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Rinvoq Side Effects

Generic name: upadacitinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Mar 31, 2022.

Note: This document contains side effect information about upadacitinib. Some dosage forms listed on this page may not apply to the brand name Rinvoq.

Applies to upadacitinib: oral tablet extended release.

Warning

Oral route (Tablet, Extended Release)

Serious InfectionsPatients 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.MortalityIn 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.MalignanciesLymphoma 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 EventsIn 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.ThrombosisThrombosis, 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 Rinvoq

Along with its needed effects, upadacitinib (the active ingredient contained in Rinvoq) 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

Less common

Rare

Incidence not known

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:

More common

Less common

For Healthcare Professionals

Applies to upadacitinib: oral tablet extended release.

Hematologic

Frequency not reported: Neutropenia, lymphopenia, anemia[Ref]

Immunologic

Uncommon (0.1% to 1%): Herpes zoster, herpes simplex (includes oral herpes), oral candidiasis

Frequency not reported: Tuberculosis (TB), cellulitis[Ref]

Metabolic

Frequency not reported: Increased lipids[Ref]

Hepatic

Frequency not reported: Liver enzyme elevation[Ref]

Oncologic

Frequency not reported: Non-melanoma skin cancer[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (e.g., acute sinusitis, laryngitis, nasopharyngitis, oropharyngeal pain, pharyngitis, pharyngotonsillitis, rhinitis, sinusitis, tonsillitis, viral upper respiratory tract infection) (14%)

Common (1% to 10%): Cough

Frequency not reported: Pneumonia[Ref]

Other

Common (1% to 10%): Pyrexia[Ref]

Cardiovascular

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

Gastrointestinal

Frequency not reported: GI perforation[Ref]

Frequently asked questions

References

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.