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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.

TRASTUZUMAB-PKRB: 453 Adverse Event Reports & Safety Profile

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453
Total FAERS Reports
31 (6.8%)
Deaths Reported
169
Hospitalizations
453
As Primary/Secondary Suspect
53
Life-Threatening
15
Disabilities
Prescription
Status

FDA Application: 761091 ·

First Report: 20151110 · Latest Report: 20250711

What Are the Most Common TRASTUZUMAB-PKRB Side Effects?

#1 Most Reported
Off label use
75 reports (16.6%)
#2 Most Reported
Nausea
46 reports (10.2%)
#3 Most Reported
Tremor
39 reports (8.6%)

All TRASTUZUMAB-PKRB Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 75 16.6% 10 39
Nausea 46 10.2% 3 16
Tremor 39 8.6% 2 9
Diarrhoea 38 8.4% 1 19
Neutropenia 34 7.5% 0 11
Chills 30 6.6% 1 14
Dyspnoea 29 6.4% 3 12
Asthenia 27 6.0% 1 15
Pyrexia 27 6.0% 3 15
Vomiting 27 6.0% 4 16
Anaemia 25 5.5% 1 3
Cardiac failure 24 5.3% 0 5
Underdose 20 4.4% 0 7
Headache 19 4.2% 2 7
Hypotension 19 4.2% 1 14
Back pain 18 4.0% 1 3
Hypertension 17 3.8% 2 8
Thrombocytopenia 17 3.8% 0 3
Pneumonia 16 3.5% 5 15
Tachycardia 16 3.5% 2 7

Who Reports TRASTUZUMAB-PKRB Side Effects? Age & Gender Data

Gender: 93.0% female, 7.0% male. Average age: 53.8 years. Most reports from: KR. View detailed demographics →

Is TRASTUZUMAB-PKRB Getting Safer? Reports by Year

YearReportsDeathsHosp.
2015 1 1 1
2018 14 3 7
2019 61 4 34
2020 60 4 31
2021 78 9 49
2022 98 1 6
2023 40 3 13
2024 43 2 23
2025 8 0 0

View full timeline →

What Is TRASTUZUMAB-PKRB Used For?

IndicationReports
Breast cancer 212
Product used for unknown indication 41
Her2 positive breast cancer 32
Breast cancer metastatic 29
Salivary gland cancer 13
Breast cancer female 10
Invasive ductal breast carcinoma 10
Breast neoplasm 9
Bile duct cancer 8
Her-2 positive gastric cancer 8

TRASTUZUMAB-PKRB vs Alternatives: Which Is Safer?

TRASTUZUMAB-PKRB vs TRASTUZUMAB-QYYP TRASTUZUMAB-PKRB vs TRAVOPROST TRASTUZUMAB-PKRB vs TRAZODONE TRASTUZUMAB-PKRB vs TREANDA TRASTUZUMAB-PKRB vs TREMELIMUMAB TRASTUZUMAB-PKRB vs TREMELIMUMAB\TREMELIMUMAB-ACTL TRASTUZUMAB-PKRB vs TRENBOLONE TRASTUZUMAB-PKRB vs TREOSULFAN TRASTUZUMAB-PKRB vs TREPROSTINIL TRASTUZUMAB-PKRB vs TREPROSTINIL DIOLAMINE

Official FDA Label for TRASTUZUMAB-PKRB

Official prescribing information from the FDA-approved drug label.