture and light. Do not transfer capsules to a pill box or other container unless it provides adequate protection from moisture.
- Keep out of reach of children: Store the medication in a safe location where children cannot access it.
- Expiration date: Do not use Dimethyl fumarate Accord after the expiry date stated on the blister and carton after “EXP.” The expiry date refers to the last day of that month.
- Inspection: Before taking each capsule, briefly inspect it. If a capsule appears damaged, cracked, or has an unusual appearance (such as discoloration or an unusual odor), do not take it. Consult your pharmacist if you are unsure.
- Disposal: Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
When traveling, keep the medication in its original packaging in your carry-on luggage to avoid temperature extremes in the cargo hold. In hot climates, consider using an insulated bag (without direct contact with ice packs) to maintain an appropriate temperature. The capsules are stable during normal travel conditions and do not require refrigeration.
What Does Dimethyl fumarate Accord Contain?
Understanding the complete composition of your medication is important, particularly if you have allergies or intolerances to specific pharmaceutical ingredients.
Active Ingredient
The active substance is dimethyl fumarate (also known as dimethyl (E)-butenedioate). Each gastro-resistant hard capsule contains either 120 mg or 240 mg of dimethyl fumarate. Dimethyl fumarate is a small molecule (molecular weight: 144.13 g/mol) classified as a fumaric acid ester. It is a white to off-white crystalline powder.
Inactive Ingredients (Excipients)
| Ingredient | Role | Notes |
|---|---|---|
| Dimethyl fumarate | Active substance | 120 mg or 240 mg per capsule |
| Microcrystalline cellulose | Filler / diluent | Provides bulk to the capsule contents |
| Croscarmellose sodium | Disintegrant | Helps the capsule contents break apart |
| Talc | Glidant / anti-adherent | Aids manufacturing process |
| Colloidal anhydrous silica | Glidant | Improves powder flow |
| Magnesium stearate | Lubricant | Prevents capsule contents from sticking |
| Methacrylic acid – ethyl acrylate copolymer | Gastro-resistant coating | Protects active ingredient from stomach acid |
| Triethyl citrate | Plasticizer (coating) | Makes the coating flexible |
| Gelatin | Capsule shell | Forms the hard capsule |
| Titanium dioxide (E171) | Capsule shell colorant | White opacifier |
| Brilliant blue FCF (E133) | Capsule shell colorant | Green capsules (240 mg) |
Appearance and Pack Sizes
Dimethyl fumarate Accord 120 mg gastro-resistant hard capsules are white and are typically used only during the first week of treatment (titration phase). Dimethyl fumarate Accord 240 mg gastro-resistant hard capsules are green and white and are used for the ongoing maintenance dose. A starter pack is available in some markets that contains both the 120 mg capsules for the first week and the 240 mg capsules for the subsequent weeks, simplifying the initiation of treatment. Maintenance packs typically contain 56 or 120 capsules of the 240 mg strength.
Marketing Authorization Holder
Dimethyl fumarate Accord is manufactured and marketed by Accord Healthcare, a global generic and biosimilar pharmaceutical company. Accord Healthcare is part of the Intas Pharmaceuticals group and is headquartered in the United Kingdom. Their products are available in more than 85 countries worldwide and are manufactured in accordance with Good Manufacturing Practice (GMP) standards as required by the EMA and other regulatory authorities.
Frequently Asked Questions About Dimethyl fumarate Accord
Dimethyl fumarate Accord is a generic version of Tecfidera. Both products contain the same active ingredient (dimethyl fumarate) at the same strengths (120 mg and 240 mg gastro-resistant capsules). Generic medicines undergo rigorous regulatory review to ensure they are bioequivalent to the originator product, meaning they deliver the same amount of active substance to the body at the same rate. You can expect the same clinical efficacy, safety profile, and dosing regimen from Dimethyl fumarate Accord as from Tecfidera. The primary difference is typically the price, with generic products generally being more affordable.
Dimethyl fumarate begins to exert its immunomodulatory effects relatively soon after starting treatment, but the full clinical benefit in terms of relapse reduction and MRI disease activity suppression may take several months to become apparent. In clinical trials, significant reductions in new MRI lesions were observed within the first 24 weeks of treatment. The full effect on relapse rate was typically evident over the first year. Your neurologist will typically assess the effectiveness of treatment after 6–12 months, using a combination of clinical assessment (relapse frequency, disability progression) and MRI findings.
Several practical strategies can help manage flushing and gastrointestinal side effects: (1) Always take the capsules with food, ideally a meal or substantial snack containing some fat. (2) For flushing, taking a standard-dose aspirin (325 mg) approximately 30 minutes before your dose can significantly reduce flushing severity and frequency. (3) Follow the recommended dose titration (120 mg twice daily for the first week). (4) If symptoms persist, your doctor may extend the titration period or temporarily reduce the dose. (5) Be patient – these side effects typically improve significantly within the first 1–2 months and often resolve entirely by month 3–6 of treatment.
Regular blood tests (complete blood counts including lymphocyte counts) are essential because dimethyl fumarate can reduce your lymphocyte count. Lymphocytes are a type of white blood cell that play a crucial role in fighting infections. While a modest decrease in lymphocytes is expected and not harmful for most patients, prolonged severe lymphopenia (very low lymphocyte counts sustained for more than 6 months) has been associated with the rare but serious brain infection PML (progressive multifocal leukoencephalopathy). By monitoring your blood counts every 6–12 months, your doctor can detect any significant decrease early and take appropriate action, such as more frequent monitoring or, if necessary, discontinuing the medication.
There is no specific contraindication against consuming moderate amounts of alcohol while taking dimethyl fumarate. However, alcohol can worsen flushing and gastrointestinal symptoms, which are already common side effects of this medication, particularly in the early weeks of treatment. If you notice that alcohol triggers or worsens flushing or stomach problems, consider reducing or avoiding alcohol intake. Additionally, both dimethyl fumarate and alcohol can potentially affect liver function, so moderate consumption is advisable. Discuss your alcohol intake with your neurologist, especially if you have any underlying liver conditions.
Inactivated (killed) vaccines, including the seasonal influenza vaccine, COVID-19 vaccines, and pneumococcal vaccine, can generally be administered during treatment with dimethyl fumarate. However, the immune response to these vaccines may be reduced, meaning they may be somewhat less effective. Live attenuated vaccines (such as MMR, varicella, yellow fever, and oral polio vaccines) should be avoided during treatment due to the risk of infection from the live vaccine strain. If you need a live vaccine, discuss the timing with your neurologist – ideally, live vaccinations should be completed at least 4–6 weeks before starting dimethyl fumarate.
References
- European Medicines Agency (EMA). Tecfidera (dimethyl fumarate) – Summary of Product Characteristics. Last updated 2025. Available at: EMA Tecfidera EPAR.
- 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). 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). N Engl J Med. 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. Mult Scler. 2017;23(2):253–265. doi:10.1177/1352458516649037.
- 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. Eur J Neurol. 2018;25(2):215–237. doi:10.1111/ene.13536.
- World Health Organization (WHO). Multiple Sclerosis Fact Sheet. 2023. Available at: WHO Multiple Sclerosis.
- British National Formulary (BNF). Dimethyl fumarate. National Institute for Health and Care Excellence (NICE). 2025.
- Multiple Sclerosis International Federation (MSIF). Atlas of MS. 3rd edition. 2020.
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