Does Rinvoq Cause Blood Clots?
Yes, Rinvoq (upadacitinib) increases the risk of venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis, and this risk is dose-dependent. 1
FDA Black Box Warning
The FDA has issued a black box warning specifically for thrombosis with Rinvoq. Thrombosis has occurred in patients treated with RINVOQ, with increased incidence of pulmonary embolism, venous and arterial thrombosis compared to TNF blockers. 1 This is the highest level of safety alert the FDA can issue for a medication.
Risk Magnitude and Context
The 2025 expert consensus statement on JAK inhibitors confirms there is a dose-dependent risk of venous thromboembolic events, especially pulmonary embolism with JAK inhibition, particularly in patients with risk factors for venous thromboembolic events. 2
Clinical trial data across multiple indications shows:
- VTE rates with upadacitinib range from 0.2-0.4 events per 100 patient-years in rheumatoid arthritis and psoriatic arthritis 3
- Rates were 0.1 events per 100 patient-years in atopic dermatitis populations 4
- These rates are generally consistent across 6-month intervals and do not appear to increase substantially over time 5
Critical Risk Factors to Assess
Before prescribing Rinvoq, you must evaluate for VTE risk factors:
- Prior history of VTE (strongest predictor)
- BMI ≥35 kg/m²
- Age ≥50 years (particularly ≥65 years)
- History of chronic lung disease
- Active cardiovascular disease
- Current smoking
- Prolonged immobilization
High-Risk Patients: Special Considerations
For patients with prior VTE history who require JAK inhibitor therapy, concurrent anticoagulation is protective. A 2024 study found 9.0 VTE events per 100 patient-years in patients with prior VTE taking JAK inhibitors without anticoagulation, versus zero events in those on concurrent anticoagulation (P=0.020). 6 If you must use Rinvoq in a patient with prior VTE, maintain therapeutic anticoagulation throughout treatment.
Dose-Dependent Risk
The risk is higher with upadacitinib 30 mg compared to 15 mg doses, though both carry increased risk compared to TNF inhibitors. 2 For approved indications where 15 mg is effective (rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis), use the lower dose to minimize VTE risk.
Clinical Monitoring
- Educate patients on VTE symptoms: leg pain/swelling, sudden chest pain, shortness of breath
- Consider baseline D-dimer in high-risk patients (though not validated for monitoring)
- Maintain vigilance for the first 6 months when most events occur
- Discontinue Rinvoq immediately if VTE occurs 1
Common Pitfall
Do not assume that absence of traditional VTE risk factors eliminates risk—the medication itself confers independent VTE risk. However, patients with multiple baseline cardiovascular risk factors account for most VTE events 3, so risk stratification before initiation is essential.