Rinvoq FDA Approval History
Last updated by Judith Stewart, BPharm on May 20, 2025.
FDA Approved: Yes (First approved August 16, 2019)
Brand name: Rinvoq
Generic name: upadacitinib
Dosage form: Extended-Release Tablets
Company: AbbVie Inc.
Treatment for: Rheumatoid Arthritis, Psoriatic Arthritis, Atopic Dermatitis, Ulcerative Colitis, Crohn's Disease, Ankylosing Spondylitis, Non-Radiographic Axial Spondyloarthritis, Polyarticular Juvenile Idiopathic Arthritis, Giant Cell Arteritis
Rinvoq (upadacitinib) is a Janus kinase (JAK) inhibitor for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.
- Rinvoq works by blocking the activity of Janus kinase enzymes in the JAK-STAT signaling pathway, an intracellular pathway that plays a major role in the release of the pro-inflammatory cytokines that stimulate inflammation in rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and giant cell arteritis.
- Rinvoq is an extended-release tablet formulation of upadacitinib indicated for the treatment of:
- adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
- adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers.
- adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more TNF blockers.
- adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
- adults with active nonradiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to TNF blocker therapy.
- patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- adults with giant cell arteritis. - Rinvoq LQ is an oral solution formulation of upadacitinib indicated for the treatment of:
- adults and pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers.
- patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. - Rinvoq LQ oral solution is not substitutable with Rinvoq extended-release tablets. Changes between Rinvoq LQ oral solution and Rinvoq extended-release tablets should be made by the healthcare provider.
- Rinvoq extended-release tablets are administered orally once daily. Rinvoq LQ oral solution is administered orally twice daily.
- Rinvoq carries a boxed warning for the risk of serious infections, an increased rate of all-cause mortality, malignancies, adverse cardiovascular events, and thrombosis. Warnings and precautions associated with Rinvoq include serious infections, hypersensitivity reactions, gastrointestinal (GI) perforations, laboratory abnormalities, and embryo-fetal toxicity.
- Adverse reactions (≥ 1%) in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis patients include upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache.
Adverse reactions (≥ 1%) in atopic dermatitis patients include upper respiratory tract infections, acne, herpes simplex, headache, increased blood creatine phosphokinase, cough, hypersensitivity, folliculitis, nausea, abdominal pain, pyrexia, increased weight, herpes zoster, influenza, fatigue, neutropenia, myalgia, and influenza like illness.
Adverse reactions (≥ 5%) in ulcerative colitis patients include upper respiratory tract infections, increased blood creatine phosphokinase, acne, neutropenia, elevated liver enzymes, pyrexia, and rash.
Adverse reactions (≥ 5%) in Crohn’s disease patients include upper respiratory tract infections, anemia, pyrexia, acne, herpes zoster, and headache.
Adverse reactions ((≥ 5%) in giant cell arteritis patients include upper respiratory tract infections, headache, fatigue, peripheral edema, cough, anemia, rash, herpes zoster, and nausea.
Development timeline for Rinvoq
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.