Tofacitinib Side Effects and Risks

Serious and Life-Threatening Side Effects

The American Academy of Dermatology reports that tofacitinib carries significant risks including serious infections, particularly herpes zoster, with the 10 mg twice daily dose conferring higher risks than the 5 mg dose 1
Serious infections, including tuberculosis, opportunistic infections, and bacterial, fungal, and viral infections, are among the most critical adverse events 1
The most common serious infections include cellulitis, urinary tract infection, pneumonia, and herpes zoster 1
Herpes zoster occurs at significantly higher rates with tofacitinib compared to TNF inhibitors and the general population, though infections remain clinically manageable 2
Zoster vaccination should be considered before initiating therapy, particularly in patients over 70 years or those over 50 at high risk 3

Pulmonary embolism risk increases five-fold with the 10 mg twice daily dose compared to TNF inhibitor therapy 2
The European Medicines Agency advises against using the 10 mg dose in patients at increased risk of pulmonary embolus 2

Lung and breast cancer are the most common nonhematologic malignancies reported 1
Lymphoma has been reported, including Epstein Barr virus-associated post-transplant lymphoproliferative disorder in renal transplant patients receiving concurrent immunosuppressive medications 1

Lymphopenia occurs in 0.04% of patients after 3 months and correlates with increased incidence of treated and serious infections 1
Neutropenia can occur, requiring drug discontinuation if ANC <500 cells/mm³ 3
Tofacitinib should not be initiated if lymphocyte count is <500 cells/mm³, ANC is <1000 cells/mm³, or hemoglobin is <9 g/dL 3

Dose-related elevations in serum lipids occur, including triglycerides, total cholesterol, LDL cholesterol, and HDL cholesterol 1
Liver enzyme elevations to more than 3 times the upper limit of normal have been recorded 1
Serum creatinine increases occur in a dose-related manner 1, 5