Hypersensitivity to upadacitinib or any component of the formulation.

Based on data from animal reproduction studies, in utero exposure to upadacitinib may cause fetal harm.

It is not known if upadacitinib is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during treatment and for 6 days following the last dose of upadacitinib.

Common(>10%):
Dermatologic: Acne vulgaris (1%-16%)
Respiratory: Upper respiratory tract infection (9%-25%)
1% to 10%
Dermatologic: Folliculitis (2%-4%), skin rash (4%-5%)
Endocrine & metabolic: Hypercholesterolemia (2%-4%), hyperlipidemia (2%)
Gastrointestinal: Abdominal pain (2%-3%), nausea (3%-4%)
Hematologic & oncologic: Lymphocytopenia (3%), neutropenia (1%-6%)
Hepatic: Increased liver enzymes
Hypersensitivity: Hypersensitivity reaction (3%)
Infection: Herpes simplex infection (?8%), herpes zoster infection (?4%), influenza (2%-3%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (1%-8%), myalgia (2%)
Respiratory: Bronchitis (4%), flu-like symptoms (2%)
<1%:
Gastrointestinal: Oral candidiasis, oral herpes simplex infection
Hematologic: Anemia
Ophthalmic: Retinal detachment
Respiratory: Pneumonia
Postmarketing:(FDA Safety Alert September 1, 2021)
Cardiovascular: Acute myocardial infarction
Hematologic & oncologic: Lymphocytopenia, malignant lymphoma
Respiratory: Lung carcinoma
Nervous system: Cerebrovascular accident

Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis:
Oral: 15 mg once daily
Atopic dermatitis:
15 mg once daily; may increase to 30 mg once daily if inadequate response.
Discontinue if an adequate response is not achieved with the 30 mg dose; use the lowest effective dose needed to maintain response.
Ulcerative colitis:
Induction: 45 mg once daily for 8 weeks; maintenance: 15 mg once daily; may increase to 30 mg once daily in patients with refractory, severe, or extensive disease.
Discontinue if an adequate response is not achieved with the 30 mg dose; use the lowest effective dose needed to maintain response.
Crohn disease:
Induction: 45 mg once daily for 12 weeks; maintenance: 15 mg once daily; may increase to 30 mg once daily.
Nonradiographic axial spondyloarthritis:
15 mg once daily.

Atopic dermatitis; moderate to severe; refractory:
Children ?12 years and Adolescents, weighing ?40 kg: Oral: 15 mg once daily; may increase to 30 mg once daily if inadequate response; in clinical trials, used as either monotherapy or in combination with topical corticosteroids

Ankylosing spondylitis, Psoriatic arthritis, Rheumatoid arthritis:
No dosage adjustment necessary for any degree of kidney dysfunction.
Atopic dermatitis:
eGFR 15 to <30 mL/minute/1.73 m…: 15 mg once daily.
eGFR <15 mL/minute/1.73 m…: Use is not recommended.
Ulcerative colitis:
eGFR 15 to <30 mL/minute/1.73 m…: Induction: 30 mg once daily for 8 weeks; maintenance: 15 mg once daily.
eGFR <15 mL/minute/1.73 m…: Use is not recommended.

Ankylosing spondylitis, Atopic dermatitis, Psoriatic arthritis, Rheumatoid arthritis:
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment is necessary.
Severe impairment (Child-Pugh class C): Use is not recommended.
Ulcerative colitis:
Mild to moderate impairment (Child-Pugh class A or B): Induction: 30 mg once daily for 8 weeks; maintenance: 15 mg once daily.
Severe impairment (Child-Pugh class C): Use is not recommended.
Hepatotoxicity during treatment:
Treatment should be interrupted if drug-induced liver injury is suspected.

Store at 2?C to 25?C.
Store in the original bottle in order to protect from moisture.