Rinvoq’s Side Effects: What to Know

Rinvoq is a brand-name prescription drug. It’s a type of drug called a Janus kinase (JAK) inhibitor and contains the active drug upadacitinib. It comes as an extended-release (ER) tablet* and is taken orally.

Rinvoq is approved by the Food and Drug Administration (FDA) as a long-term treatment in people who have tried certain other treatments for their condition but didn’t have symptom relief. These conditions include:

• moderate or severe rheumatoid arthritis (RA) in adults
• psoriatic arthritis (PsA) in adults
• moderate or severe ulcerative colitis (UC) in adults
• moderate or severe atopic dermatitis (AD) in certain adults and children ages 12 years and older

Similar to other drugs, Rinvoq may cause side effects. Read below for information about possible side effects, including common, mild, and serious ones.

For a general overview of Rinvoq, including details about its uses, see this article.

If you’d like to take Rinvoq, search here to find a healthcare professional who might prescribe it.

* ER medications release their active drug slowly into your body over time.

Some of Rinvoq’s side effects may be more common than others. These side effects may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about any side effects with Rinvoq.

Some of the more common side effects of Rinvoq that occurred during clinical studies are listed below. These side effects can vary depending on the condition Rinvoq is being taken to treat.

More common side effects of Rinvoq in people with rheumatoid arthritis or psoriatic arthritis (PsA) include:

• upper respiratory tract infection, such as the common cold
• herpes infection, such as herpes zoster or herpes simplex
• bronchitis 
• nausea
• cough

More common side effects of Rinvoq in people with atopic dermatitis (AD) include:

• upper respiratory tract infection, such as the common cold
• herpes simplex infection, such as cold sores
• increased creatinine phosphokinase levels
• headache*
• acne*

More common side effects of Rinvoq in people with ulcerative colitis (UC) include:

• upper respiratory tract infection, such as the common cold
• herpes simplex infection, such as cold sores
• hair follicle inflammation
• rash
• acne*

* For more information about this side effect, see “Rinvoq: Side effects explained” below.

Rinvoq can cause mild side effects, which are listed below. However, this list doesn’t include all possible mild side effects. To learn more about Rinvoq’s side effects, view the drug’s prescribing information.

Rinvoq’s mild side effects include:

• upper respiratory tract infection, such as the common cold
• herpes infection, such as herpes zoster or herpes simplex
• bronchitis 
• nausea
• cough
• hair follicle inflammation
• rash
• fever
• fatigue
• muscle pain
• acne*
• headache*
• weight gain*

The side effects listed above may last only a few days to weeks. However, some side effects may last longer or become severe or bothersome. Tell your doctor or pharmacist if you have concerns about side effects of Rinvoq.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Rinvoq and want to tell the FDA about it, visit MedWatch.

* For more information about this side effect, see “Rinvoq: Side effects explained” below.

It’s possible to have serious side effects with Rinvoq. Serious side effects are listed below, but this list may not include all possibilities. To learn more about Rinvoq’s side effects, view the drug’s prescribing information.

Call your doctor right away if you have serious side effects with Rinvoq. However, if you think you’re having a medical emergency or have life threatening side effects, call 911 or your local emergency number.

Serious side effects of Rinvoq and their possible symptoms include:

• Gastrointestinal (GI) perforation (hole in your GI tract, such as in your intestines). Symptoms can include:
  • abdominal pain
  • chills
  • fever
  • nausea and vomiting
• Low level of certain white blood cells called neutrophils and lymphocytes. Symptoms can include:
  • fever
  • fatigue
• Low level of hemoglobin, which is a protein found inside red blood cells. Symptoms can include:
  • fatigue
  • cold hands and feet
• High cholesterol, including low-density lipoprotein (LDL) cholesterol. This doesn’t cause symptoms, but your doctor may notice it on the results of a cholesterol test.
• Increased liver enzyme level, which doesn’t cause symptoms, but can be a sign of liver damage in rare cases.
• Risk of blood clots.*
• Risk of serious infection.*
• Risk of cardiovascular problems.*
• Risk of cancer.*
• Risk of death.*
• Allergic reaction.†

* Rinvoq has a boxed warning Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Rinvoq: Side effects explained” section below.
†For more information about this side effect, see “Rinvoq: Side effects explained” below.

Here’s detailed information about some of Rinvoq’s side effects.

Rinvoq has five boxed warnings Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source , which are listed below. These are serious warnings from the Food and Drug Administration (FDA).

Risk of blood clots. Treatment with Rinvoq raises your risk of blood clots, including:

• deep venous thrombosis (DVT), which is a blood clot in a deep vein, usually in the leg
• pulmonary embolism (PE), which is a blood clot in the lung
• arterial thrombosis, which is a blood clot in an artery

Symptoms of a blood clot may include:

• newly occurring pain in an area of your body
• shortness of breath
• swelling or pain in your arms, legs, hands, or feet

Risk of serious infections. Treatment with Rinvoq raises your risk of infection. This includes serious infections such as tuberculosis (TB).

Rinvoq works by weakening your immune system, which increases your risk of serious infections. These infections could require a hospital stay. In rare cases, they may even lead to death.

Serious infections weren’t common in Rinvoq’s clinical studies. People who took other medications that weaken the immune system in combination with Rinvoq were more likely to have infections. An example of one of those other medications is methotrexate.

Symptoms of a serious infection vary, but can include:

• cough, with or without blood
• diarrhea
• fatigue
• fever or chills
• shortness of breath
• unintended weight loss

Risk of cardiovascular problems. Another medication similar to Rinvoq has caused serious cardiovascular problems when taken by people with rheumatoid arthritis (RA). (Keep in mind that RA is one of the conditions Rinvoq treats.)

These cardiovascular problems, including heart attack and stroke, can be deadly in rare cases. People who use tobacco have an even higher risk.

Symptoms of cardiovascular problems can include:

• severe chest pain
• pain, pressure, or tightness in your jaw, neck, throat, arm, back, or stomach
• nausea or vomiting
• weakness on one side of your body
• slurred speech

Risk of cancer. Rinvoq raises the risk of certain cancers, including lymphomas and skin cancers. (Lymphomas are a type of blood cancer that affect the body’s immune system.) People who use tobacco have an even higher risk.

Rinvoq may have this risk due to how the drug affects the immune system.

Symptoms of these cancers can include:

• unintentional weight loss
• night sweats
• frequent infections
• fatigue
• fever or chills
• new skin moles or skin growths
• skin moles or skin growths that grow or change, such as in shape

Risk of death. In clinical studies, when taken by people with rheumatoid arthritis, another medication similar to Rinvoq raised the risk of death. It’s not known for sure whether Rinvoq also carries this risk.

This risk applies to people ages 50 years and older who have at least one risk factor for cardiovascular disease. (Some common risk factors for cardiovascular disease include high blood pressure, high cholesterol, and diabetes.)

Before prescribing Rinvoq, your doctor will evaluate your risk for the warnings listed above. They’ll also discuss how they’ll monitor you for these side effects.

If you notice any of the symptoms mentioned above, talk with your doctor right away. They can help determine the best plan for addressing your symptoms and treating your condition.

Weight gain is a possible side effect of Rinvoq. In clinical studies, this side effect was more common in people taking Rinvoq to treat atopic dermatitis.

Talk with your doctor if you’re concerned about weight gain while taking Rinvoq. They can suggest ways to help you manage a weight that’s healthy for you.

Treatment with Rinvoq can cause acne as a side effect. This was among the more common side effects reported in Rinvoq’s clinical studies. In these studies, acne occurred as a side effect in people taking Rinvoq for each condition it treats.

Talk with your doctor if you’re concerned about acne with Rinvoq. They can suggest ways to treat this side effect, including medicated skin cleansers, creams, and spot treatments.

You may have a headache as a side effect of Rinvoq treatment. In clinical studies, this was more common in people taking Rinvoq to treat atopic dermatitis.

Talk with your doctor if you have a headache as a side effect of taking Rinvoq. Depending on the severity, they may suggest:

• over-the-counter pain relievers, including ibuprofen (Advil)
• stopping treatment with Rinvoq

Talk with your doctor before stopping Rinvoq or taking any new medications with it. Your doctor can recommend the treatment plan that’s right for you.

Here are some common questions about the drug’s side effects and answers to them. Talk with your doctor if you have other questions about this drug.

No, neither hair loss nor weight loss was side effects reported in Rinvoq’s clinical studies.

However, weight loss can be a symptom of a serious infection. And treatment with Rinvoq raises your risk of infection.* Talk with your doctor if you have unexplained weight loss with Rinvoq. They may order tests to check for infection.

Other medications that are prescribed for the conditions Rinvoq treats may cause hair loss. Examples of such drugs include methotrexate (Trexall, others).

If you’re concerned about hair loss or weight loss with Rinvoq, talk with your doctor.

* Rinvoq has a boxed warning Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Rinvoq: Side effects explained” section above.

Depression wasn’t a side effect reported in Rinvoq’s clinical studies.

People with the autoimmune diseases Rinvoq treats are thought to have a higher risk of depression. Examples of these conditions include psoriasis and Crohn’s disease. In people with these conditions, depression may be due to the stress of having a chronic (long-term) autoimmune disease.

Talk with your doctor if you have questions about depression or are interested in its treatment options.

Side effects reported in people taking Rinvoq for PsA and RA didn’t differ in clinical studies.

Side effects in people taking Rinvoq for ulcerative colitis or atopic dermatitis did differ compared with those in people with PsA or RA.

To learn more, see “Rinvoq: More common side effects” above or view the drug’s full prescribing information. You can also talk with your doctor or pharmacist to learn more.

There was one ocular (eye-related) side effect reported in Rinvoq’s clinical studies.

One person who took Rinvoq to treat atopic dermatitis experienced retinal detachment. With retinal detachment, your retina (a thin layer at the back of your eye) tears away from the back of your eye. This is a medical emergency that can result in blindness if not treated right away.

Symptoms of retinal detachment can include:

• blurry vision
• sudden light flashes in one or both eyes
• partial vision loss

Call 911 or seek emergency medical help if you notice symptoms of retinal detachment while taking Rinvoq. If you’d like to know more about eye-related side effects, talk with your doctor.

Before beginning treatment with Rinvoq, consider the following precautions.

This drug has boxed warnings Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source , which are listed below. These are serious warnings from the Food and Drug Administration (FDA).

• Risk of blood clots. Rinvoq may cause blood clots as a side effect. These clots can be deadly in rare cases.
• Risk of serious infections. Treatment with Rinvoq raises your risk of infection. This includes serious infections such as tuberculosis (TB).
• Risk of cardiovascular problems. Another medication similar to Rinvoq has caused serious cardiovascular problems when taken by people with rheumatoid arthritis (RA). These cardiovascular problems can be deadly in extreme cases. People who use tobacco have an even higher risk.
• Risk of cancer. Rinvoq raises the risk of developing certain cancers, including lymphomas. (Lymphomas are a type of blood cancer that affect the body’s immune system.) People who use tobacco have an even higher risk.
• Risk of death. In clinical studies, another medication similar to Rinvoq raised the risk of death in people with RA. It’s not known for sure whether Rinvoq also carries this risk.

For details, see the “Rinvoq: Side effects explained” section above.

Be sure to talk with your doctor about your health history before you take Rinvoq. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health.

The conditions and factors to consider include those described below.

Diverticulitis. Taking Rinvoq may increase your risk of gastrointestinal perforation (holes in your stomach or intestines). If you have diverticulitis, you may be at higher risk of this side effect. Your doctor can help determine whether Rinvoq is safe for you to take.

Liver problems. Rinvoq may cause your liver enzymes (types of proteins) to increase. In rare cases, a large increase in these enzyme levels may be a sign of liver damage. Before taking Rinvoq, tell your doctor if you have liver problems, such as hepatitis. They may monitor you more closely during Rinvoq treatment. Your doctor may also decide to prescribe a different drug to treat your condition.

Blood disorders. Be sure to tell your doctor if you have a blood disorder, such as anemia or lymphopenia, before you start taking Rinvoq. Rinvoq may lower levels of certain blood cells. This, in turn, may worsen your condition. Your doctor may monitor you more closely than usual with lab tests during Rinvoq treatment. Or, they may advise that a different drug is safer for you.

High cholesterol. If you have high cholesterol or a history of high cholesterol, be sure your doctor is aware before you take Rinvoq. Rinvoq can raise your cholesterol level. So, the medication may worsen this condition if you already have it. If your doctor prescribes Rinvoq to you, they may monitor your cholesterol level more closely than usual.

Allergic reaction. If you’ve had an allergic reaction to Rinvoq or any of its ingredients, your doctor will likely not prescribe Rinvoq. Ask your doctor what other medications may be better options for you.

There’s no known interaction between alcohol and Rinvoq.

However, drinking alcohol could raise your risk of certain side effects. These include liver problems, fatigue, and headache.

Talk with your doctor if you drink alcohol. They can advise on how much alcohol is safe for you to consume while taking Rinvoq.

Your doctor will likely recommend that you do not take Rinvoq during pregnancy. Animal studies have shown that Rinvoq may cause harm to fetuses. However, animal studies don’t always predict what will happen in people.

If you can become pregnant, your doctor will order a pregnancy test to check that you’re not pregnant before prescribing Rinvoq to you. If you are able to become pregnant, your doctor will likely advise that you use birth control while taking Rinvoq. You should continue to do so for up to 4 weeks after your last dose.

It’s recommended that you avoid breastfeeding while taking Rinvoq and for at least 6 days after your last dose of the drug. This is because Rinvoq has been shown to pass into breast milk. While it’s not known for sure, the drug may cause side effects in a child who is breastfed.

Talk with your doctor or pharmacist to find out more information about Rinvoq. If you have questions about the drug’s side effects, your pharmacist or healthcare professional can help answer them for you.

In addition to discussing Rinvoq with your doctor, you may find the following articles helpful in learning more.

• Overview of Rinvoq. To read an overview of Rinvoq, see this article.
• Drug comparisons. To learn how Rinvoq compares with Xeljanz and Humira, read this article.
• Details about Rinvoq’s uses. To learn more about the conditions Rinvoq is prescribed to treat, see the articles below:
  • rheumatoid arthritis (RA)
  • psoriatic arthritis (PsA)
  • atopic dermatitis (AD)
  • ulcerative colitis (UC)

Disclaimer: Healthgrades 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 another 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.