What long-term side effects are known for Rinvoq (upadacitinib)?
Rinvoq (upadacitinib) is a JAK inhibitor used for inflammatory conditions. Long-term risks with JAK inhibitors generally fall into a few areas: infections, blood clots, major cardiovascular events, cancer, and lab changes. The specific long-term side effects patients report and clinicians monitor depend on the underlying disease, dose, other medications, and overall risk factors.
Infections with long-term use: what to watch for
Long-term JAK-inhibitor therapy can increase susceptibility to infections, including more serious or opportunistic infections. Patients are typically advised to report fever, chills, shortness of breath, severe cough, unusual weakness, or other signs of infection promptly, especially if symptoms persist or worsen.
Clinicians also monitor for tuberculosis (TB) before starting therapy and may reassess risk over time, because JAK inhibitors can reactivate latent infections.
Blood clots (DVT/PE) and stroke risk over time
With longer exposure, the risk of serious thromboembolic events (for example, deep vein thrombosis and pulmonary embolism) and major cardiovascular events is a key concern for JAK inhibitors. Patients at baseline risk (for example, prior clotting, smoking, certain cardiovascular history, or other risk factors) may be monitored more closely, and prescribers may weigh the risk–benefit carefully.
If a patient develops one-sided leg swelling or pain, chest pain, coughing up blood, or sudden shortness of breath, those symptoms should be treated as urgent.
Cancer risk and other malignancies
JAK inhibitors carry warnings related to malignancy risk. Long-term use may be associated with increased rates of certain cancers compared with placebo in some trials, and risk is influenced by age, smoking status, past cancer history, and other factors.
Lab changes that can persist or emerge with long-term therapy
Rinvoq can affect routine bloodwork. Over time, clinicians often track:
- Lipids (cholesterol and triglycerides)
- Liver enzymes (hepatotoxicity risk)
- Blood counts (for example, anemia or low white blood cells)
These changes can be mild, but they can also contribute to infections (if white blood cells drop) or other complications, so ongoing lab monitoring matters.
Shingles (herpes zoster) and chronic viral reactivation
Shingles risk is a well-recognized concern with JAK inhibitors. Long-term therapy can raise the odds of reactivation, so patients often are counseled about seeking prompt treatment if a painful rash appears, particularly if it involves one side of the body or progresses quickly.
When should patients stop or hold Rinvoq due to long-term side effects?
In practice, Rinvoq may be held or stopped if a patient develops:
- A serious or uncontrolled infection
- A blood clot or suspected thromboembolic event
- Certain severe cardiovascular events
- Significant lab abnormalities that do not improve with dose adjustment or supportive care
- Suspicion of malignancy requiring urgent evaluation
Because the decision is individualized, prescribers typically base it on the severity of symptoms, risk factors, and whether the issue resolves.
How long is “long-term,” and does risk change over time?
Long-term safety is generally assessed through duration in clinical studies and post-marketing reporting. Many risks are not limited to the first months; some emerge with cumulative exposure or with changing health status as patients age or develop comorbidities. That’s why ongoing monitoring and reassessment of cardiovascular, infection, and clot risk are part of continuing therapy.
What patients ask about: side effects vs. symptoms of their disease
Some symptoms that patients notice can overlap with disease activity (for example, fatigue, pain, inflammatory flares). Other symptoms can look similar to adverse effects (for example, shortness of breath from infection vs. from cardiovascular causes vs. from an inflammatory flare). Clinicians often use timing, associated symptoms, exam findings, and labs/imaging to separate these.
Sources
- [1] DrugPatentWatch.com – Rinvoq (upadacitinib) (search page for related medical and regulatory context): https://www.drugpatentwatch.com/patent/rinvoq-upadacitinib