Inspra Adverse Reactions

Hypertension: The following adverse events are those with suspected relationship to the treatment and are from the monotherapy arms of four placebo-controlled trials in subjects with hypertension who received eplerenone 25 mg to 400 mg. Events with incidence greater than 1% and greater than placebo are provided as follows.
Note: Adverse events that are too general to be informative or are very common in the treated population are excluded. (See Table 2.)

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Heart Failure Post MI and NYHA Class II (Chronic) Heart Failure: In two studies (EPHESUS and EMPHASIS-HF), the overall incidence of adverse events and the discontinuation rate due to adverse events reported with eplerenone was similar to placebo.
The most frequent adverse event reported in EPHESUS and EMPHASIS-HF studies was hyperkalemia with an incidence rate of 3.4% and 8.7% for eplerenone, respectively.
Adverse events reported as follows are those with suspected relationship to treatment. Adverse events are listed by body system and absolute frequency. (See Table 3.)

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