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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 BIOSIMILARS: 160 Adverse Event Reports & Safety Profile

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160
Total FAERS Reports
43 (26.9%)
Deaths Reported
69
Hospitalizations
160
As Primary/Secondary Suspect
11
Life-Threatening
2
Disabilities

First Report: 2014 · Latest Report: 20230827

What Are the Most Common INVESTIGATIONAL BIOSIMILARS Side Effects?

#1 Most Reported
Underdose
42 reports (26.3%)
#2 Most Reported
Off label use
31 reports (19.4%)
#3 Most Reported
Overdose
30 reports (18.8%)

All INVESTIGATIONAL BIOSIMILARS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Underdose 42 26.3% 12 10
Off label use 31 19.4% 9 8
Overdose 30 18.8% 7 8
Neutrophil count decreased 29 18.1% 5 7
Anaemia 28 17.5% 8 9
Neuropathy peripheral 25 15.6% 2 2
Diarrhoea 23 14.4% 5 8
Decreased appetite 21 13.1% 7 7
Platelet count decreased 19 11.9% 3 4
Nausea 18 11.3% 2 2
Her2 positive gastric cancer 17 10.6% 17 4
Malaise 17 10.6% 2 2
White blood cell count decreased 16 10.0% 1 3
Constipation 15 9.4% 5 2
Intentional product use issue 15 9.4% 5 6
Disease progression 10 6.3% 4 6
Neutropenia 10 6.3% 1 1
Dyspnoea 9 5.6% 3 3
Hyponatraemia 9 5.6% 0 8
Palmar-plantar erythrodysaesthesia syndrome 9 5.6% 3 2

Who Reports INVESTIGATIONAL BIOSIMILARS Side Effects? Age & Gender Data

Gender: 67.3% female, 32.7% male. Average age: 55.9 years. Most reports from: JP. View detailed demographics →

Is INVESTIGATIONAL BIOSIMILARS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2015 1 0 1
2016 16 2 15
2017 5 0 4
2018 6 0 4
2019 22 5 11
2020 35 10 9
2021 26 9 7
2022 14 4 10
2023 5 2 4

View full timeline →

What Is INVESTIGATIONAL BIOSIMILARS Used For?

IndicationReports
Her2 positive gastric cancer 80
Breast cancer 16
Rheumatoid arthritis 15
Non-small cell lung cancer 11
Diffuse large b-cell lymphoma 7

INVESTIGATIONAL BIOSIMILARS vs Alternatives: Which Is Safer?

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

Official FDA Label for INVESTIGATIONAL BIOSIMILARS

Official prescribing information from the FDA-approved drug label.