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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.

INVESTIGATIONAL PRODUCT: 5,374 Adverse Event Reports & Safety Profile

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5,374
Total FAERS Reports
740 (13.8%)
Deaths Reported
4,035
Hospitalizations
5,374
As Primary/Secondary Suspect
569
Life-Threatening
92
Disabilities

First Report: 19971229 · Latest Report: 20250911

What Are the Most Common INVESTIGATIONAL PRODUCT Side Effects?

#1 Most Reported
Febrile neutropenia
241 reports (4.5%)
#2 Most Reported
Pneumonia
229 reports (4.3%)
#3 Most Reported
Acute kidney injury
198 reports (3.7%)

All INVESTIGATIONAL PRODUCT Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Febrile neutropenia 241 4.5% 29 215
Pneumonia 229 4.3% 69 209
Acute kidney injury 198 3.7% 35 185
Pyrexia 189 3.5% 17 171
Anaemia 176 3.3% 21 151
Diarrhoea 170 3.2% 28 131
Sepsis 168 3.1% 66 147
Dyspnoea 156 2.9% 26 124
Nausea 134 2.5% 14 93
Hypotension 130 2.4% 22 116
Vomiting 128 2.4% 15 99
Neutropenia 126 2.3% 16 68
Dehydration 113 2.1% 8 103
Fatigue 111 2.1% 18 77
Death 102 1.9% 102 33
Atrial fibrillation 97 1.8% 20 85
Cytokine release syndrome 97 1.8% 11 69
Disease progression 93 1.7% 63 48
Thrombocytopenia 90 1.7% 16 58
Alanine aminotransferase increased 89 1.7% 3 42

Who Reports INVESTIGATIONAL PRODUCT Side Effects? Age & Gender Data

Gender: 47.2% female, 52.8% male. Average age: 59.3 years. Most reports from: US. View detailed demographics →

Is INVESTIGATIONAL PRODUCT Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2005 2 0 2
2006 6 0 2
2007 8 0 5
2008 4 1 0
2009 9 1 7
2010 17 5 12
2011 45 5 39
2012 103 19 84
2013 149 24 110
2014 384 43 309
2015 516 72 408
2016 634 92 535
2017 614 74 519
2018 658 67 556
2019 441 60 344
2020 225 32 178
2021 311 51 268
2022 294 25 260
2023 236 23 186
2024 77 6 58
2025 30 1 21

View full timeline →

What Is INVESTIGATIONAL PRODUCT Used For?

IndicationReports
Non-small cell lung cancer 288
Acute myeloid leukaemia 210
Product used for unknown indication 197
Malignant melanoma 181
Breast cancer 168
Plasma cell myeloma 151
Chronic lymphocytic leukaemia 104
Cardiac failure chronic 103
Neoplasm 101
Chronic obstructive pulmonary disease 89

INVESTIGATIONAL PRODUCT vs Alternatives: Which Is Safer?

INVESTIGATIONAL PRODUCT vs INVOKANA INVESTIGATIONAL PRODUCT vs IOBENGUANE I-131 INVESTIGATIONAL PRODUCT vs IOBITRIDOL INVESTIGATIONAL PRODUCT vs IODINE INVESTIGATIONAL PRODUCT vs IODINE\IOFLUPANE I-123 INVESTIGATIONAL PRODUCT vs IODIXANOL INVESTIGATIONAL PRODUCT vs IOHEXOL INVESTIGATIONAL PRODUCT vs IOMEPROL INVESTIGATIONAL PRODUCT vs IOPAMIDOL INVESTIGATIONAL PRODUCT vs IOPROMIDE

Official FDA Label for INVESTIGATIONAL PRODUCT

Official prescribing information from the FDA-approved drug label.