Rinvoq Side Effects

Generic name: upadacitinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 21, 2025.

Note: This document provides detailed information about Rinvoq Side Effects associated with upadacitinib. Some dosage forms listed on this page may not apply specifically to the brand name Rinvoq.

Applies to upadacitinib: oral tablet extended release.

Precautions

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 (the active ingredient contained in Rinvoq) 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.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

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.

This medicine may make your skin more sensitive to sunlight. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

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.

This medicine may increase the level of cholesterol and fat in your blood. Talk to your doctor if you have concerns.

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.

Serious side effects of Rinvoq

Along with its needed effects, upadacitinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking upadacitinib:

Other side effects of Rinvoq

Some side effects of upadacitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to upadacitinib: oral liquid, oral tablet extended release.

Cardiovascular adverse events

• Frequency not reported: Thrombosis (e.g., deep venous thrombosis), pulmonary embolism, arterial thrombosis^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, abdominal pain, gastroenteritis
• Frequency not reported: GI perforation^[Ref]

Dermatologic

• Very common (10% or more): Acne (10% to 16%)
• Common (1% to 10%): Folliculitis, rash
• Frequency not reported: Eczema herpeticum/Kaposi's varicelliform eruption

Hematologic

• Common (1% to 10%): Anemia, leukopenia, neutropenia^[Ref]

Hepatic

• Common (1% to 10%): Liver enzyme elevation^[Ref]

Hypersensitivity

• Common (1% to 10%): Hypersensitivity (including anaphylactic reactions, shock, angioedema, drug hypersensitivity, eyelid edema, face and pharyngeal swelling, skin eruption and urticaria)

Immunologic

• Common (1% to 10%): Lymphopenia^[Ref]

Metabolic

• Common (1% to 10%): Increased blood creatinine phosphokinase, increased weight, hyperlipidemia, hypercholesterolemia^[Ref]

Musculoskeletal

• Common (1% to 10%): Myalgia

Nervous system

• Common (1% to 10%): Headache

Ocular

• Uncommon (0.1% to 1%): Retinal detachment

Oncologic

• Uncommon (0.1% to 1%): Non-melanoma skin cancer^[Ref]

Other

• Common (1% to 10%): Pyrexia, herpes Zoster, herpes simplex (including oral herpes and oral candidiasis), fatigue, influenza-like illness, fatigue^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory tract infection (up to 25%)
• Common (1% to 10%): Bronchitis, cough
• Frequency not reported: Pneumonia^[Ref]

See also:

Frequently asked questions

• What are the most common skin conditions? (with photos)
• What are the new drugs for rheumatoid arthritis (RA)?
• Rinvoq Copay Card: Do I qualify and how much can I save?
• What are JAK inhibitors and how do they work?
• Which JAK inhibitors are approved in the U.S?
• What is the MOA and half-life for Rinvoq?
• How long does Rinvoq stay in your system?

Further information

Rinvoq side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer