GLIVEC: 995 Adverse Event Reports & Safety Profile
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995
Total FAERS Reports
769 (77.3%)
Deaths Reported
131
Hospitalizations
995
As Primary/Secondary Suspect
15
Life-Threatening
11
Disabilities
First Report: 140002 · Latest Report: 20140620
What Are the Most Common GLIVEC Side Effects?
#1 Most Reported
Death
628 reports (63.1%)
#2 Most Reported
Malignant neoplasm progression
60 reports (6.0%)
#3 Most Reported
Gastrointestinal stromal tumour
40 reports (4.0%)
All GLIVEC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 628 | 63.1% | 628 | 14 |
| Malignant neoplasm progression | 60 | 6.0% | 53 | 12 |
| Gastrointestinal stromal tumour | 40 | 4.0% | 30 | 12 |
| Chronic myeloid leukaemia | 38 | 3.8% | 34 | 6 |
| Anaemia | 30 | 3.0% | 18 | 13 |
| Second primary malignancy | 27 | 2.7% | 5 | 12 |
| Pyrexia | 21 | 2.1% | 16 | 9 |
| Blast crisis in myelogenous leukaemia | 20 | 2.0% | 20 | 3 |
| Dyspnoea | 19 | 1.9% | 14 | 9 |
| Malaise | 16 | 1.6% | 7 | 6 |
| Thrombocytopenia | 16 | 1.6% | 10 | 5 |
| Vomiting | 16 | 1.6% | 9 | 11 |
| Diarrhoea | 15 | 1.5% | 6 | 8 |
| General physical health deterioration | 15 | 1.5% | 13 | 8 |
| Nausea | 15 | 1.5% | 10 | 8 |
| No therapeutic response | 15 | 1.5% | 12 | 3 |
| Oedema | 15 | 1.5% | 5 | 4 |
| Sepsis | 15 | 1.5% | 14 | 6 |
| Drug ineffective | 14 | 1.4% | 8 | 6 |
| White blood cell count increased | 14 | 1.4% | 8 | 3 |
Who Reports GLIVEC Side Effects? Age & Gender Data
Average age: 51.9 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is GLIVEC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2004 | 1 | 1 | 0 |
| 2005 | 1 | 0 | 0 |
| 2006 | 5 | 2 | 0 |
| 2007 | 3 | 1 | 1 |
| 2008 | 6 | 4 | 1 |
| 2009 | 14 | 7 | 4 |
| 2010 | 9 | 4 | 4 |
| 2011 | 22 | 15 | 5 |
| 2012 | 77 | 57 | 11 |
| 2013 | 371 | 321 | 37 |
| 2014 | 204 | 176 | 28 |
What Is GLIVEC Used For?
| Indication | Reports |
|---|---|
| Chronic myeloid leukaemia | 636 |
| Gastrointestinal stromal tumour | 231 |
| Acute lymphocytic leukaemia | 61 |
| Gastrointestinal neoplasm | 61 |
| Chromosome analysis abnormal | 14 |
| Acute myeloid leukaemia | 10 |
| Off label use | 6 |
GLIVEC vs Alternatives: Which Is Safer?
GLIVEC vs GLOFITAMAB
GLIVEC vs GLOFITAMAB-GXBM
GLIVEC vs GLUCAGON
GLIVEC vs GLUCAGON\GLUCAGON\WATER
GLIVEC vs GLUCARPIDASE
GLIVEC vs GLUCOPHAGE
GLIVEC vs GLUCOSAMINE
GLIVEC vs GLUTAMINE
GLIVEC vs GLUTATHIONE
GLIVEC vs GLYBURIDE
Official FDA Label for GLIVEC
Official prescribing information from the FDA-approved drug label.