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Tecfidera

Generic Name: dimethyl fumarate (dye METH il FUE mar ate)
Brand Names: Tecfidera
Tecfidera (dimethyl fumarate) is used to treat relapsing forms of multiple sclerosis. Learn about side effects, interactions and indications.
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Drug Information:
Tecfidera (dimethyl fumarate) is a prescription medicine used to treat relapsing multiple sclerosis. Tecfidera may also be used for purposes not listed in this medication guide. Before taking and while you take Tecfidera, tell your doctor if you have or have had a low white blood cell counts or an infection. Tecfidera may cause a serious viral infection of the brain that can lead to disability or death. Call your doctor right away if you have any change in your mental state, decreased vision, weakness on one side of your body, or problems with speech or walking. These symptoms may start gradually and get worse quickly. Learn more

Tecfidera Side Effects

Tecfidera Side Effects

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.

In Summary

Common side effects of Tecfidera include: infection, abdominal pain, and flushing. Other side effects include: increased serum aspartate aminotransferase, pruritus, skin rash, vomiting, lymphocytopenia, and erythema of skin. See below for a comprehensive list of adverse effects.

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

  • Abdominal or stomach pain
  • diarrhea
  • nausea
  • vomiting

Less common

  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort or upset

For Healthcare Professionals

Applies to dimethyl fumarate: oral delayed release capsule

Hematologic

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

Frequency not reported: Eosinophilia

Metabolic

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

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.

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

Common (1% to 10%): Hot flush

General

Common (1% to 10%): Feeling hot

Gastrointestinal

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

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

Dermatologic

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

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).

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

Nervous system

Common (1% to 10%): Burning sensation

Hypersensitivity

Uncommon (0.1% to 1%): Serious flushing

Renal

Common (1% to 10%): Proteinuria (albumin)

Editorial References and Review

Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.

Source: Drugs.com Tecfidera (www.drugs.com/tecfidera.html).