Key takeaways

  • Rinvoq is a Janus kinase inhibitor taken as a once-daily oral tablet to treat moderate to severe ulcerative colitis (UC) in adults when tumor necrosis factor (TNF) blockers have not been effective or are not appropriate for you — and you have tried at least one other systemic therapy.
  • This medication works by blocking immune system signals that cause inflammation in the colon, helping to reduce symptoms and prevent flare-ups of ulcerative colitis.
  • Rinvoq carries serious risks including infections, certain cancers, blood clots, heart attack, and stroke, requiring careful monitoring and discussion with a doctor about your individual risk factors (such as smoking history or being age 50 or older) before starting treatment.

Rinvoq (upadacitinib) is a prescription drug used to treat moderate to severe ulcerative colitis (UC) in adults. It’s prescribed when certain other treatments haven’t worked or when those treatments aren’t appropriate for you.

Rinvoq comes as an extended-release oral tablet. (“Extended-release” means the tablets release the drug slowly into your body over a period of time.) Rinvoq also comes as an oral solution called Rinvoq LQ, but doctors don’t usually prescribe this form for UC.

The active ingredient in Rinvoq is upadacitinib. It belongs to a group of drugs called Janus kinase (JAK) inhibitors. Rinvoq is a brand-name drug that’s not available in a generic version.

Rinvoq has boxed warnings for the risk of serious infections, certain cancers, blood clots, heart attack, stroke, and death. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).

UC is a type of inflammatory bowel disease that affects your colon (large intestine). It’s a chronic (long-term) autoimmune condition.

Autoimmune conditions occur when your immune system mistakenly attacks healthy tissues in your body. With UC, your immune system mistakenly attacks the lining of your colon. This causes inflammation and ulcers (small sores) in your colon.

What are the symptoms of UC?

With UC, you’ll typically have symptoms that come and go. This is called relapse and remission. With a relapse, your symptoms flare up or get worse for a time. With remission, your symptoms are reduced or go away for a time.

Symptoms of UC can include:

Who is Rinvoq prescribed for?

Rinvoq is prescribed for adults with moderate to severe UC that’s active (causing symptoms). Rinvoq helps bring UC symptoms into remission and helps prevent future relapses.

Rinvoq is used when certain other medications, called tumor necrosis factor (TNF) blockers, haven’t worked or caused bothersome side effects. Examples of TNF blockers include infliximab (Remicade) and adalimumab (Humira). If TNF blockers aren’t appropriate for you, your doctor may prescribe Rinvoq if you’ve already tried at least one other systemic therapy.

Your doctor likely won’t prescribe Rinvoq for you if you take certain other medications. These include:

Using Rinvoq for UC may cause mild to serious side effects in some people. Rinvoq is also approved to treat other conditions, and it’s important to note that side effects may differ depending on what the drug is being used to treat.

The following lists include some of the main side effects that have been reported in people taking Rinvoq for UC. For information about other possible side effects of this drug, check out the drug’s prescribing information or talk with your doctor or pharmacist.

What are Rinvoq’s mild side effects?

Rinvoq may cause mild side effects in some people. These include:

In many cases, mild side effects from the drug can be temporary and some may be easy to manage. But if side effects are ongoing, bothersome, or severe, talk with your doctor or pharmacist.

What are Rinvoq’s serious side effects?

In rare cases, taking Rinvoq for UC may cause serious side effects. Examples include:

See the “Boxed warnings” section of this article for more details on these particular side effects.

Call your doctor right away if you have any serious side effects while using Rinvoq. If the side effects seem life threatening or if you think you’re having a medical emergency, call 911 or your local emergency number immediately.

Allergic reaction

For some people, Rinvoq can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious (such as anaphylaxis or angioedema).

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest a treatment to manage your symptoms and can determine whether you should continue Rinvoq treatment.

If you have symptoms of a severe allergic reaction, such as swelling of the lips, tongue, or throat or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you’ve had a serious allergic reaction to Rinvoq, they may have you switch to a different treatment.

With UC, your immune system mistakenly attacks the lining of your colon causing inflammation and ulcers. UC can cause symptoms such as bloody diarrhea and abdominal cramps.

UC typically causes symptoms that come and go. This is called relapse and remission. With a relapse, your symptoms flare up or get worse for a time. With remission, your symptoms improve or go away for a time.

Rinvoq works by blocking certain signals in your immune system that cause inflammation in your colon. It helps bring ulcerative colitis symptoms into remission and prevent future relapses.

Is Rinvoq effective for UC?

In studies, Rinvoq was shown to be an effective treatment for reducing active UC symptoms and preventing relapses. But keep in mind that results may vary. Talk with your doctor about what to expect from Rinvoq treatment.

Is Rinvoq used in children?

The FDA has not approved Rinvoq for treating UC in children. But the drug is FDA-approved to treat active polyarticular juvenile idiopathic arthritis, psoriatic arthritis and atopic dermatitis (eczema) in certain children.

Rinvoq comes as an extended-release oral tablet. (Rinvoq also comes as an oral solution called Rinvoq LQ, but doctors don’t usually prescribe this form for UC, as it’s not been proven safe or effective for this use.)

You should swallow Rinvoq tablets whole. You should not split, crush, or chew them. If you have difficulty swallowing tablets, ask your doctor or pharmacist for suggestions, or check out these tips for swallowing pills.

You should take Rinvoq once per day, at the same time each day. This helps keep a steady level of the drug in your body, which helps it work more effectively.

You can take Rinvoq either with or without food. However, you should not take it with grapefruit or grapefruit juice because Rinvoq can interact with them. Consuming grapefruit with Rinvoq can stop your body from breaking down Rinvoq as quickly as usual. This can cause the drug to build up in your system, increasing your risk of side effects.

What’s the usual dosage of Rinvoq?

Rinvoq is used to bring UC symptoms into remission. This is called induction treatment. The drug is also used to help prevent future flare-ups. This is called maintenance treatment.

For induction treatment, the usual recommended dosage is 45 milligrams (mg) taken once per day for 8 weeks.

For maintenance treatment, the usual recommended dosage is 15 mg taken once per day on a long-term basis. But if your condition is severe or the lower dose doesn’t work well enough, your doctor may prescribe a maintenance dosage of 30 mg once per day.

Your doctor will aim to use the lowest effective dose needed to keep your condition under control. If you have severe kidney problems, certain liver problems, or take certain other medications (like strong CYP3A4 inhibitors), your doctor may start you on a lower induction dose of 30 mg once daily.

Note: Rinvoq has other uses in addition to treating UC. The dosage may be different for these other uses. To learn more, talk with your doctor.

The price of Rinvoq depends on several factors, including your treatment plan, your insurance plan, the pharmacy you use, and your location.

Rinvoq’s manufacturer offers copay assistance through its Rinvoq Complete Savings Card. If you have commercial insurance, you may be able to sign up for this card and you could pay as little as $0 per dose of Rinvoq.

Rinvoq is a brand-name drug that’s not available as a generic. Brand-name drugs usually cost more than generics.

To learn how much you may pay for Rinvoq, talk with your doctor, pharmacist, or health insurance provider (if you have one).

This drug has boxed warnings. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

If you have questions about any of these warnings, talk with your doctor or pharmacist.

Risk of serious infection: Taking Rinvoq can make it harder for your body to fight infections. It can also raise your risk of serious or life threatening infections that may require treatment in a hospital. Examples of these serious infections include tuberculosis (TB) or infections that spread throughout your body.

Certain factors can increase your risk of developing a serious infection while taking Rinvoq. These include:

Before starting Rinvoq, tell your doctor if any of these factors apply to you. They may test you for TB before prescribing Rinvoq. And they may prescribe medication to treat any infections you have.

While taking Rinvoq, tell your doctor right away if you develop symptoms of any infection. These can include:

  • fever, sweating, or chills
  • muscle aches
  • cough
  • blood in your phlegm
  • difficulty breathing
  • warm, red, or painful skin or sores
  • diarrhea or stomach pain

Risk of certain cancers: Taking Rinvoq may raise your risk of developing certain cancers, such as leukemia, lymphoma, and skin cancer.

Certain factors can raise your risk of developing cancer while taking Rinvoq. These include:

  • if you’re a current or former smoker
  • if you’ve had cancer in the past

Before starting Rinvoq treatment, talk with your doctor if any of these factors apply to you.

While taking Rinvoq, your doctor will monitor you for possible symptoms of cancer. Tell them right away if you develop any symptoms of cancer, such as:

Symptoms of skin cancer can include a new lump, growth, or discolored patch on your skin, or a sore that doesn’t heal.

Risk of blood clots: Taking Rinvoq can raise your risk of dangerous blood clots, such as deep vein thrombosis or pulmonary embolism (and sometimes arterial thrombosis).

Certain factors can increase your risk of blood clots during Rinvoq treatment, including:

  • having a history of blood clots
  • being a current or former smoker
  • being age 50 years or older and having at least one cardiovascular risk factor
  • having other risk factors for heart disease, such as high cholesterol, high blood pressure, or obesity

Before starting Rinvoq, talk with your doctor if any of these factors apply to you.

During your Rinvoq treatment, see your doctor right away if you develop symptoms of blood clots. These can include:

Risk of heart attack, stroke, and death: Taking Rinvoq may raise the risk of heart attack, stroke, and death in people age 50 and older who have at least one heart disease risk factor.

Certain factors can increase your risk of these side effects while taking Rinvoq. These include:

Before starting Rinvoq, tell your doctor if any of these factors apply to you.

During your Rinvoq treatment, call 911 right away if you develop symptoms of heart attack or stroke.

Symptoms of heart attack can include:

  • discomfort in the center of your chest that lasts more than a few minutes or goes away and comes back
  • pain, pressure, heaviness, or tightness in your chest, throat, neck, jaw, back, or stomach
  • cold sweats
  • nausea and vomiting
  • dizziness or lightheadedness
  • difficulty breathing

Symptoms of stroke can include:

  • sudden numbness or weakness on one side of your face or body
  • confusion or slurred speech
  • difficulty speaking or walking

In addition to boxed warnings, Rinvoq has other warnings. This drug may not be a safe option for you if you have certain medical conditions or other factors that affect your health.

Talk with your doctor before using Rinvoq if any of the following apply to you:

Disclaimer: While Healthline strives for factual, comprehensive, and current information, this article is not a substitute for a licensed healthcare professional’s expertise. Always consult a doctor before taking or discontinuing any medication. Drug information is subject to change and may not cover all uses, directions, precautions, warnings, interactions, reactions, or adverse effects. The lack of a warning does not guarantee a drug’s safety, effectiveness, or appropriateness for all patients or specific uses. Learn more about our approach to content integrity.