AMITIZA: 52 Adverse Event Reports & Safety Profile
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52
Total FAERS Reports
2 (3.8%)
Deaths Reported
7
Hospitalizations
52
As Primary/Secondary Suspect
2
Life-Threatening
1
Disabilities
First Report: 20120808 · Latest Report: 20140613
What Are the Most Common AMITIZA Side Effects?
#1 Most Reported
Dyspnoea
17 reports (32.7%)
#2 Most Reported
Nausea
12 reports (23.1%)
#3 Most Reported
Abdominal pain
9 reports (17.3%)
All AMITIZA Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Dyspnoea | 17 | 32.7% | 0 | 0 |
| Nausea | 12 | 23.1% | 1 | 0 |
| Abdominal pain | 9 | 17.3% | 0 | 0 |
| Chest discomfort | 5 | 9.6% | 0 | 0 |
| Headache | 5 | 9.6% | 0 | 1 |
Who Reports AMITIZA Side Effects? Age & Gender Data
Average age: 56.6 years. Most reports from: JP. View detailed demographics →
Is AMITIZA Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2012 | 2 | 0 | 0 |
| 2013 | 9 | 0 | 2 |
| 2014 | 29 | 2 | 1 |
What Is AMITIZA Used For?
| Indication | Reports |
|---|---|
| Constipation | 39 |
Official FDA Label for AMITIZA
Official prescribing information from the FDA-approved drug label.