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Neratinib Side Effects

The most commonly reported side effects of neratinib include diarrhoea, nausea, and fatigue, based on 2,276 FDA adverse event reports from 2009 to 2025.

Neratinib side effects

Percentages show how often each reaction appears relative to total reports for neratinib.

1
Diarrhoea54.0%1,230
2
Nausea24.0%546
3
Fatigue20.4%464
4
Off Label Use17.8%406
5
Vomiting13.6%310
6
Constipation12.0%273
7
Decreased Appetite11.0%251
8
Death8.4%192
9
Disease Progression6.9%156
10
Dehydration6.1%139
11
Weight Decreased6.0%136
12
Abdominal Pain5.1%117
13
Headache5.0%114
14
Asthenia4.4%100
15
Dizziness4.4%100

These are voluntary reports and do not establish that neratinib caused these reactions.

Report severity

58.6%Serious1,334 reports
29.7%Hospitalizations676 reports
15.4%Fatal351 reports

Seriousness is determined by the reporter, not by OpenClaim.

Neratinib drug interactions

Other drugs that appear in adverse event reports alongside neratinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Trastuzumab15.2%347
2
Capecitabine12.7%290
3
Pertuzumab10.6%241
4
Docetaxel9.1%208
5
Paclitaxel5.4%122
6
Eribulin-mesylate3.5%80
7
Vinorelbine-tartrate3.4%78
8
Loperamide-hydrochloride3.1%70
9
Tamoxifen-citrate2.7%61
10
Exemestane2.7%61
11
Cyclophosphamide2.1%47
12
Lapatinib-ditosylate2.0%46
13
Letrozole2.0%46
14
Anastrozole1.8%42
15
Carboplatin1.6%37

Taken alongside

1
Loperamide-hydrochloride27.4%623
2
Acetaminophen9.0%205
3
Dexamethasone8.6%196
4
Ergocalciferol7.5%171
5
Ondansetron7.2%163
6
Omeprazole6.4%146
7
Levothyroxine-sodium5.8%131
8
Gabapentin5.4%122
9
Capecitabine5.3%121
10
Lansoprazole4.7%107
11
Zoledronic-acid4.5%103
12
Anastrozole4.3%99
13
Metoclopramide-hydrochloride4.3%98
14
Budesonide4.3%98
15
Metformin4.3%97

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports neratinib side effects

22.5% of neratinib adverse event reports involve female patients and 0.7% involve male patients. The largest age group is adult at 71%. These figures reflect who reports side effects, not underlying risk.

Sex

Female22.5%
Male0.7%
Unknown76.8%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6471.2%
65+28.8%

What is neratinib used for

Conditions and purposes for which patients were taking neratinib when the adverse event was reported.

Adenocarcinoma Of The CervixAdenocarcinoma PancreasAdjuvant TherapyAdenocarcinomaAdenocarcinoma MetastaticAdjuvant TherapyBladder CancerBlood Brain Barrier DefectBone CancerBrain Cancer MetastaticBrain NeoplasmBrain Neoplasm MalignantBreast CancerBreast Cancer FemaleBreast Cancer In Situ

Showing 15 of 129 indications

Neratinib brand names and reporting trend

Quarterly reports (20092025)

20092012202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking neratinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.