pISSN 1226-6051
eISSN 2508-786X
eISSN 2508-786X
EMA-IMEs lists non-labeled in MFDS among detected signals of alpha-adrenoceptor antagonists vs. other drugs by three data mining indices in males
| SOC | Adverse event | Disproportionality analysis | Label | EMA-IME list | ||||
|---|---|---|---|---|---|---|---|---|
| PRR | ROR | IC | X2 | MFDS | FDA | |||
| Terazosin | ||||||||
| Respiratory system disorders (1100) | COAD | 17.33 | 17.53 | 4.27 | 105.15 | N | N | Y |
| Resistance mechanism disorders (1830) | ||||||||
| Doxazosin | Sepsis | 6.86 | 6.89 | 3.17 | 14.89 | N | N | Y |
| Gastro-intestinal system disorders (0600) | Gastritis | 14.69 | 14.81 | 4.17 | 50.24 | N | N | Y |
| Vascular (extracardiac) disorders (1040) | Cerebral infarction | 2.96 | 3.07 | 1.61 | 32.88 | N | N | Y |
| Respiratory system disorders (1100) | Pharyngitis | 10.67 | 10.74 | 3.81 | 26.01 | N | N | Y |
| Pneumonia | 35.50 | 35.82 | 5.40 | 129.14 | N | N | Y | |
| COAD | 2.96 | 2.99 | 1.78 | 7.81 | N | N | Y | |
| Urinary system disorders (1300) | Azotaemia | 4.30 | 4.34 | 2.32 | 15.17 | N | N | Y |
| Resistance mechanism disorders (1830) | ||||||||
| Alfuzosin | Infection viral | 2.42 | 2.44 | 1.53 | 4.19 | N | N | Y |
| Musculo-skeletal system disorders (0200) | Fracture | 4.97 | 4.99 | 2.71 | 9.44 | N | N | Y |
| Vision disorders (0431) | Cataract | 13.72 | 13.80 | 4.00 | 57.44 | N | Y | Y |
| Gastro-intestinal system disorders (0600) | Gastritis | 12.43 | 12.51 | 3.86 | 51.32 | N | Y | Y |
| Cardiovascular disorders, general (1010) | Cardiac failure | 79.31 | 79.60 | 6.45 | 200.34 | N | N | Y |
| Respiratory system disorders (1100) | Pneumonia | 6.82 | 6.84 | 3.16 | 14.70 | N | Y | Y |
| Silodosin | COAD | 2.13 | 2.15 | 1.18 | 9.03 | N | N | Y |
| Musculo-skeletal system disorders (0200) | Fracture | 5.54 | 5.56 | 2.87 | 11.05 | N | N | Y |
| Central & peripheral nervous system disorders (0410) | Neuropathy | 5.38 | 5.44 | 2.54 | 38.88 | N | N | Y |
| Spinal stenosis | 5.19 | 5.20 | 2.77 | 10.04 | N | N | Y | |
| Vision disorders (0431) | Cataract | 7.54 | 7.57 | 3.21 | 22.34 | N | N | Y |
| Gastro-intestinal system disorders (0600) | Gastritis | 3.64 | 3.66 | 2.07 | 11.40 | N | N | Y |
| Metabolic and nutritional disorders (0800) | Hyperkalaemia | 9.59 | 9.65 | 3.45 | 45.28 | N | N | Y |
| Respiratory system disorders (1100) | Pneumonia | 5.56 | 5.59 | 2.72 | 18.53 | N | N | Y |
| COAD | 20.98 | 21.33 | 4.43 | 255.58 | N | N | Y | |
| White cell and RES* disorders (1220) | Agranulocytosis | 3.18 | 3.20 | 1.85 | 10.40 | N | N | Y |
| Urinary system disorders (1300) | ||||||||
| Tamsulosin | Urinary retention | 6.24 | 6.27 | 2.88 | 21.74 | N | N | Y |
| Skin and appendages disorders (0100) | Eczema | 5.19 | 5.19 | 2.50 | 22.47 | N | N | Y |
| Musculo-skeletal system disorders (0200) | Arthropathy | 4.50 | 4.50 | 2.42 | 10.40 | N | N | Y |
| Central & peripheral nervous system disorders (0410) | Dementia | 5.54 | 5.54 | 2.79 | 10.55 | N | N | Y |
| Vision disorders (0431) | Glaucoma | 3.70 | 3.71 | 2.10 | 9.51 | N | N | Y |
| Psychiatric disorders (0500) | Depression | 2.26 | 2.27 | 1.31 | 6.20 | N | N | Y |
| Psychosis | 5.43 | 5.44 | 2.77 | 10.28 | N | N | Y | |
| Gastro-intestinal system disorders (0600) | Ileus | 7.79 | 7.80 | 3.01 | 49.34 | N | N | Y |
| Ileus paralytic | 12.76 | 12.76 | 3.87 | 28.75 | N | N | Y | |
| Colitis | 5.96 | 5.97 | 2.61 | 46.68 | N | N | Y | |
| Oesophagitis | 4.25 | 4.25 | 2.44 | 7.15 | N | N | Y | |
| Liver and biliary system disorders (0700) | Cholecystitis | 4.94 | 4.94 | 2.50 | 14.96 | N | N | Y |
| Cholelithiasis | 3.45 | 3.45 | 2.15 | 5.05 | N | N | Y | |
| Metabolic and nutritional disorders (0800) | Acidosis | 8.89 | 8.90 | 3.33 | 25.68 | N | N | Y |
| Diabetes mellitus | 3.53 | 3.54 | 1.92 | 17.52 | N | N | Y | |
| Hyperkalaemia | 2.69 | 2.70 | 1.47 | 22.83 | N | N | Y | |
| Endocrine disorders (0900) | Hypothyroidism | 5.84 | 5.84 | 2.78 | 15.14 | N | N | Y |
| Cardiovascular disorders, general (1010) | Cardiac failure | 2.45 | 2.45 | 1.52 | 4.17 | N | N | Y |
| Aneurysm | 9.23 | 9.24 | 3.33 | 33.51 | N | N | Y | |
| Vascular (extracardiac) disorders (1040) | Vascular disorderr | 5.99 | 5.99 | 2.90 | 11.74 | N | N | Y |
| Haemorrhage intracranial | 8.50 | 8.52 | 3.14 | 48.74 | N | N | Y | |
| Cerebral infarction | 5.12 | 5.14 | 2.36 | 63.07 | N | N | Y | |
| Respiratory system disorders (1100) | Pleural effusion | 4.30 | 4.31 | 2.18 | 26.73 | N | N | Y |
| Pneumonia | 5.34 | 5.42 | 2.37 | 268.34 | N | N | Y | |
| Pneumothorax | 6.27 | 6.28 | 2.82 | 20.81 | N | N | Y | |
| Pulmonary oedema | 4.29 | 4.29 | 2.30 | 12.08 | N | N | Y | |
| Bronchitis | 2.49 | 2.49 | 1.40 | 10.41 | N | N | Y | |
| Pneumonitis | 3.87 | 3.88 | 2.07 | 16.41 | N | N | Y | |
| COAD | 6.29 | 6.31 | 2.65 | 75.24 | N | N | Y | |
| White cell and RES disorders (1220) | Agranulocytosis | 3.14 | 3.15 | 1.69 | 25.44 | N | N | Y |
| Urinary system disorders (1300) | Urinary retention | 8.37 | 8.41 | 3.02 | 131.62 | N | N | Y |
| Anuria | 8.89 | 8.90 | 3.42 | 19.26 | N | N | Y | |
| Cystitis | 13.97 | 13.99 | 3.82 | 63.23 | N | N | Y | |
| Pyelonephritis | 12.22 | 12.23 | 3.82 | 27.48 | N | N | Y | |
| UTI | 15.21 | 15.29 | 3.79 | 241.38 | N | N | Y | |
| Neoplasms (1700) | Rectal carcinoma | 6.99 | 6.99 | 3.10 | 14.36 | N | N | Y |
| Hepatic neoplasm | 3.03 | 3.03 | 1.88 | 5.29 | N | N | Y | |
| Neoplasm malignant | 4.86 | 4.88 | 2.30 | 49.71 | N | N | Y | |
| Application site disorders (1820) | Cellulitis | 3.87 | 3.87 | 2.09 | 14.32 | N | N | Y |
| Resistance mechanism disorders (1830) | Infection bacterial | 4.22 | 4.22 | 2.28 | 11.76 | N | Y | Y |
| Moniliasis | 5.18 | 5.19 | 2.47 | 25.64 | N | N | Y | |
| Herpes zoster | 3.50 | 3.51 | 1.89 | 19.02 | N | N | Y | |
| Herpes simplex | 5.84 | 5.84 | 2.78 | 15.14 | N | N | Y | |
| Abscess | 4.25 | 4.26 | 2.23 | 16.69 | N | N | Y | |
IC, information component; COAD, chronic obstructive airways disease; EMA-IME, European medicines agency-important medical events; FDA, US food and drug administration; MFDS, Ministry of food and drug safety (Korea); PRR, proportional reporting ratio; RES, reticuloendothelial system; ROR, reporting odds ratio; SOC, system-organ class; UTI; urinary tract infection; X2, chi-square; Y, the adverse event which was listed on drug labels; N, the adverse event which was not listed on drug labels