ALDACTONE: 132 Adverse Event Reports & Safety Profile
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132
Total FAERS Reports
17 (12.9%)
Deaths Reported
85
Hospitalizations
132
As Primary/Secondary Suspect
7
Life-Threatening
4
Disabilities
First Report: 20010205 · Latest Report: 20140511
What Are the Most Common ALDACTONE Side Effects?
#1 Most Reported
Renal failure acute
26 reports (19.7%)
#2 Most Reported
Hyperkalaemia
18 reports (13.6%)
#3 Most Reported
Drug interaction
18 reports (13.6%)
All ALDACTONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Renal failure acute | 26 | 19.7% | 1 | 26 |
| Drug interaction | 18 | 13.6% | 1 | 18 |
| Hyperkalaemia | 18 | 13.6% | 1 | 18 |
| Hypotension | 12 | 9.1% | 0 | 11 |
| Fall | 11 | 8.3% | 0 | 11 |
| Hyponatraemia | 11 | 8.3% | 1 | 10 |
| Vomiting | 10 | 7.6% | 1 | 10 |
| Drug hypersensitivity | 8 | 6.1% | 0 | 0 |
| Malaise | 8 | 6.1% | 0 | 7 |
| Bradycardia | 7 | 5.3% | 2 | 6 |
| Dyspnoea | 7 | 5.3% | 1 | 6 |
| Lactic acidosis | 7 | 5.3% | 0 | 7 |
| Cardiac failure | 6 | 4.6% | 0 | 6 |
| Confusional state | 6 | 4.6% | 0 | 6 |
| Dehydration | 6 | 4.6% | 0 | 6 |
| Renal failure | 6 | 4.6% | 1 | 6 |
| Agitation | 5 | 3.8% | 2 | 4 |
| Blood bilirubin increased | 5 | 3.8% | 5 | 3 |
| Chest pain | 5 | 3.8% | 0 | 3 |
| Hyperhidrosis | 5 | 3.8% | 1 | 4 |
Who Reports ALDACTONE Side Effects? Age & Gender Data
Average age: 68.7 years. Most reports from: FR. View detailed demographics →
Is ALDACTONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 4 | 2 | 4 |
| 2003 | 1 | 0 | 0 |
| 2005 | 1 | 0 | 1 |
| 2006 | 2 | 0 | 1 |
| 2008 | 7 | 2 | 6 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 0 |
| 2012 | 3 | 0 | 3 |
| 2013 | 58 | 8 | 47 |
| 2014 | 33 | 5 | 21 |
What Is ALDACTONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 24 |
| Hypertension | 23 |
| Cardiac failure | 8 |
ALDACTONE vs Alternatives: Which Is Safer?
ALDACTONE vs ALDESLEUKIN
ALDACTONE vs ALECTINIB
ALDACTONE vs ALEMTUZUMAB
ALDACTONE vs ALENDRONATE
ALDACTONE vs ALENDRONATE\CHOLECALCIFEROL
ALDACTONE vs ALENDRONIC ACID
ALDACTONE vs ALEVE
ALDACTONE vs ALEVE CAPLET
ALDACTONE vs ALFACALCIDOL
ALDACTONE vs ALFENTANIL
Official FDA Label for ALDACTONE
Official prescribing information from the FDA-approved drug label.