All About Xeljanz and Xeljanz XR

What are the side effects of Xeljanz?

Like most drugs, Xeljanz may cause mild or serious side effects. The following lists describe some of the more common side effects that Xeljanz may cause. These lists don’t include all possible side effects.

Your doctor or pharmacist can tell you more about the potential side effects of Xeljanz. They can also suggest ways to help reduce side effects.

Mild side effects

Here’s a short list of some of the mild side effects that Xeljanz can cause. To learn about other mild side effects of this drug, talk with your doctor or pharmacist, or read Xeljanz’s prescribing information.

Mild side effects of Xeljanz can include the following. These side effects may vary depending on the condition you’re taking Xeljanz to treat.

• headache
• rash
• diarrhea
• upper respiratory tract infection, including the common cold
• high blood pressure

For more information about headache and rash, see the “Side effect focus” section.

Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Xeljanz can occur, but they aren’t common. If you have serious side effects from Xeljanz, call your doctor right away. But if you think you’re having a medical emergency, you should call 911 or your local emergency number.

Serious side effects can include:

• blood disorders, such as anemia (low level of red blood cells)
• boxed warnings: risk of serious infection, blood clots, certain cancers, cardiovascular (heart or blood vessel) problems, and death in certain people
• allergic reaction

Boxed warnings are serious warnings from the Food and Drug Administration (FDA). For more information about Xeljanz’s boxed warnings, as well as allergic reaction, see the “Side effect focus” section next.

Side effect focus

Learn more about some of the side effects Xeljanz may cause.

Boxed warnings

Xeljanz has a boxed warning for serious infections, blood clots, certain cancers, and death in certain people. A boxed warning is a serious warning from the Food and Drug Administration (FDA).

Risk of serious infections: Xeljanz may increase your risk of serious infections. This risk is higher if you also take certain other immunosuppressant drugs, such as corticosteroids or methotrexate (Otrexup, Trexall). Immunosuppressant drugs lower your body’s ability to fight infections. (Xeljanz is also an immunosuppressant drug.)

Infections reported in people taking Xeljanz include certain types of bacterial infections, fungal infections, and viral infections, such as herpes zoster (shingles). Also, flare-ups of past infections such as tuberculosis (TB), hepatitis B, and hepatitis C were reported.

The most commonly reported infections during Xeljanz treatment included pneumonia, skin infection, and urinary tract infection (UTI).

Symptoms of infections will vary, but they may include:

• fever or chills
• cough
• fatigue (low energy)
• muscle aches
• rash

Risk of blood clots: If you’re age 50 years or older and have rheumatoid arthritis and at least one risk factor for heart disease, Xeljanz can increase your risk of blood clots, such as the following:

• pulmonary embolism (blood clot in your lungs)
• arterial thrombosis (blood clot in an artery)
• deep venous thrombosis (blood clot in a vein)

In this case, Xeljanz can also increase the risk of death.

Risk factors for heart disease include having high blood pressure, high cholesterol, or obesity. Smoking is also a risk factor for heart disease.

In studies, these risks were higher with a 10-milligram (mg) dose of Xeljanz taken twice daily compared with lower doses of Xeljanz.

Symptoms of blood clots can include:

• chest pain
• pain in your arm or leg
• shortness of breath
• swelling in your arm or leg
• difficulty breathing

Risk of cancer: Xeljanz can increase your risk of certain types of cancer.

Studies of people taking Xeljanz reported several types of cancer, including:

• lymphoma (cancer in your lymphatic system)
• lung cancer
• breast cancer
• colorectal cancer
• stomach cancer
• prostate cancer
• renal cell cancer (a type of kidney cancer)
• malignant melanoma (a type of skin cancer)

Some cancer symptoms include:

• changes in moles or other skin changes
• fatigue (low energy)
• repeated infections
• unexplained weight loss

The risk of cancer was also higher for people taking Xeljanz who’d had a kidney transplant and who were taking certain other immunosuppressant drugs. Some people taking kidney transplant rejection drugs with Xeljanz may have an increased risk of reactivation of certain immune system viruses, such as Epstein-Barr virus.

Risk of major cardiovascular events: Xeljanz may increase the risk of major cardiovascular (heart or blood vessel) events in people ages 50 years or older who have rheumatoid arthritis and at least one risk factor for cardiovascular disease. In studies, this risk affected adults in this age group who took Xeljanz 5 mg or 10 mg twice per day for rheumatoid arthritis.

Examples of serious cardiovascular events include heart attack and stroke. Cardiovascular disease risk factors include having high blood pressure, high cholesterol, or obesity. In studies, people who had a history of smoking had an even higher risk of major cardiovascular events.

Risk of death in certain people: Xeljanz may increase the risk of death in some people. This includes people who have rheumatoid arthritis, who are ages 50 years and older, and who have at least one risk factor for cardiovascular disease. (Examples are listed in the preceding paragraph.)

What might help

Your doctor will order blood tests to check for signs of infection before you start taking Xeljanz. If you have an infection, your doctor may have you wait to start Xeljanz until your infection has been treated. They’ll also monitor you for infections while you’re taking Xeljanz and for a while after you stop treatment.

If you have heart disease or a history of blood clots, you should not take Xeljanz. If you develop blood clots or experience a heart attack or stroke during treatment, your doctor will have you stop taking the drug. In the case of blood clots, they’ll also monitor you to determine whether you need treatment for blood clots.

Your doctor can evaluate your risk of these side effects and assess whether Xeljanz is right for you. They can recommend a dosage and a treatment duration that’s safe for you.

Ask your doctor about all the risks and benefits of Xeljanz, including the risk of cancer and immune system problems. Be sure to share your medical history and tell your doctor if you’ve had cancer in the past or are currently having any cancer treatments.

Rash

Some people taking Xeljanz may develop a rash. This was a common side effect during studies.

It’s possible to get a rash when past infections in your body flare up. For example, a flare-up of the chickenpox virus in your body can cause shingles, which is a serious side effect of Xeljanz.

A rash may also occur from an allergic reaction to Xeljanz.

What might help

It’s important to call your doctor if you develop a rash while you’re taking Xeljanz. Your rash could mean you’re having a flare-up of a past infection or an allergic reaction.

Your doctor will assess what type of rash you have and recommend appropriate treatment for it.

Headache

Headache is a common side effect of Xeljanz. In studies, people taking Xeljanz twice per day for ulcerative colitis had more headaches than people taking the drug for its other approved uses.

What might help

If you get headaches while you’re taking Xeljanz, keep a record of them. This can help your doctor learn more about what may be causing your headaches.

If needed, your doctor can recommend a treatment that’s safe and effective to help relieve your headache. But do not take pain medications without first talking with your doctor or pharmacist.

Allergic reaction

Some people may have an allergic reaction to Xeljanz.

Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth, swelling, or discoloration in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause difficulty breathing.

Call your doctor right away if you have an allergic reaction to Xeljanz. But if you think you’re having a medical emergency, call 911 or your local emergency number.

What does Xeljanz cost?

Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.

If you have questions about the cost of Xeljanz or how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Xeljanz manufacturer’s website to see if it has support options that you are eligible for.

What is Xeljanz used for?

If you have certain autoimmune conditions, your doctor may prescribe Xeljanz for you. This prescription drug is used in adults and some children.

For all uses, Xeljanz may be prescribed when another type of drug called a tumor necrosis factor (TNF) blocker didn’t work or caused bothersome side effects. An example of a TNF blocker is adalimumab (Humira).

Doctors may prescribe Xeljanz tablet or Xeljanz XR tablet for the following in adults:

• Moderate to severe ulcerative colitis (UC): With UC, you have inflammation in your digestive tract. This can cause abdominal pain and atypical bowel movements.
• Moderate to severe rheumatoid arthritis (RA): With RA, you have pain, swelling, and possible structural irregularities in your joints.
• Active psoriatic arthritis (PsA): “Active” means you’re experiencing symptoms. With PsA, you have pain and swelling in your joints. You can also have patches of skin that are different in color from the rest of your skin and may become scaly in appearance.
• Active ankylosing spondylitis (AS): With active AS, you have pain and swelling in your spine and back.

In addition, Xeljanz tablet or liquid solution can be prescribed for children ages 2 years and older with juvenile idiopathic arthritis that affects multiple joints, referred to as polyarticular course juvenile idiopathic arthritis. This condition is a type of arthritis that affects children, the cause of which is unknown (also referred to as idiopathic). And being polyarticular, it affects at least five joints.

With autoimmune conditions, your immune system attacks tissues in your own body and causes inflammation. Xeljanz works to treat certain autoimmune conditions by blocking inflammatory responses inside your body.

Note: No form of Xeljanz should be taken together with other strong immunosuppressant drugs. This includes azathioprine (Azasan, Imuran) and cyclosporine (Gengraf, Neoral). In addition, no form of Xeljanz should be taken with biologic disease-modifying antirheumatic drugs. Talk with your doctor about which medications are safe to use with Xeljanz.

What are some frequently asked questions about Xeljanz?

Find answers to some commonly asked questions about Xeljanz.

Can Xeljanz be used for alopecia, such as alopecia areata?

No, Xeljanz isn’t approved to treat alopecia or alopecia areata. Alopecia is also simply called hair loss. With alopecia areata, you have hair loss in small patches.

Doctors may prescribe Xeljanz off-label for this purpose. With off-label use, a drug is used for another purpose than what it’s approved for.

Some studies have shown that tofacitinib (the active ingredient in Xeljanz) may be effective for treating hair loss. But people taking tofacitinib who then stopped taking it had hair shedding within 4 to 5 weeks of ending treatment.

If you’d like to know more about taking Xeljanz for hair loss, talk with your doctor. They can help you learn about the risks and benefits of treatment. Keep in mind that if you have insurance, it may not cover off-label use of Xeljanz.

Does Xeljanz cause weight gain or weight loss?

No, Xeljanz doesn’t lead to weight gain or weight loss. But serious side effects of this drug or your condition itself may cause unexplained weight loss.

For example, weight loss can occur with diarrhea, serious infection, and cancer. And these side effects can occur with Xeljanz. (For more information about serious infection and cancer risks, see the “What are the side effects of Xeljanz?” section.)

In addition, other medications you’re taking for your condition may cause weight changes.

It’s important to let your doctor know if you have any changes in your appetite or body weight while you’re taking Xeljanz. Your doctor will order tests to make sure you’re not having certain serious side effects from treatment. Your doctor can also explain ways to help you manage a body weight that’s healthy for you.

How does Xeljanz compare with Rinvoq?

Xeljanz and Rinvoq belong to the same group of medications, called Janus kinase inhibitors. This means they have some similar uses and side effects. But they also have some differences.

Xeljanz contains the active ingredient tofacitinib, while Rinvoq contains the active ingredient upadacitinib.

Xeljanz and Rinvoq are approved to treat some of the same conditions in adults when certain other drugs haven’t worked. Specifically, they’re prescribed for:

• rheumatoid arthritis
• psoriatic arthritis
• ulcerative colitis
• ankylosing spondylitis

Both drugs are also approved to treat polyarticular juvenile idiopathic arthritis in children ages 2 years and older. Rinvoq has additional approved uses.

Xeljanz and Rinvoq have similar serious side effects as well. To learn more about Xeljanz’s side effects, see the “What are the side effects of Xeljanz?” section. To learn more about Rinvoq’s side effects, see the drug’s prescribing information.

If you’d like to know more about these drugs, talk with your doctor or pharmacist.

What should I know about Xeljanz vs. Humira?

You may wonder how Xeljanz compares with Humira.

Xeljanz contains the active ingredient tofacitinib, while Humira contains the active ingredient adalimumab. Humira is given as an injection under your skin. Xeljanz comes as tablets and a liquid solution, and Xeljanz XR comes as tablets. All forms of Xeljanz are swallowed.

These medications have some shared uses and some unique ones. They’re both prescribed for adults with:

• rheumatoid arthritis
• psoriatic arthritis
• ulcerative colitis
• ankylosing spondylitis

They’re also both prescribed for polyarticular juvenile idiopathic arthritis in children ages 2 years and older.

In addition, Humira is approved to treat certain other conditions, which your doctor or pharmacist can tell you about.

To learn more about how these drugs compare, talk with your doctor or pharmacist.

How is Xeljanz taken?

Your doctor will explain how you should take Xeljanz. They’ll also explain how much to take and how often. Be sure to follow your doctor’s instructions.

Generally, you’ll start by taking the lowest dosage of Xeljanz, and your doctor will assess how you do with the drug. Your doctor may adjust your dosage if needed. But that’ll depend on how the treatment is working to manage your condition.

The following text describes commonly used dosages, but always take the dosage your doctor prescribes.

Taking Xeljanz

Xeljanz and Xeljanz XR come as tablets that you’ll swallow.

Xeljanz also comes as a liquid solution for children that can be swallowed.

You can take Xeljanz at any time of day. There’s not a time of day that’s best to take it. But try to take the drug at the same time every day to avoid missing doses.

If your doctor prescribes Xeljanz to be taken twice per day, take your two doses about 12 hours apart, once in the morning and once in the evening.

Dosages

Your doctor will recommend the dosage that’s right for you, depending on:

• your age
• medical conditions you may have
• other medications you may be taking

In some cases, your dose of Xeljanz may be adjusted based on your liver or kidney function.

Xeljanz forms and strengths

Xeljanz comes in the following forms and strengths. Strengths are given in milligrams (mg) for the tablets and milligrams per milliliter (mg/mL) for the liquid solution.

Dosage for ulcerative colitis

If you start taking Xeljanz for ulcerative colitis (UC), your doctor will prescribe a higher dosage to start. This helps bring on remission (a period when you have few or no symptoms of UC). This is referred to as the induction phase.

Your doctor will then lower your dosage, which may be enough to keep your UC symptoms from returning. This is referred to as the maintenance phase.

The following are the UC dosages recommended for Xeljanz and Xeljanz XR:

• Xeljanz: The induction dosage is 10 mg twice per day for 8 to 16 weeks. Then you’ll take a maintenance dosage of 5 mg twice per day.
• Xeljanz XR: The induction dosage is 22 mg once per day for 8 to 16 weeks. Then you’ll take a maintenance dosage of 11 mg once per day.

Dosage for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis

For rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, the recommended dosage of Xeljanz is 5 mg twice per day.

The recommended dosage of Xeljanz XR for these conditions is 11 mg once per day.

Children’s dosage

For juvenile idiopathic arthritis (JIA) that affects multiple joints in children ages 2 years and older, Xeljanz’s dosage is based on body weight in kilograms (kg). For reference, 1 kg is about 2.2 pounds (lb). Depending on a child’s weight, they may take either Xeljanz tablet or liquid solution. (Xeljanz XR is not approved for use in children.)

The manufacturer of Xeljanz recommends the following dosages for JIA:

Questions about taking Xeljanz

Here we answer some common questions related to taking Xeljanz.

• What if I miss a dose of Xeljanz? Take the missed dose as soon as you remember. But if it’s close to the time you’ll take your next dose, do not take two doses together. Instead, just take your next scheduled dose like usual. And try setting a reminder to help you remember to take your doses on a regular schedule.
• Will I need to take Xeljanz long term? As long as the drug is working well to manage your symptoms, your doctor may have you keep taking it regularly. Ask your doctor if taking Xeljanz long term is right for you.
• Can Xeljanz tablets be chewed, crushed, or split? You may be able to crush or chew Xeljanz tablets. But do not split, crush, or chew Xeljanz XR tablets. Doing so can alter how they work. If you have difficulty swallowing pills, ask your pharmacist or doctor about other options.
• Should I take Xeljanz with food? Food doesn’t change how Xeljanz works. So you can take Xeljanz with or without food.
• How long does Xeljanz take to work? Xeljanz starts to work soon after you take a dose. But keep in mind that it may take a few weeks to experience reductions in your symptoms. Ask your doctor when you can expect to notice your symptoms easing. When you start taking the drug, your doctor will monitor you to make sure the drug is working.

Questions for your doctor

You may have questions about Xeljanz and your treatment plan. It’s important to discuss all your concerns with your doctor.

Here are a few tips that might help guide your discussion:

• Before your appointment, write down questions like:
  • how will Xeljanz affect my body, mood, or lifestyle?
• Bring someone with you to your appointment if doing so will help you feel more comfortable.
• If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.

Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.

What should be considered before taking Xeljanz?

Before starting treatment with Xeljanz, talk with your doctor about any medical conditions you have. In addition, tell your doctor about any medications or supplements you’re taking.

Here, we describe a few risks and precautions for taking Xeljanz.

Interactions

Medications you take can interact with other medications, vaccines, and even foods. This can change how effective or safe the drug is for you.

Before taking Xeljanz, be sure to tell your doctor about all medications you take (including prescription and over-the-counter types). Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any Xeljanz interactions these items may cause.

Note: The following lists do not contain all types of drugs that may interact with Xeljanz. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with Xeljanz.

Interactions with drugs or supplements

Xeljanz can interact with several types of drugs. Your doctor or pharmacist can tell you more about these interactions. (For information about interactions with other immunosuppressant drugs specifically, see the next section.)

Medications that interact with Xeljanz can either increase or decrease the drug’s effects.

For instance, certain drugs slow down the removal of Xeljanz from your body. This can raise your risk of side effects from Xeljanz. Examples of these drugs include:

• the antibiotic clarithromycin (Biaxin)
• the antifungal fluconazole (Diflucan)

Other kinds of drugs can speed up the removal of Xeljanz from your body. This can make Xeljanz less effective for your condition. A few examples of these kinds of drugs include:

• the antibiotic rifampin (Rifadin)
• the HIV drug efavirenz
• the seizure drugs carbamazepine (Epitol, Tegretol) and phenytoin (Dilantin)

Interactions with immunosuppressant drugs

If taken with other immunosuppressant drugs, Xeljanz can increase the risk of serious infection. (Immunosuppressant drugs lower your body’s ability to fight infections.)

Examples of immunosuppressant drugs include:

• adalimumab (Humira)
• azathioprine (Imuran)
• cyclosporine (Neoral)
• etanercept (Enbrel)
• golimumab (Simponi)
• infliximab (Remicade)

Boxed warnings

Xeljanz has boxed warnings for the risks of certain health conditions. A boxed warning is a serious warning from the Food and Drug Administration (FDA). These warnings are described here.

Risk of serious infections: Taking Xeljanz can increase your risk of serious bacterial, viral, and fungal infections.

Risk of blood clots: If you’re age 50 years or older and have rheumatoid arthritis and at least one risk factor for heart disease, Xeljanz can increase your risk of blood clots. This includes pulmonary embolism (blood clot in the lungs), arterial thrombosis (blood clot in an artery), and deep venous thrombosis (blood clot in a vein). In this case, Xeljanz can also increase the risk of death.

Risk of cancer and problems with your immune system: Xeljanz can increase your risk of certain cancers, including lymphoma (cancer in your lymphatic system). These drugs can also increase the risk of immune system disorders in certain people.

Risk of major cardiovascular events: Xeljanz may increase the risk of major cardiovascular (heart or blood vessel) events in people ages 50 years or older who have rheumatoid arthritis and at least one risk factor for cardiovascular disease. Examples of serious cardiovascular events include heart attack and stroke. Cardiovascular disease risk factors include having high blood pressure, high cholesterol, or obesity.

Risk of death in certain people: Xeljanz may increase the risk of death in certain people. This includes people ages 50 years and older who have rheumatoid arthritis and at least one cardiovascular risk factor.

If you’d like to know more about these boxed warnings, see the “What are the side effects of Xeljanz?” section for more information.

Other warnings

Before taking Xeljanz, discuss your health history with your doctor. Xeljanz may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

• gastrointestinal tract problems
• liver problems, including hepatitis B or hepatitis C
• kidney problems
• current infections or a weakened immune system
• heart or lung problems
• a history of blood clots
• recent vaccination
• pregnancy
• breastfeeding
• an allergic reaction to Xeljanz or any of its ingredients

Xeljanz and alcohol

Drinking alcohol can increase the risk of liver problems. Xeljanz may worsen liver function in some people. Drinking alcohol while taking Xeljanz can further increase your risk of liver problems.

This risk may be higher if Xeljanz is taken with certain other immunosuppressant drugs. (Immunosuppressant drugs lower your body’s ability to fight infections.)

Ask your doctor whether it’s safe for you to drink alcohol while you’re taking Xeljanz. Your doctor may order liver function tests to assess how your liver is working before and while you take this drug.

Pregnancy and breastfeeding

It’s not known whether Xeljanz is safe to take if you’re pregnant. Ask your doctor about the risks and benefits of taking this drug during pregnancy.

Also, Xeljanz may affect your ability to become pregnant while you’re taking the drug or after you’ve taken it. Be sure to talk with your doctor about any plans for pregnancy before starting this treatment.

Xeljanz may pass into breast milk, so it’s not recommended to take it while you’re breastfeeding. Ask your doctor for more information about the risks of taking Xeljanz while breastfeeding.

What should be done in case of overdose?

Do not take more Xeljanz than your doctor prescribes. Taking more than this can lead to serious side effects.

What to do in case you take too much Xeljanz

Call your doctor if you think you’ve taken too much Xeljanz. You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. However, if you have severe symptoms, immediately call 911 (or your local emergency number) or go to the nearest emergency room.