NEORAL: 258 Adverse Event Reports & Safety Profile
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258
Total FAERS Reports
49 (19.0%)
Deaths Reported
132
Hospitalizations
258
As Primary/Secondary Suspect
13
Life-Threatening
9
Disabilities
First Report: 1996 · Latest Report: 20140525
What Are the Most Common NEORAL Side Effects?
#1 Most Reported
Blood creatinine increased
18 reports (7.0%)
#2 Most Reported
Death
17 reports (6.6%)
#3 Most Reported
Immunosuppressant drug level increased
14 reports (5.4%)
All NEORAL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Blood creatinine increased | 18 | 7.0% | 2 | 7 |
| Death | 17 | 6.6% | 17 | 1 |
| Immunosuppressant drug level increased | 14 | 5.4% | 3 | 7 |
| Renal failure | 13 | 5.0% | 3 | 7 |
| Interstitial lung disease | 11 | 4.3% | 6 | 3 |
| Kidney transplant rejection | 11 | 4.3% | 3 | 7 |
| Renal impairment | 11 | 4.3% | 1 | 3 |
| Maternal exposure during pregnancy | 10 | 3.9% | 0 | 3 |
| Oral administration complication | 9 | 3.5% | 4 | 4 |
| Pyrexia | 9 | 3.5% | 2 | 5 |
| Renal failure acute | 9 | 3.5% | 0 | 8 |
| Drug interaction | 8 | 3.1% | 1 | 6 |
| Dyspnoea | 8 | 3.1% | 4 | 7 |
| Oedema | 8 | 3.1% | 2 | 3 |
| Oedema peripheral | 8 | 3.1% | 1 | 8 |
| Diabetes mellitus | 7 | 2.7% | 0 | 2 |
| Drug ineffective | 7 | 2.7% | 2 | 3 |
| General physical health deterioration | 7 | 2.7% | 5 | 5 |
| Hepatic function abnormal | 7 | 2.7% | 3 | 4 |
| Platelet count decreased | 7 | 2.7% | 0 | 4 |
Who Reports NEORAL Side Effects? Age & Gender Data
Average age: 54.8 years. Most reports from: JP. View detailed demographics →
Is NEORAL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 1 |
| 2004 | 4 | 0 | 4 |
| 2007 | 1 | 1 | 1 |
| 2008 | 1 | 1 | 0 |
| 2009 | 1 | 0 | 1 |
| 2010 | 3 | 1 | 2 |
| 2011 | 14 | 2 | 9 |
| 2012 | 27 | 4 | 17 |
| 2013 | 49 | 5 | 36 |
| 2014 | 43 | 9 | 25 |
What Is NEORAL Used For?
| Indication | Reports |
|---|---|
| Renal transplant | 52 |
| Off label use | 22 |
| Interstitial lung disease | 18 |
| Prophylaxis against transplant rejection | 14 |
| Product used for unknown indication | 13 |
| Immunosuppression | 12 |
| Nephrotic syndrome | 10 |
| Aplastic anaemia | 8 |
| Heart transplant | 8 |
| Liver transplant | 8 |
NEORAL vs Alternatives: Which Is Safer?
NEORAL vs NEOSTIGMINE
NEORAL vs NEOSTIGMINE METHYLSULFATE
NEORAL vs NEPAFENAC
NEORAL vs NERATINIB
NEORAL vs NETARSUDIL
NEORAL vs NETUPITANT\PALONOSETRON
NEORAL vs NEULASTA
NEORAL vs NEUPOGEN
NEORAL vs NEUPRO
NEORAL vs NEURONTIN
Official FDA Label for NEORAL
Official prescribing information from the FDA-approved drug label.