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Tecfidera Side Effects

Generic Name: dimethyl fumarate

Note: This document contains side effect information about dimethyl fumarate. Some of the dosage forms listed on this page may not apply to the brand name Tecfidera.

For the Consumer

Applies to dimethyl fumarate: oral capsule delayed release

Along with its needed effects, dimethyl fumarate (the active ingredient contained in Tecfidera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dimethyl fumarate:

More Common

  • Cough or hoarseness
  • feeling of warmth
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • redness of the face, neck, arms, and occasionally, upper chest

Incidence Not Known

  • Black, tarry stools
  • chest pain
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, or rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • tightness in the chest
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Some side effects of dimethyl fumarate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

For Healthcare Professionals

Applies to dimethyl fumarate: oral delayed release capsule

Hematologic

Common (1% to 10%): Lymphopenia, leucopenia, WBC decreased

Frequency not reported: Eosinophilia[Ref]

Metabolic

Very common (10% or more): Ketones in urine, 1+ or greater (45%), 1,25-dihydroxyvitamin D decreased (25%), (PTH) increased (29%)[Ref]

Cardiovascular

The incidence of flushing was highest early in the course of treatment (primarily in month 1) and usually decreased over time. The majority of events were mild to moderate in severity.[Ref]

Very common (10% or more): Flushing (34% to 40%)

Common (1% to 10%): Hot flush[Ref]

General

Common (1% to 10%): Feeling hot[Ref]

Gastrointestinal

The incidence of gastrointestinal events was highest early in the course of treatment (primarily in month 1) and usually decreased over time.[Ref]

Very common (10% or more): Diarrhea (14%), nausea (12%), abdominal pain (upper) (10%), abdominal pain (9% to 18%)

Common (1% to 10%): Vomiting, dyspepsia, gastritis, gastrointestinal disorder, gastroenteritis[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, erythema[Ref]

Hepatic

Increases in hepatic transaminases (AST and ALT) generally occurred during the first six months of treatment, and most patients had levels less than 3 times the upper limit of normal (ULN).[Ref]

Common (1% to 10%): AST increased, ALT increased[Ref]

Nervous system

Common (1% to 10%): Burning sensation[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Serious flushing[Ref]

Renal

Common (1% to 10%): Proteinuria (albumin)[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Tecfidera (dimethyl fumarate)." Biogen Inc, Cambridge, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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