Upadacitinib

Pronunciation: OOP-PAH-da-sit-tin-ib
Generic name: upadacitinib
Brand names: Rinvoq, Rinvoq LQ
Dosage form: oral extended-release tablet, oral solution
Drug class: Antirheumatics

Medically reviewed by Carmen Pope, BPharm. Last updated on May 2, 2024.

What is upadacitinib?

Upadacitinib is an oral Janus kinase (JAK) inhibitor that may be used alone or in combination with other medications to treat several conditions that have inflammation as a characteristic symptom. It works by decreasing the activity of the immune system. Upadacitinib may also be used to treat:

• rheumatoid arthritis in people who are unable to take or have not responded well to one or more tumor necrosis factor (TNF) inhibitor medication(s)
• psoriatic arthritis (a condition that causes joint pain and swelling, and scales on the skin) in adults who are unable to take or did not respond to or tolerate one or more TNF inhibitor medication(s)
• symptoms of eczema (atopic dermatitis; a skin disease that causes the skin to be dry and itchy and to sometimes develop red, scaly rashes) in adults and children 12 years and older who cannot use other medications for their condition or whose eczema has not responded to other medications
• ulcerative colitis (a condition that causes swelling and sores in the lining of the colon [large intestine] and rectum) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) in adults who cannot take or who did not respond to one or more TNF inhibitor medication(s).

Upadacitinib is used to treat ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas, causing pain, swelling, and joint damage) in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s).

Other conditions that upadacitinib may be used to treat include:

• active non-radiographic axial spondyloarthritis (a condition in which the body attacks the joints of the spine and other areas, causing pain and signs of swelling), but without changes seen on X-ray, in adults who are unable to take or who did not respond to one or more TNF inhibitor medication(s)
• active polyarticular juvenile idiopathic arthritis in children aged 2 years of age and older who have had an inadequate response or intolerance to one or more TNF blockers.

There are two formulations of upadacitinib: Rinvoq extended-release tablets and Rinvoq LQ liquid solution. These two formulations are not interchangeable.

• Upadacitinib is not recommended in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Upadacitinib was FDA approved on August 16, 2019, under the name Rinvoq and Rinvoq LQ was approved on April 26, 2024. There is no generic for Rinvoq.

What is the cost of upadacitinib?

The cost of prescription drugs varies depending on your insurance plan and which pharmacy you use. Refer to our price guide page for more information about the cost of Rinvoq.

You may also be eligible for a Rinvoq savings card or Rinvoq coupon. Ask your doctor or pharmacist if you qualify.

Upadacitinib side effects

Get emergency medical help if you have signs of an allergic reaction to upadacitinib: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

affects your immune system and may cause certain white blood cells to grow out of control. Call your doctor right away if you have:

• fever, swollen glands, night sweats;

• vomiting, diarrhea, weight loss;

• a new skin lesion, or a mole that has changed in size or color;

• weakness on one side of your body, problems with speech or vision;

• changes in your mental state;

• blood in your urine, burning when you urinate, little or no urination; or

• tenderness near the transplanted kidney.

Some people taking upadacitinib have developed heart attacks, strokes, or serious blood clots. Seek emergency medical attention if you have:

• heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• signs of a stroke - sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung - chest pain, sudden cough or shortness of breath, dizziness, coughing up blood; or

• signs of a blood clot deep in the body - pain, swelling, or warmth in one leg.

Upadacitinib may cause serious side effects. Call your doctor at once if you have:

• wheezing, trouble breathing, severe or worsening cough;

• increased urination, pain or burning when you urinate;

• fever, chills, cough with mucus, chest pain, feeling short of breath;

• abnormal blood tests;

• signs of tuberculosis - fever, cough, night sweats, loss of appetite, weight loss, and feeling very tired;

• signs of shingles - flu-like symptoms, tingly or painful blistering rash on one side of your body;

• symptoms of herpes virus - cold sores around your mouth, skin sores or blisters, itching, tingling, burning pain in your thigh or lower back;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding;

• a hole (perforation) in your digestive tract - fever, severe stomach pain, change in bowel habits; or

• signs of hepatitis - loss of appetite, vomiting, stomach pain (upper right side), dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatment may be delayed or permanently discontinued if you have certain side effects.

Common upadacitinib side effects may include:

• flu symptoms;

• nausea;

• acne, rash, headache;

• stomach pain;

• weight gain;

• muscle pain;

• folliculitis (redness or crusting around your hair follicles);

• cold symptoms such as stuffy nose, sneezing, sore throat;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough; or

• low red blood cells (anemia) - pale skin, tiredness, feeling light-headed or short of breath, cold hands and feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Taking upadacitinib may increase your risk of life-threatening medical problems including serious infections, a hole or tear in your digestive tract, a heart attack or stroke, blood clots, or cancer.

Call your doctor right away if you have a fever, night sweats, constant tiredness, weight loss, stomach pain, diarrhea or changes in bowel habits, trouble breathing, wheezing, a severe cough, or lumps in your neck, armpits, or groin.

Seek emergency medical attention if you have sudden shortness of breath, chest pain spreading to your neck or arms, nausea, severe dizziness, a cold sweat, weakness on one side of your body, slurred speech, or pain, redness, or swelling in an arm or leg.

If you've had hepatitis B, it may come back or get worse. Tell your doctor if you don't feel well and you have right-sided upper stomach pain, vomiting, loss of appetite, or yellowing of your skin or eyes.

Before taking this medicine

You should not take upadacitinib if you are allergic to .

Before you start taking upadacitinib, tell your doctor if you have any signs of infection such as fever, sweating, chills, cough, body aches, tiredness, open sores or skin wounds, shortness of breath, diarrhea, stomach pain, weight loss, painful urination, or coughing up blood.

To make sure upadacitinib is safe for you, tell your doctor if you have ever had:

• a weak immune system or HIV;

• an active or chronic infection;

• tuberculosis (or if anyone in your household has tuberculosis);

• herpes zoster (also called shingles);

• any type of cancer;

• diverticulitis, an ulcer in your stomach or intestines;

• heart problems, heart attack, stroke, or blood clot;

• high cholesterol;

• chronic lung disease;

• eye problems (especially a problem with your retina);

• diabetes;

• low red or white blood cell counts;

• recently received or scheduled to receive any vaccine;

• are a current or past smoker;

• liver disease (especially hepatitis B or C); or

• kidney disease.

Make sure you are current on all vaccines before you start using upadacitinib.

Using upadacitinib may increase your risk of developing certain cancers, such as lymphoma, lung cancer or skin cancer. Ask your doctor about this risk.

You may need to have a negative pregnancy test before starting this treatment.

May harm an unborn baby. Use effective birth control while using upadacitinib and for at least 4 weeks after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 6 days after your last dose.

How should I take upadacitinib?

Take upadacitinib exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Rinvoq tablets

Rinvoq tablets are usually taken once per day, with or without food.

• Swallow the tablet whole and do not crush, chew, or break a tablet.
• Call your doctor if you see part of the Rinvoq tablet in your stool.
• You may need frequent medical tests before and while taking Rinvoq.

Store this medicine in the original container at room temperature away from moisture and heat.

Rinvoq LQ

Rinvoq LQ is not the same as Rinvoq tablets. Do not switch between Rinvoq LQ and Rinvoq tablets your healthcare provider has made the change.

Your healthcare provider will tell you what dose to give. This is based on your child's weight. The dosage is usually given twice daily.

• Only use the syringe provided. Do not share with other people or use with other medicines. The syringe should be clean and dry before use.
• The first time you use a new bottle of Rinvoq LQ, you will need to insert the syringe adapter. Once inserted, do not remove.
• Insert the tip of the syringe into the adapter, then turn the bottle upside down.
• Pull the plunger down and flick the syringe to get any large air bubbles out. Small air bubbles are normal.
• Measure the dose. Move the plunger until it is even with the marking for the dose.
• Turn the bottle upright, carefully remove the syringe, and place the lid back on the bottle.
• Check the dose is correct. If correct, place the syringe against the inside of your child's cheek and push the plunger to give the entire dose into the child's mouth. The solution must be given within 1 hour of filling the syringe.
• Give the child a drink of water.
• Remove the plunger from the syringe and rinse both parts in water then leave to dry.

Upadacitinib Dosing Information

Usual Adult Dose for Rheumatoid Arthritis, Ankylosing Spondylitis, and Non-radiographic Axial Spondyloarthritis

• 15 mg orally once a day

Upadacitinib may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

• Not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm³, absolute neutrophil count (ANC) of less than 1000 cells/mm³, or hemoglobin level of less than 8 g/dL.

Usual Dose for Psoriatic Arthritis

• Adults: 15 mg orally once daily
• Children aged 2 to less than 18 years weighing at least 10 kg: the dosage is based on body weight.

Usual Dose for Atopic Dermatitis

• Adults less than 65 years and children 12 years and older weighing at least 40kg:
  • Initiation dose: 15 mg orally once daily
  • Maximum dose: 30 mg orally once daily (if no response with the initial dose).
• Adults 65 years and older: 15 mg once daily.
• Severe renal impairment: 15 mg once daily. 

Use the lowest dose to maintain response.

• Not recommended to use in combination with other JAK inhibitors, biological immunomodulators, or other immunosuppressants.

Usual Dose for Ulcerative Colitis

Adults:

• Induction dose: 45 mg once daily for 8 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment or with
    drug interactions. 

Usual Dose for Crohn's disease

Adults:

• Induction dose: 45 mg once daily for 12 weeks.
• Maintenance dose: 15 mg once daily.
  • A maintenance dosage of 30 mg once daily may be considered for patients with refractory, severe, or extensive disease.
  • Discontinue if an adequate therapeutic response is not achieved with the 30 mg dosage. Use the lowest effective dosage needed to maintain response.
  • Dosage modification may be needed for kidney or liver impairment or with
    drug interactions. 

Usual Dose for Polyarticular Juvenile Idiopathic Arthritis

• The recommended dosage is based on body weight.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

If you take too much upadacitinib, call your healthcare provider or Poison Help line at 1-800-222-1222, or go to the nearest hospital emergency room. 

What should I avoid while taking upadacitinib?

Avoid receiving a "live" vaccine, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Upadacitinib may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Grapefruit may interact with and cause side effects. Avoid consuming grapefruit products.

What other drugs will affect upadacitinib?

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect , especially:

• phenytoin;

• an antibiotic - clarithromycin, rifampin;

• antifungal medicine - itraconazole, ketoconazole, posaconazole, voriconazole;

• drugs that weaken the immune system - azathioprine, cyclosporine, and others;

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others; or

• steroid medicine - dexamethasone, prednisone, and others.

This list is not complete and many other drugs may interact with . This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Storage

Store Rinvoq tablets between 36°F to 77°F (2°C to 25°C) in the original bottle to protect from moisture.

Store Rinvoq LQ between 36°F to 86°F (2°C to 30°C). Throw away (discard) any remaining Rinvoq LQ 60 days after opening the bottle.

Keep out of the reach of children. 

Ingredients

Active ingredient:

Inactive ingredients, Rinvoq 15 mg tablets: colloidal silicon dioxide, ferrosoferric oxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide. 

Inactive ingredients, Rinvoq 30 mg tablets: colloidal silicon dioxide, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide.

Inactive ingredients, Rinvoq 45 mg tablets: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid, and titanium dioxide.

Inactive ingredients, Rinvoq LQ: citric acid anhydrous, purified water, sodium benzoate, sodium citrate dihydrate, and sucralose. 

Manufacturer

AbbVie Inc.

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