Rinvoq (Upadacitinib) – Oral

Warning:

Rinvoq (upadacitinib) carries a boxed warning about the increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB). You may take a test for latent TB before and during therapy. 

There is also a higher risk of all-cause mortality, including sudden cardiovascular death, and major adverse cardiac events (e.g., heart attack or stroke) with another Janus kinase (JAK) inhibitor than tumor necrosis factor (TNF) blocker in people with rheumatoid arthritis.

People taking Rinqov have reported certain malignancies with JAK inhibitors, including a higher rate of lymphomas and lung cancers, than with TNF blockers.

There have also been reports of thrombosis (blood clots that block veins or arteries) occurring in people taking Rinvoq. People who experience symptoms of thrombosis should stop taking Rinvoq immediately and seek medical attention.

What Is Rinvoq?

Rinvoq (upadacitinib) is a prescription immunosuppressant medication used to treat rheumatoid arthritis (RA), active psoriatic arthritis (PsA), and atopic dermatitis (also known as eczema).

It is typically used in people who have already tried one or more tumor necrosis factor (TNF) blockers, another medication class that helps treat conditions like RA.

Rinvoq is part of a group of medications called Janus kinase (JAK) inhibitors. It works by inhibiting the production of inflammatory cells that play a role in RA.

This medication comes in an extended-release tablet form, taken by mouth once a day.

Drug Facts

Generic Name: Upadacitinib

Brand Name(s): Rinvoq

Administration Route(s): Oral

Drug Availability: Prescription

Therapeutic Classification: Antirheumatic

Available Generically: No

Controlled Substance: N/A

Active Ingredient: Upadacitinib

Dosage Form(s): Extended-release tablet

What Is Rinvoq Used For?

The Food and Drug Administration (FDA) approved Rinvoq to treat:

  • Moderate to severe RA in adults aged 18 and older who have tried one or more TNF blockers
  • Active PsA in adults who have tried one or more TNF blockers
  • Refractory, moderate to severe atopic dermatitis in people aged 12 years and older whose disease is not adequately controlled by other systemic (body-wide) therapies (such as biologics).

Your healthcare provider may also prescribe Rinvoq for you if you can’t tolerate methotrexate (a medication commonly used to treat RA and PsA), or if methotrexate hasn’t been effective at controlling your symptoms.

You may take Rinvoq as a monotherapy or with methotrexate or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Monotherapy is the use of only medication at a time to treat a condition.

Rinvoq (Upadacitinib) Drug Information - Illustration by Dennis Madamba

Verywell / Dennis Madamba

How to Take Rinvoq

Take Rinvoq exactly as your healthcare provider prescribes it. This medication is typically prescribed for once-a-day dosing. You should swallow the tablets whole without splitting, crushing, or chewing them.

Storage

Keep this medication in its original container and away from the reach of children or pets. Don’t let it get wet. Store the tablets between 36 degrees and 77 degrees Fahrenheit.

Off-Label Uses

A healthcare provider may prescribe medications for conditions not indicated by the FDA when the decision is supported by scientific evidence or expert clinical experience. This is known as off-label use.

Rinvoq is sometimes used off-label for treating other chronic inflammatory disorders, including:

  • Alopecia areata, a type of hair loss caused by immune dysfunction
  • Allergic asthma

There is no well-established recommended dose for off-label uses.

How Long Does Rinvoq Take to Work?

Rinvoq can begin to have an effect within two to four hours, but it can take weeks or longer to notice its benefits.

What Are the Side Effects of Rinvoq?

Rinvoq can cause mild to serious side effects. It helps to know the signs of these side effects so you can get medical attention as needed.

This is not a complete list of side effects and others may occur. A medical professional can advise you on side effects. If you experience other effects, contact your pharmacist or a medical professional. You may report side effects to the FDA at www.fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Rinvoq include:

People taking Rinvoq for atopic dermatitis may also experience:

  • Allergic reactions
  • Inflamed hair follicles
  • Abdominal pain
  • Weight gain
  • Low white blood cell count (neutropenia)
  • Increased blood levels of creatine phosphokinase (enzyme found mainly in the heart, brain, and muscles that connect to your bones)

Tell your healthcare provider if you develop any of these conditions. They might be able to treat your side effects or switch you to another medication if necessary.

Severe Side Effects

This medication can cause potentially harmful or life-threatening side effects.

Severe side effects of Rinvoq include:

  • Infections: Severe infections can include tuberculosis and other bacterial, invasive fungal, or viral infections. These infections can cause fevers, fatigue, coughing, and difficulty breathing.
  • Major cardiovascular events: This medication increases the risk of heart attack, stroke, or cardiovascular-related death in people aged 50 years and older who have at least one heart disease risk factor. Current past smokers are especially at risk.
  • Cancer: Rinvoq changes the way your immune system works. Taking this medication increases the risk of lymphoma and other types of cancer. Symptoms can vary—the most common symptoms include weight loss, fatigue, bleeding, or bruising.
  • Blood clots: Deep vein thrombosis (DVT), pulmonary embolisms (PE), and arterial blood clots can occur when taking this medication. Symptoms can vary, but the most common symptoms are swelling of your arm or leg, shortness of breath, and chest pain.
  • Liver damage: This medication can cause severe liver damage, which can be monitored with blood tests.
  • Gastrointestinal perforation: A severe bleed may occur due to a tear in the lining of the digestive tract.
  • Anemia: This medication can cause low red blood cell counts, which can cause fatigue and low energy.

Your provider may routinely monitor you for these side effects while you are taking Rinvoq, but you can also develop symptoms in between your scheduled medical care. Get medical attention if you develop severe side effects.

Long-Term Side Effects

Taking this medication can cause lasting effects even after you stop using it:

  • Cancer that develops while you are taking this Rinvoq will not resolve by discontinuing the medication.
  • When taken during pregnancy, Rinvoq can cause harm to the fetus.
  • An infection or blood clot can cause severe damage to the body, leading to health problems after you stop taking this medication.

Report Side Effects

Rinvoq may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much of Rinvoq Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (extended-release tablets):
    • For rheumatoid arthritis:
      • Adults—15 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss your medication dose, take it as soon as possible. If it is close to when you need to take your next dose, you can take your next dose without doubling up. Then, resume your regular schedule.

Overdose: What Happens If I Take Too Much Rinvoq?

If you take too much Rinvoq, you have a higher chance of developing side effects. Immediately tell your healthcare provider how much you took and they will advise you on whether you need medical observation.

If you develop any side effects, you will need to be treated for the symptoms. By 24 hours after an overdose, the medication should no longer remain at toxic levels in your body, and you can resume your dosing according to your provider’s instruction.

What Happens If I Overdose on Rinvoq?

If you think you or someone else may have overdosed on Rinvoq, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Rinvoq, call 911 immediately.

Precautions

Drug Content Provided and Reviewed by IBM Micromedex®

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if this medicine is working properly and to decide whether you should continue to use it. Blood tests are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 4 weeks after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Using this medicine together with azathioprine or cyclosporine is not recommended.

You will need to have a skin test for tuberculosis before you start using this medicine. Tell your doctor if you or anyone in your home has ever had a positive reaction to a tuberculosis skin test.

Your body's ability to fight infections may be reduced while you are using upadacitinib. It is very important that you call your doctor at the first sign of an infection. Check with your doctor right away if you have a fever, chills, cough, flu-like symptoms, or unusual tiredness or weakness.

This medicine may increase your risk of serious heart or blood vessel problems (eg, heart attack, stroke), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Call your doctor right away if you have chest pain or discomfort, confusion, difficulty in speaking, double vision, headache, inability to move arms, legs, or facial muscles, nausea, pain or discomfort in the arms, jaw, back, or neck, sweating, trouble breathing, or vomiting.

This medicine may increase your risk of cancer (eg, lymphoma, lung cancer, non-melanoma skin cancer). Tell your doctor right away if you have black, tarry stools, general feeling of illness, swollen glands, weight loss, yellow skin and eyes, persistent non-healing sore, reddish patch or irritated area, shiny bump, pink growth, or white, yellow or waxy scar-like area on the skin.

This medicine may increase your risk of developing blood clots (eg, arterial thrombosis, deep vein thrombosis, pulmonary embolism), especially in patients with rheumatoid arthritis who are 50 years of age and older and with a heart or blood vessel disease. Check with your doctor right away if you have anxiety, chest pain, cough, dizziness, lightheadedness, or fainting, fast heartbeat, pain, redness, or swelling in the arm or leg, pains in the chest, groin, or legs, especially calves of the legs, severe headaches, sudden loss of coordination, sudden onset of slurred speech, sudden vision changes, or trouble breathing.

Upadacitinib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection:

  • If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor right away if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects, such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

While you are being treated with upadacitinib, and after you stop treatment with it, do not have any immunizations (vaccines) without your doctor's approval. Upadacitinib may lower your body's resistance and there is a chance you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Rinvoq?

There are several cases in which Rinvoq should not be used, as it can be harmful to the person. People who are pregnant or breastfeeding, for example, should avoid this medication. Talk to your healthcare provider about your treatment options.

You shouldn’t take this medication if you have any of the following conditions:

  • Absolute lymphocyte count (ALC) less than 500 per cubic millimeter (cells/mm3)
  • Absolute neutrophil count (ANC) less than 1,000 cells/mm3
  • Hemoglobin level less than 8 grams per deciliter ( g/dL)
  • Liver disease
  • A severe infection

Your provider may reconsider prescribing Rinvoq for you after these conditions resolve.

Before prescribing, a provider will also carefully assess the risks and benefits of this medication if you have:

  • Cancer
  • An increased risk of blood clots
  • An increased risk of gastrointestinal perforation

What Other Medications Interact With Rinvoq?

Rinvoq can interact with the following medications:

  • Other JAK inhibitors, biologic DMARDs, or potent immunosuppressants such as azathioprine and cyclosporine
  • Rifampin or Dilantin (phenytoin) can decrease the effects of Rinvoq.
  • Ketoconazole, itraconazole, posaconazole, voriconazole or clarithromycin can increase the amount of Rinvoq in your blood.
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, Aleve (naproxen) or Advil and Motrin (ibuprofen), can increase the risk of gastrointestinal perforation when taken with Rinvoq.

You should also avoid getting a live vaccine during, or immediately before, treatment with this medication. Before starting Rinvoq, talk to your healthcare provider about all immunizations you plan to receive. You may need to make sure your vaccinations are up to date before you can start Rinvoq.

What Medications Are Similar?

There are several anti-inflammatory medications used for treating RA, including other JAK inhibitors such as: 

This is a list of medications that are similar to Rinvoq. Do not take these medications together. Talk to your healthcare provider about your treatment options.

Frequently Asked Questions

  • What is Rinvoq used for?

    Rinvoq is prescribed to treat moderate to severe rheumatoid arthritis in people who have already tried one or more other therapies.

  • How does Rinvoq work?

    Rinvoq prevents inflammation in the body. It is a Janus kinase (JAK) inhibitor that interferes with the genetic mechanisms that cause the production of certain inflammatory cells that cause effects of rheumatoid arthritis.

  • What drugs should not be taken with Rinvoq?

    You should not take biologic rheumatoid arthritis drugs, JAK inhibitors, or strong immunosuppressors with this medication. Your healthcare provider might also advise you to avoid NSAIDs while taking Rinvoq. Taking them together can increase the risk of gastrointestinal perforation.

  • What are the side effects of Rinvoq?

    Rinvoq can cause an increased risk of infections, nausea, fever, cough, and elevated cholesterol. Serious side effects include liver damage, risk of cancer, gastrointestinal bleeding, blood clots, and serious infections.

  • How do I stop taking Rinvoq?

    If you need to stop taking Rinvoq, make sure you follow your healthcare provider’s instructions for decreasing or stopping the medication.

How Can I Stay Healthy While Taking Rinvoq?

While taking Rinvoq, tell your provider about all other medications you plan to take, including over-the-counter medications, vitamins, and supplements. You may also want to familiarize yourself with the potential side effects and communicate with your provider if you start to experience anything unusual. Maintain your regular medical visits so you can stay on top of side effects and treatment progress. 

Taking immunosuppressants can raise your risk of infections and increase the likelihood of developing more severe disease from COVID-19. Try to maintain infection-preventing strategies, such as handwashing, avoiding contact with anyone who might be sick, and staying up to date on your recommended vaccines.

RA is a life-changing disease that can be difficult and overwhelming to manage. Be sure to communicate with your healthcare team, which may include a primary healthcare provider, rheumatologist, pharmacist, and physical therapist, about how you are feeling. With the help of your healthcare team, you can work toward overcoming the challenges of living with this condition.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare professional. Consult your doctor before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

Was this page helpful?
3 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. Food and Drug Administration. Rinvoq label.

  2. Gambardella A, Licata G, Calabrese G, et al. Dual efficacy of upadacitinib in 2 patients with concomitant severe atopic dermatitis and alopecia areata. Dermatitis. 2021 Aug 16. doi:10.1097/DER.0000000000000780

  3. Betancor D, Valverde-Monge M, Sastre J. Upadacitinib-induced remission of allergic asthma: A case report. J Allergy Clin Immunol Pract. 2021 Jul 16:S2213-2198(21)00788-1. doi:10.1016/j.jaip.2021.06.055