ONARTUZUMAB: 98 Adverse Event Reports & Safety Profile
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98
Total FAERS Reports
26 (26.5%)
Deaths Reported
84
Hospitalizations
98
As Primary/Secondary Suspect
8
Life-Threatening
4
Disabilities
First Report: 20111209 · Latest Report: 20140708
What Are the Most Common ONARTUZUMAB Side Effects?
#1 Most Reported
Pyrexia
12 reports (12.2%)
#2 Most Reported
Vomiting
11 reports (11.2%)
#3 Most Reported
Dehydration
11 reports (11.2%)
All ONARTUZUMAB Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Pyrexia | 12 | 12.2% | 3 | 12 |
| Dehydration | 11 | 11.2% | 5 | 10 |
| Vomiting | 11 | 11.2% | 2 | 11 |
| Fatigue | 9 | 9.2% | 3 | 8 |
| Nausea | 9 | 9.2% | 4 | 8 |
| Decreased appetite | 8 | 8.2% | 1 | 8 |
| Diarrhoea | 8 | 8.2% | 1 | 7 |
| Malignant neoplasm progression | 8 | 8.2% | 4 | 8 |
| Oedema peripheral | 8 | 8.2% | 3 | 6 |
| Pneumonia | 8 | 8.2% | 4 | 8 |
| Pulmonary embolism | 8 | 8.2% | 2 | 6 |
| Abdominal pain | 7 | 7.1% | 1 | 6 |
| Deep vein thrombosis | 7 | 7.1% | 1 | 5 |
| Dyspnoea | 6 | 6.1% | 3 | 5 |
| Asthenia | 5 | 5.1% | 2 | 4 |
| Neutropenia | 5 | 5.1% | 1 | 4 |
| Pleural effusion | 5 | 5.1% | 3 | 5 |
| Respiratory failure | 5 | 5.1% | 5 | 4 |
Who Reports ONARTUZUMAB Side Effects? Age & Gender Data
Gender: 38.5% female, 61.5% male. Average age: 60.4 years. Most reports from: US. View detailed demographics →
Is ONARTUZUMAB Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2012 | 21 | 7 | 19 |
| 2013 | 45 | 11 | 41 |
| 2014 | 23 | 3 | 20 |
What Is ONARTUZUMAB Used For?
| Indication | Reports |
|---|---|
| Gastrooesophageal cancer | 42 |
| Non-small cell lung cancer | 27 |
| Colorectal cancer metastatic | 8 |
Official FDA Label for ONARTUZUMAB
Official prescribing information from the FDA-approved drug label.