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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.

GEMCITABINE\OXALIPLATIN: 80 Adverse Event Reports & Safety Profile

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80
Total FAERS Reports
16 (20.0%)
Deaths Reported
10
Hospitalizations
80
As Primary/Secondary Suspect
2
Life-Threatening

Active Ingredient: GEMCITABINE HYDROCHLORIDE\OXALIPLATIN ·

First Report: 20110101 · Latest Report: 20250423

What Are the Most Common GEMCITABINE\OXALIPLATIN Side Effects?

#1 Most Reported
Lymphoma
33 reports (41.3%)
#2 Most Reported
Disease progression
21 reports (26.3%)
#3 Most Reported
Off label use
9 reports (11.3%)

All GEMCITABINE\OXALIPLATIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Lymphoma 33 41.3% 4 3
Disease progression 21 26.3% 6 4
Off label use 9 11.3% 3 2
Platelet count decreased 8 10.0% 6 4
Acute kidney injury 7 8.8% 7 4
Diarrhoea 7 8.8% 7 4
Malignant neoplasm progression 7 8.8% 1 0
Tumour lysis syndrome 6 7.5% 6 4
Vomiting 6 7.5% 6 4
Burkitt's lymphoma 5 6.3% 5 4
Chest discomfort 5 6.3% 5 4
Chest pain 5 6.3% 5 4
Cough 5 6.3% 5 4
Cytomegalovirus infection 5 6.3% 0 0
Epstein-barr virus infection 5 6.3% 0 0
Gastric dilatation 5 6.3% 5 4
Hyperkalaemia 5 6.3% 5 4
Post procedural haemorrhage 5 6.3% 5 4
Restlessness 5 6.3% 5 4
Sepsis 5 6.3% 5 2

Who Reports GEMCITABINE\OXALIPLATIN Side Effects? Age & Gender Data

Gender: 46.0% female, 54.0% male. Average age: 55.5 years. Most reports from: DE. View detailed demographics →

Is GEMCITABINE\OXALIPLATIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 0
2014 1 0 1
2016 1 1 1
2018 8 5 4
2019 2 1 0
2020 2 0 0
2022 3 1 0
2023 1 0 0
2024 1 0 1
2025 1 0 1

View full timeline →

What Is GEMCITABINE\OXALIPLATIN Used For?

IndicationReports
Diffuse large b-cell lymphoma 54

Official FDA Label for GEMCITABINE\OXALIPLATIN

Official prescribing information from the FDA-approved drug label.