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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.

PYROTINIB: 245 Adverse Event Reports & Safety Profile

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245
Total FAERS Reports
8 (3.3%)
Deaths Reported
118
Hospitalizations
245
As Primary/Secondary Suspect
14
Life-Threatening
3
Disabilities

First Report: 20160214 · Latest Report: 20250908

What Are the Most Common PYROTINIB Side Effects?

#1 Most Reported
Myelosuppression
62 reports (25.3%)
#2 Most Reported
Diarrhoea
57 reports (23.3%)
#3 Most Reported
Vomiting
39 reports (15.9%)

All PYROTINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Myelosuppression 62 25.3% 2 35
Diarrhoea 57 23.3% 6 10
Vomiting 39 15.9% 3 7
Nausea 35 14.3% 4 4
Alanine aminotransferase increased 32 13.1% 3 14
Anaemia 28 11.4% 3 1
Palmar-plantar erythrodysaesthesia syndrome 28 11.4% 2 1
Aspartate aminotransferase increased 26 10.6% 3 8
Hypokalaemia 25 10.2% 3 9
White blood cell count decreased 25 10.2% 4 10
Fatigue 22 9.0% 3 0
Disease progression 21 8.6% 0 4
Thrombocytopenia 21 8.6% 0 1
Decreased appetite 20 8.2% 6 1
Neutropenia 20 8.2% 0 0
Leukopenia 19 7.8% 0 0
Stomatitis 17 6.9% 2 1
Neutrophil count decreased 16 6.5% 4 5
Platelet count decreased 16 6.5% 1 6
Asthenia 15 6.1% 1 6

Who Reports PYROTINIB Side Effects? Age & Gender Data

Gender: 95.3% female, 4.7% male. Average age: 53.1 years. Most reports from: CN. View detailed demographics →

Is PYROTINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2016 1 0 0
2017 1 0 0
2018 1 0 1
2019 7 0 6
2020 24 1 11
2021 33 1 29
2022 20 0 14
2023 27 0 21
2024 31 0 18
2025 21 0 14

View full timeline →

What Is PYROTINIB Used For?

IndicationReports
Breast cancer 70
Breast cancer metastatic 52
Her2 positive breast cancer 44
Invasive ductal breast carcinoma 19
Invasive breast carcinoma 8
Metastases to central nervous system 7
Chemotherapy 5

PYROTINIB vs Alternatives: Which Is Safer?

PYROTINIB vs QSYMIA PYROTINIB vs QUETIAPINE PYROTINIB vs QUINACRINE PYROTINIB vs QUINAPRIL PYROTINIB vs QUINAPRIL\QUINAPRIL PYROTINIB vs QUINIDINE PYROTINIB vs QUININE PYROTINIB vs QUIZARTINIB PYROTINIB vs RABEPRAZOLE PYROTINIB vs RACECADOTRIL

Official FDA Label for PYROTINIB

Official prescribing information from the FDA-approved drug label.