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:

• 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
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• tightness in the chest
• trouble breathing
• 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:

• Abdominal or stomach pain
• diarrhea
• nausea
• vomiting

• 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]

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.

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