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Dimethyl fumarate Side Effects

In Summary

Commonly reported side effects of dimethyl fumarate include: infection, abdominal pain, and flushing. Other side effects include: increased serum aspartate aminotransferase, pruritus, skin rash, vomiting, lymphocytopenia, and erythema. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to dimethyl fumarate: oral capsule delayed release

In addition to its needed effects, some unwanted effects may be caused by dimethyl fumarate. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when 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

Minor Side Effects

Some of the side effects that can occur with dimethyl fumarate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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[Ref]

Metabolic

Very common (10% or more): Ketones in urine, 1+ or greater (45%), 1,25-dihydroxyvitamin D decreased (25%), (PTH) increased (29%)[Ref]

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.[Ref]

Very common (10% or more): Flushing (34% to 40%)
Common (1% to 10%): Hot flush[Ref]

General

Common (1% to 10%): Feeling hot[Ref]

Gastrointestinal

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

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[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, erythema[Ref]

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).[Ref]

Common (1% to 10%): AST increased, ALT increased[Ref]

Nervous system

Common (1% to 10%): Burning sensation[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Serious flushing[Ref]

Renal

Common (1% to 10%): Proteinuria (albumin)[Ref]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Tecfidera (dimethyl fumarate)." Biogen Inc, Cambridge, MA.

Not all side effects for dimethyl fumarate may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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