Dimethyl Fumarate is an active pharmaceutical ingredient in the Other Immunosuppressants group (L04AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 19, 2024[1]
Dimethyl fumarate is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
How to take
GB
CACanada· Health Canada
18 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
JAMP
Dimethyl Fumarate (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability. The efficacy of dimethyl fumarate in patients with primary progressive multiple sclerosis has not been established.
JAMP Dimethyl Fumarate should only be prescribed by clinicians who are experienced in the diagnosis and management of multiple sclerosis. 1 Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of dimethyl fumarate in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics, Pediatrics).
2 Geriatrics Geriatrics (> 65 years of age): Clinical studies of dimethyl fumarate did not include sufficient numbers of patients aged 65 and over to determine whether the safety and efficacy of dimethyl fumarate may differ in elderly patients compared to younger patients.
EUEuropean Union· EMA
5 products
Uses
EUOfficial regulatory label· revised August 26, 2025[3]
Dimethyl fumarate Accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).
How to take
EU
USUnited States· FDA
2 products
Uses
USOfficial regulatory label· revised July 13, 2021[4]
1 INDICATIONS AND USAGE Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 )
How to take
Drug interactions
Known interactions involving Dimethyl Fumarate. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PLGB512890021 · revised April 19, 2024
[2]Health Canada (DPD) · 02516047 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/006471 · revised August 26, 2025
[4]FDA DailyMed · 074d2820-6cb4-43… · revised July 13, 2021 [PDF]
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Posology The starting dose is 120 mg twice a day. 4). If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses.
Otherwise the patient should wait until the next scheduled dose. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
2). 8). 2). Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly. Renal and hepatic impairment Dimethyl fumarate has not been studied in patients with renal or hepatic impairment.
2). 4). Paediatric population The posology is the same in adults and in paediatric patients aged 13 years and older. 2. There are limited data available in children between 10 and 12 years old. The safety and efficacy of dimethyl fumarate in children aged less than 10 years have not yet been established.
Method of administration Dimethyl fumarate is for oral use. The capsule should be swallowed whole. The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the minitablets (present inside the capsule shell) prevents irritant effects on the gut.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 19, 2024[1]
8. The long-term safety of dimethyl fumarate in paediatric population has not yet been established. 5 Interaction with other medicinal products and other forms of interaction Dimethyl fumarate has not been studied in combination with anti-neoplastic or immunosuppressive therapies and caution should, therefore, be used during concomitant administration.
In multiple sclerosis clinical studies, the concomitant treatment of relapses with a short course of intravenous corticosteroids was not associated with a clinically relevant increase of infection. Concomitant administration of non-live vaccines according to national vaccination schedules may be considered during dimethyl fumarate therapy.
In a clinical study involving a total of 71 patients with relapsing remitting multiple sclerosis, patients on dimethyl fumarate 240 mg twice daily for at least 6 months (n=38) or non-pegylated interferon for at least 3 months (n=33), mounted a comparable immune response (defined as ≥2-fold increase from pre- to post-vaccination titer) to tetanus toxoid (recall antigen) and a conjugated meningococcal C polysaccharide vaccine (neoantigen), while the immune response to different serotypes of an unconjugated 23-valent pneumococcal polysaccharide vaccine (T-cell independent antigen) varied in both treatment groups.
A positive immune response defined as a ≥4-fold increase in antibody titer to the three vaccines, was achieved by fewer subjects in both treatment groups. Small numerical differences in the response to tetanus toxoid and pneumococcal serotype 3 polysaccharide were noted in favour of non-pegylated interferon.
No clinical data are available on the efficacy and safety of live attenuated vaccines in patients taking dimethyl fumarate. Live vaccines might carry an increased risk of clinical infection and should not be given to patients treated with dimethyl fumarate unless, in exceptional cases, this potential risk is considered to be outweighed by the risk to the individual of not vaccinating.
During treatment with dimethyl fumarate, simultaneous use of other fumaric acid derivatives (topical or systemic) should be avoided. In humans, dimethyl fumarate is extensively metabolised by esterases before it reaches the systemic circulation and further metabolism occurs through the tricarboxylic acid cycle, with no involvement of the cytochrome P450 (CYP) system.
Potential drug interaction risks were not identified from in vitro CYP- inhibition and induction studies, a p-glycoprotein study, or studies of the protein binding of dimethyl fumarate and monomethyl fumarate (a primary metabolite of dimethyl fumarate).
Commonly used medicinal products in patients with multiple sclerosis, intramuscular interferon beta-1a and glatiramer acetate, were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.
Evidence from healthy volunteer studies suggests that dimethyl fumarate- associated flushing is likely to be prostaglandin mediated. In two healthy volunteer studies, the administration of 325 mg (or equivalent) non-enteric coated acetylsalicylic acid, 30 minutes prior to dimethyl fumarate, dosing over 4 days and over 4 weeks, respectively, did not alter the pharmacokinetic profile of dimethyl fumarate.
Potential risks associated with acetylsalicylic acid therapy should be considered prior to co-administration with dimethyl fumarate in patients with Relapsing Remitting MS. 8). g. 4 Blood/laboratory tests). Consumption of alcoholic drinks should be avoided within two hours of taking dimethyl fumarate, as alcohol may lead to increased frequency of gastrointestinal adverse reactions.
In vitro CYP induction studies did not demonstrate an interaction between dimethyl fumarate and oral contraceptives. In an in vivo study, co- administration of dimethyl fumarate with a combined oral contraceptive (norgestimate and ethinyl estradiol) did not elicit any relevant change in oral contraceptive exposure.
No interaction studies have been performed with oral contraceptives containing other progestogens, however an effect of dimethyl fumarate on their exposure is not expected. Paediatric population Interaction studies have only been performed in adults.
6 Fertility, pregnancy and lactation Pregnancy There are no or limited amount of data from the use of dimethyl fumarate in pregnant women. 3). 5). Dimethyl fumarate should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the foetus.
Breast-feeding It is unknown whether dimethyl fumarate or its metabolites are excreted in human milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue Dimethyl fumarate therapy.
The benefit of breast-feeding for the child and the benefit of therapy for the woman should be taken into account. Fertility There are no data on the effects of dimethyl fumarate on human fertility. 3). 7 Effects on ability to drive and use machines Dimethyl fumarate has no or negligible influence on the ability to drive and use machines.
No studies on the ability to drive and use machines have been conducted but no effects […]
GBOfficial regulatory label· Warnings and precautions· revised April 19, 2024[1]
8). The clinical implications of these changes are unknown. g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Drug-induced liver injury, including liver enzyme increase (≥3 upper limit of normal (ULN)) and elevation of total bilirubin levels (≥2 ULN) can result from treatment with dimethyl fumarate. The time to onset can be directly, several weeks or longer.
Resolution of the adverse reactions has been observed after treatment was discontinued. g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
8). Prior to initiating treatment with dimethyl fumarate, a current complete blood count, including lymphocytes, must be performed. If lymphocyte count is found to be below the normal range, thorough assessment of possible causes should be completed prior to initiation of treatment with this medicinal product.
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients. 5 x 109/L). After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
5 x 109/L) persisting for more than 6 months. 8 x 109/L for more than 6 months, the benefit/risk of dimethyl fumarate treatment should be reassessed. - in patients with lymphocyte counts below lower limit of normal (LLN) as defined by local laboratory reference range, regular monitoring of absolute lymphocyte counts is recommended.
Additional factors that might further augment the individual PML risk should be considered (see subsection on PML below). 1). Upon recovery and in the absence of alternative treatment options, decisions about whether or not to restart dimethyl fumarate after treatment discontinuation should be based on clinical judgement.
Magnetic Resonance imaging (MRI) Before initiating treatment with dimethyl fumarate, a baseline MRI should be available (usually within 3 months) as a reference. The need for further MRI scanning should be considered in accordance with national and local recommendations.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 19, 2024[1]
1. Suspected or confirmed Progressive Multifocal Leukoencephalopathy (PML)
This is not medical advice. Consult a qualified healthcare professional.
Physicians who choose to treat geriatric patients should consider that treatment with JAMP Dimethyl Fumarate in the context of a greater frequency of other concomitant diseases and concomitant drug therapy warrants caution and may necessitate additional or more frequent monitoring (see 7 WARNINGS AND PRECAUTIONS, Geriatrics).
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations Dosing in special populations: Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 5 of 43 • Renal or hepatic impairment: Dimethyl Fumarate has not been studied in patients with renal or hepatic impairment.
Based on the pharmacokinetics and metabolic fate of dimethyl fumarate in healthy adults, neither condition would be expected to affect exposure to MMF and therefore no dosage adjustment is necessary. However, caution should be exercised when treating patients with these conditions (see 7 WARNINGS AND PRECAUTIONS, Special Populations; 10 CLINICAL PHARMACOLOGY, Pharmacokinetics).
• Pediatric patients: JAMP Dimethyl Fumarate is not indicated for use in pediatric patients (see 1 INDICATIONS and 10 CLINICAL PHARMACOLOGY). • Geriatric patients: Clinical studies of dimethyl fumarate had limited exposure to patients aged 55 years and above, and did not include sufficient numbers of patients aged 65 and over to determine whether the safety and efficacy of dimethyl fumarate differs in elderly patients compared to younger patients.
Based on the mechanism of action there are no theoretical reasons for any requirement for dose adjustments in the elderly. Physicians who choose to treat geriatric patients should consider that treatment with JAMP Dimethyl Fumarate in the context of a greater frequency of other concomitant diseases and concomitant drug therapy warrants caution and may necessitate additional or more frequent monitoring (see 7 WARNINGS AND PRECAUTIONS, Geriatrics).
2 Recommended Dose and Dosage Adjustment • Initial dose: The starting dose for JAMP Dimethyl Fumarate is 120 mg twice a day orally, for a total of 240 mg per day. • Usual dose: After 7 days, increase to the recommended dose of 240 mg twice a day orally, for a total of 480 mg per day.
Temporary dose reduction to 120 mg twice a day (total of 240 mg per day) may reduce the occurrence of flushing and gastrointestinal (GI) side effects. Within one month, the recommended dose of 240 mg twice a day orally should be resumed.
JAMP Dimethyl Fumarate can be taken with or without food. For those patients who may experience gastrointestinal side effects, taking JAMP Dimethyl Fumarate with food may improve tolerability. Administration of 325 mg non-enteric coated acetylsalicylic acid prior to dimethyl fumarate dosing reduced the occurrence and severity of flushing in a 4-day healthy volunteer study.
Longer term use of acetylsalicylic acid to manage flushing has not been studied and is not recommended (see 10 CLINICAL PHARMACOLOGY). Health Canada has not authorized an indication for pediatric use. 4 Administration Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 6 of 43 JAMP Dimethyl Fumarate is taken orally, with or without food.
Capsules should be taken by swallowing whole. The capsule and its contents should not be crushed, divided, or dissolved, as the enteric-coating of the minitablets in the capsule helps to prevent irritant effects on the stomach. 5 Missed Dose If a dose is missed, the missed dose can be taken if there is at least 4 hours between the morning and evening doses.
Otherwise, treatment should be continued with the next dose as planned.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
, Clinical Trial Adverse Reactions). Administration of JAMP Dimethyl Fumarate with food or a temporary dose reduction to 240 mg/day may improve tolerability in patients who experience gastrointestinal adverse events (see 4 DOSAGE AND ADMINISTRATION, Recommended Dose and Dosage Adjustment).
Dimethyl Fumarate has not been evaluated in patients with severe active gastrointestinal disease and caution should be exercised when treating these patients. Hematologic JAMP Dimethyl Fumarate (dimethyl fumarate) may decrease lymphocyte counts (see 8 ADVERSE REACTIONS, Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
In the MS placebo-controlled trials, mean lymphocyte counts decreased by Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 8 of 43 approximately 30% during the first year of treatment with dimethyl fumarate then remained stable at this reduced level for the duration of treatment.
91 x 109/L). 8 x 109/L for at least six months. 5 x 109/L with continued therapy. Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. 2 Pharmacodynamics. The following precautions should be taken: • Prior to initiating treatment with JAMP Dimethyl Fumarate, obtain a complete blood count (CBC), including lymphocytes, if no recent (within 6 months) result is available.
A CBC, including lymphocytes, is also recommended after 6 months of treatment, then every 6 to 12 months, and as clinically indicated. 5 x 109/L persisting for more than 6 months. • Assess the benefit-risk in patients who experience moderate lymphopenia for more than 6 months.
• In patients with lymphocyte counts below lower limit of normal (LLN) as defined by local laboratory reference range, regular monitoring of absolute lymphocyte counts is recommended. Additional factors that might further augment the individual PML risk should be considered (see also Progressive Multifocal Leukoencephalopathy below).
• In all cases of lymphopenia, lymphocyte counts should be followed until recovery. Where JAMP Dimethyl Fumaratetreatment has been stopped, decisions about whether or not to restart JAMP Dimethyl Fumarate should be individualized based on clinical circumstances.
• A CBC is also recommended prior to switching patients to other therapies that are known to reduce lymphocyte counts to avoid additive immune effects (see 8 ADVERSE REACTIONS, Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
• Patients with pre-existing low lymphocyte counts, and patients concomitantly taking other immunomodulating treatments, were excluded from the multiple sclerosis clinical trials. , immunodeficiency syndrome), due to the potential risk of additive immune system effects.
Hepatic/Biliary During clinical trials in patients with multiple sclerosis, elevations in liver transaminases (ALT and AST) > 1 x the upper limit of normal (ULN) and less than 3 x ULN occurred more frequently Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 9 of 43 in patients treated with dimethyl fumarate than in patients that received placebo.
The increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate relative to placebo was primarily seen during the first 6 months of treatment (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Reactions, Hepatic Transaminases).
Prior to initiating treatment with JAMP Dimethyl Fumarate, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained (within 6 months). During treatment, evaluation of transaminases is recommended after 6 months of treatment, then every 6 to 12 months, and as clinically indicated.
Discontinue JAMP Dimethyl Fumarate if clinically significant liver injury induced by JAMP Dimethyl Fumarate is suspected. Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate in the postmarketing setting.
The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.
These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.
Immune Infections:
Treatment with JAMP Dimethyl Fumarate should not be initiated in patients with signs and symptoms of a serious infection. Decreases in lymphocyte counts observed in patients treated with dimethyl fumarate in clinical trials were not associated with increased frequencies of infections.
However, due to the potential risk of infections in patients who develop sustained […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
01/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Pediatrics..............................................................................................................
3 Less Common Clinical Trial Adverse Reactions ................................................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ...............................................................................................
5 Post-Market Adverse Reactions ......................................................................... 19 9 DRUG INTERACTIONS ............................................................................................... 2 Drug Interactions Overview................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
• JAMP Dimethyl Fumarate is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredients, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Posology The starting dose is 120 mg twice a day. 4). 3 If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses.
Otherwise the patient should wait until the next scheduled dose. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg twice a day should be resumed.
2). 8). 2). Based on the mode of action of the active substance there are no theoretical reasons for any requirement for dose adjustments in the elderly. Renal and hepatic impairment Dimethyl fumarate Accord has not been studied in patients with renal or hepatic impairment.
2). 4). Paediatric population The posology is the same in adults and in paediatric patients aged 13 years and older. There are limited data available in children between 10 and 12 years old. 1 but no recommendation on a posology can be made.
The safety and efficacy of dimethyl fumarate in children aged less than 10 years have not been established. No data are available. Method of administration For oral use. The capsule should be swallowed whole. The capsule or its contents should not be crushed, divided, dissolved, sucked or chewed as the enteric-coating of the mini tablet prevents irritant effects on the gastrointestinal tract.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised August 26, 2025[3]
e. diarrhoea (14%), nausea (12%), abdominal pain (10%), abdominal pain upper (10%)). Flushing and gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing and gastrointestinal events, these events may continue to occur intermittently throughout treatment with dimethyl fumarate.
The most commonly reported adverse reactions leading to treatment discontinuation are flushing (3%) and gastrointestinal events (4%). In phase 2 and 3 placebo-controlled and uncontrolled clinical studies, a total of 2,513 patients have received dimethyl fumarate for periods of up to 12 years with an overall exposure equivalent to 11,318 person-years.
A total of 1,169 patients have received at least 5 years of treatment with dimethyl fumarate, and 426 patients have received at least 10 years of treatment with dimethyl fumarate. The experience in uncontrolled clinical trials is consistent with the experience in the placebo-controlled clinical trials.
Tabulated list of adverse reactions Adverse reactions arising from clinical studies, post-authorisation safety studies and spontaneous reports, are presented in the table below. The adverse reactions are presented as MedDRA preferred terms under the MedDRA System Organ Class.
The incidence of the adverse reactions below is expressed according to the following categories: - Very common (≥1/10) - Common (≥1/100 to <1/10) - Uncommon (≥1/1, 000 to <1/100) - Rare (≥1/10, 000 to <1/1,000) - Very rare (<1/10,000) - Not known (frequency cannot be estimated from the available data) MedDRA system organ class Adverse reaction Frequency category Infections and infestations Gastroenteritis Common Progressive multifocal leukoencephalopathy (PML) Not known Herpes zoster Not known 10 Blood and lymphatic system disorders Lymphopenia Common Leucopenia Common Thrombocytopenia Uncommon Immune system disorders Hypersensitivity Uncommon Anaphylaxis Not known Dyspnoea Not known Hypoxia Not known Hypotension Not known Angioedema Not known Nervous system disorders Burning sensation Common Vascular disorders Flushing Very common Hot flush Common Respiratory, thoracic and mediastinal disorders Rhinorrhoea Not known Gastrointestinal disorders Diarrhoea Very common Nausea Very common Abdominal pain upper Very common Abdominal pain Very common Vomiting Common Dyspepsia Common Gastritis Common Gastrointestinal disorder Common Hepatobiliary disorders Aspartate aminotransferase increased Common Alanine aminotransferase increased Common Drug-induced liver injury Rare Skin and subcutaneous tissue disorders Pruritus Common Rash Common Erythema Common Alopecia Common Renal and urinary disorders Proteinuria Common General disorders and administration site conditions Feeling hot Common Investigations Ketones measured in urine Very common Albumin urine present Common White blood cell count decreased Common Description of selected adverse reactions Flushing In the placebo-controlled studies, the incidence of flushing (34% versus 4%) and hot flush (7% versus 2%) was increased in patients treated with dimethyl fumarate compared to placebo, respectively.
g. warmth, redness, itching, and burning sensation). Flushing events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience flushing, these events may continue to occur intermittently throughout treatment with dimethyl fumarate.
In patients with flushing, the majority had flushing events that were mild or moderate in severity. Overall, 3% of patients treated with dimethyl fumarate discontinued due to flushing. 5). g. diarrhoea [14% versus 10%], nausea [12% versus 9%], upper abdominal pain [10% versus 6%], abdominal pain [9% versus 4%], vomiting [8% versus 5%] 11 and dyspepsia [5% versus 3%]) was increased in patients treated with dimethyl fumarate compared to placebo, respectively.
Gastrointestinal events tend to begin early in the course of treatment (primarily during the first month) and in patients who experience gastrointestinal adverse reactions, these events may continue to occur intermittently throughout treatment with dimethyl fumarate.
In the majority of patients who experienced gastrointestinal events, it was mild or moderate in severity. Four per cent (4%) of patients treated with dimethyl fumarate discontinued due to gastrointestinal adverse reactions. 2). Hepatic function Based on data from placebo-controlled studies, the majority of patients with elevations had hepatic transaminases that were <3 times the ULN.
The increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate relative to placebo was primarily seen during the first 6 months of treatment. Elevations of alanine aminotransferase and aspartate aminotransferase ≥3 times ULN, respectively, were seen in 5% and 2% of patients treated with placebo and 6% and 2% of patients treated with dimethyl fumarate.
Discontinuations due to elevated hepatic transaminases were <1% and similar in patients treated with dimethyl fumarate or placebo. Elevations in transaminases ≥3 times ULN with concomitant elevations in total bilirubin >2 times ULN, were not observed in placebo-controlled studies.
Increase of liver enzymes and cases of drug-induced liver injury (elevations in […]
EUOfficial regulatory label· Warnings and precautions· revised August 26, 2025[3]
8). The clinical implications of these changes are unknown. g. creatinine, blood urea nitrogen and urinalysis) is recommended prior to treatment initiation, after 3 and 6 months of treatment, every 6 to 12 months thereafter and as clinically indicated.
Hepatic function Drug-induced liver injury, including liver enzyme increase (≥ 3 times upper limit of normal (ULN)) and elevation of total bilirubin levels (≥ 2 x ULN) can result from treatment with dimethyl fumarate. The time to onset can be days, several weeks or longer.
Resolution of the adverse reactions has been observed after treatment was discontinued. g. alanine aminotransferase (ALT), aspartate aminotransferase (AST)) and total bilirubin levels are recommended prior to treatment initiation and during treatment as clinically indicated.
8). Prior to initiating treatment with dimethyl fumarate, a current complete blood count, including lymphocytes, must be performed. If lymphocyte count is found to be below the normal range, thorough assessment of possible causes should be completed prior to initiation of treatment.
Dimethyl fumarate has not been studied in patients with pre-existing low lymphocyte counts and caution should be exercised when treating these patients. 5 x 109/L). After starting therapy, complete blood counts, including lymphocytes, must be performed every 3 months.
5 x 109/L) persisting for more than 6 months. 8 x 109/L for more than 6 months, the benefit/risk balance of treatment with dimethyl fumarate should be re-assessed. • In patients with lymphocyte counts below lower limit of normal (LLN) as defined by local laboratory reference range, regular monitoring of absolute lymphocyte counts is recommended.
Additional factors that might further augment the individual PML risk should be considered (see subsection on PML below). 1). Upon recovery and in the absence of alternative treatment options, decisions about whether or not to restart dimethyl fumarate after treatment discontinuation should be based on clinical judgement.
Magnetic resonance imaging (MRI) Before initiating treatment with dimethyl fumarate, a baseline MRI should be available (usually within 3 months) as a reference. The need for further MRI scanning should be considered in accordance with national and local recommendations.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised August 26, 2025[3]
1. Suspected or confirmed progressive multifocal leukoencephalopathy (PML).
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised July 13, 2021[4]
1 ) Swallow dimethyl fumarate delayed-release capsules whole and intact. 1 Dosing Information The starting dose for dimethyl fumarate delayed-release capsules are 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally.
Temporary dose reductions to 120 mg twice a day may be considered for individuals who do not tolerate the maintenance dose. Within 4 weeks, the recommended dose of 240 mg twice a day should be resumed. Discontinuation of dimethyl fumarate delayed-release capsules should be considered for patients unable to tolerate return to the maintenance dose.
The incidence of flushing may be reduced by administration of dimethyl fumarate delayed-release capsules with food. 3) ]. Dimethyl fumarate delayed-release capsules should be swallowed whole and intact. Dimethyl fumarate delayed-release capsules should not be crushed or chewed and the capsule contents should not be sprinkled on food.
Dimethyl fumarate delayed-release capsules can be taken with or without food. 4) ] . 5) ].
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 1,102 reports total. [5]
Multiple Sclerosis Relapse 125
Flushing 93
Multiple Sclerosis 76
Drug Ineffective 64
Gastrointestinal Disorder 63
Nausea 38
Treatment Failure 38
Abdominal Pain Upper 37
Abdominal Discomfort 36
Diarrhoea 34
Drug Intolerance 34
Dizziness 30
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised July 13, 2021[4]
1) ]. 2) ]. 3) ]. 4) ]. 5) ]. 6) ]. Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. 1 ) To report SUSPECTED ADVERSE REACTIONS, contact MSN pharmaceuticals Inc. gov/medwatch .
1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate were flushing, abdominal pain, diarrhea, and nausea. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate with an overall exposure of 2244 person-years [ see Clinical Studies (14) ].
The adverse reactions presented in the table below are based on safety information from 769 patients treated with dimethyl fumarate 240 mg twice a day and 771 placebo-treated patients. , nausea, vomiting, diarrhea, abdominal pain, and dyspepsia).
The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with dimethyl fumarate compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate and less than 1% of placebo patients discontinued due to gastrointestinal events.
The incidence of serious GI events was 1% in patients treated with dimethyl fumarate. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate was seen primarily during the first six months of treatment, and most patients with elevations had levels < 3 times the upper limit of normal (ULN) during controlled trials.
Elevations of alanine aminotransferase and aspartate aminotransferase to ≥ 3 times the ULN occurred in a small number of patients treated with both dimethyl fumarate and placebo and were balanced between groups. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN.
Discontinuations due to elevated hepatic transaminases were < 1% and were similar in patients treated with dimethyl fumarate or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.
Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received dimethyl fumarate and been followed for periods up to 4 years with an overall exposure of 4603 person-years.
Approximately 1162 patients have received more than 2 years of treatment with dimethyl fumarate. The adverse reaction profile of dimethyl fumarate in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials.
2 Post Marketing Experience The following adverse reaction has been identified during post-approval use of dimethyl fumarate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
5) ]. 3) ] . Rhinorrhea has been reported with dimethyl fumarate administration in post marketing experience.
USOfficial regulatory label· Warnings and precautions· revised July 13, 2021[4]
5 WARNINGS AND PRECAUTIONS Anaphylaxis and angioedema: Discontinue and do not restart dimethyl fumarate if these occur. 1 ) Progressive multifocal leukoencephalopathy (PML): Withhold dimethyl fumarate at the first sign or symptom suggestive of PML.
2 ) Herpes zoster and other serious opportunistic infections: Consider withholding dimethyl fumarate in cases of serious infection until the infection has resolved. 3 ) Lymphopenia: Obtain a CBC including lymphocyte count before initiating dimethyl fumarate, after 6 months, and every 6 to 12 months thereafter.
5 x 10 9 /L persist for more than six months. 4 ) Liver injury: Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating dimethyl fumarate and during treatment, as clinically indicated. Discontinue dimethyl fumarate if clinically significant liver injury induced by dimethyl fumarate is suspected.
1 Anaphylaxis and Angioedema Dimethyl fumarate can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Signs and symptoms have included difficulty breathing, urticaria, and swelling of the throat and tongue.
Patients should be instructed to discontinue dimethyl fumarate and seek immediate medical care should they experience signs and symptoms of anaphylaxis or angioedema. 2 Progressive Multifocal Leukoencephalopathy Progressive multifocal leukoencephalopathy (PML) has occurred in patients with MS treated with dimethyl fumarate.
PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. A fatal case of PML occurred in a patient who received dimethyl fumarate for 4 years while enrolled in a clinical trial.
4) ] . The patient had no other identified systemic medical conditions resulting in compromised immune system function and had not previously been treated with natalizumab, which has a known association with PML. The patient was also not taking any immunosuppressive or immunomodulatory medications concomitantly.
9x10 9 /L). 8 x 10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold dimethyl fumarate and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised July 13, 2021[4]
4 CONTRAINDICATIONS Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate. 1) ]. Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate.
( 4 )
This is not medical advice. Consult a qualified healthcare professional.
MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML. In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes. 8). PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of lymphopenia (lymphocyte counts below LLN). Prolonged moderate to severe lymphopenia appears to increase the risk of PML with dimethyl fumarate, however, risk cannot be excluded in patients with mild lymphopenia.
Additional factors that might contribute to an increased risk for PML in the setting of lymphopenia are: - duration of dimethyl fumarate therapy. Cases of PML have occurred after approximately 1 to 5 years of treatment, although the exact relationship with duration of treatment is unknown.
8), and - prior immunosuppressive or immunomodulatory therapy (see below). Physicians should evaluate their patients to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are typical of MS or possibly suggestive of PML.
At the first sign or symptom suggestive of PML, dimethyl fumarate should be withheld and appropriate diagnostic evaluations, including determination of JCV DNA in cerebrospinal fluid (CSF) by quantitative polymerase chain reaction (PCR) methodology, need to be performed.
The symptoms of PML may be similar to an MS relapse. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Physicians should be particularly alert to symptoms suggestive of PML that the patient may not notice. Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
PML can only occur in the presence of a JCV infection. It should be considered that the influence of lymphopenia on the accuracy of serum anti-JCV antibody testing has not been studied in dimethyl fumarate treated patients. It should also be noted that a negative anti-JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
If a patient develops PML, dimethyl fumarate must be permanently discontinued. Prior treatment with immunosuppressive or […]
1 Mechanism of Action.......................................................................................... 2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ...............................................................................................
24 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 27 12 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 27 PART II: SCIENTIFIC INFORMATION ......................................................................................
28 13 PHARMACEUTICAL INFORMATION ........................................................................... 28 14 CLINICAL TRIALS .......................................................................................................
37 Pr JAMP Dimethyl Fumarate (dimethyl fumarate delayed-release capsules) Page 4 of 43 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS JAMP Dimethyl Fumarate (dimethyl fumarate) is indicated as monotherapy for: • treatment of relapsing remitting multiple sclerosis (MS), to reduce the frequency of clinical exacerbations and to delay the progression of disability.
The efficacy of dimethyl fumarate in patients with primary progressive multiple […]
MRI imaging may be considered as part of increased vigilance in patients considered at increased risk of PML. In case of clinical suspicion of PML, MRI should be performed immediately for diagnostic purposes. 8). PML is an opportunistic infection caused by John-Cunningham virus (JCV), which may be fatal or result in severe disability.
PML cases have occurred with dimethyl fumarate and other medicinal products containing fumarates in the setting of lymphopenia (lymphocyte counts below LLN). Prolonged moderate to severe 5 lymphopenia appears to increase the risk of PML with dimethyl fumarate, however, risk cannot be excluded in patients with mild lymphopenia.
Additional factors that might contribute to an increased risk of PML in the setting of lymphopenia are: - duration of dimethyl fumarate therapy. Cases of PML have occurred after approximately 1 to 5 years of treatment, although the exact relationship with duration of treatment is unknown.
8), and - prior immunosuppressive or immunomodulatory therapy (see below). Physicians should evaluate their patients to determine if the symptoms are indicative of neurological dysfunction and, if so, whether these symptoms are typical of MS or possibly suggestive of PML.
At the first sign or symptom suggestive of PML, dimethyl fumarate should be withheld and appropriate diagnostic evaluations, including determination of JCV DNA in cerebrospinal fluid (CSF) by quantitative polymerase chain reaction (PCR) methodology, need to be performed.
The symptoms of PML may be similar to an MS relapse. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
Physicians should be particularly alert to symptoms suggestive of PML that the patient may not notice. Patients should also be advised to inform their partner or caregivers about their treatment, since they may notice symptoms that the patient is not aware of.
PML can only occur in the presence of a JCV infection. It should be considered that the influence of lymphopenia on the accuracy of serum anti-JCV antibody testing has not been studied in dimethyl fumarate treated patients. It should also be noted that a negative anti-JCV antibody test (in the presence of normal lymphocyte counts) does not preclude the possibility of subsequent JCV infection.
If a patient develops PML, dimethyl fumarate must be permanently discontinued. Prior treatment with immunosuppressive or immunomodulating therapies No […]
MRI findings may be apparent before clinical signs or symptoms. Cases of PML, diagnosed based on MRI findings and the detection of JCV DNA in the cerebrospinal fluid in the absence of clinical signs or symptoms specific to PML, have been reported in patients treated with other MS medications associated with PML.
Many of these patients subsequently became symptomatic with PML. Therefore, monitoring with MRI for signs that may be consistent with PML may be useful, and any suspicious findings should lead to further investigation to allow for an early diagnosis of PML, if present.
Lower PML-related mortality and morbidity have been reported following discontinuation of another MS medication associated with PML in patients with PML who were initially asymptomatic compared to patients with PML who had characteristic clinical signs and symptoms at diagnosis.
It is not known whether these differences are due to early detection and discontinuation of MS treatment or due to differences in disease in these patients. 3 Herpes Zoster and Other Serious Opportunistic Infections Serious cases of herpes zoster have occurred with dimethyl fumarate, including disseminated herpes zoster, herpes zoster ophthalmicus, herpes zoster meningoencephalitis, and herpes zoster meningomyelitis.
These events may occur at any time during treatment. Monitor patients on dimethyl fumarate for signs and symptoms of herpes zoster. If herpes zoster occurs, appropriate treatment for herpes zoster should be administered. Other serious opportunistic infections have occurred with dimethyl fumarate, including cases of serious viral (herpes simplex virus, West Nile virus, cytomegalovirus), fungal (Candida and Aspergillus), and bacterial (Nocardia, Listeria monocytogenes, Mycobacterium tuberculosis) infections.
These infections have been reported in patients with reduced absolute lymphocyte counts (ALC) as well as in patients with normal ALC. These infections have affected the brain, meninges, spinal cord, gastrointestinal tract, lungs, skin, eye, and ear.
Patients with symptoms and signs consistent with any of these infections should undergo prompt diagnostic evaluation and receive appropriate treatment. 2) ]. 4 Lymphopenia Dimethyl fumarate may decrease lymphocyte counts. In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with dimethyl fumarate and then remained stable.
Four weeks after stopping dimethyl fumarate, mean lymphocyte counts increased but did not return to baseline. 91 x 10 9 /L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with dimethyl fumarate or placebo, respectively.
2)] . 5 x 10 9 /L with continued therapy. Dimethyl fumarate has not been studied in patients with preexisting low lymphocyte counts. Obtain a CBC, including lymphocyte count, before initiating treatment with dimethyl fumarate, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated.
5 x 10 9 /L persisting for more than six months. Given the potential for delayed recovery of lymphocyte counts, continue to obtain lymphocyte counts until their recovery if dimethyl fumarate is discontinued or interrupted due to lymphopenia.
Decisions about whether or not to restart dimethyl fumarate should be individualized based on clinical circumstances. 5 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with dimethyl fumarate in the postmarketing setting.
The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate. Signs and symptoms of liver injury, including elevation of serum aminotransferases to greater than 5-fold the upper limit of normal and elevation of total bilirubin to greater than 2-fold the upper limit of normal have been observed.
These abnormalities resolved upon treatment discontinuation. Some cases required hospitalization. None of the reported cases resulted in liver failure, liver transplant, or death. However, the combination of new serum aminotransferase elevations with increased levels of bilirubin caused by drug-induced hepatocellular injury is an important predictor of serious liver injury that may lead to acute liver failure, liver transplant, or death in some patients.
1) ]. Obtain serum aminotransferase, alkaline phosphatase (ALP), and total bilirubin levels prior to treatment with dimethyl fumarate and during treatment, as clinically indicated. Discontinue dimethyl fumarate if clinically significant liver injury induced by dimethyl fumarate is suspected.
, warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of dimethyl fumarate treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate and usually improved or resolved over time.
In the majority of patients who experienced flushing, it was mild or moderate in severity. Three percent (3%) of patients discontinued dimethyl fumarate for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization.
Administration of dimethyl fumarate with food may reduce the incidence of flushing. 3) ].