Tecfidera Side Effects
Generic name: dimethyl fumarate
Medically reviewed by Drugs.com. Last updated on Oct 25, 2020.
Note: This document contains side effect information about dimethyl fumarate. Some of the dosage forms listed on this page may not apply to the brand name Tecfidera.
Common side effects of Tecfidera include: infection, abdominal pain, and flushing. Other side effects include: increased serum aspartate aminotransferase, pruritus, skin rash, vomiting, lymphocytopenia, and erythema of skin. See below for a comprehensive list of adverse effects.
For the Consumer
Applies to dimethyl fumarate: oral capsule delayed release
Side effects requiring immediate medical attention
Along with its needed effects, dimethyl fumarate (the active ingredient contained in Tecfidera) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking dimethyl fumarate:
- feeling of warmth
- 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
- difficulty with swallowing
- fast heartbeat
- hives, itching, or skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- painful blisters on the trunk of the body
- 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
Side effects not requiring immediate medical attention
Some side effects of dimethyl fumarate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
For Healthcare Professionals
Applies to dimethyl fumarate: oral delayed release capsule
Common (1% to 10%): Lymphopenia, leucopenia, WBC decreased
Very common (10% or more): Ketones in urine, 1+ or greater (45%), 1,25-dihydroxyvitamin D decreased (25%), (PTH) increased (29%)[Ref]
Very common (10% or more): Flushing (34% to 40%)
Common (1% to 10%): Hot flush[Ref]
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]
Common (1% to 10%): Feeling hot[Ref]
Very common (10% or more): Diarrhea (14%), nausea (12%), abdominal pain (upper) (10%), abdominal pain (9% to 18%)
The incidence of gastrointestinal events was highest early in the course of treatment (primarily in month 1) and usually decreased over time.[Ref]
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]
Common (1% to 10%): Burning sensation[Ref]
Uncommon (0.1% to 1%): Serious flushing[Ref]
Common (1% to 10%): Proteinuria (albumin)[Ref]
Frequently asked questions
- How do Vumerity and Tecfidera compare for multiple sclerosis (MS)?
- Can it cause stomach damage?
- What are the new drugs used for multiple sclerosis (MS)?
- Is Tecfidera an immunosuppressant?
- Can I stop taking Tecfidera? What happens if I do?
- Can you drink alcohol while taking Tecfidera?
- What causes flushing with Tecfidera?
- How long can you take Tecfidera?
- Gilenya vs Tecfidera. How do they compare?
- Does Tecfidera cause weight gain or loss?
- How long does it take Tecfidera to start working?
- Can Tecfidera cause progressive multifocal leukoencephalopathy (PML)?
- Can Tecfidera cause low lymphocytes?
More about Tecfidera (dimethyl fumarate)
- During Pregnancy or Breastfeeding
- Dosage Information
- Patient Tips
- Drug Images
- Drug Interactions
- Compare Alternatives
- Support Group
- Pricing & Coupons
- En Español
- 90 Reviews
- Generic Availability
- Drug class: selective immunosuppressants
- FDA Approval History
Related treatment guides
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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.