Rinvoq (upadacitinib) is a prescription drug used to treat moderate to severe ulcerative colitis (UC) in adults. It’s used when certain other treatments haven’t worked. Rinvoq is a brand-name drug that’s not available in a generic version.
Rinvoq comes as an extended-release oral tablet. (“Extended-release” means the tablets release the medication slowly into your body over a long 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. Rinvoq belongs to a group of drugs called Janus kinase (JAK) inhibitors.
To learn more about the drug and its other uses, see this in-depth Rinvoq article.
Rinvoq has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “What should I know before taking Rinvoq?” section.
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:
- diarrhea that may contain mucus or blood
- urgently needing to pass stools
- abdominal pain or cramps
- rectal bleeding
- weight loss
- anemia
- fatigue
Who is Rinvoq is 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).
Your doctor likely won’t prescribe Rinvoq for you if you take certain other medications. These include:
- other JAK inhibitors such as tofacitinib (Xeljanz)
- biologics such as ustekinumab (Stelara)
- strong immunosuppressants such as azathioprine (Azasan, Imuran) and cyclosporine (Neoral, others)
Using Rinvoq for UC* may cause side effects in some people. These side effects can be mild or serious.
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, talk with your doctor or pharmacist.
You can also learn more from the Rinvoq side effects article or from the drug’s prescribing information.
* Rinvoq is also approved to treat other conditions. It’s important to note that side effects from Rinvoq may differ depending on the condition it’s being used to treat.
What are Rinvoq’s mild side effects?
Rinvoq may cause mild side effects in some people. These include:
- upper respiratory tract infections, such as the common cold
- herpes simplex infection, such as cold sores
- acne
- skin rash
- folliculitis (inflamed hair follicles)
In many cases, mild side effects from the drug can be temporary. Some side effects may be easy to manage, too. But if side effects last for a longer time, or if they bother you or become 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:
- gastrointestinal perforation (tear in the lining of the stomach or intestine)
- low level of white blood cells
- high cholesterol
- elevated liver enzymes, which may be a sign of liver damage
- serious infections,* such as pneumonia, cellulitis, shingles, and tuberculosis (TB)
- certain cancers*
- blood clots*
- heart attack or stroke*
- increased risk of death*
* Rinvoq has a boxed warning for this side effect. A boxed warning is the most serious warning from the FDA. For details, see the “What should I know before taking Rinvoq?” section.
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 reactionFor some people, Rinvoq can cause an allergic reaction. In general, symptoms of allergic reaction can be mild or serious.
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 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.
This section answers some frequently asked questions about using Rinvoq for UC.
How does Rinvoq compare with Entyvio for treating UC?
Upadacitinib (Rinvoq) and vedolizumab (Entyvio) are both potential treatment options for moderate to severe UC. Both are used to help bring UC symptoms into remission and help prevent future relapses. These drugs have some similarities and some differences.
Rinvoq belongs to a group of drugs called JAK inhibitors. It comes as an oral tablet that you take once per day. Entyvio belongs to a group of drugs called biologics. Doses are initially given by intravenous (IV) infusion (an injection into a vein given over a period of time). But after the first two doses, you may be able to receive it as an injection under the skin once every 2 weeks.
Both Rinvoq and Entyvio weaken your immune system and can raise your risk of getting infections, including serious or even life threatening infections. Rinvoq also has boxed warnings* about other serious side effects, including blood clots, cancer, heart attack and stroke. But Entyvio isn’t known to cause these side effects.
To find out more about how these treatments compare, talk with your doctor.
*A boxed warning is the most serious warning from the FDA. For details, see the “What should I know before taking Rinvoq?” section.
How does Rinvoq compare with Xeljanz for treating UC?
Rinvoq and tofacitinib (Xeljanz) are similar drugs used for moderate to severe UC. Both are used to help bring UC symptoms into remission and help prevent future relapses.
Rinvoq comes as an extended-release oral tablet that’s taken once daily. Xeljanz is available in three forms: an oral tablet, an extended-release oral tablet (called Xeljanz XR), and an oral solution. The Xeljanz tablet and solution are taken twice per day. Xeljanz XR is taken once per day.
Rinvoq and Xeljanz both belong to a class of drugs called JAK inhibitors. They work in the same way and can cause similar side effects. Both have boxed warnings* about the risks of serious infections, cancer, blood clots, heart attack, stroke, and death. (To learn more, see the “What should I know before taking Rinvoq?” section.)
To find out more about how these drugs compare, talk with your doctor.
With UC, your immune system mistakenly attacks the lining of your colon. This causes inflammation and ulcers in your colon. 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.
How does Rinvoq work?
Rinvoq works by blocking certain signals that are sent in your immune system. These signals lead to inflammation. By blocking these signals, Rinvoq helps reduce the inflammation in your colon.
Rinvoq works to bring ulcerative colitis symptoms into remission and help prevent future relapses.
Is Rinvoq used in children?
The FDA has not approved Rinvoq for treating UC in children. But Rinvoq may be used for other uses in children. The drug is FDA approved to treat psoriatic arthritis and atopic dermatitis (eczema) in certain children.
To learn more about the drug’s uses in children, see this in-depth Rinvoq article.
Rinvoq is an effective treatment for UC. In studies, it was shown to help reduce active UC symptoms and help prevent future relapses.
For more details about how Rinvoq performed in clinical studies, see the drug’s prescribing information. But keep in mind that results may vary with Rinvoq. For more information about what you might be able to expect from Rinvoq treatment, talk with your doctor.
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.
What is the usual dosage of Rinvoq?
Rinvoq is used to bring UC symptoms into remission (a period in which symptoms are reduced or go away). This is called induction treatment. The drug is also used to help prevent future relapses (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, your doctor may prescribe a maintenance dosage of 30 mg taken once per day.
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.
How do you take Rinvoq?
You should swallow Rinvoq tablets whole. You should not split, crush, or chew the tablets.
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 make Rinvoq build up in your body, which can raise your risk of its side effects.
How often should I take Rinvoq?
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.
The price of Rinvoq depends on several factors. These can include your treatment plan, your insurance plan, the pharmacy you use, and your location.
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).
Before you use Rinvoq, there’s some important information to keep in mind. The drug may not be a safe option for you if you have certain medical conditions or other factors that affect your health. Some of these are mentioned in the following sections.
Boxed warnings
This drug has boxed warnings. These are the most serious warnings from the Food and Drug Administration (FDA). A boxed warning 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 infections: Taking Rinvoq can make it harder for your body to fight infections. It can also raise your risk of getting serious or life threatening infections that may require treatment in a hospital. Examples of these serious infections include TB or infections that spread throughout your body.
Certain factors can raise your risk of developing a serious infection while taking Rinvoq. These include:
- if you have an ongoing infection or infections that keep coming back
- if you’ve had chickenpox, shingles, TB, or hepatitis B or C
- if you already have a weakened immune system
- if you have diabetes, chronic lung disease, or HIV
- if you live in or travel to certain places that have an increased risk of getting certain infections
Before you start taking Rinvoq, tell your doctor if any of these factors apply to you. Your doctor 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
- muscle aches
- cough
- difficulty breathing
- skin rash
- diarrhea
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 currently smoke or have smoked in the past
- 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 your doctor right away if you develop any symptoms of cancer, such as:
- swollen lymph nodes
- night sweats
- unexpected weight loss
- fatigue
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.
Certain factors can raise your risk of blood clots during your Rinvoq treatment, including:
- if you have a history of blood clots
- if you currently smoke or have smoked before
- if you’re age 50 years or older
- if you have other risk factors for heart disease, such as high cholesterol, high blood pressure, or obesity
Before you start taking Rinvoq, talk with your doctor if any of these factors apply to you. They can help determine whether Rinvoq is right for you.
During your Rinvoq treatment, see your doctor right away if you develop symptoms of blood clots. These can include:
- pain, swelling, redness, or deepening of skin color in your leg or arm
- shortness of breath
- chest pain
Risk of heart attack, stroke, and death: Taking Rinvoq may raise your risk of heart attack, stroke, and death.
Certain factors can raise your risk of these side effects while taking Rinvoq. These include:
- if you currently smoke or have smoked in the past
- if you’re age 50 years or older
- if you have other risk factors for heart disease, such as high cholesterol, high blood pressure, or obesity
Before starting Rinvoq treatment, tell your doctor if any of these factors apply to you. Your doctor can determine whether Rinvoq is right for you.
During your Rinvoq treatment, call 911 right away if you develop symptoms of heart attack or stroke. Symptoms of heart attack can include:
- pain, pressure, or tightness in your chest, throat, jaw, or arm
- cold sweats
- dizziness
- difficulty breathing
Symptoms of stroke can include:
- sudden numbness or weakness on one side of your face or body
- confusion
- difficulty speaking or walking
What other warnings should I know about?
In addition to boxed warnings, Rinvoq has other warnings. If any of the following medical conditions or other health factors apply to you, talk with your doctor before using Rinvoq:
- if you have liver or kidney problems
- if you’ve had diverticulitis or ulcers in your stomach or intestine
- if you have a low level of white blood cells
- if you have anemia
- if you have high cholesterol
- if you take a corticosteroid drug such as prednisone (Rayos) or a nonsteroidal anti-inflammatory drugs (NSAID) such as ibuprofen (Advil, Motrin)
- pregnancy or breastfeeding
- alcohol consumption
- recent or upcoming vaccinations
- if you’ve had an allergic reaction to the drug or any of its ingredients
Disclaimer: Healthline 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.