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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\GEMCITABINE: 10,210 Adverse Event Reports & Safety Profile

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10,210
Total FAERS Reports
2,206 (21.6%)
Deaths Reported
3,666
Hospitalizations
10,210
As Primary/Secondary Suspect
767
Life-Threatening
81
Disabilities

Active Ingredient: GEMCITABINE\GEMCITABINE HYDROCHLORIDE ·

First Report: 20010621 · Latest Report: 20250601

What Are the Most Common GEMCITABINE\GEMCITABINE Side Effects?

#1 Most Reported
Disease progression
951 reports (9.3%)
#2 Most Reported
Thrombocytopenia
939 reports (9.2%)
#3 Most Reported
Neutropenia
907 reports (8.9%)

All GEMCITABINE\GEMCITABINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Disease progression 951 9.3% 310 84
Thrombocytopenia 939 9.2% 177 299
Neutropenia 907 8.9% 166 239
Anaemia 721 7.1% 149 299
Nausea 603 5.9% 81 303
Malignant neoplasm progression 551 5.4% 157 104
Off label use 542 5.3% 78 209
Death 511 5.0% 511 72
Vomiting 499 4.9% 71 268
Pyrexia 498 4.9% 70 348
Diarrhoea 452 4.4% 74 208
Fatigue 434 4.3% 81 169
Drug ineffective 397 3.9% 102 57
Febrile neutropenia 369 3.6% 102 191
Leukopenia 333 3.3% 43 76
Abdominal pain 299 2.9% 52 169
Dyspnoea 276 2.7% 64 171
Asthenia 272 2.7% 65 109
Neuropathy peripheral 263 2.6% 66 68
Pneumonia 261 2.6% 110 178

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

Gender: 47.8% female, 52.2% male. Average age: 60.6 years. Most reports from: US. View detailed demographics →

Is GEMCITABINE\GEMCITABINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 1 1
2002 1 0 1
2003 8 1 1
2005 6 2 6
2006 6 3 3
2007 11 3 4
2008 20 7 10
2009 36 16 22
2010 49 6 29
2011 67 17 40
2012 139 24 83
2013 149 27 78
2014 484 114 309
2015 699 136 478
2016 706 139 466
2017 797 150 481
2018 597 73 353
2019 297 19 162
2020 67 3 38
2021 34 1 13
2022 1 0 1
2023 1 0 1
2024 2 0 2
2025 1 0 1

View full timeline →

What Is GEMCITABINE\GEMCITABINE Used For?

IndicationReports
Pancreatic carcinoma 1,434
Pancreatic carcinoma metastatic 1,171
Adenocarcinoma pancreas 693
Product used for unknown indication 485
Non-small cell lung cancer 314
Cholangiocarcinoma 292
Ovarian cancer 256
Transitional cell carcinoma 255
Bladder cancer 240
Breast cancer metastatic 229

GEMCITABINE\GEMCITABINE vs Alternatives: Which Is Safer?

GEMCITABINE\GEMCITABINE vs GEMFIBROZIL GEMCITABINE\GEMCITABINE vs GEMTUZUMAB OZOGAMICIN GEMCITABINE\GEMCITABINE vs GEMZAR GEMCITABINE\GEMCITABINE vs GENTAMICIN GEMCITABINE\GEMCITABINE vs GEODON GEMCITABINE\GEMCITABINE vs GILENYA GEMCITABINE\GEMCITABINE vs GILOTRIF GEMCITABINE\GEMCITABINE vs GILTERITINIB GEMCITABINE\GEMCITABINE vs GIMERACIL\OTERACIL\TEGAFUR GEMCITABINE\GEMCITABINE vs GINKGO

Official FDA Label for GEMCITABINE\GEMCITABINE

Official prescribing information from the FDA-approved drug label.