ZELBORAF: 358 Adverse Event Reports & Safety Profile
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358
Total FAERS Reports
102 (28.5%)
Deaths Reported
84
Hospitalizations
358
As Primary/Secondary Suspect
7
Life-Threatening
11
Disabilities
First Report: 20111029 · Latest Report: 20140615
What Are the Most Common ZELBORAF Side Effects?
#1 Most Reported
Disease progression
62 reports (17.3%)
#2 Most Reported
Death
49 reports (13.7%)
#3 Most Reported
Rash
45 reports (12.6%)
All ZELBORAF Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Disease progression | 62 | 17.3% | 29 | 4 |
| Death | 49 | 13.7% | 49 | 4 |
| Rash | 45 | 12.6% | 4 | 10 |
| Arthralgia | 29 | 8.1% | 2 | 9 |
| Fatigue | 17 | 4.8% | 3 | 8 |
| Nausea | 16 | 4.5% | 3 | 10 |
| Asthenia | 14 | 3.9% | 2 | 4 |
| Dysphagia | 14 | 3.9% | 1 | 4 |
| Erythema | 14 | 3.9% | 4 | 2 |
| Photosensitivity reaction | 14 | 3.9% | 3 | 4 |
| Pyrexia | 13 | 3.6% | 1 | 6 |
| Diarrhoea | 12 | 3.4% | 4 | 6 |
| Pain in extremity | 12 | 3.4% | 1 | 5 |
| Drug ineffective | 11 | 3.1% | 6 | 3 |
| Malignant neoplasm progression | 11 | 3.1% | 7 | 2 |
| Skin papilloma | 11 | 3.1% | 1 | 6 |
| Vomiting | 11 | 3.1% | 3 | 8 |
| Alopecia | 10 | 2.8% | 3 | 3 |
| Hyperkeratosis | 10 | 2.8% | 1 | 3 |
| Metastases to central nervous system | 10 | 2.8% | 4 | 1 |
Who Reports ZELBORAF Side Effects? Age & Gender Data
Average age: 59.5 years. Most reports from: US. View detailed demographics →
Is ZELBORAF Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 4 | 0 | 1 |
| 2012 | 17 | 3 | 4 |
| 2013 | 80 | 19 | 23 |
| 2014 | 82 | 27 | 35 |
What Is ZELBORAF Used For?
| Indication | Reports |
|---|---|
| Metastatic malignant melanoma | 130 |
| Malignant melanoma | 109 |
| Product used for unknown indication | 90 |
| Neoplasm malignant | 22 |
ZELBORAF vs Alternatives: Which Is Safer?
ZELBORAF vs ZEMPLAR
ZELBORAF vs ZENATANE
ZELBORAF vs ZETIA
ZELBORAF vs ZICONOTIDE
ZELBORAF vs ZIDOVUDINE
ZELBORAF vs ZILEUTON
ZELBORAF vs ZILUCOPLAN
ZELBORAF vs ZIMBERELIMAB
ZELBORAF vs ZINC
ZELBORAF vs ZINC\ZINC
Official FDA Label for ZELBORAF
Official prescribing information from the FDA-approved drug label.