Tecfidera (dimethyl fumarate) is a brand-name prescription medication. It’s used to treat relapsing forms of multiple sclerosis (MS).

Tecfidera is classified as a disease-modifying therapy for MS. It reduces the risk of MS relapse by up to 49 percent over two years. It also reduces the risk of having worsening physical disability by about 38 percent.

Tecfidera comes as a delayed-released oral capsule. It’s available in two strengths: 120-mg capsules and 240-mg capsules.

Tecfidera is a brand-name drug. It’s not currently available as a generic drug.

Tecfidera contains the drug dimethyl fumarate.

Tecfidera can cause mild or serious side effects. The following list contains some of the key side effects that may occur while taking Tecfidera. This list doesn’t include all possible side effects.

For more information on the possible side effects of Tecfidera, or tips on how to deal with a troubling side effect, talk with your doctor or pharmacist.

More common side effects

The more common side effects of Tecfidera include:

  • flushing (reddening of the face and neck)
  • stomach upset
  • stomach pain
  • diarrhea
  • nausea
  • vomiting
  • itchy skin
  • rash

These side effects may decrease or go away within a few weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects can include the following:

  • severe flushing
  • progressive multifocal leukoencephalopathy (PML)
  • decreased white blood cell levels (lymphopenia)
  • liver damage
  • severe allergic reaction

See below for information about each serious side effect.

PML

Progressive multifocal leukoencephalopathy (PML) is a life-threatening infection of the brain caused by the JC virus. It usually only happens in people whose immune system isn’t fully working. Very rarely, PML has occurred in people with MS who were taking Tecfidera. In these cases, the people who developed PML also had decreased white blood cell levels.

To help prevent PML, your doctor will do blood tests regularly during your treatment to check your white blood cell levels. If your levels get too low, your doctor may recommend that you stop taking Tecfidera.

Your doctor will also monitor you for symptoms of PML while you take the drug. Symptoms may include:

  • weakness on one side of your body
  • vision problems
  • clumsiness
  • memory problems
  • confusion

If you have these symptoms while taking Tecfidera, call your doctor right away. Your doctor will likely do tests to check whether you have PML, and they may stop your treatment with Tecfidera.

Flushing

Flushing (reddening of your face or neck) is a common side effect of Tecfidera. It happens in up to 40 percent of people who take the drug. Flushing effects typically occur soon after you start taking Tecfidera, and then improve or go away entirely over a period of several weeks.

In most cases, flushing is mild to moderate in severity and symptoms include:

  • feelings of warmth in the skin
  • skin redness
  • itching
  • feeling of burning

For some, symptoms of flushing can become severe and intolerable. About 3 percent of people who take Tecfidera end up stopping the drug due to severe flushing.

Taking Tecfidera with food can help reduce flushing. Taking an aspirin 30 minutes before taking Tecfidera can also help.

Lymphopenia

Tecfidera can cause lymphopenia, a decreased level of white blood cells called lymphocytes. Lymphopenia can increase your risk of infections. Symptoms of lymphopenia can include:

  • fever
  • enlarged lymph nodes
  • painful joints

Your doctor will do blood tests before and during your treatment with Tecfidera. If your lymphocyte levels become too low, your doctor may suggest that you stop taking Tecfidera for a set amount of time, or permanently.

Liver effects

Tecfidera can cause liver side effects. It may increase levels of certain liver enzymes that are measured by blood tests. This increase usually happens during the first six months of treatment.

For most people, these increases don’t cause problems. But for a small number of people, they may become severe and indicate liver damage. Symptoms of liver damage can include:

  • fatigue
  • loss of appetite
  • yellowing of your skin or the whites of your eyes

Before and throughout your treatment with Tecfidera, your doctor will do blood tests to check your liver function. If your liver enzymes increase too much, your doctor may have you stop taking this drug.

Severe allergic reaction

Serious allergic reactions, including anaphylaxis, can occur in some people who take Tecfidera. This can occur at any time during treatment. Symptoms of an allergic reaction can include:

  • trouble breathing
  • skin rash or hives
  • swelling of your lips, tongue, throat

If you have an allergic reaction, call your doctor or local poison control center right away. If your symptoms are severe, call 911 or go to the nearest emergency room.

If you've had a serious allergic reaction to this drug in the past, you may not be able to take it again. Using the drug again could be fatal. If you've had a reaction to this medication before, talk to your doctor before taking it again.

Rash

About 8 percent of people who take Tecfidera get a mild skin rash after taking Tecfidera for a few days. The rash may go away with continued use. If it doesn’t go away or it becomes bothersome, talk to your doctor.

If a rash appears suddenly after you take the drug, it could be an allergic reaction. If you also have trouble breathing or swelling of your lips or tongue, this could be a severe anaphylactic reaction. If you think you're having a severe allergic reaction to this drug, call 911.

Hair loss

Hair loss isn’t a side effect that has occurred in studies of Tecfidera. However, some people who take Tecfidera have had hair loss.

In one report, a woman who started taking Tecfidera began to lose hair after taking the drug for two to three months. Her hair loss slowed after she continued taking the drug for two more months, and her hair began to grow back.

Weight gain/Weight loss

Weight gain or weight loss isn’t a side effect that has occurred in studies of Tecfidera. However, some people who take the drug have had weight gain. Some others have had weight loss while taking Tecfidera. It’s not clear if Tecfidera is the cause of weight gain or loss.

Fatigue

People who take Tecfidera can experience fatigue. In one study, fatigue happened in 17 percent of people who took it. This side effect may decrease or go away with continued use of the drug.

Stomach pain

About 18 percent of people who take Tecfidera have stomach pain. This side effect is most common during the first month of treatment and usually decreases or goes away with continued use of the drug.

Diarrhea

About 14 percent of people who take Tecfidera have diarrhea. This side effect is most common during the first month of treatment and usually decreases or goes away with continued use.

Effect on sperm or male fertility

Human studies haven’t evaluated the effect of Tecfidera on sperm or male fertility. In animal studies, Tecfidera didn’t affect fertility, but studies in animals don’t always predict what will happen in humans.

Headache

Some people who take Tecfidera have headaches. However, it’s unclear if Tecfidera is the cause. In one study, 16 percent of people who took Tecfidera had headaches, but headaches happened more often in people who took a placebo pill.

Itching

About 8 percent of people who take Tecfidera have itchy skin. This effect may go away with continued use of the drug. If it doesn’t go away or if it becomes bothersome, talk to your doctor.

Depression

Some people who take Tecfidera have a depressed mood. However, it’s unclear if Tecfidera is the cause. In one study, 8 percent of people who took Tecfidera had feelings of depression, but this happened more often in people who took a placebo pill.

If you have symptoms of depression that become bothersome, talk with your doctor about ways to improve your mood.

Shingles

In clinical studies, Tecfidera didn’t increase the risk of shingles. However, there’s a report of shingles in a woman with multiple sclerosis who took Tecfidera.

Cancer

In clinical studies, Tecfidera didn’t increase the risk of cancer. In fact, some researchers are investigating whether Tecfidera might help prevent or treat some cancers.

Nausea

About 12 percent of people who take Tecfidera have nausea. This effect may go away with continued use of the drug. If it doesn’t go away or if it becomes bothersome, talk to your doctor.

Constipation

Constipation hasn’t been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have constipation. It’s not clear if this is a side effect of Tecfidera.

Bloating

Bloating hasn’t been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have bloating. It’s not clear if this is a side effect of Tecfidera.

Insomnia

Insomnia (trouble falling asleep or staying asleep) hasn’t been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have insomnia. It’s not clear if this is a side effect of the drug.

Bruising

In clinical studies, Tecfidera didn’t increase the risk of bruising. However, many people who have MS say that they often having bruising. The reason for this isn’t clear. A few theories are listed below.

  • As MS progresses, maintaining balance and coordination can become more difficult. This could result in bumping into things or falling, both of which could cause bruising.
  • A person with MS who takes Tecfidera might also take aspirin to help prevent flushing. Aspirin can increase bruising.
  • People who have taken steroids may have thinner skin, which can make them bruise more easily. So people with MS who have a history of steroid use could experience more bruising.

If you’re concerned about bruising while taking Tecfidera, talk with your doctor. Your doctor may do blood tests to check for other causes.

Joint pain

Joint pain can occur in people who take Tecfidera. In one study, 12 percent of people who took Tecfidera had joint pain. Another report described three people who had moderate to severe joint or muscle pain after starting Tecfidera.

This side effect may decrease or go away with continued use of the drug. Joint pain can also improve when Tecfidera is stopped.

Dry mouth

Dry mouth hasn’t been reported in clinical studies of Tecfidera. However, people who take Tecfidera sometimes have dry mouth. It’s not clear if this is a side effect of Tecfidera.

Effects on eyes

Eye-related side effects haven’t been reported in clinical studies of Tecfidera. However, some people who take the drug have said that they’ve had symptoms such as:

  • dry eyes
  • eye twitching
  • blurry vision

It’s not clear if these eye effects are caused by the drug or by something else. If you have these effects and they don’t go away or they become bothersome, talk with your doctor.

Flu-like symptoms

The flu or flu-like symptoms have occurred in studies of people taking Tecfidera. In one such study, 6 percent of people who took the drug had these effects, but the effects happened more often in people who took a placebo pill.

Long-term side effects

Studies evaluating the effects of Tecfidera have lasted from two to six years. In one study lasting six years, the most common side effects were:

  • MS relapse
  • sore throat or runny nose
  • flushing
  • respiratory infection
  • urinary tract infection
  • headache
  • diarrhea
  • fatigue
  • stomach pain
  • pain in the back, arms, or legs

If you’re taking Tecfidera and have side effects that don’t go away or become severe or bothersome, talk with your doctor. They may suggest ways to lessen or eliminate the side effects, or they may suggest that you stop taking the drug.

Tecfidera is approved by the Food and Drug Administration (FDA) for treating multiple sclerosis (MS).

Tecfidera for MS

Tecfidera is approved for treating relapsing forms of MS, the most common forms of MS. In these forms, attacks of worsening or new symptoms occur (relapse), followed by periods of partial or complete recovery (remission).

Tecfidera reduces the risk of MS relapse by up to 49 percent over two years. It also reduces the risk of having worsening physical disability by about 38 percent.

Tecfidera for psoriasis

Tecfidera is used off-label to treat plaque psoriasis. Off-label use is when a drug is approved to treat one condition but is used to treat a different condition.

In a clinical study, about 33 percent of people taking Tecfidera had their plaques clear or almost completely clear after 16 weeks of treatment. About 38 percent of people taking the drug had a 75 percent improvement in an index of plaque severity and area affected.

Several medications are available to treat relapsing forms of multiple sclerosis (MS). Examples of these medications include:

  • interferon beta-1a (Avonex, Rebif)
  • interferon beta-1b (Betaseron)
  • glatiramer acetate (Copaxone, Glatopa)
  • IV immunoglobulin (Bivigam, Gammagard, others)
  • monoclonal antibodies such as:
  • fingolimod (Gilenya)
  • teriflunomide (Aubagio)

Note: Some of the drugs listed here are used off-label to treat relapsing forms of MS.

You may wonder how Tecfidera compares to other medications that are prescribed for similar uses. Below are comparisons between Tecfidera and several medications.

Tecfidera vs. Aubagio

Tecfidera and Aubagio (teriflunomide) are both classified as disease-modifying therapies. They both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Aubagio are both FDA-approved for treating relapsing forms of multiple sclerosis (MS).

Drug forms

Tecfidera comes as a delayed-release oral capsule that’s taken twice daily. Aubagio comes as an oral tablet that’s taken once daily.

Side effects and risks

Tecfidera and Aubagio have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and AubagioTecfideraAubagio
More common side effects• diarrhea
• nausea
• flushing
• stomach pain
• vomiting
• stomach upset
• itchy skin
• rash
• headache
• hair loss
• joint pain
Serious side effects• liver damage
• severe allergy
• brain infection (PML)
• low white blood cell levels (lymphopenia)
• serious flushing
• severe infection
• severe skin reactions
• nerve damage
• increased blood pressure
• lung damage
boxed warnings:* serious liver damage, fetal harm

* Aubagio has boxed warnings from the FDA. These are the strongest warning that the FDA requires. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Tecfidera and Aubagio are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, in one analysis, they were compared indirectly and were found to have similar benefits.

Costs

Tecfidera and Aubagio are only available as brand-name drugs. Generic versions of these drugs aren’t available. Generic forms are typically less expensive than brand-name drugs.

Tecfidera generally costs a little bit more than Aubagio. However, the exact price you pay will depend on your insurance plan.

Tecfidera vs. Copaxone

Tecfidera and Copaxone (glatiramer acetate) are both classified as disease-modifying therapies. They both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Copaxone are both FDA-approved for treating relapsing forms of multiple sclerosis (MS).

Drug forms

One advantage of Tecfidera is that it’s taken by mouth. It comes as a delayed-release oral capsule that’s taken twice daily.

Copaxone must be injected. It comes as a self-injectable subcutaneous injection. It can be given at home either once daily or three times per week.

Side effects and risks

Tecfidera and Copaxone have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and CopaxoneTecfideraCopaxone
More common side effects• nausea
• vomiting
• rash
• itchy skin
• flushing
• stomach pain
• stomach upset
• diarrhea
• palpitations
• fast heartbeat
• vision problems
• trouble swallowing
• injection site pain, redness, and itching
• weakness
• fever
• chills
• fluid retention
• respiratory infections
• back pain
• anxiety
• shortness of breath
Serious side effects(few similar serious side effects)• brain infection (PML)
• low white blood cell levels (lymphopenia)
• serious flushing
• liver damage
• severe allergy
• severe injection reaction
• chest pain

Effectiveness

Both Tecfidera and Copaxone are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera may be more effective than Copaxone for preventing relapse and slowing worsening of disability.

Costs

Tecfidera is only available as a brand-name drug. Copaxone is available as a brand-name drug. It’s also available in a generic form called glatiramer acetate.

The generic form of Copaxone is much less expensive than Tecfidera. Brand-name Copaxone and Tecfidera generally cost about the same. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Ocrevus

Tecfidera and Ocrevus (ocrelizumab) are both classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Ocrevus are both FDA-approved for treating relapsing forms of multiple sclerosis (MS). Ocrevus is also approved for treating progressive forms of MS.

Drug forms

An advantage of Tecfidera is that it can be taken by mouth. It comes as a delayed-release oral capsule that’s taken twice daily.

Ocrevus must be injected using an intravenous (IV) infusion. It must be administered in a clinic or hospital. After the first two doses, Ocrevus is given every six months.

Side effects and risks

Tecfidera and Ocrevus have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and OcrevusTecfideraOcrevus
More common side effects• diarrhea• flushing
• stomach pain
• nausea
• vomiting
• stomach upset
• itchy skin
• rash
• depression
• respiratory infections
• back pain
• herpes infections (if exposed to the virus)
• pain in arms and legs
• cough
• swelling in legs
• skin infection
Serious side effects• brain infection (PML)• low white blood cell levels (lymphopenia)
• serious flushing
• liver damage
• severe allergy
• severe infusion reaction
• cancer
• severe infections
• hepatitis B reactivation

Effectiveness

Both Tecfidera and Ocrevus are effective for treating MS, but it’s not clear if one works better than the other. The effectiveness of these drugs hasn’t been directly compared in clinical studies.

Costs

Tecfidera and Ocrevus are available as brand-name medications. They’re not available in generic forms, which can be less expensive than brand-name drugs.

Ocrevus may cost less than Tecfidera. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Tysabri

Tecfidera and Tysabri (natalizumab) are both classified as disease-modifying therapies. Both drugs decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Tysabri are both FDA-approved for treating relapsing forms of multiple sclerosis (MS). Tysabri is also approved for treating Crohn’s disease.

Drug forms

One advantage of Tecfidera is that it’s taken by mouth. Tecfidera comes as a delayed-release oral capsule that’s taken twice daily.

Tysabri must be administered as an intravenous (IV) infusion that’s given in a clinic or hospital. It’s given once every month.

Side effects and risks

Tecfidera and Tysabri have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and TysabriTecfideraTysabri
More common side effects• rash
• itchy skin
• diarrhea
• stomach upset
• flushing
• stomach pain
• nausea
• vomiting
• headache
• fatigue
• joint pain
• weight loss or gain
• urinary tract infection
• vaginal infection
• respiratory infection
• flu-like symptoms
• stomach infection
• depression
• pain in arms and legs
• vertigo
• irregular menstruation
• constipation
Serious side effects• brain infection (PML)*
• liver damage
• severe allergy
• low white blood cell levels (lymphopenia)
• serious flushing
• life-threatening herpes infection (if exposed to the virus)
• serious infections

* Both of these drugs have been linked with progressive multifocal leukoencephalopathy (PML), but only Tysabri has a related boxed warning from the FDA. This is the strongest warning the FDA requires. A boxed warning alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Both Tecfidera and Tysabri are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tysabri may be more effective than Tecfidera for preventing relapse.

It’s important to note that due to its risk of PML, Tysabri is usually not a first-choice medication for MS.

Costs

Tecfidera and Tysabri are only available as brand-name drugs. Generic versions of these drugs aren’t available. Generics typically cost less than brand-name medications.

Tecfidera generally costs more than Tysabri. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. Gilenya

Tecfidera and Gilenya (fingolimod) are both classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and Gilenya are both FDA-approved for treating relapsing forms of multiple sclerosis (MS).

Drug forms

Tecfidera comes as a delayed-release oral capsule that’s taken twice daily. Gilenya comes as an oral capsule that’s taken once daily.

Side effects and risks

Tecfidera and Gilenya have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and GilenyaTecfideraGilenya
More common side effects• diarrhea
• nausea
• stomach pain
• stomach upset
• flushing
• vomiting
• itchy skin
• rash
• respiratory infections such as flu or bronchitis
• shingles
• headache
• weakness
• pain in the back or arms and legs
• hair loss
• cough
• vision problems
Serious side effects• brain infection (PML)
• liver damage
• severe allergy
• low white blood cell levels (lymphopenia)
• serious flushing• abnormal heartbeat or slow heart rate
• severe herpes infection (if exposed to the virus)
• serious infections
• reduced lung function
• fluid in the eye (macular edema)
• brain disorder (posterior reversible encephalopathy syndrome)
• increased blood pressure
• skin cancer
• lymphoma
• seizures

Effectiveness

Both Tecfidera and Gilenya are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera and Gilenya work about equally well for preventing relapse.

Costs

Tecfidera and Gilenya are only available as brand-name drugs. Generic versions of these drugs aren’t available. Generics typically cost less than brand-name medications.

Tecfidera and Gilenya generally cost about the same. The actual amount you pay will depend on your insurance plan.

Tecfidera vs. interferon (Avonex, Rebif)

Tecfidera and interferon (Avonex, Rebif) are both classified as disease-modifying therapies. Both decrease certain immune functions of the body, but they work in different ways.

Uses

Tecfidera and interferon (Avonex, Rebif) are each FDA-approved for treating relapsing forms of multiple sclerosis (MS).

Drug forms

One advantage of Tecfidera is that it’s taken by mouth. Tecfidera comes as a delayed-release oral capsule that’s taken twice daily.

Avonex and Rebif are two different brand names of interferon beta-1a. Both forms must be injected. Rebif comes as a subcutaneous injection that’s given under the skin three times per week. Avonex comes as an intramuscular injection that’s given into a muscle once weekly. Both are self-administered at home.

Side effects and risks

Tecfidera and interferon have some similar side effects and some that differ. Below are examples of these side effects.

Both Tecfidera and interferonTecfideraInterferon
More common side effects• rash
• nausea
• stomach pain
• flushing
• vomiting
• stomach upset
• itchy skin
• diarrhea
• injection site pain or irritation
• flu-like symptoms
• respiratory infections
• headache
• fatigue
• weakness
• fever
• chest pain
• sleepiness
• thyroid disorder
• pain in the back, joints, or muscles
• vision problems
• dizziness
• hair loss
• urinary tract infections
Serious side effects• liver damage
• severe allergy
• serious flushing
• brain infection (PML)
• low white blood cell levels (lymphopenia)
• depression
• suicidal thoughts
• blood disorders
• seizures
• heart failure

Effectiveness

Both Tecfidera and interferon are effective for treating MS. The effectiveness of these drugs hasn’t been directly compared in clinical studies. However, according to one analysis, Tecfidera may be more effective than interferon for preventing relapse and slowing worsening of disability.

Costs

Tecfidera and interferon (Rebif, Avonex) are only available as brand-name drugs. Generic versions of these drugs aren’t available. Generics typically cost less than brand-name medications.

Tecfidera and interferon generally cost about the same. The actual amount you pay will depend on your insurance.

Tecfidera vs. Protandim

Tecfidera is an FDA-approved drug for treating relapsing forms of multiple sclerosis (MS). Several clinical studies have shown that it can prevent MS relapse and slow worsening of physical disability.

Protandim is a dietary supplement that contains several ingredients, including:

  • milk thistle
  • ashwagandha
  • green tea
  • turmeric
  • bacopa

Some claim that Protandim works like Tecfidera works. Protandim is sometimes called a “natural Tecfidera.”

However, Protandim has never been studied in people with MS. Therefore, there is no reliable clinical research that it works.

Note: If your doctor has prescribed Tecfidera for you, don’t replace it with Protandim. If you would like to explore other treatment options, talk with your doctor.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Dosage for multiple sclerosis

When Tecfidera is started, the dosage is 120 mg twice a day for the first seven days. After this first week, the dosage is increased to 240 mg twice daily. This is the long-term maintenance dose.

For people who have bothersome side effects from Tecfidera, the maintenance dosage can be temporarily decreased to 120 mg twice daily. The higher maintenance dosage of 240 mg twice daily should be started again within four weeks.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. If it’s almost time for your next dose, just take that one dose. Don’t try to catch up by taking two doses at once.

Will I need to use this drug long term?

Yes, this medication is intended to be taken long term.

Take Tecfidera exactly according to your doctor’s instructions.

Timing

Tecfidera is taken twice daily. It’s usually taken with the morning meal and the evening meal.

Taking Tecfidera with food

Tecfidera should be taken with food. This can help reduce the flushing side effect. Flushing can also be reduced by taking 325 mg of aspirin 30 minutes before taking Tecfidera.

Can Tecfidera be crushed?

Tecfidera shouldn’t be crushed, or opened and sprinkled on food. Tecfidera capsules should be swallowed whole.

Animal studies show that Tecfidera may be harmful to a fetus and may not be safe to take during pregnancy. However, animal studies don’t always predict what will happen in humans.

Studies haven’t evaluated the effects of Tecfidera regarding pregnancy or birth defects in humans.

If you’re pregnant or planning to become pregnant, talk with your doctor about whether you should take Tecfidera.

If you become pregnant while taking Tecfidera, you can take part in the Tecfidera Pregnancy Registry. A pregnancy registry helps gather information on how certain drugs can affect pregnancy. If you’d like to join the registry, ask your doctor, call 866-810-1462, or visit the registry’s website.

There haven’t been enough studies to show whether Tecfidera appears in breast milk.

Some experts recommend avoiding breastfeeding while taking this drug. However, others don’t. If you’re taking Tecfidera and would like to breastfeed your child, talk with your doctor about the potential risks and benefits.

Multiple sclerosis (MS) is an autoimmune disease. With this type of condition, the immune system, which fights disease, mistakes healthy cells for enemy invaders and attacks them. This can cause chronic inflammation.

With MS, this chronic inflammation is thought to cause nerve damage, including the demyelination that causes many MS symptoms. Oxidative stress (OS) is also thought to cause this damage. OS is an imbalance of certain molecules in your body.

Tecfidera is thought to help treat MS by causing the body to produce a protein called Nrf2. This protein is thought to help regain the body’s molecular balance. This effect, in turn, helps reduce the damage caused by inflammation and OS.

In addition, Tecfidera changes some of the body’s immune cell functions to decrease certain inflammatory responses. It may also prevent the body from activating certain immune cells. These effects could also help reduce MS symptoms.

How long does it take to work?

Tecfidera will begin to work in your body right away, but it can take several weeks to reach its full effect.

While it’s working, you may not notice much improvement in your symptoms. This is because it’s mainly intended to prevent relapses.

Tecfidera doesn’t interact with alcohol. However, alcohol might worsen certain side effects of Tecfidera, such as:

  • diarrhea
  • nausea
  • flushing

Avoid drinking excessive amounts of alcohol while taking Tecfidera.

Tecfidera may interact with other medications. Below is a list of medications that may interact with Tecfidera. This list may not contain all drugs that may interact with Tecfidera.

Different drug interactions can cause different effects. For instance, some can interfere with how well a drug works, while others can cause increased side effects.

Before taking Tecfidera, be sure to tell your doctor and pharmacist about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Tecfidera and ocrelizumab (Ocrevus)

Taking Tecfidera with ocrelizumab can increase the risk of immunosuppression and resulting serious infections. Immunosuppression is when the immune system is weakened.

Tecfidera and ibuprofen

There are no known interactions between ibuprofen and Tecfidera.

Tecfidera and aspirin

There are no known interactions between aspirin and Tecfidera. Aspirin is commonly used 30 minutes before taking Tecfidera to prevent flushing.

Here are answers to some frequently asked questions about Tecfidera.

Why does Tecfidera cause flushing?

It’s not exactly clear why Tecfidera causes flushing. However, it likely has to do with the dilation (widening) of blood vessels in the face where the flushing occurs.

How can you prevent flushing from Tecfidera?

You may not be able to entirely prevent flushing caused by Tecfidera, but there are two things you can do to help reduce it:

  • Take Tecfidera with a meal.
  • Take 325 mg of aspirin 30 minutes before taking Tecfidera.

If these steps don’t help and you still have bothersome flushing, talk with your doctor.

Does Tecfidera make you tired?

Some people who take Tecfidera say they feel fatigue. However, feelings of tiredness or sleepiness are not side effects that have been found in clinical studies of Tecfidera.

Is Tecfidera an immunosuppressant?

Tecfidera does affect the immune system. It reduces some immune system functions to decrease inflammatory responses. It may also reduce activation of certain immune cells.

However, Tecfidera isn’t usually categorized as an immunosuppressant. It’s sometimes called an immunomodulator, which means that it affects some functions of the immune system.

Do I need to worry about sun exposure while taking Tecfidera?

Tecfidera doesn’t make your skin more sensitive to the sun like some drugs do. However, if you experience flushing from Tecfidera, sun exposure could worsen the flushing feeling.

How effective is Tecfidera?

Tecfidera has been found to reduce MS relapse by up to 49 percent over two years. It’s also been found to reduce the risk of having worsening physical disability by about 38 percent.

Why do I have different dosing directions after the first week?

It’s common for medications to be started at a lower dosage and then increased later. This allows your body to process a lower dosage as it adjusts to the medication.

For Tecfidera, you start with a lower dosage of 120 mg twice daily during the first seven days. After that, the dosage is increased to 240 mg twice daily, and this is the dosage you would stay on. However, if you have too many side effects with the higher dosage, your doctor may lower your dosage for a time.

Do I need to get blood tests while I’m on Tecfidera?

Yes. Before you start taking Tecfidera, your doctor will do blood tests to check your blood cell counts and your liver function. These tests will likely be repeated during your treatment with the drug. For the first year of treatment, these tests are typically done at least every six months.

Taking too much of this medication can increase your risk of serious side effects.

Overdose symptoms

Symptoms of an overdose can include:

  • diarrhea
  • nausea
  • flushing
  • vomiting
  • rash
  • upset stomach
  • headache

What to do in case of overdose

If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

Before taking Tecfidera, talk with your doctor about any medical conditions you have. Tecfidera may not be right for you if you have certain medical conditions. These conditions include:

  • Immune system suppression: If your immune system is suppressed, Tecfidera may worsen this condition. This effect can increase your risk of serious infections.
  • Liver disease: Tecfidera can cause liver damage. If you already have liver disease, it may worsen your condition.

When Tecfidera is dispensed from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically one year from the date the medication was dispensed.

The purpose of such expiration dates is to guarantee the effectiveness of the medication during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. However, an FDA study showed that many medications may still be good beyond the expiration date listed on the bottle.

How long a medication remains good can depend on many factors, including how and where the medication is stored. Tecfidera should be stored at room temperature in the original container and protected from light.

If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

The following information is provided for clinicians and other healthcare professionals.

Mechanism of action

The mechanism of action of Tecfidera is complex and not fully understood. It works for multiple sclerosis (MS) through anti-inflammatory effects and antioxidant effects. Inflammation and oxidative stress are thought to be important pathological processes in patients with MS.

Tecfidera induces the nuclear 1 factor (erythroid-derived 2)-like 2 (Nrf2) antioxidant pathway, which protects against oxidative damage in the central nervous system and reduces nerve demyelination.

Tecfidera also inhibits multiple immune pathways related to toll-like receptors, which reduces inflammatory cytokine production. Tecfidera also reduces activation of immune T-cells.

Pharmacokinetics and metabolism

After oral administration of Tecfidera, it’s rapidly metabolized by esterases to its active metabolite, monomethyl fumarate (MMF). Therefore, dimethyl fumarate isn’t quantifiable in the plasma.

The time to MMF maximum concentration (Tmax) is 2–2.5 hours.

Exhalation of carbon dioxide is responsible for elimination of 60 percent of the drug. Renal and fecal elimination are minor routes.

The half-life of MMF is about 1 hour.

Contraindications

Tecfidera is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any excipients.

Storage

Tecfidera should be stored at room temperature, 59°F to 86°F (15°C to 30°C). It should be stored in the original container and protected from light.

Prescribing information

The full Tecfidera prescribing information can be found here.

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.