Tecfidera

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/10/2021
Tecfidera Side Effects Center

What Is Tecfidera?

Tecfidera (dimethyl fumarate) is a fumaric acid ester used to treat relapsing forms of multiple sclerosis (MS).

What Are Side Effects of Tecfidera?

Side effects of Tecfidera include:

  • flushing,
  • abdominal pain,
  • diarrhea,
  • nausea,
  • vomiting,
  • rash,
  • itching,
  • redness, and
  • indigestion.

Dosage for Tecfidera

The starting dose of Tecfidera is 120 mg twice daily for seven days by mouth. After seven days, maintenance doses of Tecfidera are 240 mg taken twice daily by mouth.

What Drugs, Substances, or Supplements Interact with Tecfidera?

Tecfidera may interact with other drugs. Tell your doctor all medications and supplements you use.

Tecfidera During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to be become pregnant before using Tecfidera; it is unknown how it would affect a fetus. There is a pregnancy registry that monitors pregnancy outcomes in women exposed to Tecfidera during pregnancy and you may be encouraged to enroll. It is unknown if Tecfidera passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Tecfidera (dimethyl fumarate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

QUESTION

What kind of disease is multiple sclerosis? See Answer
Tecfidera Consumer Information

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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.

Read the entire detailed patient monograph for Tecfidera (Dimethyl Fumarate Delayed Release Capsules)

SLIDESHOW

What Is Multiple Sclerosis? MS Symptoms, Causes, Diagnosis See Slideshow
Tecfidera Professional Information

SIDE EFFECTS

The following important adverse reactions are described elsewhere in labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The most common adverse reactions (incidence ≥10% and ≥2% more than placebo) for TECFIDERA were flushing, abdominal pain, diarrhea, and nausea.

Adverse Reactions In Placebo-Controlled Trials

In the two well-controlled studies demonstrating effectiveness, 1529 patients received TECFIDERA with an overall exposure of 2244 person-years [see Clinical Studies].

The adverse reactions presented in the table below are based on safety information from 769 patients treated with TECFIDERA 240 mg twice a day and 771 placebo-treated patients.

Table 1: Adverse Reactions in Study 1 and 2 reported for TECFIDERA 240 mg BID at ≥ 2% higher incidence than placebo

  TECFIDERA
N=769
%
Placebo
N=771
%
Flushing 40 6
Abdominal pain 18 10
Diarrhea 14 11
Nausea 12 9
Vomiting 9 5
Pruritus 8 4
Rash 8 3
Albumin urine present 6 4
Erythema 5 1
Dyspepsia 5 3
Aspartate aminotransferase increased 4 2
Lymphopenia 2 <1

Gastrointestinal

TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4%) of patients treated with TECFIDERA and less than 1% of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1% in patients treated with TECFIDERA.

Hepatic Transaminases

An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the first six months of treatment, and most patients with elevations had levels < 3 times the upper limit of normal (ULN) during controlled trials. Elevations of alanine aminotransferase and aspartate aminotransferase to ≥ 3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases ≥ 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1% and were similar in patients treated with TECFIDERA or placebo.

Eosinophilia

A transient increase in mean eosinophil counts was seen during the first 2 months of therapy.

Adverse Reactions In Placebo-Controlled And Uncontrolled Studies

In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person-years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction profile of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials.

Post Marketing Experience

The following adverse reaction has been identified during post approval use of TECFIDERA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Liver function abnormalities (elevations in transaminases ≥ 3 times ULN with concomitant elevations in total bilirubin > 2 times ULN) have been reported following TECFIDERA administration in post marketing experience [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Tecfidera (Dimethyl Fumarate Delayed Release Capsules)

© Tecfidera Patient Information is supplied by Cerner Multum, Inc. and Tecfidera Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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