Rinvoq (upadacitinib) is a brand-name drug prescribed for certain inflammatory conditions, such as rheumatoid arthritis. As with other drugs, Rinvoq can cause side effects, such as upper respiratory tract infections, fever, and nausea.
Rinvoq is approved by the Food and Drug Administration (FDA) to treat the following conditions in adults in certain situations:
The FDA has also approved the drug to treat the following conditions in children in certain situations:
- polyarticular juvenile idiopathic arthritis in children ages 2 years and older
- psoriatic arthritis in children ages 2 years and older
- atopic dermatitis in children ages 12 years and older
Rinvoq belongs to a drug class called Janus kinase inhibitors. The drug is not available in a generic version. Rinvoq comes as an extended-release oral tablet. (This type of tablet releases the drug in your body slowly over a period of time.) It also comes as an oral solution called Rinvoq LQ, which is typically prescribed to certain children.
Read on to learn about potential common, mild, and serious side effects of Rinvoq. For a general overview of the drug, including details about its uses, see this article.
Rinvoq can cause certain side effects, some of which are more common than others. These side effects are usually temporary, lasting for a few days or weeks. But if the side effects last for longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Some of the more common side effects of Rinvoq reported in clinical trials are:
- cough
- fever
- nausea
- upper respiratory tract infections, such as the common cold*
* For more information about this side effect, see “Side effect specifics” below.
These are just a few of the more common side effects reported by people who took Rinvoq in clinical trials. Other possible side effects of the drug are discussed in the following sections.
Mild side effects can occur while taking Rinvoq. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Rinvoq’s prescribing information.
Mild side effects of Rinvoq can include:
- cough
- fever
- nausea
- upper respiratory tract infections, such as the common cold*
* For more information about this side effect, see “Side effect specifics” below.
These side effects are usually temporary, lasting for a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking Rinvoq and want to tell the FDA about it, visit MedWatch.
Rinvoq may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Rinvoq’s prescribing information.
If you develop serious side effects while taking Rinvoq, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects and their symptoms can include:
- Gastrointestinal perforation (a hole in your stomach, large intestine, or small intestine). Symptoms can include:
- chills
- fever
- pain and tenderness in your abdomen
- Changes in levels of cholesterol, liver enzymes, and certain blood cells.*
- Serious infections.†
- Blood clots.†
- Certain cancers.†
- Cardiovascular problems.†
- Increased risk of death.†
- Allergic reaction.*
* For more information, see “Side effect specifics” below.
† Rinvoq has boxed warnings for these side effects. A boxed warning is a serious warning from the Food and Drug Administration (FDA). To learn more, see “Side effect specifics” below.
Though rare, Rinvoq may cause long-term side effects. These are side effects that might develop at any time while you’re taking a drug, even if you’ve taken the drug for a long time.
Examples of long-term side effects reported in Rinvoq’s clinical trials include certain cancers, cardiovascular problems, low blood cell counts, and increased cholesterol.
Long-term side effects may also refer to side effects that might not go away, even after you stop taking the drug.
However, stopping Rinvoq treatment typically does not result in side effects known as withdrawal symptoms. These can occur when you stop taking a drug that your body has developed a dependence on. (With drug dependence, your body relies on a drug to function as usual.) Rinvoq is not known to lead to dependence.
Note that stopping Rinvoq treatment may cause symptoms of the condition you’re taking the drug for to return or worsen.
To find out more about possible long-term side effects that may occur with Rinvoq, talk with your doctor.
Rinvoq may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Is weight gain or weight loss a side effect of Rinvoq?
It’s possible for weight gain to occur with Rinvoq. But weight loss is not a known side effect of the drug.
Weight gain was reported as a rare side effect in clinical trials of Rinvoq for treating atopic dermatitis, which is a type of eczema. However, weight gain wasn’t reported as a side effect of taking Rinvoq to treat other conditions that the drug is approved for.
Also, Rinvoq is sometimes taken with methotrexate (Trexall) to treat rheumatoid arthritis (RA). Weight gain is a possible side effect of methotrexate.
Weight loss was not a reported side effect of Rinvoq. However, weight loss is a symptom of two of the drug’s possible side effects: serious infections and increased risk of certain cancers.* If you experience unexplained weight loss while taking Rinvoq, contact your doctor. They’ll determine what’s causing the weight loss and recommend treatment options if needed.
If you have more questions about Rinvoq and your weight, talk with your doctor.
* Rinvoq has boxed warnings for these side effects. A boxed warning is a serious warning from the Food and Drug Administration (FDA). To learn more, see “Side effect specifics” below.
Does Rinvoq cause hair loss?
No, hair loss wasn’t a side effect reported in clinical trials of Rinvoq.
However, hair loss is a possible side effect of methotrexate, which is sometimes taken with Rinvoq to treat RA.
If you have more questions, or if you’re concerned about hair loss while taking Rinvoq, talk with your doctor.
Does Rinvoq suppress my immune system?
Yes, Rinvoq works by suppressing (decreasing the activity of) your immune system. This is why the drug is known as an immunosuppressant.
Reducing the activity of your immune system can help reduce inflammation and relieve symptoms of your condition. However, having a suppressed immune system also increases your risk of infections, including serious infections. (See “Side effect specifics” below for details about possible infections while taking Rinvoq.)
Because of this risk of infections, you’ll need to avoid getting live vaccines right before starting Rinvoq and while taking the drug. Live vaccines contain a small amount of a live virus or bacterium. This is unlike inactive vaccines, which don’t contain any live virus or bacterium.
Examples of live vaccines that you should avoid while you’re taking Rinvoq include those for:
- chickenpox
- the flu (in nasal spray form* [FluMist])
- measles, mumps, and rubella (MMR)
- smallpox
- rotavirus
- typhoid (in oral tablet form)
- yellow fever
Before you start taking Rinvoq, tell your doctor about any recent vaccines you’ve had. Also talk with them about whether you need any live vaccines. If you’ve recently received or need a live vaccine, your doctor may delay starting your treatment with Rinvoq.
If you have more questions about Rinvoq and how it affects your immune system, talk with your doctor.
* It’s important to note that the nasal spray flu vaccine is a live vaccine, but the flu shot is an inactive vaccine. So it’s safe to get the injected flu vaccine during Rinvoq treatment.
Does Rinvoq make you tired?
It’s possible that Rinvoq may make you tired. In clinical trials, people taking Rinvoq for atopic dermatitis or Crohn’s disease reported fatigue as a side effect. However, people taking the drug to treat other conditions the drug is approved for did not report experiencing fatigue.
Note that fatigue can be a symptom of other side effects Rinvoq can cause. For example, feeling tired is a symptom of cancer, and Rinvoq may increase the risk of certain cancers.*
In addition, fatigue is also a symptom of some of the conditions Rinvoq treats, such as ulcerative colitis and Crohn’s disease. Taking Rinvoq may actually help ease the fatigue that such conditions cause.
After starting Rinvoq treatment, if you have fatigue that’s bothersome, let your doctor know. They can diagnose the cause and discuss ways to lessen this side effect.
* Rinvoq has a boxed warning for this side effect. A boxed warning is a serious warning from the FDA. To learn more, see “Side effect specifics” below.
As you look into treatment options for your condition, you may have questions about the cost of certain medications. You may also wonder if there are savings options, such as a copay card, or whether treatment is covered by your insurance.
The price you’ll pay for Rinvoq can vary. It will depend on your treatment plan, any insurance coverage you have, and the pharmacy you use.
To find out about your specific insurance coverage, talk with your insurance provider or pharmacist. To help save money on your Rinvoq prescription, explore the coupon option below.
Save on your Rinvoq prescription
Use your insurance to pay as little as $- through Rinvoq’s manufacturer savings card.
Only $-/mo initially*for a limited time
Easy to use digital savings cardDelivered digitally today
Redeem at your local pharmacyAccepted at all pharmacies
Learn more about some of the side effects that Rinvoq may cause.
Upper respiratory tract infections
Upper respiratory tract infections are a possible side effect of Rinvoq. This is a type of infection that affects your throat or nasal passages. The common cold is one example of an upper respiratory tract infection.
People taking Rinvoq may be at higher risk of upper respiratory tract infections. These infections occurred more often in people taking Rinvoq than in people who took a placebo. (A placebo is a treatment without an active ingredient.)
Symptoms of an upper respiratory tract infection may vary depending on the location and severity of your infection. But common symptoms can include:
- coughing
- discomfort in your nose or nasal passages
- mild fever
- pain or pressure behind your face, either with or without nasal congestion
- runny nose or excessive mucus production
- scratchy or sore throat
- sneezing
What you can do
Symptoms of upper respiratory tract infections usually go away within about a week. These symptoms can usually be treated with over-the-counter medications. But if your symptoms get worse or don’t go away, talk with your doctor.
Changes in levels of cholesterol, liver enzymes, and certain blood cells
Rinvoq may cause changes in blood levels of cholesterol, liver enzymes, and certain blood cells.
Specifically, Rinvoq may cause:
- low levels of:
- certain white blood cells
- red blood cells
- high levels of:
- cholesterol
- certain liver enzymes, including aspartate aminotransferase and alanine aminotransferase
These changes are usually minor and typically don’t cause any symptoms. But in rare cases, these changes may be signs of a more serious condition.
What you can do
While taking Rinvoq, you’ll have blood tests to check your levels of cholesterol, liver enzymes, and certain blood cells. This way, your doctor can ensure that the levels are staying within a healthy range.
If there are changes in these levels, your doctor may adjust your treatment. This could involve changing your Rinvoq dosage or adding another medication to treat your side effects. Or your doctor may recommend trying a medication other than Rinvoq to treat your condition.
Serious infections
Rinvoq has a boxed warning about serious infections. A boxed warning is a serious warning from the Food and Drug Administration (FDA).
Rinvoq works by reducing the activity of your immune system. This makes your immune system weaker. With a weakened immune system, you may have an increased risk of serious infections. In clinical trials, these infections sometimes required treatment in the hospital. In rare cases, they led to death.
Examples of serious infections that have been reported in people taking Rinvoq include:
- bacterial infections, such as cellulitis
- fungal infections, such as oral thrush, cryptococcosis, and pneumocystosis
- pneumonia
- tuberculosis
- viral infections, such as shingles and herpes simplex
Serious infections weren’t common in clinical trials of Rinvoq. People were more likely to have this side effect if they were taking other medications that also weaken the immune system, such as methotrexate (Trexall). Taking a higher dosage of Rinvoq may also increase the risk of serious infections.
What you can do
Be sure to tell your doctor whether you have an active infection before taking Rinvoq. They may want to delay starting treatment until your infection goes away.
If you develop symptoms of a serious infection while taking Rinvoq, talk with your doctor right away. They may have you stop taking Rinvoq in order to treat your infection. They may also decide to have you stop Rinvoq and try a different drug for your condition.
Certain cancers
Rinvoq has a boxed warning about certain cancers. A boxed warning is a serious warning from the FDA.
People taking Rinvoq may have an increased risk of certain types of cancer. These types of cancer include lymphoma and non-melanoma skin cancer. But it’s important to note that cancer also occurred in some people who took a placebo in clinical trials of Rinvoq. (A placebo is a treatment without an active ingredient.)
With cancer, cells in your body divide uncontrollably. This can result in the formation of a tumor.
Symptoms of cancer may include weight loss, fatigue, skin changes, and a persistent cough. However, the symptoms may vary depending on the type of cancer you have. If you have any persistent or worrisome symptoms, you should talk with your doctor.
What you can do
Before you take Rinvoq, tell your doctor whether you have a history of cancer or are currently receiving treatment for cancer. They may recommend that you try a different medication to treat your condition.
Blood clots
Rinvoq has a boxed warning about blood clots. A boxed warning is a serious warning from the FDA.
With blood clots, your blood turns from a liquid to a gel and stops flowing. Blood clots are important to help your body stop bleeding, such as when you get a cut. But when blood doesn’t clot properly, serious health problems can occur.
Some types of blood clots are particularly severe. These include:
- deep vein thrombosis (a blood clot in a vein)
- arterial thrombosis (a blood clot in an artery)
- pulmonary embolism (a blood clot in an artery in a lung)
Though rare, Rinvoq may cause these types of clots and, in severe cases, death. Symptoms of a blood clot may include pain in a new area of your body, shortness of breath, and swelling or pain. Swelling or pain may affect one or both of your arms, legs, hands, or feet.
What you can do
If you develop symptoms of a blood clot while taking Rinvoq, talk with your doctor right away. They may have you stop taking Rinvoq and try a different medication to treat your condition.
Cardiovascular problems
Rinvoq has a boxed warning about cardiovascular problems. A boxed warning is a serious warning from the FDA.
Rinvoq may raise your risk of cardiovascular problems. Examples include:
- stroke
- heart attack
- death caused by a cardiovascular issue
A similar drug has caused these problems in people with rheumatoid arthritis who:
- are ages 50 years and older
- have at least one risk factor for cardiovascular problems
- are taking a type of medication known as a Janus kinase (JAK) inhibitor
Keep in mind that smoking can also increase the risk of cardiovascular problems during Rinvoq treatment.
What you can do
While taking Rinvoq, watch for any symptoms of cardiovascular issues. Examples include feeling short of breath or having chest pain. You may also feel numbness or weakness on one side of your body. Call your doctor if you have any of these symptoms. But call 911 or your local emergency number if your symptoms feel severe.
If you’re at risk of cardiovascular problems with Rinvoq, your doctor may recommend that you do not take the drug. If you have a stroke or heart attack while taking Rinvoq, your doctor will recommend that you stop taking this medication.
Increased risk of death
Rinvoq has a boxed warning about an increased risk of death in certain people. A boxed warning is a serious warning from the FDA.
It’s possible that Rinvoq may raise the risk of death in some people. Another similar drug has increased this risk in certain people with rheumatoid arthritis who:
- are ages 50 years and older
- have at least one risk factor for cardiovascular problems
What you can do
Ask your doctor about your risk of complications with Rinvoq. Your doctor can determine whether you have a higher risk of death with this drug.
Allergic reaction
As with most drugs, Rinvoq can cause an allergic reaction in some people. In clinical trials, allergic reactions were rare. However, in some cases, allergic reactions were severe.
Symptoms can be mild or serious and may include:
- rash
- itching
- flushing
- swelling under your skin, typically in your lips, eyelids, feet, or hands
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Rinvoq. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Rinvoq may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Rinvoq. Factors to consider include those in the list below.
Boxed warnings
Rinvoq has boxed warnings about serious infections, certain cancers, and blood clots. These are serious warnings from the Food and Drug Administration (FDA). A boxed warning alerts doctors and patients about drug effects that may be dangerous.
- Serious infections: Rinvoq can weaken your immune system and increase your risk of serious infections, such as pneumonia.
- Cancer: Rinvoq may increase your risk of lymphoma or certain other types of cancer.
- Blood clots: Rinvoq may increase your risk of blood clots, including deep vein thrombosis and pulmonary embolism.
- Cardiovascular problems: Rinvoq may increase your risk of cardiovascular problems such as stroke, heart attack, and death caused by a cardiovascular issue.
- Increased risk of death: It’s possible that Rinvoq may increase the risk of death in certain people.
For more information about Rinvoq’s boxed warnings, see the “Side effect specifics” section above.
Other precautions
Be sure to talk with your doctor about your health history before you take Rinvoq. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include:
Blood disorders: If you have a history of blood disorders, be sure to tell your doctor before you start taking Rinvoq. Examples of blood disorders include anemia, lymphopenia, and neutropenia. Rinvoq can decrease the levels of certain blood cells. For this reason, your doctor may order more lab tests than usual during your Rinvoq treatment. Or they may prescribe a drug other than Rinvoq for you.
Diverticulitis: Rinvoq treatment may increase your risk of gastrointestinal perforation. You may be at higher risk of this side effect if you have a history of diverticulitis. Be sure to discuss your medical history with your doctor before starting Rinvoq treatment.
Risk factors for severe infections: If you have an active infection, your doctor will recommend treating it before starting Rinvoq. If you have a history of certain viral or bacterial infections, they may reactivate (cause symptoms again). These infections include tuberculosis, hepatitis B, hepatitis C, and shingles. Because Rinvoq suppresses the immune system, taking it can worsen your infection. Your doctor will likely treat any active infection you have before you start taking Rinvoq.
Other conditions may increase the risk of serious infections. These include diabetes, chronic lung disease, and HIV. If you have any of these conditions, let your doctor know. This will help them determine whether Rinvoq is right for you.
Recent vaccination with a live vaccine: Before you start taking Rinvoq, tell your doctor about any vaccines you’ve recently received or are planning to receive. Rinvoq can weaken your immune system. As a result, certain vaccines called live vaccines could make you sick if you get them right before or during Rinvoq treatment. For more information, see “Does Rinvoq suppress my immune system?” above.
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or certain other medications: Rinvoq treatment may increase your risk of gastrointestinal perforation. Your risk of this side effect may increase further if you take certain medications. Examples include NSAIDs, such as ibuprofen (Motrin, Advil) and naproxen (Aleve). Methotrexate (Trexall) and corticosteroids, such as prednisone (Rayos), can also increase this risk.
If you take any of these medications, be sure to tell your doctor. Your doctor may adjust your Rinvoq treatment to make sure the drug is safe for you to take.
High cholesterol: Rinvoq can increase cholesterol levels. If you currently have high cholesterol, or if you have a history of high cholesterol, make your doctor aware of this before you start taking Rinvoq. They may monitor you more closely than usual during treatment.
Conditions that decrease digestion time: Pieces of Rinvoq oral tablet may appear in stool. This can happen more often when substances move quicker than usual through the digestive system. Decreased digestion time can occur in people who’ve had certain digestive system procedures, such as a colostomy or a bowel resection.
If you have a condition that decreases digestion time, tell your doctor. Also let them know if you regularly see the medication in your stool. This could indicate that your body is not breaking down the drug effectively. In this case, your doctor may recommend a treatment other than Rinvoq for your condition.
Liver problems: Rinvoq may cause increased levels of certain enzymes (a type of protein) made in the liver. These enzymes are called alanine aminotransferase and aspartate aminotransferase. A large increase in these enzyme levels is sometimes a sign of liver damage.
If you have liver problems or a history of liver problems, make sure to tell your doctor. They may monitor you more closely than usual during your Rinvoq treatment. Or they may prescribe a drug other than Rinvoq to treat your condition.
Allergic reaction: If you’ve had an allergic reaction to Rinvoq or any of its ingredients, you should not take this drug. Ask your doctor whether other medications are better options for you.
Kidney problems: If you have kidney problems, tell your doctor. Rinvoq is not recommended for treatment of certain conditions if you have severe kidney problems. Your doctor may recommend a lower dosage of Rinvoq or a drug other than Rinvoq to treat your condition.
Alcohol with Rinvoq
There aren’t any known interactions between alcohol and Rinvoq. However, drinking alcohol could increase your risk of certain side effects from Rinvoq. These side effects include nausea and liver problems.
If you drink alcohol, talk with your doctor about whether it’s safe for you to drink it while taking Rinvoq.
Pregnancy and breastfeeding while taking Rinvoq
Taking Rinvoq during pregnancy isn’t recommended. Based on animal studies, it’s thought that Rinvoq could cause harm to a fetus.
If you can become pregnant, you should use birth control while taking Rinvoq. And you should continue to use birth control for 4 weeks after your last dose of Rinvoq.
You should not breastfeed while taking Rinvoq or for at least 6 days after your last dose of the drug. This is because animal studies have shown Rinvoq can pass into breast milk. So it’s likely that the drug can pass into human breast milk and may cause side effects in a child who’s breastfed.
If you’re pregnant, planning to become pregnant, breastfeeding, or thinking about breastfeeding, talk with your doctor. They may recommend treatment options other than Rinvoq.
Side effects can occur while taking Rinvoq, but they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention.
It’s important to note that your doctor may recommend taking Rinvoq on its own to treat your condition. Or you may take it in combination with other drugs, such as methotrexate (Trexall). Some side effects of other drugs and Rinvoq overlap, but the drugs may cause different side effects as well. Your doctor or pharmacist can help explain the similarities and differences in side effects that each drug can cause.
You should talk with your doctor if you experience any symptoms of:
- infection
- blood clots
- cancer
- cardiovascular problems, such as heart attack or stroke
- gastrointestinal perforation (a hole in your stomach or intestines)
- allergic reaction
These side effects could be serious and may require medical attention. See the “Side effect specifics” section above for more information.
You should also contact your doctor right away if you become pregnant while taking Rinvoq.
If you have more questions about Rinvoq, or if you have any concerns about side effects of the drug, talk with your doctor or pharmacist.
Besides talking with your doctor, you can do some research on your own. These articles might help:
- More information about Rinvoq: For details about other aspects of Rinvoq, refer to this article.
- Cost: If you’d like to learn about Rinvoq and cost, see this article.
- Dosage: For information about the dosage of Rinvoq, view this article.
- A look at your condition: For details about some of the conditions Rinvoq treats, refer to our rheumatoid arthritis hub, eczema hub, psoriasis hub, arthritis hub, or inflammatory bowel disease hub.
Disclaimer: Medical News Today 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.