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Upadacitinib Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 21, 2024.

Applies to upadacitinib: oral tablet extended release.

Important warnings This medicine can cause some serious health issues

Oral route (tablet, extended release)

Serious Infections. Patients treated with upadacitinib are at increased risk for developing serious infections that may lead to hospitalization or death.

Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

If a serious infection develops, interrupt upadacitinib until the infection is controlled.

Reported infections include:Active tuberculosis, which may present with pulmonary or extrapulmonary disease.

Patients should be tested for latent tuberculosis before upadacitinib use and during therapy.

Treatment for latent infection should be considered prior to upadacitinib use.Invasive fungal infections, including cryptococcosis and pneumocystosis.Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogensThe risks and benefits of treatment with upadacitinib should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with upadacitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.Mortality. In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another Janus kinase (JAK) inhibitor to tumor necrosis factor (TNF) blockers, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor.Malignancies. Lymphoma and other malignancies have been observed in patients treated with upadacitinib.

In RA patients treated with another JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.Major Adverse Cardiovascular Events. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers.

Patients who are current or past smokers are at additional increased risk.

Discontinue upadacitinib in patients that have experienced a myocardial infarction or stroke.Thrombosis. Thrombosis, including deep venous thrombosis, pulmonary embolism, and arterial thrombosis have occurred in patients treated with JAK inhibitors used to treat inflammatory conditions.

Many of these adverse events were serious and some resulted in death.

In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of thrombosis was observed when compared with TNF blockers.

Avoid upadacitinib in patients at risk.

Patients with symptoms of thrombosis should discontinue upadacitinib and be promptly evaluated.

Serious side effects of upadacitinib

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:

More common side effects

  • body aches or pain
  • chills
  • cough
  • ear congestion
  • fever
  • headache
  • itching, pain, redness, swelling, tenderness, warmth on the skin
  • loss of voice
  • runny or stuffy nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less common side effects

  • black, tarry stools
  • burning or stinging of the skin
  • chest tightness
  • difficulty swallowing
  • dizziness
  • fast heartbeat
  • hives, itching, skin rash
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lower back or side pain
  • painful blisters on the trunk of the body
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • painful or difficult urination
  • pale skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • ulcers, sores, or white spots in the mouth or tongue
  • unusual bleeding or bruising

Rare side effects

  • coughing or spitting up blood
  • difficulty with breathing
  • heartburn
  • indigestion
  • muscle aches
  • nausea
  • night sweats
  • pale skin
  • persistent non-healing sore
  • pink growth
  • reddish patch or irritated area
  • severe stomach pain, cramping, or burning
  • shiny bump
  • sudden high fever or low-grade fever for months
  • trouble breathing
  • vomiting of material that looks like coffee grounds, severe and continuing
  • white, yellow or waxy scar-like area

Incidence not known

  • chest pain or discomfort
  • confusion
  • difficulty in speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • no blood pressure or pulse
  • pain or discomfort in the arms, jaw, back, or neck
  • slow speech
  • stopping of heart
  • sweating
  • unconsciousness

Other side effects of upadacitinib

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:

More common side effects

  • blemishes on the skin
  • pimples

Less common side effects

  • burning, itching, and pain in hairy areas, pus at the root of hair
  • difficulty in moving
  • muscle cramps, pains, or stiffness

For healthcare professionals

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

Cardiovascular adverse events

Gastrointestinal

Dermatologic

Hematologic

Hepatic

Hypersensitivity

Immunologic

Metabolic

Musculoskeletal

Nervous system

Ocular

Oncologic

Other

Respiratory

References

1. (2019) "Product Information. Rinvoq (upadacitinib)." AbbVie US LLC

Frequently asked questions

Further information

Upadacitinib 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.