Drug Safety Information for EPLERENONE (Eplerenone)

Safety-related Labeling Changes for INSPRA (EPLERENONE) Rx Drug: FDA Link

Adverse Drug Reactions for EPLERENONE* (Eplerenone)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with EPLERENONE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Renal failure acute136
2Dyspnoea121
3Cardiac failure110
4Nausea99
5Drug interaction92
6Dizziness*91
7Hypotension88
8Renal failure82
9Fatigue77
10Diarrhoea76
11Hyperkalaemia75
12Asthenia72
13Fall68
14Vomiting65
15Malaise64
16Cardiac failure congestive63
17Headache62
18Condition aggravated60
19Dehydration57
20Anaemia56

* This side effect also appears in "Top 10 Side Effects of EPLERENONE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking EPLERENONE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hypertension833
2Cardiac failure646
3Product used for unknown indication517
4Cardiac failure congestive308
5Cardiac failure chronic142
6Cardiac disorder84
7Acute myocardial infarction68
8Myocardial infarction52
9Blood pressure46
10Ill-defined disorder45

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for EPLERENONE

Total Reports Filed with FDA: 8913


Number of FDA Adverse Event Reports by Patient Age for EPLERENONE

Total Reports Filed with FDA: 8913*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Eplerenone (Eplerenone, Inspra)

Charts are based on 8913 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and EPLERENONE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.