Medicine guide
Dimethyl Fumarate
240 mg · Capsule, Delayed Release
- Prescription only
- Active substance
- Dimethyl Fumarate
- Made by
- Quallent Pharmaceuticals Health LLC
- 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 · 2025-10-30
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
Starting dose: 120 mg twice a day, orally, for 7 days ( 2.1 )
Full directions ↓Do not take it if
Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules.
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
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 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.
- ( 1 )
From the official label · 2025-10-30 · 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 delayed-release capsules 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 · 2025-10-30
Do not take it if
- Dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules.
- 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 delayed-release capsules.
- ( 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 capsules with or without food ( 2.1 ) 2.1 Dosing Information The starting dose for dimethyl fumarate delayed-release capsules is 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 capsules 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 delayed-release capsules if these occur. ( 5.1 )
- Progressive Multifocal Leukoencephalopathy (PML):
- Withhold dimethyl fumarate delayed-release capsules at the first sign or symptom suggestive of PML. ( 5.2 )
- Consider withholding dimethyl fumarate delayed-release capsules in cases of serious infection until the infection has resolved. ( 5.3 )
- Lymphopenia:
- Obtain a CBC including lymphocyte count before initiating dimethyl fumarate delayed-release capsules, after 6 months, and every 6 to 12 months thereafter. Consider interruption of dimethyl fumarate delayed-release capsules if lymphocyte counts <0.5 x 10 9 /L persist for more than 6 months. ( 5.4 )
- Liver Injury:
- Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels before initiating dimethyl fumarate delayed-release capsules and during treatment, as clinically indicated. Discontinue dimethyl fumarate delayed-release capsules if clinically significant liver injury induced by dimethyl fumarate delayed-release capsules is suspected. ( 5.5 ) 5.1 Anaphylaxis and Angioedema Dimethyl fumarate delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules. 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 delayed-release capsules for 4 years while enrolled in a clinical trial. During the clinical trial, the patient experienced prolonged lymphopenia (lymphocyte counts predominantly <0.5x10 9 /L for 3.5 years) while taking dimethyl fumarate delayed-release capsules [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 <0.8x10 9 /L persisting for more than 6 months. At the first sign or symptom suggestive of PML, withhold dimethyl fumarate delayed-release capsules 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 delayed-release capsules, 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 delayed-release capsules 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 delayed-release capsules, 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules and then remained stable. Four weeks after stopping dimethyl fumarate delayed-release capsules, mean lymphocyte counts increased but did not return to baseline. Six percent (6%) of dimethyl fumarate delayed-release capsules patients and <1% of placebo patients experienced lymphocyte counts <0.5x10 9 /L (lower limit of normal 0.91x10 9 /L). The incidence of infections (60% vs 58%) and serious infections (2% vs 2%) was similar in patients treated with dimethyl fumarate delayed-release capsules or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x10 9 /L or < 0.5x10 9 /L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x10 9 /L for 3.5 years) [see Warnings and Precautions ( 5.2 )]. In controlled and uncontrolled clinical trials, 2% of patients experienced prolonged, severe lymphopenia, (defined as lymphocyte counts <0.5 x 10 9 /L for at least six months); in this group of patients, the majority of lymphocyte counts remained <0.5x10 9 /L with continued therapy. In these patients with prolonged, severe lymphopenia, the median time for lymphocyte counts to return to normal after discontinuing dimethyl fumarate delayed-release capsules was 96.0 weeks. In these controlled and uncontrolled clinical studies, among patients who did not experience prolonged, severe lymphopenia during treatment, the median times for lymphocyte counts to return to normal after discontinuing dimethyl fumarate delayed-release capsules were as follows:
- 4.3 weeks in patients with mild lymphopenia (lymphocyte count ≥0.8x10 9 /L) at discontinuation,
- 10.0 weeks in patients with moderate lymphopenia (lymphocyte count 0.5 to <0.8x10 9 /L) at discontinuation, and
- 16.7 weeks in patients with severe lymphopenia (lymphocyte count <0.5x10 9 /L) at discontinuation. Dimethyl fumarate delayed-release capsules have not been studied in patients with pre-existing low lymphocyte counts. Obtain a CBC, including lymphocyte count, before initiating treatment with dimethyl fumarate delayed-release capsules, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated. Consider interruption of dimethyl fumarate delayed-release capsules 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 delayed-release capsules are 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 delayed-release capsules 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 delayed-release capsules in the postmarketing setting. The onset has ranged from a few days to several months after initiation of treatment with dimethyl fumarate delayed-release capsules. 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 delayed-release capsules and during treatment, as clinically indicated. Discontinue dimethyl fumarate delayed-release capsules if clinically significant liver injury induced by dimethyl fumarate delayed-release capsules is suspected. 5.6 Flushing Dimethyl fumarate delayed-release capsules may cause flushing (e.g., warmth, redness, itching, and/or burning sensation). In clinical trials, 40% of dimethyl fumarate delayed-release capsules treated patients experienced flushing. Flushing symptoms generally began soon after initiating dimethyl fumarate delayed-release capsules 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 delayed-release capsules for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization. Administration of dimethyl fumarate delayed-release capsules 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 delayed-release capsules dosing may reduce the incidence or severity of flushing [see Dosing and Administration ( 2.1 ) and Clinical Pharmacology ( 12.3 )]. 5.7 Serious Gastrointestinal Reactions Serious gastrointestinal reactions, including perforation, ulceration, hemorrhage, and obstruction, some with fatal outcomes, have been reported in the postmarketing setting with the use of fumaric acid esters, including dimethyl fumarate delayed-release capsules, with or without concomitant aspirin use. The majority of these events have occurred within 6 months of fumaric acid ester treatment initiation. In controlled clinical trials, the incidence of serious gastrointestinal adverse events was 1% in patients treated with dimethyl fumarate delayed-release capsules; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%) [see Adverse Reactions ( 6.1 )] . Monitor patients, promptly evaluate, and discontinue dimethyl fumarate delayed-release capsules for new or worsening severe gastrointestinal signs and symptoms.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- Risk Summary Available data from the dimethyl fumarate Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
- Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data) .
- 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).
- The background risk of major birth defects and miscarriage for the indicated population is unknown.
- All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
- Data Human Data In a prospective observational dimethyl fumarate Pregnancy Registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI:
- 1.9 to 6.1).
- No specific pattern of major birth defects was identified.
- Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.
- 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
- 8.1 Pregnancy Risk Summary Available data from the dimethyl fumarate Pregnancy Registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes.
- Most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see Data) .
- 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).
- The background risk of major birth defects and miscarriage for the indicated population is unknown.
- All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
- Data Human Data In a prospective observational dimethyl fumarate Pregnancy Registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% CI:
- 1.9 to 6.1).
- No specific pattern of major birth defects was identified.
- Important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort.
- 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 delayed-release capsules 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 delayed-release capsules 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 )]
- Serious Gastrointestinal Reactions [see Warnings and Precautions ( 5.7 )] Most common adverse reactions (incidence ≥10% and ≥2% placebo) were flushing, abdominal pain, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Quallent Pharmaceuticals Health LLC at 1-877-605-7243 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. In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received dimethyl fumarate delayed-release capsules and been followed for periods up to 13 years with an overall exposure of 11,318 person-years. Approximately 1169 patients have received more than 5 years of treatment with dimethyl fumarate delayed-release capsules, and 426 patients have received at least 10 years of treatment with dimethyl fumarate delayed-release capsules. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received dimethyl fumarate delayed-release capsules 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 delayed-release capsules 240 mg twice a day and 771 placebo-treated patients. The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for dimethyl fumarate delayed-release capsules were flushing, abdominal pain, diarrhea, and nausea. Table 1:
- Adverse Reactions in Study 1 and 2 reported for Dimethyl Fumarate Delayed-Release Capsules 240 mg BID at ≥ 2% higher incidence than placebo Dimethyl Fumarate Delayed-Release Capsules 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 Lymphopenia 2 <1 Gastrointestinal Dimethyl fumarate delayed-release capsules 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 delayed-release capsules compared with placebo. Four percent (4%) of patients treated with dimethyl fumarate delayed-release capsules and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in clinical trial patients treated with dimethyl fumarate delayed-release capsules; these events, none of which were fatal, included vomiting (0.3%) and abdominal pain (0.3%). Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with dimethyl fumarate delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the first 2 months of therapy. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of dimethyl fumarate delayed-release capsules. 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. Gastrointestinal Disorders:
- Acute Pancreatitis; Gastrointestinal perforation, ulceration, obstruction, and hemorrhage [see Warnings and Precautions ( 5.7 )] Hepatobiliary Disorders:
- Liver function abnormalities (elevations in transaminases ≥ 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN) [see Warnings and Precautions ( 5.5 )] Infections and Infestations:
- Herpes zoster infection and other serious opportunistic infections [see Warnings and Precautions ( 5.3 )] Respiratory, Thoracic, and Mediastinal Disorders:
- Rhinorrhea Skin and Subcutaneous:
- Alopecia
Quoted from the official label, section “Adverse Reactions”.
Same active substance, strength and form in other countries
Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.
Medicine passport: one printable page to show a pharmacist abroad
Bulgaria14 matching products
- Dimtelzo 240 mg · gastro-resistant capsule, hard2 makers
- Arbicen 240 mg · gastro-resistant capsule, hard
- Cohiber 240 mg · gastro-resistant capsule, hard
- Dimecon 240 mg gastro-resistant capsules, hard · capsule, hard
- Dimethyl fumarate Frontier Dimethyl fumarate Frontier 240 mg gastro-resistant hard capsules · gastro-resistant capsule, hard
- Dimethyl fumarate G.L. Pharma Dimethyl fumarate G.L. Pharma 240 mg gastro-resistant hard capsules · gastro-resistant capsule, hard
- Dimethyl fumarate Gedeon Richter 240 mg · gastro-resistant capsule, hard
- Dimethyl fumarate MSN 240 mg · gastro-resistant capsule, hard
European UnionNo exact match for this strength and form
Canada7 matching products
- APO-DIMETHYL FUMARATE 240 mg · capsule (delayed-release)
- AURO-DIMETHYL FUMARATE 240 mg · capsule (delayed-release)
- GLN-DIMETHYL FUMARATE 240 mg · capsule (delayed-release)
- JAMP DIMETHYL FUMARATE 240 mg · capsule (delayed-release)
- PMS-DIMETHYL FUMARATE 240 mg · capsule (delayed-release)
- SANDOZ DIMETHYL FUMARATE DELAYED-RELEASE CAPSULES 240 mg · capsule (delayed-release)
- TECFIDERA 240 mg · capsule (delayed-release)
Details
| Made by | Quallent Pharmaceuticals Health LLC |
|---|---|
| Active substance | Dimethyl Fumarate |
| Strength | 240 mg |
| Form | Capsule, Delayed Release |
| Route | Oral |
| Packs | 1 BOTTLE in 1 CARTON / 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE |
| NDC | 82009-138 |
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).
Other strengths and forms
43 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.
Dimethyl Fumarate120 mgPrescription only Accord Healthcare Inc. · Dimethyl FumarateDimethyl Fumarate240 mgPrescription only Accord Healthcare Inc. · Dimethyl FumarateDimethyl Fumarate120 mgPrescription only Upsher-Smith Laboratories, LLC · Dimethyl FumarateDimethyl Fumarate240 mgPrescription only Upsher-Smith Laboratories, LLC · Dimethyl FumarateDimethyl Fumarate120 mgPrescription only Camber Pharmaceuticals, Inc. · Dimethyl FumarateDimethyl Fumarate240 mgPrescription only Camber Pharmaceuticals, Inc. · Dimethyl Fumarate