Research Article
Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan
Table 2
Incidence of adverse drug reactions in safety analysis population.
| | Adverse drug reactions: SOC | (%) | Major types: PT (occurrence ≥ 0.1%) ( (%)) |
| | Number of patients in safety analysis population | 3,166 (100) | |
| | Patients with adverse drug reactions | 75 (2.37) | | | Total number of adverse drug reactions | 82 | | | Infections and infestations | 1 (0.03) | | | Neoplasms (benign, malignant, and unspecified, including cysts and polyps) | 1 (0.03) | | | Blood and lymphatic system disorders | 1 (0.03) | | | Metabolism and nutrition disorders | 25 (0.79) | Hyperkalemia: 20 (0.63) | | Nervous system disorders | 10 (0.32) | Dizziness: 7 (0.22) | | Ear and labyrinth disorders | 1 (0.03) | | | Cardiac disorders | 1 (0.03) | | | Vascular disorders | 3 (0.09) | | | Respiratory, thoracic, and mediastinal disorders | 1 (0.03) | | | Gastrointestinal disorders | 6 (0.19) | | | Hepatobiliary disorders | 2 (0.06) | | | Skin and subcutaneous tissue disorders | 5 (0.16) | | | Renal and urinary disorders | 10 (0.32) | Renal impairment: 7 (0.22) | | General disorders and administration site conditions | 4 (0.13) | | | Investigations | 11 (0.35) | Increased serum potassium: 6 (0.19) |
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Calculated with MedDRA/J17.1 System Organ Class and preferred terms.
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