COLACE: 31 Adverse Event Reports & Safety Profile
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31
Total FAERS Reports
8 (25.8%)
Deaths Reported
13
Hospitalizations
31
As Primary/Secondary Suspect
3
Life-Threatening
First Report: 2012 · Latest Report: 20140429
What Are the Most Common COLACE Side Effects?
#1 Most Reported
Cardio-respiratory arrest
9 reports (29.0%)
#2 Most Reported
Haemorrhage intracranial
7 reports (22.6%)
#3 Most Reported
Acidosis
6 reports (19.4%)
All COLACE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Cardio-respiratory arrest | 9 | 29.0% | 8 | 7 |
| Haemorrhage intracranial | 7 | 22.6% | 6 | 7 |
| Acidosis | 6 | 19.4% | 6 | 6 |
| Renal failure | 5 | 16.1% | 5 | 5 |
Who Reports COLACE Side Effects? Age & Gender Data
Average age: 56.4 years. Most reports from: US. View detailed demographics →
Is COLACE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 1 | 0 | 0 |
| 2013 | 8 | 7 | 6 |
| 2014 | 6 | 0 | 2 |
What Is COLACE Used For?
| Indication | Reports |
|---|---|
| Constipation | 6 |
| Product used for unknown indication | 5 |
Official FDA Label for COLACE
Official prescribing information from the FDA-approved drug label.