Medicine guide

Dimethyl Fumarate

120 mg · Capsule, Delayed Release

Prescription only

Active substance: Dimethyl Fumarate
Made by: MSN LABORATORIES PRIVATE LIMITED
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2021-07-13

Used for

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…

The label’s usual adult dose

120 mg twice a day, orally, for 7 days ( 2.1 ) Maintenance dose after 7 days:

Full directions ↓

Do not take it if

Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01

42other products contain Dimethyl Fumarate — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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 )

From the official label · 2021-07-13 · DailyMed

How it works

From this product’s own US prescribing label.

The mechanism by which dimethyl fumarate (DMF) exerts its therapeutic effect in multiple sclerosis is unknown.
DMF and the metabolite, monomethyl fumarate (MMF), have been shown to activate the Nuclear factor (erythroid-derived 2)-like 2 (Nrf2) pathway in vitro and in vivo in animals and humans.

Half-life1 h

Mostly cleared after≈ 5 hfive half-lives — our arithmetic

How the body breaks it down

In humans, dimethyl fumarate is extensively metabolized by esterases, which are ubiquitous in the gastrointestinal tract, blood, and tissues, before it reaches the systemic circulation.

With food

Following administration of dimethyl fumarate 240 mg twice a day with food, the mean C max of MMF was 1.87 mg/L and AUC was 8.21 mg.hr/L in MS patients.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2021-07-13

Do not take it if

Dimethyl fumarate is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate.
Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.1) ].
Known hypersensitivity to dimethyl fumarate or any of the excipients of dimethyl fumarate.
( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

Starting dose:
120 mg twice a day, orally, for 7 days ( 2.1 ) Maintenance dose after 7 days:
240 mg twice a day, orally ( 2.1 ) Swallow dimethyl fumarate delayed-release capsules whole and intact.
Do not crush, chew, or sprinkle capsule contents on food ( 2.1 ) Take dimethyl fumarate delayed-release capsule with or without food ( 2.1 )
2.1 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.
Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate delayed-release capsule dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology (12.3) ].
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.
2.2 Blood Tests Prior to Initiation of Therapy Obtain a complete blood cell count (CBC) including lymphocyte count before initiation of therapy [ see Warnings and Precautions (5.4) ] .
Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment with dimethyl fumarate delayed-release capsules [ see Warnings and Precautions (5.5) ].

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Anaphylaxis and angioedema:
Discontinue and do not restart dimethyl fumarate if these occur.
( 5.1 ) Progressive multifocal leukoencephalopathy (PML):
Withhold dimethyl fumarate at the first sign or symptom suggestive of PML.
( 5.2 ) Herpes zoster and other serious opportunistic infections:
Consider withholding dimethyl fumarate in cases of serious infection until the infection has resolved.
( 5.3 ) Lymphopenia:
Obtain a CBC including lymphocyte count before initiating dimethyl fumarate, after 6 months, and every 6 to 12 months thereafter.
Consider interruption of dimethyl fumarate if lymphocyte counts <0.5 x 10 9 /L persist for more than six months.
( 5.4 ) 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.
( 5.5 )
5.1 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.
5.2 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.
During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 10 9 /L for 3.5 years) while taking dimethyl fumarate [ see Warnings and Precautions (5.4) ] .
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.
PML has also occurred in the postmarketing setting in the presence of lymphopenia (<0.9x10 9 /L).
While the role of lymphopenia in these cases is uncertain, the PML cases have occurred predominantly in patients with lymphocyte counts <0.8 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.
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.
5.3 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.
Consider withholding dimethyl fumarate treatment in patients with herpes zoster or other serious infections until the infection has resolved [ see Adverse Reactions (6.2) ].
5.4 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.
Six percent (6%) of dimethyl fumarate patients and <1% of placebo patients experienced lymphocyte counts <0.5 x 10 9 /L (lower limit of normal 0.91 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.
There was no increased incidence of serious infections observed in patients with lymphocyte counts<0.8 x 10 9 /L or <0.5 x 10 9 /L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5 x 10 9 /L for 3.5 years) [see Warnings and Precautions (5.2)] .
In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5 x 10 9 /L for at least six months, and in this group the majority of lymphocyte counts remained <0.5 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.
Consider interruption of dimethyl fumarate in patients with lymphocyte counts less than 0.5 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.
Consider withholding treatment from patients with serious infections until resolution.Decisions about whether or not to restart dimethyl fumarate should be individualized based on clinical circumstances.
5.5 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.
Elevations of hepatic transaminases (most no greater than 3 times the upper limit of normal) were observed during controlled trials [see Adverse Reactions (6.1) ].
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.
5.6 Flushing Dimethyl fumarate may cause flushing (e.g., 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.
Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to dimethyl fumarate dosing may reduce the incidence or severity of flushing [see Dosing and Administration (2.1) and Clinical Pharmacology (12.3) ].

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Risk Summary There are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women.
In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see Data] In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested.
This dose also produced evidence of maternal toxicity (reduced body weight).
Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day.
In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested.
The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD.
Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested.
Neurobehavioral impairment was observed at all doses.
A no-effect dose for developmental toxicity was not identified.
The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD.
IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, may cause fetal harm.
( 8.1 )
8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of dimethyl fumarate in pregnant women.
In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. [see Data] In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
The background risk of major birth defects and miscarriage for the indicated population is unknown.
Data Animal Data In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested.
This dose also produced evidence of maternal toxicity (reduced body weight).
Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day.
In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested.
The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD.
Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested.
Neurobehavioral impairment was observed at all doses.
A no-effect dose for developmental toxicity was not identified.
The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD.
8.2 Lactation Risk Summary There are no data on the presence of DMF or MMF in human milk.
The effects on the breastfed infant and on milk production are unknown.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dimethyl fumarate and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use Clinical studies of dimethyl fumarate did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Side effects

The following important adverse reactions are described elsewhere in labeling:
Anaphylaxis and Angioedema [see Warnings and Precautions (5.1) ].
Progressive multifocal leukoencephalopathy [see Warnings and Precautions (5.2) ].
Herpes Zoster and Other Serious Opportunistic Infections [ see Warnings and Precautions (5.3) ].
Lymphopenia [ see Warnings and Precautions (5.4) ].
Liver Injury [ see Warnings and Precautions (5.5) ].
Flushing [ see Warnings and Precautions (5.6) ].
Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact MSN pharmaceuticals Inc. at 1-855-668-2369 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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.
Table 1:Adverse Reactions in Study 1 and 2 reported for dimethyl fumarate 240 mg BID at ≥ 2% higher incidence than placebo Dimethyl Fumarate N=769 % Placebo N=771 % Flushing 40 6 Abdominal pain 18 10 Diarrhea 14 11 Nausea 12 9 Vomiting 9 5 Pruritus 8 4 Rash 8 3 Albumin urine present 6 4 Erythema 5 1 Dyspepsia 5 3 Aspartate aminotransferase increased 4 2 Lymphophenia 2 <1 Gastrointestinal Dimethyl fumarate caused GI events (e.g., 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.
6.2 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.
Liver function abnormalities (elevations in transaminases ≥ 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN) have been reported following dimethyl fumarate administration in postmarketing experience [ See Warnings and Precautions (5.5) ].
Herpes zoster infection and other serious opportunistic infections have has been reported with dimethyl fumarate administration in postmarketing experience [ See Warnings and Precautions (5.3) ] .
Rhinorrhea has been reported with dimethyl fumarate administration in post marketing experience.

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

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Bulgaria14 matching products

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European UnionNo exact match for this strength and form

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Canada7 matching products

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Details

Made by	MSN LABORATORIES PRIVATE LIMITED
Active substance	Dimethyl Fumarate
Strength	120 mg
Form	Capsule, Delayed Release
Route	Oral
Packs	1 BOTTLE in 1 CARTON / 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE · 1 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
NDC	69539-042

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

43 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Capsule, Delayed Release34 products
- 120 mg16
  120 mg · 16 companies
  +8 more
- 240 mg18
  240 mg · 18 companies
  +10 more
Kit7 products
- —7
  — · 7 companies
Capsule2 products
- 120 mg
- 240 mg

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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