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.

Some side effects of Tecfidera may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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
  • shortness of breath
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swollen glands
  • 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
  • itching skin
  • nausea
  • rash
  • 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

General

The most frequently reported side effects included flushing, abdominal pain, diarrhea and nausea.

Gastrointestinal

Very common (10% or more): Abdominal pain (18%), diarrhea (14%), nausea (12%)
Common (1% to 10%): Vomiting (9%), dyspepsia (5%)

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

Cardiovascular

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

Hematologic

Common (1% to 10%): Lymphopenia (2%)
Frequency not reported: Eosinophilia

Dermatologic

Common (1% to 10%): Pruritus (8%), rash (8%), erythema (5%)

Genitourinary

Albumin urine present (6%)

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%): Aspartate aminotransferase (AST) increased (4%)
Frequency not reported: Alanine aminotransferase (ALT) increased

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