pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
The important medical adverse events of cyclosporine identified as signal in each of SOC from FAERS database
| SOCs | IMEs | Primary suspected cases, n | ROR | IC | Drug label |
Drug label |
|---|---|---|---|---|---|---|
| (95% CI) | (IC025) | (MFDS) | (FDA) | |||
| Infections and infestations | CMV infection | 297 | 14.6 (13.0–16.4) | 3.8 (3.6) | Y | Y |
| Bronchopulmonary aspergillosis | 68 | 7.5 (5.9–9.6) | 2.8 (2.4) | N | N | |
| Aspergillus infection | 59 | 6.4 (5.0–8.3) | 2.6 (2.2) | N | N | |
| Renal and urinary disorders | Renal impairment | 359 | 3.5 (3.2–3.9) | 1.8 (1.6) | Y | Y |
| Nephropathy toxic | 185 | 18.0 (15.5–20.9) | 4.0 (3.8) | Y | Y | |
| Cystitis haemorrhagic | 78 | 20.5 (16.4–25.8) | 4.1 (3.8) | N | N | |
| Blood and lymphatic system disorders | Aplastic anaemia | 130 | 29.6 (24.7–35.4) | 4.6 (4.4) | N | N |
| Pancytopenia | 112 | 2.1 (1.7–2.5) | 1.0 (0.7) | N | Y |
|
| Thrombotic microangiopathy | 111 | 11.0 (9.1–13.3) | 3.4 (3.0) | Y | Y | |
| Nervous system disorders | Posterior reversible encephalopathy syndrome | 134 | 12.9 (10.8–15.3) | 3.6 (3.3) | Y | Y |
| Encephalopathy | 54 | 2.2 (1.7–2.9) | 1.1 (0.7) | Y | Y | |
| Neurotoxicity | 50 | 2.4 (1.8–3.1) | 1.2 (0.7) | Y | Y | |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | post transplant lymphoproliferative disorder | 118 | 19.0 (15.8–22.8) | 4.1 (3.8) | Y | Y |
| myelodysplastic syndrome | 39 | 2.9 (2.1–3.9) | 1.5 (0.9) | N | N | |
| acute myeloid leukaemia | 35 | 2.3 (1.6–3.2) | 1.1 (0.6) | N | N | |
| Respiratory, thoracic and mediastinal disorders | Acute respiratory distress syndrome | 38 | 2.2 (1.6–3.1) | 1.1 (0.6) | N | N |
| Obliterative bronchiolitis | 34 | 21.5 (15.2–30.3) | 4.0 (3.4) | N | N | |
| Pulmonary haemorrhage | 21 | 2.8 (1.8–4.2) | 1.4 (0.7) | N | N | |
| Gastrointestinal disorders | Impaired gastric emptying | 43 | 4.9 (3.6–6.6) | 2.2 (1.7) | N | N |
| Pneumatosis intestinalis | 11 | 3.4 (1.9–6.2) | 1.6 (0.6) | N | N | |
| Anal ulcer | 5 | 6.1 (2.5–14.8) | 2.0 (0.5) | N | N | |
AE, adverse event; CMV, cytomegalovirus; IC, information component; IME, important medical adverse events; ROR, reporting odds ratio; ROR, reporting odds ratio; SOC, system-organ class; MFDS, Ministry of Food and Drug Safety; FDA, Food and Drug Administration.
a Y, the IME which was listed on the adverse reaction section of cyclosporine of the drug label; N, the IME which was not listed on the adverse reaction section of cyclosporine of the drug label
* the IME identified by Post Market Surveillance