upadacitinib
Brand names: Rinvoq
Rinvoq contains upadacitinib and it is a medicine that reduces inflammation in your body. It is used to treat several conditions, including arthritis and Crohn's disease.
What it does
Rinvoq can treat rheumatoid arthritis, psoriatic arthritis, atopic dermatitis (eczema), ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.
Common side effects
Upper respiratory tract infections (like a cold), Acne, Herpes simplex (cold sores)
Key warnings
Rinvoq can cause serious side effects, including serious infections, cancer, blood clots, major heart problems, and death.
How It Works
Rinvoq is a JAK inhibitor. It works by blocking certain enzymes in your body called Janus kinases (JAKs). By blocking these enzymes, Rinvoq helps to reduce inflammation and relieve symptoms of the conditions it treats.
How to Take It
Take Rinvoq exactly as your doctor tells you. The usual dose is 15 mg to 45 mg once a day. You can take Rinvoq with or without food. Do not switch between the oral solution and the extended-release tablets without talking to your doctor.
Pregnancy & Breastfeeding
Rinvoq may harm your unborn baby. You should use effective birth control while taking Rinvoq and for some time after your last dose. Talk to your doctor if you are pregnant or plan to become pregnant. Do not breastfeed while taking Rinvoq.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
Storage
Store Rinvoq tablets at room temperature, between 36°F to 77°F, in the original bottle to protect from moisture. Store the oral solution between 36°F to 86°F and throw away any remaining solution 60 days after opening the bottle.
Side Effects (from patient reports)
Based on 30,886 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 72,798 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2016–2025.
Total Reports
72,798
Death-Related Reports
2,641
Hospitalization Reports
17,708
Top Indication
Rheumatoid Arthritis
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | PAIN | 4,942 |
| 2 | ARTHRALGIA | 4,342 |
| 3 | DRUG INEFFECTIVE | 4,175 |
| 4 | COVID-19 | 3,131 |
| 5 | RHEUMATOID ARTHRITIS | 3,037 |
| 6 | PAIN IN EXTREMITY | 2,575 |
| 7 | FATIGUE | 2,433 |
| 8 | FALL | 2,255 |
| 9 | SURGERY | 2,204 |
| 10 | HEADACHE | 1,792 |
| 11 | THERAPY INTERRUPTED | 1,783 |
| 12 | PNEUMONIA | 1,779 |
| 13 | DEATH | 1,630 |
| 14 | BACK PAIN | 1,598 |
| 15 | DIARRHOEA | 1,583 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Rinvoq can cause serious side effects, including serious infections, cancer, blood clots, major heart problems, and death. Your doctor will check you for tuberculosis before you start Rinvoq. Tell your doctor if you have any symptoms of infection, such as fever, cough, or fatigue. If you have a heart attack or stroke, stop taking Rinvoq.
Known Drug Interactions
( 7.2 ) 7.1 Strong CYP3A4 Inhibitors Upadacitinib exposure is increased when it is co-administered with a strong CYP3A4 inhibitor (such as ketoconazole, clarithromycin, and grapefruit), which may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )] .
Mechanism: Ketoconazole slows down the enzyme that processes upadacitinib, which can cause the drug to build up in your body.
What to do: Your doctor may need to monitor you more closely for side effects while taking these together.
( 7.2 ) 7.1 Strong CYP3A4 Inhibitors Upadacitinib exposure is increased when it is co-administered with a strong CYP3A4 inhibitor (such as ketoconazole, clarithromycin, and grapefruit), which may increase the risk of adverse reactions [see Clinical Pharmacology ( 12.3 )] .
Mechanism: Clarithromycin blocks the liver enzymes that normally break down upadacitinib, leading to higher drug levels and a greater risk of side effects.
What to do: Use this combination with caution and report any side effects to your healthcare provider.
7.2 Strong CYP3A4 Inducers Upadacitinib exposure is decreased when it is co-administered with strong CYP3A4 inducers (such as rifampin), which may lead to reduced therapeutic effect [see Clinical Pharmacology ( 12.3 )] .
Mechanism: Rifampin makes your liver work faster to break down upadacitinib. This lowers the amount of medicine in your body and may stop it from working correctly.
What to do: Your doctor may need to monitor your condition closely or change your treatment since upadacitinib may be less effective.
upadacitinib ↑ upadacitinib Dosing recommendations for co-administration of upadacitinib with PAXLOVID depends on the upadacitinib indication. Refer to the upadacitinib product label for more information.
Mechanism: Ritonavir slows down how the body breaks down upadacitinib, which can cause the levels of this medicine to rise in your blood.
What to do: Your doctor will need to check the specific reason you are taking upadacitinib to decide if your dose needs to be changed.
Common Questions
Can I take Rinvoq with other medicines?
What should I do if I get an infection?
Can Rinvoq cause cancer?
Can Rinvoq cause blood clots?
How often will my doctor check my blood?
Can I get vaccines while taking Rinvoq?
What if I need surgery?
Can Rinvoq affect my liver?
Is there a risk of gastrointestinal (GI) perforations?
Can Rinvoq cause medication residue in stool?
What are the common side effects of upadacitinib?
Does upadacitinib interact with other medications?
What drug class is upadacitinib?
Is upadacitinib safe during pregnancy?
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Related Health & Safety Data
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What the FDA Data Shows for upadacitinib
The FDA label for upadacitinib (sold under brand names such as Rinvoq) classifies it as a prescription-only medication in the JAK Inhibitor class. Rinvoq can treat rheumatoid arthritis, psoriatic arthritis, atopic dermatitis (eczema), ulcerative colitis, Crohn’s disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis. Official labeling lists 12 commonly reported side effects, including Upper respiratory tract infections (like a cold), Acne, Herpes simplex (cold sores).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 30,886 voluntary reports. The database also lists 4 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: October 10, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages