Dimethyl fumarate is used to treat relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).
Dimethyl fumarate may also be used for purposes not listed in this medication guide.
uses
What is Tecfidera (Dimethyl Fumarate) used for?
- Multiple Sclerosis
warnings
What is the most important information I should know about Tecfidera (Dimethyl Fumarate)?
You should not use this medicine if you have had a severe allergic reaction to dimethyl fumarate or diroximel fumarate (Vumerity).
Tell your doctor if you have ever had:
- an active infection; or
- low white blood cell (WBC) counts.
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dimethyl fumarate on the baby.
Dimethyl fumarate is not approved for use by anyone younger than 18 years old.
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Side Effects
What are the side effects of Tecfidera (Dimethyl Fumarate)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Dimethyl fumarate may cause a serious brain infection that can lead to disability or death. Call your doctor right away if you have problems with speech, thought, vision, or muscle movement. These symptoms may start gradually and get worse quickly.
Also call your doctor at once if you have:
- symptoms of herpes virus–flu-like symptoms, cold sores around your mouth, tingly or painful blistering rash, burning pain in your thigh or lower back;
- low white blood cell counts–fever, mouth sores, skin sores, sore throat, cough, trouble breathing; or
- liver problems–loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- stomach pain, indigestion, nausea, vomiting, diarrhea;
- redness, rash, itching; or
- flushing (sudden warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Tecfidera (Dimethyl Fumarate) if I’m pregnant or breastfeeding?
Tell your doctor if you are pregnant or breastfeeding.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of dimethyl fumarate on the baby.
Interactions
What drugs and food should I avoid while taking Tecfidera (Dimethyl Fumarate)?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Dosage Guidelines & Tips
How to take Tecfidera (Dimethyl Fumarate)?
Use Tecfidera (Dimethyl Fumarate) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using dimethyl fumarate.
Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.
You may take dimethyl fumarate with or without food. Taking the medicine with food may help prevent flushing (sudden warmth, redness, or tingly feeling).
Swallow the capsule whole and do not crush, chew, break, or open it.
While using dimethyl fumarate, you will need frequent blood tests.
Store this medicine in the original container at room temperature, away from moisture, heat, and light.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Overdose Signs
What happens if I overdose on Tecfidera (Dimethyl Fumarate)?
(800) 222-1222
911
Images
BG-12 240 mg
Color: green
Shape: capsule
Imprint: BG-12 240 mg
H, D12
Color: blue
Shape: capsule
Imprint: H, D12
H, D15
Color: white
Shape: capsule
Imprint: H, D15