Cyclosporine: Side Effects, Uses & Monitoring
Kidney, Liver, and Heart Transplantation Cyclosporine capsules (modified) is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants.
- Data source
- FDA labeling via NIH DailyMed (label 5baaf78c…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Tremor | 55% |
| Creatinine elevations ≥30% | 55% |
| Hypertension | 53% |
| Hirsutism | 45% |
| Renal dysfunction | 38% |
| Body as a whole–general | 29.1% |
| Gastrointestinal system | 28.7% |
| Cardiovascular system | 28% |
| Hypertension** | 27.5% |
| Central and peripheral nervous system | 26.4% |
| Creatinine elevations ≥50% | 26% |
| Infection or potential infection | 24.7% |
| Urinary system | 24.2% |
| Nausea | 24% |
| Upper respiratory tract | 23% |
| Urinary tract infections | 21.1% |
| Resistance mechanism | 21.1% |
| Increased creatinine | 19.8% |
| Leukopenia | 19% |
| Hypertrichosis | 19% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
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.
Conditions associated with Cyclosporine in labeling
Frequently Asked Questions
What is Cyclosporine used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Cyclosporine?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Cyclosporine. Individual risk varies.
Does Cyclosporine require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Cyclosporine.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.