Does Tecfidera (dimethyl fumarate) cause side effects?
Tecfidera (dimethyl fumarate) is an oral disease-modifying agent used to treat relapsing forms of multiple sclerosis (MS).
Although the exact mechanism of how Tecfidera works is unknown, it is thought to have protective effects on the nervous system and anti-inflammatory properties. Tecfidera prevents the immune cells from attacking the central nervous system. Tecfidera reduces the number of annual relapses rate.
Common side effects of Tecfidera include
- abdominal pain,
- diarrhea, and
Serious side effects of Tecfidera include
- decreased white blood cell counts and
- increased liver enzymes.
No potential drug interactions of Tecfidera were identified in clinical studies.
There are no adequate data on the developmental risk associated with the use of Tecfidera in pregnant women. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Tecfidera during pregnancy.
It is unknown if Tecfidera is secreted into breast milk. Consult your doctor before breastfeeding.
What are the important side effects of Tecfidera (dimethyl fumarate)?
The most common side effects associated with dimethyl fumarate treatment are
- abdominal pain,
- diarrhea, and
A decrease in white blood cell count also occurs. Patients should check their baseline white blood cell count or have a recently completed blood cell count (CBC) (within 6 months) before starting treatment. Increase in liver enzymes has also been reported in clinical studies.
Tecfidera (dimethyl fumarate) side effects list for healthcare professionals
The following important adverse reactions are described elsewhere in labeling:
- Anaphylaxis and Angioedema
- Progressive multifocal leukoencephalopathy
- Liver Injury
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
- abdominal pain,
- diarrhea, and
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.
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
|Albumin urine present||6||4|
|Aspartate aminotransferase increased||4||2|
- 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.
- 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.
- 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.
Tecfidera (dimethyl fumarate) is an oral disease-modifying agent used to treat relapsing forms of multiple sclerosis (MS). Common side effects of Tecfidera include flushing, abdominal pain, diarrhea, and nausea. Serious side effects of Tecfidera include decreased white blood cell counts and increased liver enzymes. There is no adequate data on the developmental risk associated with the use of Tecfidera in pregnant women. It is unknown if Tecfidera is secreted into breast milk.
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Related Disease Conditions
Multiple Sclerosis (MS)
Multiple sclerosis or MS is an autoimmune disorder in which brain and spinal cord nerve cells become demyelinated. This damage results in symptoms that may include numbness, weakness, vertigo, paralysis, and involuntary muscle contractions. Different forms of MS can follow variable courses from relatively benign to life-threatening. MS is treated with disease-modifying therapies. Some MS symptoms can be treated with medications.
MS (Multiple Sclerosis) vs. ALS (Amyotrophic Lateral Sclerosis)
ALS (amyotrophic lateral sclerosis, Lou Gehrig's disease) and MS (multiple sclerosis) are both diseases of the nervous system (neurodegenerative). ALS is a disease in which the nerve cells in the body are attacked by the immune system, although it's not considered an autoimmune disease by some scientists. MS is an autoimmune disease in which the insulated covering of the nerves (myelin sheath) in the CNS (central nervous system) degenerate, or deteriorate. Scientists don't know the exact cause of either problem. However, they have discovered that mutations in the gene that produces the SOD1 enzyme were associated with some cases of familial ALS. Scientists also theorize that multiple sclerosis may be caused by infection or vitamin D deficiency. ALS occurs between 50-70 years of age (the average age of occurrence ALS is 55), and mostly affects men. While MS occurs between 20-60 years of age, and mostly affects women. About 30,000 people in the US have ALS, and an average of 5,000 new diagnoses per year (that's about 15 new cases per week). Worldwide, MS affects more than 2.3 million people, with about 10,000 new cases diagnosed each year (that's about 200 new diagnoses per week).Some of the signs and symptoms of both diseases include muscle weakness, muscle spasms, problems walking, fatigue, slurred speech, and problems swallowing. ALS signs and symptoms that are different from MS include problems holding the head upright, clumsiness, muscle cramps and twitches, problems holding objects, and uncontrollable periods of laughing or crying. MS signs and symptoms that are different from ALS include vision problems, vertigo and balance problems, sexual problems, memory problems, depression, mood swings, and digestive problems. There is no cure for either disease, however the prognosis and life expectancy are different. Multiple sclerosis is not a fatal condition, while ALS progresses rapidly and leads to death.
Multiple Sclerosis (MS) Symptoms and Treatments
Multiple sclerosis (MS) symptoms vary from person to person and can last for days to months without periods of remission. Symptoms of MS include sexual problems and problems with the bowel, bladder, eyes, muscles, speech, swallowing, brain, and nervous system. The early symptoms and signs of multiple sclerosis usually start between ages 20-40. MS in children, teens, and those over age 40 is rare. Treatment options for multiple sclerosis vary depending on the type and severity of symptoms. Medications may be prescribed to manage MS symptoms.
Is Multiple Sclerosis (MS) Contagious?
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Multiple Sclerosis (MS) and Pregnancy
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Multiple Sclerosis (MS) Early Warning Signs and Types
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Alternative Treatment (CAM) for MS
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Can Stress Cause Multiple Sclerosis (MS)?
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Early Signs of Multiple Sclerosis
Multiple sclerosis (MS) is a progressive disease of the brain and spinal cord (central nervous system). MS is an autoimmune disease; the body’s immune system mistakenly attacks the cells of the nervous system.
What Are the Early Signs of Multiple Sclerosis?
Multiple sclerosis is an autoimmune disease in which the immune system attacks the central nervous system (spinal cord and brain) by damaging and destroying the protective myelin sheath around the nerve fibers. Someone with multiple sclerosis might develop problems with muscle control, vision, bladder control and other body functions.
What Are the Very First Signs of Multiple Sclerosis?
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Treatment & Diagnosis
Medications & Supplements
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