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
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 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
  • 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

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)

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