Rinvoqupadacitinib
According to the FDA label: RINVOQ/RINVOQ LQ is a Janus kinase (JAK) inhibitor. RINVOQ is 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. ( 1.1 ) Limitations of Use RINVOQ is not recommended for use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.
76,996 adverse event reports submitted to the FDA (2016–2026)
Top Reported Adverse Events
The most frequently reported events in association with Rinvoq in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Tap any term below for a plain-language definition.
Pain 5,132 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Arthralgia 4,538 reports
Drug Ineffective 4,403 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →COVID-19 3,175 reports
The illness caused by the SARS-CoV-2 coronavirus.
Full definition in the glossary →Rheumatoid Arthritis 3,152 reports
An autoimmune condition where the immune system attacks the joints, causing pain and swelling. It often appears in reports because it is a condition being treated, not always a reaction.
Full definition in the glossary →Pain in Extremity 2,692 reports
Pain in an arm or leg.
Full definition in the glossary →Fatigue 2,552 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Surgery 2,396 reports
A report noting that a surgical procedure occurred. This may be recorded as part of a person's medical history or treatment.
Full definition in the glossary →Fall 2,385 reports
A report that the person fell down. Falls are tracked because they can signal issues like dizziness, weakness, or balance problems.
Full definition in the glossary →Headache 1,873 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Pneumonia 1,858 reports
An infection that inflames the air sacs in the lungs, which can cause cough, fever, and difficulty breathing.
Full definition in the glossary →- Therapy Interrupted 1,800 reports
Death 1,784 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Diarrhoea 1,692 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Back Pain 1,673 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 50,450 |
| Male | 21,407 |
| Unknown | 11 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 724 |
| 18-34 | 3,957 |
| 35-49 | 6,531 |
| 50-64 | 15,908 |
| 65-74 | 9,414 |
| 75+ | 4,946 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Rinvoq. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 36,567 |
| Non-Serious | 25,208 |
| Hospitalization | 18,865 |
| Death | 2,843 |
| Disability | 757 |
| Life-Threatening | 750 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Rinvoq. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2016 | 1 |
| 2017 | 5 |
| 2018 | 7 |
| 2019 | 221 |
| 2020 | 2,841 |
| 2021 | 5,923 |
| 2022 | 16,499 |
| 2023 | 15,075 |
| 2024 | 15,229 |
| 2025 | 17,202 |
| 2026 (partial) | 3,993 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Rinvoq
In FDA adverse event reports that mention Rinvoq, these medications appeared most often in the same report.
- Methotrexate (4,619 reports)
- Prednisone (3,302 reports)
- Folic Acid (2,287 reports)
- Adalimumab (2,179 reports)
- Ergocalciferol (2,049 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026