COAPROVEL: 80 Adverse Event Reports & Safety Profile
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80
Total FAERS Reports
6 (7.5%)
Deaths Reported
29
Hospitalizations
80
As Primary/Secondary Suspect
4
Disabilities
First Report: 20070612 · Latest Report: 20140410
What Are the Most Common COAPROVEL Side Effects?
#1 Most Reported
Product contamination microbial
28 reports (35.0%)
#2 Most Reported
Hyponatraemia
8 reports (10.0%)
#3 Most Reported
Renal failure acute
7 reports (8.8%)
All COAPROVEL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product contamination microbial | 28 | 35.0% | 0 | 0 |
| Hyponatraemia | 8 | 10.0% | 0 | 8 |
| Bradycardia | 7 | 8.8% | 1 | 7 |
| Renal failure acute | 7 | 8.8% | 0 | 7 |
| Hypertension | 6 | 7.5% | 0 | 0 |
| Drug ineffective | 5 | 6.3% | 0 | 0 |
| Hypokalaemia | 5 | 6.3% | 1 | 5 |
| Hypotension | 5 | 6.3% | 1 | 5 |
Who Reports COAPROVEL Side Effects? Age & Gender Data
Average age: 71.5 years. Most reports from: SA. View detailed demographics →
Is COAPROVEL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2009 | 1 | 0 | 0 |
| 2010 | 2 | 0 | 2 |
| 2011 | 3 | 1 | 3 |
| 2012 | 4 | 0 | 1 |
| 2013 | 17 | 3 | 11 |
| 2014 | 18 | 1 | 10 |
What Is COAPROVEL Used For?
| Indication | Reports |
|---|---|
| Hypertension | 57 |
| Product used for unknown indication | 13 |
Official FDA Label for COAPROVEL
Official prescribing information from the FDA-approved drug label.