Tofacitinib can cause adverse effects ranging from relatively common mild reactions to serious or potentially life-threatening complications. Risk varies with indication, dose, age, medical history and concomitant medicines.
Commonly reported reactions
Current U.S. labeling identifies upper respiratory tract infection, nasopharyngitis, diarrhea and headache among common adverse reactions in adult rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis populations.
For ulcerative colitis, commonly reported reactions include nasopharyngitis, elevated cholesterol, headache, upper respiratory tract infection, increased creatine phosphokinase, rash, diarrhea and herpes zoster.
Important adverse effects
| Risk | Why it matters |
|---|---|
| Serious infections | May require hospitalization or can be fatal |
| Tuberculosis | May occur as new infection or reactivation |
| Herpes zoster | Risk is increased with immune modulation |
| Malignancy | Lymphoma and other cancers have been reported |
| Major cardiovascular events | Includes myocardial infarction and stroke |
| Thrombosis | Venous and arterial thrombotic events can occur |
| Gastrointestinal perforation | Serious abdominal complication |
| Laboratory abnormalities | Can affect blood counts, liver enzymes and lipids |
| Hypoglycemia in diabetes | Current U.S. labeling includes a specific warning |
| Hypersensitivity | Serious allergic reactions can occur |
Important warning signs
Urgent medical assessment may be appropriate for symptoms such as severe breathing difficulty, chest pain, sudden weakness, speech difficulty, severe infection symptoms, significant abdominal pain, severe allergic symptoms or other acute symptoms.
Monitoring
Monitoring may include complete blood counts, liver enzymes, lipid levels and assessment for infections.