Table 1.
Summary of adverse drug reactions by the Medical Dictionary for Regulatory Activities System Organ Class and Preferred Terms
| Medical Dictionary for Regulatory Activities System Organ Class | Medical Dictionary for Regulatory Activities Preferred Terms | Number of adverse drug reactions (ADRs)
|
Total | |
|---|---|---|---|---|
| Serious | Nonserious | |||
| Blood and lymphatic system disorder | Anemia | 4 | 4 | |
| Nervous system disorders | Cerebral hemorrhage | 1 | 1 | |
| Vascular disorders | Embolism venous | 1 | 1 | |
| Hemorrhage | 6 | 1 | 7 | |
| Gastrointestinal disorders | Diarrhea | 2 | 2 | |
| Feces discolored | 1 | 1 | ||
| Gastric hemorrhage | 1 | 1 | ||
| Gastric ulcer hemorrhage | 1 | 1 | ||
| Gastrointestinal hemorrhage | 1 | 1 | ||
| Gingival bleeding | 1 | 1 | ||
| Hematemesis | 1 | 1 | ||
| Hematochezia | 1 | 1 | ||
| Hepatobiliary disorders | Hepatic function abnormal | 4 | 4 | |
| Hyperbilirubinemia | 1 | 1 | ||
| Jaundice | 1 | 1 | ||
| Liver disorder | 1 | 1 | ||
| Skin and subcutaneous tissue disorders | Hemorrhage subcutaneous | 3 | 9 | 12 |
| Rash | 1 | 1 | ||
| Musculoskeletal and connective tissue disorders | Hemarthrosis | 3 | 3 | |
| Joint swelling | 1 | 1 | ||
| Renal and urinary disorders | Hematuria | 1 | 1 | |
| Reproductive system and breast | Metrorrhagia | 1 | 1 | |
| General disorders and administration site conditions | Edema | 1 | 1 | |
| Investigations | Alanine aminotransferase increased | 1 | 1 | |
| Aspartate aminotransferase increased | 1 | 1 | ||
| Hemoglobin decreased | 1 | 1 | ||
| Liver function test abnormal | 1 | 1 | ||
| Platelet count increased | 1 | 1 | ||
| Injury, poisoning, and procedural complications | Subcutaneous hematoma | 1 | 1 | |
| Wound hemorrhage | 2 | 5 | 7 | |
| Postprocedural hematoma | 4 | 4 | ||
| Wound hematoma | 1 | 1 | ||
| Total | 15 | 52 | 67 | |
Note: This research was originally published as an abstract in Blood. Kuroda Y, Hotoda H, Nishikawa Y, and Nishiwaki A. Post-Marketing Safety Experience with Edoxaban in Japan for Thromboprophylaxis Following Major Orthopedic Surgery. Blood. 2012;120:Abstract 4697. © the American Society of Hematology.23