SANDIMMUN: 48 Adverse Event Reports & Safety Profile
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48
Total FAERS Reports
11 (22.9%)
Deaths Reported
30
Hospitalizations
48
As Primary/Secondary Suspect
6
Life-Threatening
1
Disabilities
First Report: 2007 · Latest Report: 20140511
What Are the Most Common SANDIMMUN Side Effects?
#1 Most Reported
Jaundice
7 reports (14.6%)
#2 Most Reported
Hepatic enzyme increased
7 reports (14.6%)
#3 Most Reported
Haemolysis
7 reports (14.6%)
All SANDIMMUN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Blood bilirubin increased | 7 | 14.6% | 0 | 7 |
| Haemolysis | 7 | 14.6% | 0 | 7 |
| Hepatic enzyme increased | 7 | 14.6% | 0 | 7 |
| Jaundice | 7 | 14.6% | 0 | 7 |
Who Reports SANDIMMUN Side Effects? Age & Gender Data
Average age: 52.1 years. Most reports from: JP. View detailed demographics →
Is SANDIMMUN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 2 | 1 | 0 |
| 2008 | 1 | 0 | 1 |
| 2009 | 4 | 0 | 3 |
| 2011 | 3 | 0 | 2 |
| 2012 | 5 | 2 | 2 |
| 2013 | 14 | 2 | 11 |
| 2014 | 7 | 3 | 4 |
What Is SANDIMMUN Used For?
| Indication | Reports |
|---|---|
| Renal transplant | 7 |
| Prophylaxis | 6 |
| Off label use | 5 |
Official FDA Label for SANDIMMUN
Official prescribing information from the FDA-approved drug label.