What the label lists and what reports show
Cyclosporine side effects
Cyclosporine's FDA label lists its adverse reactions in its own words. FAERS holds 115,545 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye irritation (10,006 reports).
- Generic listed
- Boxed warning
Check it at the source: the cyclosporine FDA label on DailyMed (effective August 10, 2026, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsKidney, Liver, and Heart Transplantation The principal adverse reactions of cyclosporine therapy are renal dysfunction, tremor, hirsutism, hypertension, and gum hyperplasia. Hypertension Hypertension, which is usually mild to moderate, may occur in approximately 50% of patients following renal transplantation and in most cardiac transplant patients. Glomerular Capillary Thrombosis Glomerular capillary thrombosis has been found in patients treated with cyclosporine and may progress to graft failure. The pathologic changes resembled those seen in the hemolytic-uremic syndrome and included thrombosis of the renal microvasculature, with platelet-fibrin thrombi occluding glomerular capillaries and afferent arterioles, microangiopathic hemolytic anemia, thrombocytopenia, and decreased renal function. …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | Sandimmune (N = 227)% | Azathioprine (N = 228)% | Kidney (N = 705)% | Heart (N = 112)% | Liver (N = 75)% |
|---|---|---|---|---|---|
| Renal Dysfunction | 32 | 6 | 25 | 38 | 37 |
| Hypertension | 26 | 18 | 13 | 53 | 27 |
| Hirsutism | 21 | < 1 | 21 | 28 | 45 |
| Tremor | 12 | 0 | 21 | 31 | 55 |
| Gum Hyperplasia | 4 | 0 | 9 | 5 | 16 |
| Paresthesia | 3 | 0 | 1 | 2 | 1 |
| Leukopenia | 2 | 19 | < 1 | 6 | 0 |
| Lymphoma | < 1 | 0 | 1 | 6 | 1 |
| Sinusitis | < 1 | 0 | 4 | 3 | 7 |
| Gynecomastia | < 1 | 0 | < 1 | 4 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective August 10, 2026 (SPL set 94461af3-11f1-4670-95d4-2965b9538ae3), via openFDA; the full label on DailyMed
What do FAERS reports show?
115,545 reports list cyclosporine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 14,506 are coded as a death and 28,361 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Cyclosporine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions