Xeljanz side effects

Common Xeljanz side effects | Serious side effects | Infection | Malignancies | Blood problems | Cholesterol | How long do side effects last? | Warnings | Interactions | How to avoid side effects

Xeljanz is a brand-name prescription drug used to treat autoimmune conditions in which the immune system overreacts and attacks healthy cells, causing inflammation, pain, and tissue damage. It is approved to treat rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polyarticular juvenile idiopathic arthritis, and ulcerative colitis. Tofacitinib, the active ingredient in Xeljanz, works by disrupting key cellular processes involved with inflammation. 

Xeljanz and its extended-release formulation, Xeljanz XR, have several side effects, some of which can be serious. People taking Xeljanz should be familiar with these side effects as well as other possible problems before taking this medicine.

RELATED: What is Xeljanz?

Common side effects of Xeljanz

The most common side effects of Xeljanz include:

• Elevated cholesterol levels
• Upper respiratory tract infections
• Nasal congestion, runny nose, and sore throat
• Skin rash
• Headache
• Diarrhea
• Nausea
• Vomiting 
• Fever
• High blood pressure
• Acne

Serious side effects of Xeljanz

The most serious side effects of Xeljanz are:

• Severe infections, including tuberculosis 
• Malignancies, including lymphoma and non-melanoma skin cancers
• Low white blood cell counts
• Tears in the stomach or intestines (gastrointestinal perforation)
• Blood clots
• Anemia
• Increased risk of heart attack or stroke in people over 50 years old with heart disease risk factors
• Increased risk of death in people over 50 years old with heart disease risk factors 
• Severe allergic reactions

Xeljanz and infection

Xeljanz suppresses the immune system, which can leave people more vulnerable to infections. In clinical trials, approximately 20% of people taking Xeljanz experienced infections while 18% of people taking a placebo experienced infections. The most commonly experienced infections include upper respiratory tract infections and urinary tract infections. The most serious infections include pneumonia, diverticulitis, and appendicitis. 

There is also a risk for reactivation of latent infections, such as hepatitis B or varicella (shingles). In addition, there have been reports of people experiencing opportunistic infections such as tuberculosis, herpes zoster, histoplasmosis, candidiasis, and others. People taking Xeljanz should carefully watch for signs of infection and report any signs or symptoms to a healthcare provider. 

Xeljanz and malignancies

The immune system is often the first line of defense against cancerous cells. As an immunosuppressant, Xeljanz may increase the risk for cancer. People taking Xeljanz may be at an increased risk of non-melanoma skin cancer. Other types of cancers experienced with Xeljanz include lung, breast, gastric, colorectal, and prostate cancer. The most concerning types of cancer reported are lymphoma and, in people taking Xeljanz after a kidney transplant, a type of lymphoma associated with Epstein-Barr Virus infection. People prescribed Xeljanz may be advised to regularly check their skin for any changes and report any signs that may indicate cancer. 

Xeljanz and blood problems

White blood cells are the body’s primary defense against infections and cancers. Xeljanz can suppress bone marrow, resulting in a reduction of white blood cells, red blood cells, and hemoglobin. In particular, Xeljanz can cause a drop in two types of white blood cells: neutrophils and lymphocytes. For this reason, people taking Xeljanz should have regular blood tests. If white blood cell counts or hemoglobin drops too low, doses may be reduced or Xeljanz may be discontinued altogether.

Xeljanz and cholesterol

In clinical trials, Xeljanz raised both LDL and HDL cholesterol levels, which peaked in about one month to six weeks after starting treatment. The overall impact on cardiovascular health and mortality has not been determined. People with high cholesterol or high triglycerides may need to be monitored while takingXeljanz. Most people will have blood tests after one or two months to assess cholesterol levels.

How long do Xeljanz side effects last?

Side effects like headaches, nausea, rash, and diarrhea should improve as the body adjusts to the medication. 

Serious side effects, like infections, often need treatment to resolve. Serious infections and malignancies may require weeks or months of medical treatment. 

Infections are still a risk even when Xeljanz has been discontinued. It could take the immune system up to six weeks to return to normal after Xeljanz has been discontinued. 

Some serious side effects, such as gastrointestinal tears and blood clots, may require emergency medical treatment and could have lifelong complications. 

Xeljanz contraindications and warnings

Xeljanz, like all immunosuppressants, can cause serious problems, particularly infections. Some people may be at more risk than others.

People with an active infection or those who have recently had a live vaccine should avoid using Xeljanz. People who are at risk of a gastrointestinal tear should use Xeljanz with caution.

Abuse and dependence

The U.S. Food and Drug Administration (FDA) does not consider tofacitinib a drug with a potential for abuse or physical dependence.

Overdose

Taking too much Xeljanz increases the risk for side effects. If too much Xeljanz is taken, talk to a healthcare professional or get emergency medical treatment.

Restrictions

The FDA has attached a black box warning to Xeljanz in regard to serious infections, cancers, blood clots, and an increased risk of death in certain people. People with specific pre-existing conditions may be recommended to monitor or avoid the use of Xeljanz in order to reduce the risk of serious side effects.

Contraindications include:

• Hypersensitivity to Xeljanz
• Low lymphocyte counts, low neutrophil counts, or low hemoglobin: Because Xeljanz suppresses bone marrow, it can lower two types of white blood cells (neutrophils and lymphocytes) as well as red blood cells. People who are deficient in white blood cells or red blood cells should not take Xeljanz. 
• Active infection: Tofacitinib weakens the immune system, so people with an active infection should not start treatment with Xeljanz.
• Risks for blood clots: The risk for serious blood clot problems such as deep vein thrombosis, pulmonary embolism, and arterial thrombosis increases when people take JAK inhibitors, a family of drugs that includes Xeljanz. People at risk for blood clots may be recommended not to take Xeljanz.
• Severe liver disease: Because tofacitinib is broken down by the liver, people with severe hepatic impairment cannot safely take Xeljanz. 

Some people may have pre-existing conditions that increase the risks associated with Xeljanz treatment, but they can still take the drug. Doses may be reduced in some cases, but in all cases, healthcare professionals will monitor the person more carefully for problems. People with certain risk factors may need to use Xeljanz with caution:

• Risk of infection: There are a number of risk factors for developing serious infections. These include older age, a history of infections, latent infections, travel to parts of the world where infection (like tuberculosis) is a risk, diabetes, and interstitial lung disease. People at risk for infection can take Xeljanz, but they will need to carefully watch for signs of an infection.
• Risk of cancer: Drugs like Xeljanz suppress the immune system and increase the risk of cancer. People at risk for cancer will need to be vigilant for signs of cancer. Most patients will be asked to periodically check their skin or get a regular checkup for any unusual changes.
• Risk of cardiovascular disease: In clinical trials, people older than the age of 50 who had at least one risk factor for cardiovascular disease had a higher mortality rate than other people. Regular monitoring is required for people who have risk factors for cardiovascular disease, such as previous heart attack, heart problems, high blood pressure, or high cholesterol.
• Risk of stomach or intestinal tears: Stomach or intestinal tears (gastrointestinal perforation) are a serious adverse reaction associated with Xeljanz, so people at risk for gastrointestinal tears will need close monitoring. Risk factors include chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) or a history of diverticulitis.
• Liver or kidney problems: Both the liver and kidneys are responsible for clearing tofacitinib from the body. If they’re not functioning well, tofacitinib concentrations in the blood can increase, raising the risk of side effects. People with moderate to severe renal impairment or moderate hepatic impairment may take lower doses than usual.

Pregnancy and nursing

Xeljanz can be prescribed to pregnant women. There is no information on how tofacitinib affects a human fetus or the course of pregnancy. In animal studies, however, tofacitinib did cause birth defects and fetal death at high doses. Women who are not pregnant but are of reproductive age may be encouraged to use birth control until four weeks after Xeljanz is discontinued.

Xeljanz may be present in breast milk. Women on Xeljanz should not breastfeed until at least 18 hours have passed since the last dose of Xeljanz or 36 hours after the last dose of Xeljanz XR has been taken. 

Children

Xeljanz is FDA-approved to treat polyarticular course juvenile idiopathic arthritis (pcJIA) in children as young as 2 years of age. Common side effects of Xeljanz when treating pcJIA include upper respiratory tract infections, nasal congestion, sore throat, runny nose, headache, fever, nausea, and vomiting. 

Seniors

People aged 65 years and older who are taking Xeljanz are more likely to experience infections than younger adults. When prescribed Xeljanz, older patients may require close monitoring for infection.

Xeljanz interactions

Xeljanz works by suppressing the immune system, so its most significant drug interactions involve drugs that also suppress the immune system. However, several drugs block the ability of the liver to break down tofacitinib, so taking these drugs may require Xeljanz dosage adjustments. 

• Live vaccines: Live vaccines are normally safe when given to healthy patients, but can cause serious infections in people taking immunosuppressants, so they are never given to anyone taking Xeljanz. 
• Biologic DMARDs: Monoclonal antibodies, such as Humira (adalimumab), Orencia (abatacept), and Enbrel (etanercept), treat rheumatoid arthritis and other autoimmune disorders by suppressing the immune system just like Xeljanz. Also called biologic DMARDs (as opposed to non-biologic DMARDs like Xeljanz), these drugs are generally avoided in people taking Xeljanz. 
• Immunosuppressive drugs: There is an increased risk of infections and cancer when combining Xeljanz with other immunosuppressive drugs.. Certain immunosuppressive drugs, such as azathioprine and cyclosporine, are used to treat rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, but healthcare professionals avoid combining them with Xeljanz. Methotrexate is an exception as it is sometimes used with Xeljanz.
• CYP3A4 inhibitors: CYP3A4 inhibitors are drugs that can block the ability of the liver to process Xeljanz. The liver breaks down about 70% of a dose of Xeljanz using an enzyme called CYP3A4. Some drugs block that enzyme from working properly, so they’re called CYP3A4 inhibitors. With this enzyme blocked, Xeljanz can accumulate in the blood, increasing the risk and severity of adverse effects. A doctor or healthcare provider may prescribe a low dose of Xeljanz to people who are taking a strong or moderate CYP3A4 inhibitor. 
• CYP3A4 inducers: CYP3A4 inducers are drugs that can increase the processing of tofacitinib in the liver. Taking these drugs with Xeljanz may decrease the effectiveness of Xeljanz. Examples of CYP3A4 inducers include rifampin, phenobarbital, and phenytoin. 

How to avoid Xeljanz side effects

Many side effects of Xeljanz can be bothersome, but some can be serious. Here are a few tips to avoid side effects and serious complications from Xeljanz. 

1. Tell the prescribing healthcare provider about all medical conditions

Most of the risks and side effects of Xeljanz can be attributed to certain risk factors, so make sure to give the prescribing healthcare provider a complete medical history, particularly: 

• Past or present infections, including:
  • Tuberculosis or exposure to tuberculosis
  • Hepatitis B or hepatitis C infection
  • HIV infection
  • Diverticulitis
• A weakened immune system
• Diabetes
• Chronic lung disease
• Blood clots
• Stomach or intestinal ulcers
• Stomach pain
• Liver problems
• Kidney problems
• Pregnancy or pregnancy plans
• Breastfeeding or breastfeeding plans

Some parts of the world have a high incidence of tuberculosis, and some areas of the U.S. have a high incidence of certain types of serious fungal infections, so make sure to tell the prescribing healthcare provider about where you’ve traveled or lived in the past. This will help the doctor test for possible latent infections.

2. Tell the healthcare provider about all medications being taken

Side effects of Xeljanz may be caused or worsened by drug interactions. Tell the prescribing healthcare provider about all prescription drugs, over-the-counter medicines, and dietary supplements being taken. In particular, make sure the prescribing healthcare provider knows about any recent live vaccines or other medicines being taken to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, or polyarticular juvenile idiopathic arthritis.

3. Take Xeljanz as directed

Take Xeljanz exactly as directed on the prescription label. Do not take more than prescribed.

4. Read the medication guide

Pfizer, the manufacturer of Xeljanz, includes a medication guide with every prescription. The guide outlines how to take this medication and contains information about potential side effects and complications. It also includes a list of symptoms that indicate there may be a serious problem. Read this medication guide each time you pick up a prescription. If you notice symptoms listed in the guide, immediately seek out medical advice.

5. Know when to get help

Get medical help if you have:

• Trouble breathing
• Shortness of breath
• Chest pain
• Swelling of the extremities
• Fever
• Pain in the stomach area
• Changes in bowel movements
• Swelling of the face, mouth, or throat
• Hives
• Clay-colored bowel movements
• Dark urine
• Yellow skin or eyes
• Fatigue and loss of appetite
• Unplanned weight loss

Related resources for Xeljanz side effects:

• Tofacitinib drug summary, Prescriber’s Digital Reference
• Xeljanz, Epocrates
• Xeljanz prescribing information, U.S. National Library of Medicine