Side Effects – Tecfidera® (dimethyl fumarate)

Tecfidera side effects

Treatment for relapsing multiple sclerosis (MS) means staying on therapy for as long as you and your doctor decide it's right for you. As a result, many people are rightfully concerned about the side effects of any given treatment. The side effects of Tecfidera have been documented for up to 4 years. Tecfidera may cause serious side effects including allergic reactions, PML (a rare brain infection that usually leads to death or severe disability) and decreases in white blood cell counts. Therefore, your doctor should do blood tests before starting treatment and while you take Tecfidera.

Tecfidera may cause allergic reactions.

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.

You should always talk to your doctor before taking Tecfidera if you're pregnant, interested in becoming pregnant, breastfeeding or plan to breastfeed. That's because it isn't known how taking Tecfidera would affect an unborn baby or if it passes into your breast milk. If you're pregnant while taking Tecfidera, talk to your doctor about enrolling in the Tecfidera Pregnancy Registry to monitor your health and the health of your baby.

Tecfidera Pregnancy Registry:
1-866-810-1462
www.TecfideraPregnancyRegistry.com

Common side effects

The most common side effects of Tecfidera in clinical studies were flushing and stomach problems. People tended to have symptoms at the start of treatment, and they usually decreased over time. Talk to your doctor about taking Tecfidera with food or aspirin as it may help with flushing. If you are experiencing stomach problems ask your doctor or pharmacist if they have suggestions to help.

  • Common side effects
  • Flushing

    Symptoms are mostly mild to moderate and usually described as redness, itching, or rash



    Stomach problems

    Symptoms may include nausea, vomiting, diarrhea, stomach pain, or indigestion


 
Open Close

Indication

TECFIDERA (dimethyl fumarate) is a prescription medicine used to treat people with relapsing forms of multiple sclerosis.

Important Safety Information

Important Safety Information and Indication

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.

Before taking and while you take TECFIDERA, tell your doctor about any low white blood cell counts or infections or any other medical conditions.

What are the possible side effects of TECFIDERA?

TECFIDERA may cause serious side effects including allergic reactions, PML, which is a rare brain infection that usually leads to death or severe disability, and decreases in your white blood cell count. Your doctor may check your white blood cell count before you take TECFIDERA and from time to time during treatment.

The most common side effects of TECFIDERA include flushing and stomach problems. These can happen especially at the start of treatment and may decrease over time. Taking TECFIDERA with food may help reduce flushing. Call your doctor if these symptoms 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.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. It is not known if TECFIDERA will harm your unborn baby or if it passes into your breast milk. Also tell your doctor if you are taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

For additional important safety information, please see full Prescribing Information and Patient Information. This is not intended to replace discussions with your doctor.