pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
The important medical adverse events of tacrolimus 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 | 705 | 24.7 (22.9–26.7) | 4.5 (4.3) | Y | Y |
| Sepsis | 501 | 2.8 (2.5–3.0) | 1.4 (1.3) | Y | Y | |
| Septic shock | 380 | 5.7 (5.1–6.3) | 2.5 (2.3) | Y | Y | |
| Renal and urinary disorders | Acute kidney injury | 1198 | 2.8 (2.7–3.0) | 1.5 (1.4) | Y | Y |
| Renal impairment | 754 | 5.1 (4.7–5.4) | 2.3 (2.2) | Y | Y | |
| Nephropathy toxic | 274 | 18.3 (16.2–20.7) | 4.1 (3.9) | Y | Y | |
| Blood and lymphatic system disorders | Thrombotic microangiopathy | 768 | 61.8 (57.1–66.9) | 5.6 (5.5) | Y | Y |
| Leukopenia | 337 | 4.0 (3.6–4.4) | 2.0 (1.8) | Y | Y | |
| Pancytopenia | 24 | 13.0 (2.7–3.5) | 1.6 (1.4) | Y |
Y | |
| Nervous systemdisorders | Posterior reversible encephalopathy syndrome | 379 | 26.1 (23.5–29.0) | 4.5 (4.4) | Y | Y |
| Neurotoxicity | 182 | 5.9 (5.1–6.8) | 2.5 (2.3) | Y | Y | |
| Encephalopathy | 175 | 4.9 (4.2–5.7) | 2.3 (2.0) | Y | Y | |
| Neoplasms benign, malignant and unspecified (incl cysts andpolyps) | Post transplant lymphoproliferative disorder | 500 | 64.6 (58.5–71.2) | 5.6 (5.5) | Y | Y |
| Kaposi's sarcoma | 158 | 29.5 (25.0–34.8) | 4.6 (4.4) | N | Y | |
| Diffuse large B-cell lymphoma | 145 | 12.2 (10.4–14.5) | 3.5 (3.2) | N | N | |
| Respiratory, thoracic and mediastinal disorders | Respiratory failure | 431 | 3.9 (3.6–4.3) | 2.0 (1.8) | Y |
Y |
| Acute respiratory distress syndrome | 124 | 4.9 (4.1–5.9) | 2.3 (2.0) | Y | Y | |
| Respiratory distress | 113 | 2.8 (2.3–3.3) | 1.4 (1.1) | Y |
Y | |
| Gastrointestinal disorders | Ascites | 143 | 3.1 (2.6–3.7) | 1.6 (1.3) | Y | Y |
| Pancreatitis acute | 75 | 2.4 (1.9–3.1) | 1.3 (0.9) | Y |
Y | |
| Pneumatosis intestinalis | 43 | 9.3 (6.8–12.6) | 3.0 (2.5) | N | N | |
AE, adverse event; CMV, cytomegalovirus; IC, information component; IME, important medical adverse events; 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 tacrolimus of the drug label; N, the IME which was not listed on the adverse reaction section of tacrolimus of the drug label
* the IME identified by Post Market Surveillance