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Upadacitinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jun 19, 2021.

For the Consumer

Applies to upadacitinib: oral tablet extended release

Warning

Oral route (Tablet, Extended Release)

Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred. If a serious infection develops, interrupt upadacitinib until the infection is controlled. Prior to starting upadacitinib, perform a test for latent TB; if it is positive, start treatment for TB prior to starting upadacitinib. Monitor all patients for active TB during treatment, even if the initial latent tuberculosis test is negative. Lymphoma and other malignancies have been observed in patients treated with upadacitinib. Thrombosis, including deep vein thrombosis, pulmonary embolism, and arterial thrombosis, have occurred in patients treated with Janus kinase inhibitors used to treat inflammatory conditions

Side effects requiring immediate medical attention

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

  • 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

  • Black, tarry stools
  • burning or stinging of the skin
  • 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
  • ulcers, sores, or white spots in the mouth or tongue
  • unusual bleeding or bruising

Rare

  • 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 abdominal or stomach pain, cramping, or burning
  • shiny bump
  • sudden high fever or low-grade fever for months
  • troubled breathing with exertion
  • vomiting of material that looks like coffee grounds, severe and continuing
  • white, yellow or waxy scar-like area

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, North Chicago, IL.

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.