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
- 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
- itching skin
- Acid or sour stomach
- stomach discomfort or upset
For Healthcare Professionals
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%)
Very common (10% or more): Flushing (34% to 40%)
Common (1% to 10%): Hot flush
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.
Common (1% to 10%): Feeling hot
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
The incidence of gastrointestinal events was highest early in the course of treatment (primarily in month 1) and usually decreased over time.
Common (1% to 10%): Pruritus, rash, erythema
Common (1% to 10%): AST increased, ALT increased
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%): Burning sensation
Uncommon (0.1% to 1%): Serious flushing
Common (1% to 10%): Proteinuria (albumin)
More about Tecfidera (dimethyl fumarate)
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