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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.

NERATINIB: 2,089 Adverse Event Reports & Safety Profile

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2,089
Total FAERS Reports
327 (15.7%)
Deaths Reported
609
Hospitalizations
2,089
As Primary/Secondary Suspect
26
Life-Threatening
9
Disabilities
Jul 17, 2017
FDA Approved
Prescription
Status
Yes
Generic Available

FDA Application: 208051 ·

Patent Expires: Oct 15, 2028 · First Report: 200103 · Latest Report: 20250825

What Are the Most Common NERATINIB Side Effects?

#1 Most Reported
Diarrhoea
1,193 reports (57.1%)
#2 Most Reported
Nausea
527 reports (25.2%)
#3 Most Reported
Fatigue
446 reports (21.3%)

All NERATINIB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 1,193 57.1% 150 358
Nausea 527 25.2% 56 150
Fatigue 446 21.4% 71 118
Off label use 383 18.3% 137 178
Vomiting 297 14.2% 44 128
Constipation 267 12.8% 23 67
Decreased appetite 245 11.7% 62 93
Death 181 8.7% 181 48
Disease progression 142 6.8% 92 78
Weight decreased 132 6.3% 55 55
Dehydration 129 6.2% 12 75
Abdominal pain 114 5.5% 19 29
Headache 110 5.3% 6 38
Dizziness 96 4.6% 6 32
Abdominal pain upper 95 4.6% 6 26
Asthenia 95 4.6% 18 36
Dyspepsia 94 4.5% 29 29
Rash 92 4.4% 2 11
Hospitalisation 88 4.2% 15 87
Cough 80 3.8% 38 51

Who Reports NERATINIB Side Effects? Age & Gender Data

Gender: 98.8% female, 1.2% male. Average age: 58.1 years. Most reports from: US. View detailed demographics →

Is NERATINIB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 1
2002 1 0 0
2008 1 1 1
2009 2 0 2
2010 16 3 13
2012 2 0 1
2013 6 0 2
2014 5 0 1
2015 35 27 23
2016 57 26 38
2017 314 15 48
2018 236 51 106
2019 180 63 85
2020 160 48 70
2021 85 14 35
2022 72 5 29
2023 71 14 32
2024 48 12 26
2025 21 3 10

View full timeline →

What Is NERATINIB Used For?

IndicationReports
Breast cancer 714
Breast cancer female 417
Product used for unknown indication 280
Her2 positive breast cancer 274
Breast cancer metastatic 207
Her-2 positive breast cancer 88
Neoplasm malignant 20
Metastatic neoplasm 19
Metastases to central nervous system 15
Off label use 15

NERATINIB vs Alternatives: Which Is Safer?

NERATINIB vs NETARSUDIL NERATINIB vs NETUPITANT\PALONOSETRON NERATINIB vs NEULASTA NERATINIB vs NEUPOGEN NERATINIB vs NEUPRO NERATINIB vs NEURONTIN NERATINIB vs NEVIRAPINE NERATINIB vs NEXAVAR NERATINIB vs NEXIUM NERATINIB vs NEXPLANON

Official FDA Label for NERATINIB

Official prescribing information from the FDA-approved drug label.