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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.

LAPATINIB: 1,983 Adverse Event Reports & Safety Profile

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1,983
Total FAERS Reports
267 (13.5%)
Deaths Reported
498
Hospitalizations
1,983
As Primary/Secondary Suspect
63
Life-Threatening
10
Disabilities

First Report: 20040314 · Latest Report: 20250908

What Are the Most Common LAPATINIB Side Effects?

#1 Most Reported
Diarrhoea
382 reports (19.3%)
#2 Most Reported
Disease progression
227 reports (11.4%)
#3 Most Reported
Palmar-plantar erythrodysaesthesia syndrome
182 reports (9.2%)

All LAPATINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 382 19.3% 35 131
Disease progression 227 11.5% 37 21
Palmar-plantar erythrodysaesthesia syndrome 182 9.2% 18 24
Malignant neoplasm progression 173 8.7% 41 21
Nausea 161 8.1% 17 67
Metastases to central nervous system 160 8.1% 32 32
Neutropenia 160 8.1% 11 27
Vomiting 155 7.8% 16 67
Asthenia 148 7.5% 19 38
Fatigue 139 7.0% 13 50
Off label use 118 6.0% 12 42
Rash 108 5.5% 8 18
Thrombocytopenia 102 5.1% 8 20
Metastases to lymph nodes 95 4.8% 3 29
Metastases to lung 92 4.6% 8 10
Anaemia 89 4.5% 9 15
Metastases to bone 86 4.3% 12 8
Drug ineffective 84 4.2% 20 7
Death 80 4.0% 79 17
Mucosal inflammation 80 4.0% 8 19

Who Reports LAPATINIB Side Effects? Age & Gender Data

Gender: 96.6% female, 3.4% male. Average age: 54.1 years. Most reports from: US. View detailed demographics →

Is LAPATINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 3 0 3
2005 2 0 1
2006 7 1 6
2007 11 0 6
2008 9 3 3
2009 77 29 27
2010 49 7 26
2011 46 4 14
2012 70 3 13
2013 87 15 31
2014 83 20 40
2015 60 11 15
2016 65 0 21
2017 87 7 36
2018 54 13 30
2019 83 11 52
2020 78 8 38
2021 87 12 32
2022 45 12 16
2023 26 5 6
2024 3 0 0
2025 1 0 0

View full timeline →

What Is LAPATINIB Used For?

IndicationReports
Breast cancer 447
Breast cancer metastatic 434
Her2 positive breast cancer 241
Product used for unknown indication 233
Her-2 positive breast cancer 151
Invasive ductal breast carcinoma 113
Breast cancer female 37
Neoplasm malignant 33
Metastases to central nervous system 30
Colorectal cancer metastatic 25

LAPATINIB vs Alternatives: Which Is Safer?

LAPATINIB vs LAPATINIB DITOSYLATE LAPATINIB vs LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN LAPATINIB vs LARONIDASE LAPATINIB vs LAROTRECTINIB LAPATINIB vs LASILIX LAPATINIB vs LASIX LAPATINIB vs LASMIDITAN LAPATINIB vs LATANOPROST LAPATINIB vs LATANOPROSTENE BUNOD LAPATINIB vs LATANOPROST\NETARSUDIL

Official FDA Label for LAPATINIB

Official prescribing information from the FDA-approved drug label.