Medicine guide

Tecfidera

240 mg · Capsule

Prescription only

Active substance: Dimethyl Fumarate
Made by: Biogen Inc.
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 · 2025-06-04

Used for

TECFIDERA 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

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

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

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 2026-10-02

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

TECFIDERA 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.
TECFIDERA 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 · 2025-06-04 · 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 TECFIDERA 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 · 2025-06-04

Do not take it if

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of TECFIDERA.
Reactions have included anaphylaxis and angioedema [see Warnings and Precautions ( 5.1 )].
Known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA.
( 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 TECFIDERA capsules whole and intact.
Do not crush, chew, or sprinkle capsule contents on food ( 2.1 ) Take TECFIDERA with or without food ( 2.1 )
2.1 Dosing Information The starting dose for TECFIDERA 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 TECFIDERA should be considered for patients unable to tolerate return to the maintenance dose.
The incidence of flushing may be reduced by administration of TECFIDERA with food.
Alternatively, administration of non-enteric coated aspirin (up to a dose of 325 mg) 30 minutes prior to TECFIDERA dosing may reduce the incidence or severity of flushing [see Clinical Pharmacology ( 12.3 )] .
TECFIDERA should be swallowed whole and intact.
TECFIDERA should not be crushed or chewed, and the capsule contents should not be sprinkled on food.
TECFIDERA 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 TECFIDERA [see Warnings and Precautions ( 5.5 )] .

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

Other warnings

Anaphylaxis and Angioedema: Discontinue and do not restart TECFIDERA if these occur.
( 5.1 ) Progressive Multifocal Leukoencephalopathy (PML):
Withhold TECFIDERA at the first sign or symptom suggestive of PML.
( 5.2 ) Herpes Zoster and Other Serious Opportunistic Infections:
Consider withholding TECFIDERA in cases of serious infection until the infection has resolved.
( 5.3 ) Lymphopenia:
Obtain a CBC including lymphocyte count before initiating TECFIDERA, after 6 months, and every 6 to 12 months thereafter.
Consider interruption of TECFIDERA 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 TECFIDERA and during treatment, as clinically indicated.
Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.
( 5.5 )
5.1 Anaphylaxis and Angioedema TECFIDERA 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 TECFIDERA 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 TECFIDERA.
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 TECFIDERA 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 TECFIDERA [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 TECFIDERA and perform an appropriate diagnostic evaluation.
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 TECFIDERA, 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 TECFIDERA 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 TECFIDERA, 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 TECFIDERA treatment in patients with herpes zoster or other serious infections until the infection has resolved [see Adverse Reactions ( 6.2 )].
5.4 Lymphopenia TECFIDERA may decrease lymphocyte counts.
In the MS placebo controlled trials, mean lymphocyte counts decreased by approximately 30% during the first year of treatment with TECFIDERA and then remained stable.
Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline.
Six percent (6%) of TECFIDERA 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 TECFIDERA 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 TECFIDERA 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 TECFIDERA 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.
TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.
Obtain a CBC, including lymphocyte count, before initiating treatment with TECFIDERA, 6 months after starting treatment, and then every 6 to 12 months thereafter, and as clinically indicated.
Consider interruption of TECFIDERA 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 TECFIDERA is discontinued or interrupted due to lymphopenia.
Consider withholding treatment from patients with serious infections until resolution.
Decisions about whether or not to restart TECFIDERA should be individualized based on clinical circumstances.
5.5 Liver Injury Clinically significant cases of liver injury have been reported in patients treated with TECFIDERA in the postmarketing setting.
The onset has ranged from a few days to several months after initiation of treatment with TECFIDERA.
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 TECFIDERA and during treatment, as clinically indicated.
Discontinue TECFIDERA if clinically significant liver injury induced by TECFIDERA is suspected.
5.6 Flushing TECFIDERA may cause flushing (e.g., warmth, redness, itching, and/or burning sensation).
In clinical trials, 40% of TECFIDERA treated patients experienced flushing.
Flushing symptoms generally began soon after initiating TECFIDERA 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 TECFIDERA for flushing and <1% had serious flushing symptoms that were not life-threatening but led to hospitalization.
Administration of TECFIDERA 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 TECFIDERA 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 TECFIDERA, 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 TECFIDERA; 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 TECFIDERA 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 TECFIDERA 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 2-4% and 15-20%, respectively.
Data Human Data In a prospective observational TECFIDERA 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.
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 TECFIDERA and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.
IN SPECIFIC POPULATIONS
8.1 Pregnancy Risk Summary Available data from the TECFIDERA 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 2-4% and 15-20%, respectively.
Data Human Data In a prospective observational TECFIDERA 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 TECFIDERA 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 TECFIDERA 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”.

Use in children

Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Pediatric Use”.

Use in older people

Clinical studies of TECFIDERA 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 “Geriatric Use”.

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 Biogen at 1-800-456-2255 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 TECFIDERA 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 TECFIDERA, and 426 patients have received at least 10 years of treatment with TECFIDERA.
Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received TECFIDERA 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 TECFIDERA 240 mg twice a day and 771 placebo-treated patients.
The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea.
Table 1:
Adverse Reactions in Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥ 2% higher incidence than placebo TECFIDERA 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 TECFIDERA 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 TECFIDERA compared with placebo.
Four percent (4%) of patients treated with TECFIDERA 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 TECFIDERA; 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 TECFIDERA 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 TECFIDERA 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 TECFIDERA 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 TECFIDERA.
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”.

What to discuss with your doctor

Advise the patient to read the FDA-approved patient labeling ( Patient Information ).
Dosage Inform patients that they will be provided two strengths of TECFIDERA 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 TECFIDERA capsules whole and intact.
Inform patients to not crush, chew, or sprinkle capsule contents on food.
Inform patients that TECFIDERA can be taken with or without food [see Dosage and Administration ( 2.1 )].
Anaphylaxis and Angioedema Advise patients to discontinue TECFIDERA 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 TECFIDERA.
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 TECFIDERA.
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 TECFIDERA 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 ( 5.3 ), Adverse Reactions ( 6.1 )] .
Liver Injury Inform patients that TECFIDERA may cause liver injury.
Instruct patients treated with TECFIDERA 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 ( 5.4 )] .
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 TECFIDERA with food or taking a non-enteric coated aspirin prior to taking TECFIDERA 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 TECFIDERA 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 )] .
PPI-41347-18 Manufactured for: Biogen Inc.
Cambridge, MA 02142 TECFIDERA is a registered trademark of Biogen. © Biogen 2013 - 2024

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

FORMS AND STRENGTHS TECFIDERA is available as hard gelatin delayed-release capsules containing 120 mg or 240 mg of dimethyl fumarate.
The 120 mg capsules have a green cap and white body, printed with “BG-12 120 mg” in black ink on the body.
The 240 mg capsules have a green cap and a green body, printed with “BG-12 240 mg” in black ink on the body.
Delayed-release capsules : 120 mg and 240 mg ( 3 )

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

What it looks like and how it is packed

TECFIDERA is available as hard gelatin delayed-release capsules in two strengths containing either 120 mg or 240 mg of dimethyl fumarate.
The green and white 120 mg capsules are printed with “BG-12 120 mg” in black ink.
The green 240 mg capsules are printed with “BG-12 240 mg” in black ink.
TECFIDERA is available as follows:
30-day Starter Pack, (NDC 64406-007-03):
7-day bottle 120 mg capsules, quantity 14 23-day bottle 240 mg capsules, quantity 46 120 mg capsules:
7-day bottle of 14 capsules (NDC 64406-005-01) 240 mg capsules:
30-day bottle of 60 capsules (NDC 64406-006-02)
Store at 15°C to 30°C (59 to 86°F).
Protect the capsules from light.
Store in original container.

Quoted from the official label, section “How Supplied”.

What is in it

TECFIDERA contains dimethyl fumarate which is also known by its chemical name, dimethyl (E) butenedioate, (C 6 H 8 O 4 ).
It has the following structure:
Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13.
TECFIDERA is 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:
microcrystalline cellulose, silicified microcrystalline cellulose, croscarmellose sodium, talc, silica colloidal silicon dioxide, magnesium stearate, triethyl citrate, methacrylic acid copolymer - Type A, methacrylic acid copolymer dispersion, simethicone (30% emulsion), sodium lauryl sulphate, and polysorbate 80.
The capsule shell, printed with black ink, contains the following inactive ingredients:
gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.
Structural Formula

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

This label’s list of inactive ingredients names none of: lactose, wheat or gluten, colour dyes, sugars, sugar alcohols, alcohol (ethanol), aspartame (phenylalanine), gelatin, peanut oil, soy, parabens, sulfites, titanium dioxide.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (19)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 19 of 19

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

European UnionNo exact match for this strength and form

Every strength and form (10)

Canada7 matching products

Every strength and form (14)

Details

Made by	Biogen Inc.
Active substance	Dimethyl Fumarate
Strength	240 mg
Form	Capsule
Route	Oral
Packs	1 BOTTLE, PLASTIC in 1 CARTON / 60 CAPSULE in 1 BOTTLE, PLASTIC
NDC	64406-006

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

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

Capsule2 products
- 120 mg
- 240 mg
Kit1 products
- —

Same active substance

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

Dimethyl Fumarate120 mgPrescription onlyCapsule, Delayed Release Accord Healthcare Inc. · Dimethyl Fumarate Dimethyl Fumarate240 mgPrescription onlyCapsule, Delayed Release Accord Healthcare Inc. · Dimethyl Fumarate Dimethyl Fumarate120 mgPrescription onlyCapsule, Delayed Release Upsher-Smith Laboratories, LLC · Dimethyl Fumarate Dimethyl Fumarate240 mgPrescription onlyCapsule, Delayed Release Upsher-Smith Laboratories, LLC · Dimethyl Fumarate Dimethyl Fumarate120 mgPrescription onlyCapsule, Delayed Release Camber Pharmaceuticals, Inc. · Dimethyl Fumarate Dimethyl Fumarate240 mgPrescription onlyCapsule, Delayed Release Camber Pharmaceuticals, Inc. · Dimethyl Fumarate

See every product with Dimethyl Fumarate