Prescription medication · JAK Inhibitor
upadacitinib
Also sold as Rinvoq. 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.
Data updated 2026-05-15
- 72,798
- FDA reportsOften reported
- 4
- InteractionsFew interactions
- Rx
- Availability
What the data shows
upadacitinib (Rinvoq) is a prescription JAK Inhibitor, more reported than most tracked drugs (72,798 FDA reports), with 4 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
upadacitinib (Rinvoq) is a prescription JAK Inhibitor. 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.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from upadacitinib's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of upadacitinib's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of upadacitinib's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
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.
This is a plain-language summary of upadacitinib's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
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 72,798 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for upadacitinib, by number of reports
- Pain
Pain
4,942 reports
- Joint pain
Joint pain
4,342 reports
- COVID-19
COVID-19
3,131 reports
- Rheumatoid arthritis
Rheumatoid arthritis
3,037 reports
- Limb pain
Limb pain
2,575 reports
- Tiredness
Tiredness
2,433 reports
- Fall
Fall
2,255 reports
- Surgery
Surgery
2,204 reports
- Headache 1,792
Headache
1,792 reports
- Treatment stopped 1,783
Treatment stopped
1,783 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for upadacitinib each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where upadacitinib sits
upadacitinib has more FDA adverse-event reports than 81% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is upadacitinib; the line is the median (50th percentile).
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
Reports Mentioning Death
2,641
3.6% of reports — not proof of cause
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 |
| 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 |
| 16 | PERIPHERAL SWELLING | 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.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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
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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 72,798 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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