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Dimethyl fumarate, also known as Tecfidera, has several important safety considerations that should be reviewed thoroughly before use. If you have any questions or concerns, please consult your healthcare provider.

• Severe Allergic Reactions: There is a risk of severe allergic reactions, including potentially life-threatening conditions such as facial or neck swelling and anaphylaxis. If you experience symptoms like difficulty breathing, hives, or swelling of the throat or tongue, seek medical attention immediately.

• Serious Infections: This medication can impair your immune system, increasing the likelihood of serious opportunistic infections. These are infections that are typically mild in healthy individuals but can pose significant risks to those with weakened immunity. You may be at increased risk if you are taking other immune-suppressing drugs or have pre-existing conditions that increase infection risk.

• Low White Blood Cell Counts (Lymphopenia): Treatment with dimethyl fumarate may reduce your lymphocyte levels, a type of white blood cell, leading to a higher risk of infections. Regular blood tests are necessary before and during treatment to ensure blood cell levels remain within a safe range.

• Liver Damage: Some patients have experienced liver damage, sometimes necessitating hospitalization. This risk is higher in individuals with pre-existing liver conditions or those taking other liver-affecting medications, especially during the first few months of treatment. Liver damage typically resolves after discontinuing the medication.

• Flushing: Flushing, characterized by warmth, redness, itching, or a burning sensation on the skin, can occur but generally subsides over time. To minimize flushing, taking aspirin (up to 325 mg) 30 minutes before your dose may be advised if deemed safe by your healthcare provider. Taking the medication with food can also help reduce this effect.

• Serious Stomach and Intestine Problems: Although rare, some patients have reported serious gastrointestinal issues, such as ulcers, perforation, bleeding, and bowel obstruction, usually within the first six months of treatment. Inform your healthcare provider immediately if you experience new or worsening symptoms such as stomach pain, acid reflux, nausea, vomiting, or bloating.

There are currently no known contraindications for the use of dimethyl fumarate. Always discuss your medical history and any current medications with your healthcare provider before starting treatment.

Common side effects:

• Flushing
• Stomach pain
• Diarrhea
• Nausea
• Vomiting
• Itchiness
• Rash

Less common but important to monitor:

• Redness of the skin
• Upset stomach or indigestion
• Elevated liver enzyme levels
• Low white blood cell count

Serious side effects:

• Signs of liver damage (fever, fatigue, nausea, vomiting, yellowing of the skin or eyes, clay-colored stools, dark urine)
• Serious infections (fever, cough, weakness, difficulty speaking or thinking, muscle pain, personality changes, confusion)
• Severe gastrointestinal issues (rectal bleeding, bloody diarrhea, intense stomach pain)
• Serious allergic reactions (difficulty breathing, rash, swelling of the lips or tongue)