Rinvoq is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat moderate-to-severe rheumatoid arthritis (RA) in certain situations.
Specifically, Rinvoq is used to treat RA that hasn’t responded to treatment with methotrexate (Trexall). It’s also approved for this use in adults with RA who had side effects from methotrexate treatment. Rinvoq is taken long-term for these uses.
Here are some fast facts on Rinvoq:
- Active ingredient: upadacitinib
- Drug class: Janus kinase inhibitor
- Drug form: extended-release oral tablet
- FDA approval year: 2019
Like other drugs, Rinvoq can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Rinvoq, including details on the drug’s use, 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:
- upper respiratory tract infections, such as the common cold (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 medication guide.
Mild side effects of Rinvoq can include:
- upper respiratory tract infections, such as the common cold (see “Side effect specifics” below)
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.
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 medication guide.
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:
- pain and tenderness in your abdomen (belly)
- Changes in the levels of cholesterol, liver enzymes, and certain blood cells (see “Side effect specifics” below).
- Serious infections (see “Side effect specifics” below).*
- Blood clots (see “Side effect specifics” below).*
- Cancer (see “Side effect specifics” below).*
- Allergic reaction (see “Side effect specifics” below).
Rinvoq may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Is weight gain a side effect of Rinvoq?
No, weight gain wasn’t a side effect reported in clinical trials of Rinvoq.
If you have further questions about Rinvoq and your weight, talk with your doctor.
Does Rinvoq cause hair loss?
But hair loss is a possible side effect of methotrexate, which is sometimes taken with Rinvoq to treat RA.
If you have further questions, or if you’re concerned about hair loss while taking Rinvoq, talk with your doctor.
Does Rinvoq suppress my immune system?
Reducing the activity of your immune system can help reduce inflammation (damage and swelling) and relieve symptoms of RA. But having a suppressed immune system also increases your risk for infections, including serious infections. (See “Side effect specifics” below for details about possible infections while taking Rinvoq.)
Because of this risk for infections, you’ll need to avoid getting live vaccines while taking Rinvoq. Live vaccines contain a small amount of a live germ or virus (unlike inactive vaccines, which don’t contain any live virus).
Examples of live vaccines that you should avoid while you’re taking Rinvoq include those for:
- the flu (in nasal spray form* [FluMist])
- measles, mumps, and rubella (MMR)
- typhoid (in oral tablet form)
- yellow fever
Before you start taking Rinvoq, talk with your doctor to see if you need any live vaccines. You may need to delay starting treatment with Rinvoq until your vaccines are up to date.
If you have further questions about Rinvoq and how it affects your immune system, talk with your doctor.
* It’s important to note that the nasal flu spray is a live vaccine, but the flu shot is an inactive vaccine. So, it’s safe to get the flu shot during Rinvoq treatment.
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 for upper respiratory tract infections. These infections weren’t common in clinical trials of Rinvoq. But they did occur more often in people taking Rinvoq than people who took a placebo. (A placebo is a treatment without an active drug.)
Symptoms of an upper respiratory tract infection may vary depending on the location and severity of your infection. But common symptoms can include:
- 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
* In clinical trials, this side effect was more common in children than in adults.
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
Specifically, Rinvoq may cause:
- low levels of:
- high levels of:
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 ensure that your levels of cholesterol, liver enzymes, and certain blood cells are staying normal. 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 rheumatoid arthritis (RA).
Rinvoq works to treat RA 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 for 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 (a serious lung infection)
- 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).
What you can do
Be sure to tell your doctor if 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.
People taking Rinvoq may have an increased risk for 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 drug.)
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 (lack of energy), skin changes, or a persistent cough. But 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 if 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 RA.
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)
Rarely, 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 RA.
As with most drugs, Rinvoq can cause an allergic reaction in some people. It isn’t known how often this side effect may have occurred in clinical trials of Rinvoq. Symptoms can be mild or serious and may include:
- flushing (warmth, swelling, or redness in your skin)
- 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 or not 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.
Rinvoq has boxed warnings about serious infections, cancer, 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 for serious infections, such as pneumonia.
- Cancer. Rinvoq may increase your risk for lymphoma or certain other types of cancer.
- Blood clots. Rinvoq may increase your risk for blood clots, including deep vein thrombosis and pulmonary embolism.
For more information about Rinvoq’s boxed warnings, see the “Side effect specifics” 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 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 for gastrointestinal perforation (holes in your stomach or intestines). You may be at higher risk for this side effect if you have a history of diverticulitis. Be sure to discuss your medical history with your doctor before starting Rinvoq treatment.
Use of nonsteroidal anti-inflammatory drugs (NSAIDs) or certain other medications. Rinvoq treatment may increase your risk for gastrointestinal perforation. Your risk for this side effect may increase if you take certain medications. These medications include NSAIDs such as ibuprofen (Motrin) and naproxen (Aleve). Certain other medications, including methotrexate (Trexall) and corticosteroids such as prednisone, 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 everything 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.
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 rheumatoid arthritis.
Allergic reaction. If you’ve had an allergic reaction to Rinvoq or any of its ingredients, you shouldn’t take this drug. Ask your doctor about which other medications are better options for you.
Alcohol use with Rinvoq
There aren’t any known interactions between alcohol and Rinvoq. But drinking alcohol could increase your risk for certain side effects from Rinvoq. These side effects include nausea and liver problems.
Talk with your doctor about whether it’s safe for you to drink alcohol while taking Rinvoq.
Pregnancy and breastfeeding while taking Rinvoq
Taking Rinvoq during pregnancy isn’t recommended. Animal studies have shown that Rinvoq could cause harm to a fetus. But animal studies don’t always predict what will happen in people.
If you or your partner are able to 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 shouldn’t breastfeed while taking Rinvoq or for at least 6 days after your last dose of the drug. This is because Rinvoq has been shown to pass into human breast milk and may cause side effects in a breastfed child.
If you’re pregnant, planning to become pregnant, 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 Rinvoq may be taken on its own to treat rheumatoid arthritis (RA). Or, it may be used 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:
- blood clots
- gastrointestinal perforation (holes 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 talk with your doctor right away if you get 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.
For more information on RA, see our list of rheumatology articles.
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 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.