Cyclosporine: Side Effects, Uses & Monitoring

Facts extracted from current FDA product labeling for Cyclosporine. Educational only — not medical advice.

Reported adverse reactions

ReactionHighest frequency reported*
Tremor55%
Creatinine elevations ≥30%55%
Hypertension53%
Hirsutism45%
Renal dysfunction38%
Body as a whole–general29.1%
Gastrointestinal system28.7%
Cardiovascular system28%
Hypertension**27.5%
Central and peripheral nervous system26.4%
Creatinine elevations ≥50%26%
Infection or potential infection24.7%
Urinary system24.2%
Nausea24%
Upper respiratory tract23%
Urinary tract infections21.1%
Resistance mechanism21.1%
Increased creatinine19.8%
Leukopenia19%
Hypertrichosis19%

*Highest percentage across placebo-controlled trial tables summarized in current labeling.

Labeled uses

Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. Cyclosporine capsules (modified) has been used in combination with azathioprine and corticosteroids. Rheumatoid Arthritis Cyclosporine capsules (modified) is indicated for the treatment of patients with severe active, rheumatoid arthritis where the disease has not adequately responded to methotrexate. Cyclosporine capsules (modified) can be used in combination with methotrexate in rheumatoid arthritis patients who do not respond adequately to methotrexate alone. Psoriasis Cyclosporine capsules (modified) is indicated for the treatment of adult, nonimmunocompromised patients with severe (i.e., extensive and/or disabling), recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy (e.g., PUVA, retinoids, or methotrexate) or in patients for whom other systemic therapies are contraindicated or cannot be tolerated.   While rebound rarely occurs, most patients will experience relapse with cyclosporine capsules (modified) as with other therapies upon cessation of treatment.

Source: FDA labeling via NIH DailyMed (set 5baaf78c…). Not affiliated with FDA or NIH.

Medical disclaimer: Always consult a qualified healthcare professional about any medication.