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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

AFINITOR: 708 Adverse Event Reports & Safety Profile

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708
Total FAERS Reports
284 (40.1%)
Deaths Reported
234
Hospitalizations
708
As Primary/Secondary Suspect
25
Life-Threatening
14
Disabilities

First Report: 200704 · Latest Report: 20140625

What Are the Most Common AFINITOR Side Effects?

#1 Most Reported
Death
192 reports (27.1%)
#2 Most Reported
Malignant neoplasm progression
70 reports (9.9%)
#3 Most Reported
Dyspnoea
58 reports (8.2%)

All AFINITOR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 192 27.1% 192 22
Malignant neoplasm progression 70 9.9% 47 25
Dyspnoea 58 8.2% 19 28
Stomatitis 57 8.1% 17 17
Diarrhoea 47 6.6% 11 27
Fatigue 44 6.2% 9 16
Cough 34 4.8% 8 16
Pyrexia 34 4.8% 10 29
Rash 29 4.1% 7 10
Nausea 28 4.0% 7 15
Drug ineffective 27 3.8% 5 5
Anaemia 26 3.7% 11 14
General physical health deterioration 26 3.7% 17 14
Pneumonitis 26 3.7% 9 10
Asthenia 25 3.5% 13 19
Decreased appetite 25 3.5% 9 11
Vomiting 24 3.4% 6 19
Malaise 21 3.0% 8 13
Pneumonia 20 2.8% 10 16
Dehydration 16 2.3% 11 10

Who Reports AFINITOR Side Effects? Age & Gender Data

Average age: 56.4 years. Most reports from: US. View detailed demographics →

Is AFINITOR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 1 0 0
2010 5 4 4
2011 13 4 8
2012 41 14 21
2013 168 60 83
2014 215 65 71

View full timeline →

What Is AFINITOR Used For?

IndicationReports
Breast cancer 153
Breast cancer metastatic 85
Pancreatic neuroendocrine tumour 41
Renal cancer 35
Metastatic renal cell carcinoma 27
Renal cell carcinoma 27
Off label use 26
Neuroendocrine tumour 24
Angiomyolipoma 17
Neoplasm malignant 13

AFINITOR vs Alternatives: Which Is Safer?

AFINITOR vs AFLIBERCEPT AFINITOR vs AGALSIDASE ALFA AFINITOR vs AGALSIDASE BETA AFINITOR vs AGOMELATINE AFINITOR vs ALAWAY AFINITOR vs ALBENDAZOLE AFINITOR vs ALBIGLUTIDE AFINITOR vs ALBUMIN AFINITOR vs ALBUMIN HUMAN AFINITOR vs ALBUTEROL

Official FDA Label for AFINITOR

Official prescribing information from the FDA-approved drug label.