Tecfidera Side Effects
Generic Name: dimethyl fumarate
Note: This page contains side effects data for the generic drug dimethyl fumarate. It is possible that some of the dosage forms included below may not apply to the brand name Tecfidera.
It is possible that some side effects of Tecfidera may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
For the Consumer
Applies to dimethyl fumarate: oral capsule delayed release
As well as its needed effects, dimethyl fumarate (the active ingredient contained in Tecfidera) may cause unwanted side effects that require medical attention.
If any of the following side effects occur while taking dimethyl fumarate, check with your doctor immediately: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 dimethyl fumarate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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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