GLEEVEC: 266 Adverse Event Reports & Safety Profile
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266
Total FAERS Reports
94 (35.3%)
Deaths Reported
76
Hospitalizations
266
As Primary/Secondary Suspect
7
Life-Threatening
5
Disabilities
First Report: 2005 · Latest Report: 20140621
What Are the Most Common GLEEVEC Side Effects?
#1 Most Reported
Death
72 reports (27.1%)
#2 Most Reported
Nausea
26 reports (9.8%)
#3 Most Reported
Diarrhoea
24 reports (9.0%)
All GLEEVEC Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 72 | 27.1% | 72 | 3 |
| Nausea | 26 | 9.8% | 3 | 10 |
| Diarrhoea | 24 | 9.0% | 2 | 9 |
| Fatigue | 23 | 8.7% | 1 | 8 |
| Vomiting | 23 | 8.7% | 3 | 11 |
| Fall | 20 | 7.5% | 1 | 12 |
| Muscle spasms | 18 | 6.8% | 1 | 8 |
| Asthenia | 15 | 5.6% | 1 | 10 |
| Malaise | 15 | 5.6% | 2 | 8 |
| Rash | 14 | 5.3% | 0 | 3 |
| Malignant neoplasm progression | 12 | 4.5% | 4 | 8 |
| Swelling | 12 | 4.5% | 1 | 7 |
| Myalgia | 11 | 4.1% | 0 | 3 |
| Pain | 11 | 4.1% | 0 | 6 |
| Cerebrovascular accident | 10 | 3.8% | 2 | 4 |
| Dyspnoea | 10 | 3.8% | 3 | 7 |
| Second primary malignancy | 10 | 3.8% | 1 | 2 |
| White blood cell count decreased | 10 | 3.8% | 1 | 3 |
| Abdominal discomfort | 9 | 3.4% | 1 | 4 |
| Abdominal pain | 9 | 3.4% | 0 | 5 |
Who Reports GLEEVEC Side Effects? Age & Gender Data
Average age: 64.8 years. Most reports from: COUNTRY NOT SPECIFIED. View detailed demographics →
Is GLEEVEC Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 3 | 1 | 1 |
| 2007 | 1 | 0 | 1 |
| 2008 | 1 | 0 | 0 |
| 2010 | 7 | 0 | 3 |
| 2011 | 7 | 1 | 4 |
| 2012 | 13 | 1 | 6 |
| 2013 | 36 | 14 | 15 |
| 2014 | 70 | 36 | 16 |
What Is GLEEVEC Used For?
| Indication | Reports |
|---|---|
| Chronic myeloid leukaemia | 94 |
| Gastrointestinal stromal tumour | 28 |
| Gastric cancer | 9 |
| Neoplasm malignant | 9 |
| Soft tissue cancer | 7 |
| Soft tissue neoplasm | 7 |
| Soft tissue sarcoma | 6 |
| Acute lymphocytic leukaemia | 5 |
GLEEVEC vs Alternatives: Which Is Safer?
GLEEVEC vs GLICLAZIDE
GLEEVEC vs GLIMEPIRIDE
GLEEVEC vs GLIMEPIRIDE\ROSIGLITAZONE
GLEEVEC vs GLIPIZIDE
GLEEVEC vs GLIVEC
GLEEVEC vs GLOFITAMAB
GLEEVEC vs GLOFITAMAB-GXBM
GLEEVEC vs GLUCAGON
GLEEVEC vs GLUCAGON\GLUCAGON\WATER
GLEEVEC vs GLUCARPIDASE
Official FDA Label for GLEEVEC
Official prescribing information from the FDA-approved drug label.