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Tecfidera (Dimethyl fumarate): Uses, Side Effects and Dosage

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Prescription (Rx)
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120 mg, 240 mg, 120 mg, 240 mg
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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Tecfidera

What is TECFIDERA?

  • TECFIDERA is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

  • It is not known if TECFIDERA is safe and effective in children under 18 years of age.

Who should not take TECFIDERA?

  • Do not use TECFIDERA if you have had an allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing) to TECFIDERA or any of its ingredients. See below for a complete list of ingredients.

Before taking and while you take TECFIDERA, tell your doctor if you have or have had:

  • low white blood cell counts or an infection
  • any other medical conditions

Tell your doctor if you are:

  • pregnant or plan to become pregnant. It is not known if TECFIDERA will harm your unborn baby. You and your doctor will have to decide if you should take TECFIDERA while you are pregnant or if you plan to become pregnant.
  • breastfeeding or plan to breastfeed. It is not known if TECFIDERA passes into your breast milk. You and your doctor should decide if you will take TECFIDERA or breastfeed.taking prescription or over-the-counter medicines, vitamins, or herbal supplements

How should I take TECFIDERA?

  • Take TECFIDERA exactly as your doctor tells you to take it
  • The recommended starting dose is one 120 mg capsule taken by mouth 2 times a day for 7 days
  • The recommended dose after 7 days is one 240 mg capsule taken by mouth 2 times a day

  • TECFIDERA can be taken with or without food

  • Swallow TECFIDERA whole. Do not crush, chew, or sprinkle capsule contents on food.
  • Protect TECFIDERA from light. You can do this by storing the capsules in their original container.
  • If you take too much TECFIDERA, call your doctor or go to the nearest hospital emergency room right away.

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects including:

  • allergic reaction (such as welts, hives, swelling of the face, lips, mouth or tongue, or difficulty breathing)
  • PML a rare brain infection that usually leads to death or severe disability
  • decreases in your white blood cell count Your doctor should do a blood test before you start treatment with TECFIDERA and while on therapy.

  • liver problems. Your doctor should do blood tests to check your liver function before you start taking TECFIDERA and during treatment if needed. Tell your doctor right away if you get any of these symptoms of a liver problem during treatment.

    • severe tiredness
    • loss of appetite
    • pain on the right side of your stomach
    • have dark or brown (tea color) urine
    • yellowing of your skin or the white part of your eyes
  • herpes zoster infections (shingles), including central nervous system infections
  • other serious infections

  • serious gastrointestinal problems, including bleeding, ulcers, blockage, and tears (perforation) of the stomach or intestines. Tell your healthcare provider right away if you have any of these symptoms during treatment:

    • Stomach-area pain that does not go away
    • Bright red or black stools (that look like tar)
    • Severe vomiting
    • Severe diarrhea
    • Coughing up blood or blood clots
    • Vomiting blood or your vomit looks like "coffee grounds"

The most common side effects of TECFIDERA include:

  • flushing, redness, itching, or rash
  • nausea, vomiting, diarrhea, stomach pain, or indigestion. These events can be serious in some patients (see "TECFIDERA may cause serious side effects including," above).
  • Flushing and stomach problems are the most common reactions, especially at the start of therapy, and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if you have any of these symptoms and they bother you or do not go away. Ask your doctor if taking aspirin before taking TECFIDERA may reduce flushing.

These are not all the possible side effects of TECFIDERA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

General Information about the safe and effective use of TECFIDERA

  • Medicines are sometimes prescribed for purposes other than those listed in this Patient Information. Do not use TECFIDERA for a condition for which it was not prescribed. Do not give TECFIDERA to other people, even if they have the same symptoms that you have. It may harm them.
  • If you would like more information, talk to your doctor or pharmacist. You can ask your doctor or pharmacist for information about TECFIDERA that is written for healthcare professionals.

What are the ingredients in TECFIDERA?

Active ingredient: dimethyl fumarate

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. Capsule Shell: gelatin, titanium dioxide, FD&C blue 1; brilliant blue FCF, yellow iron oxide and black iron oxide.

Manufactured for: Biogen Inc., Cambridge, MA 02142, www.TECFIDERA.com or call 1-800-456-2255

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: NDA 204063 · View the label on DailyMed

Revision date stated in the text: March 2024

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Tecfidera

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Dimethyl fumarate 240 mg
Dosage form Kit, Capsule
Marketing status not in the current FDA NDC Directory
Company (applicant) BIOGEN
FDA approval NDA 204063New Drug Application (NDA) Approved March 27, 2013
Reference listed drug This is the reference listed drug (RLD) that generics are compared with.
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
120 mg, 240 mg – 1 in 1 kit NDC 64406-007-03
120 mg – 14 in 1 bottle, plastic / 1 in 1 carton
240 mg – 60 in 1 bottle, plastic / 1 in 1 carton

Source: FDA drug labeling via NLM DailyMed, data as of November 5, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.