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. Many people are rightfully concerned about the side effects of any given treatment. The safety of TECFIDERA has been documented in clinical studies for up to 4 years. It's important to know about these side effects before starting TECFIDERA.

Safety information to consider before starting treatment

It's important to talk to your doctor if you've had an allergic reaction to TECFIDERA or any of its ingredients. You should also discuss the serious side effects associated with TECFIDERA, including:

  • Allergic reactions (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.

Common side effects of TECFIDERA

In clinical studies, the most common side effects of TECFIDERA were:

They tended to happen earlier in treatment and usually decreased over time.

Try taking TECFIDERA with food, such as breakfast or dinner, which may help with flushing. Ask your doctor if taking aspirin may also help with flushing.

You could have other side effects, so if you have any that bother you or don't go away, be sure to talk to your doctor.

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
TecfideraPregnancyRegistry.com

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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?

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 www.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.