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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.
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.
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:
Incidence not known
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:
Applies to dimethyl fumarate: oral delayed release capsule
Common (1% to 10%): Lymphopenia, leucopenia, WBC decreased
Frequency not reported: Eosinophilia
Very common (10% or more): Ketones in urine, 1+ or greater (45%), 1,25-dihydroxyvitamin D decreased (25%), (PTH) increased (29%)
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
Common (1% to 10%): Feeling hot
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
Common (1% to 10%): Pruritus, rash, erythema
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
Common (1% to 10%): Burning sensation
Uncommon (0.1% to 1%): Serious flushing
Common (1% to 10%): Proteinuria (albumin)