dimethyl fumarate
Capsule, Delayed Release · Oral
Uses
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.
Dosage and administration
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 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 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 )] .
Dosage forms and strengths
Dimethyl fumarate delayed-release capsules, USP are available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate, USP. The 120 mg capsules have a green cap and white body, printed with “T127 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “T128 240 mg” in black ink on the body. Delayed-release capsules: 120 mg and 240 mg
Contraindications
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.
Warnings and precautions
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 ) Herpes Zoster and Other Serious Opportunistic Infections: 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 109/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, uticaria, 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 <0.8x 10 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.
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 Upsher-Smith Laboratories, LLC at 1-855-899-9180 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 po st 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
Use in specific populations
8.1 Pregnancy Risk Summary Available data from the dimethyl fumarate delayed-release capsules 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 delayed-release capsules 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: 1.9-6.1). 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.
Overdosage
Cases of overdose with dimethyl fumarate delayed-release capsules have been reported. The symptoms described in these cases were consistent with the known adverse event profile of dimethyl fumarate delayed-release capsules. There are no known therapeutic interventions to enhance elimination of dimethyl fumarate delayed-release capsules nor is there a known antidote. In the event of overdose, initiate symptomatic supportive treatment as clinically indicated.
Description
Dimethyl fumarate delayed-release capsules, USP contain dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ). It has the following structure: tec00-0006-01 Dimethyl fumarate, USP is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13. Dimethyl fumarate delayed-release capsules, USP are provided as hard gelatin delayed-release capsules for oral administration, containing 120 mg or 240 mg of dimethyl fumarate consisting of the following inactive ingredients: silicified microcrystalline cellulose, microcrystalline cellulose, talc, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, triethyl citrate, methacrylic acid copolymer dispersion, sodium lauryl sulphate, and polysorbate 80. The capsule shell, printed with black ink, contains the following inactive ingredients: gelatin, titanium dioxide, sodium lauryl sulfate, brilliant blue FCF, and tartrazine (Yellow No. 5). The black inks contain: shellac, isopropyl alcohol, butyl alcohol, propylene glycol, black iron oxide, and ammonium hydroxide or potassium hydroxide, dehydrated alcohol, and strong ammonia solution.
How supplied
Dimethyl fumarate delayed-release capsules, USP are available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate. The 120 mg capsules have a green cap and white body, printed with “T127 120 mg” in black ink on the body. The 240 mg capsules have a green cap and a green body, printed with “T128 240 mg” in black ink on the body. Dimethyl fumarate delayed-release capsules, USP are available as follows: 120 mg capsules: 7-day bottle of 14 capsules (NDC 24979-127-21) - Store in original container. Bottle of 500 capsules (NDC 24979-127-02) 240 mg capsules: 30-day bottle of 60 capsules (NDC 24979-128-04) - Store in original container. Bottle of 500 capsules (NDC 24979-128-02) Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature] Protect the capsules from light.
Patient information
Advise the patient to read the FDA-approved patient labeling (Patient Information) Dosage Inform patients that they will be provided two strengths of dimethyl fumarate delayed-release capsules when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow dimethyl fumarate delayed-release capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that dimethyl fumarate delayed-release capsules can be taken with or without food [see Dosage and Administration ( 2.1 )] . Anaphylaxis and Angioedema Advise patients to discontinue dimethyl fumarate delayed-release capsules and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions ( 5.1 )] . Progressive Multifocal Leukoencephalopathy Inform patients that progressive multifocal leukoencephalopathy (PML) has occurred in patients who received dimethyl fumarate delayed-release capsules. Inform the patient that PML is characterized by a progression of deficits and usually leads to death or severe disability over weeks or months. Instruct the patient of the importance of contacting their doctor if they develop any symptoms suggestive of PML. Inform the patient that 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 [see Warnings and Precautions ( 5.2 )] . Herpes Zoster and Other Serious Opportunistic Infections Inform patients that herpes zoster and other serious opportunistic infections have occurred in patients who received dimethyl fumarate delayed-release capsules. Instruct the patient of the importance of contacting their doctor if they develop any signs or symptoms associated with herpes zoster or other serious opportunistic infections [see Warnings and Precautions ( 5.3 )] . Lymphocyte Counts Inform patients that dimethyl fumarate delayed-release capsules may decrease lymphocyte counts. A blood test should be obtained before they start therapy. Blood tests are also recommended after 6 months of treatment, every 6 to 12 months thereafter, and as clinically indicated [see Warnings and Precautions ( 5.4 ), Adverse Reactions ( 6.1 )] . Liver Injury Inform patients that dimethyl fumarate delayed-release capsules may cause liver injury. Instruct patients treated with dimethyl fumarate delayed-release capsules to report promptly any symptoms that may indicate liver injury, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice. A blood test should be obtained before patients start therapy and during treatment, as clinically indicated [see Warnings and Precautions ( 5.5 )] . Flushing Inform patients that flushing is one of the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe flushing. Advise patients experiencing flushing that taking dimethyl fumarate delayed-release capsules with food or taking a non-enteric coated aspirin prior to taking dimethyl fumarate delayed-release capsules may help [see Adverse Reactions ( 6.1 )] . Gastrointestinal (GI) Events Inform patients that GI events (abdominal pain, diarrhea, and nausea) are some of the most common adverse reactions, especially at the initiation of therapy, and may decrease over time. Some patients may experience more severe GI events. Advise patients to immediately contact their healthcare provider and discontinue dimethyl fumarate delayed-release capsules if they experience gastrointestinal bleeding (e.g., rectal bleeding, bloody diarrhea, hematemesis) or other serious gastrointestinal adverse events (e.g., severe abdominal pain, severe vomiting and/or diarrhea) [see Warnings and Precautions ( 5.7 )] . Distributed by UPSHER-SMITH LABORATORIES, LLC Maple Grove, MN 55369 Product of India LA-3118-06 Revised: 11/2025
Label text from the FDA structured product label by Upsher-Smith Laboratories, LLC (revised Jan 19, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dimethyl Fumarate in 38 products
dimethyl fumarate NDC products (46)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-5288 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | A-S Medication Solutions | ANDA |
| 16729-417 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Accord Healthcare Inc. | ANDA |
| 16729-416 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Accord Healthcare Inc. | ANDA |
| 69238-1626 | Kit | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1319 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Amneal Pharmaceuticals NY LLC | ANDA |
| 69238-1318 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Amneal Pharmaceuticals NY LLC | ANDA |
| 67877-555 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Ascend Laboratories, LLC | ANDA |
| 67877-556 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Ascend Laboratories, LLC | ANDA |
| 67877-557 | Kit | Ascend Laboratories, LLC | ANDA |
| 59651-084 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 59651-083 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Aurobindo Pharma Limited | ANDA |
| 31722-657 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-680 | Kit | Camber Pharmaceuticals, Inc. | ANDA |
| 31722-658 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Camber Pharmaceuticals, Inc. | ANDA |
| 69097-322 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Cipla USA Inc. | ANDA |
| 69097-323 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Cipla USA Inc. | ANDA |
| 69097-552 | Kit | Cipla USA Inc. | ANDA |
| 82249-745 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | CivicaScript LLC | ANDA |
| 82249-747 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | CivicaScript LLC | ANDA |
| 43598-429 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Dr. Reddy's Laboratories Inc. | ANDA |
| 43598-430 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Dr. Reddy's Laboratories Inc. | ANDA |
| 68462-308 | Dimethyl Fumarate 240 mg/1 Capsule | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-570 | Kit | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 68462-307 | Dimethyl Fumarate 120 mg/1 Capsule | Glenmark Pharmaceuticals Inc., USA | ANDA |
| 51407-441 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 84677-030 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 84677-029 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 51407-442 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Golden State Medical Supply, Inc. | ANDA |
| 33342-579 | Kit | Macleods Pharmaceuticals Limited | ANDA |
| 33342-349 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-350 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Macleods Pharmaceuticals Limited | ANDA |
| 33342-351 | Kit | Macleods Pharmaceuticals Limited | ANDA |
| 69539-042 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-043 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 69539-240 | Kit | MSN LABORATORIES PRIVATE LIMITED | ANDA |
| 82009-138 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Quallent Pharmaceuticals Health LLC | ANDA |
| 70512-852 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | SOLA Pharmaceuticals, LLC | ANDA |
| 70512-853 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | SOLA Pharmaceuticals, LLC | ANDA |
| 43547-025 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Solco Healthcare US, LLC | ANDA |
| 43547-024 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Solco Healthcare US, LLC | ANDA |
| 24979-128 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Upsher-Smith Laboratories, LLC | ANDA |
| 24979-127 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Upsher-Smith Laboratories, LLC | ANDA |
| 70771-1530 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Zydus Lifesciences Limited | ANDA |
| 70771-1531 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Zydus Lifesciences Limited | ANDA |
| 70710-1204 | Dimethyl Fumarate 120 mg/1 Capsule, Delayed Release | Zydus Pharmaceuticals USA Inc. | ANDA |
| 70710-1205 | Dimethyl Fumarate 240 mg/1 Capsule, Delayed Release | Zydus Pharmaceuticals USA Inc. | ANDA |
Frequently asked questions
What is dimethyl fumarate 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 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…
What are the side effects of dimethyl fumarate?
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… See the full label for the complete list.
Who makes dimethyl fumarate?
dimethyl fumarate is listed by 19 labelers in the FDA NDC directory, including A-S Medication Solutions, Accord Healthcare Inc., Amneal Pharmaceuticals NY LLC, Ascend Laboratories, LLC.