Safety and Antihypertensive Effect of Selara® (Eplerenone): Results from a Postmarketing Surveillance in Japan

Table 3

Incidence of serious adverse drug reactions.

Serious adverse drug reactions	(%)
Safety analysis population	3,166
Patients with adverse drug reactions	16 (0.51)
Neoplasms (benign, malignant, and unspecified, including cysts and polyps)	1 (0.03)
Acute myeloid leukemia	1 (0.03)
Metabolism and nutrition disorders	10 (0.32)
Hyperkalemia	9 (0.28)
Decreased appetite	1 (0.03)
Hepatobiliary disorders	1 (0.03)
Hepatic function abnormal	1 (0.03)
Renal and urinary disorders	3 (0.09)
Renal impairment	3 (0.09)
General disorders and administration site conditions	1 (0.03)
Drug interaction	1 (0.03)
Investigations	2 (0.06)
Blood potassium increased	2 (0.06)

Calculated with MedDRA/J17.1 System Organ Class and preferred terms.