TRASTUZUMAB-ANNS: 1,371 Adverse Event Reports & Safety Profile

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1,371

Total FAERS Reports

13 (0.9%)

Deaths Reported

Hospitalizations

1,371

As Primary/Secondary Suspect

Life-Threatening

Prescription

Status

FDA Application: 761073 ·

First Report: 2016 · Latest Report: 20250905

What Are the Most Common TRASTUZUMAB-ANNS Side Effects?

#1 Most Reported

Product storage error

346 reports (25.2%)

#2 Most Reported

Circumstance or information capable of leading to medication error

257 reports (18.7%)

#3 Most Reported

Off label use

104 reports (7.6%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Product storage error	346	25.2%	0	0
Circumstance or information capable of leading to medication error	257	18.8%	0	0
Off label use	104	7.6%	3	23
Intercepted product administration error	89	6.5%	0	0
Product dose omission issue	68	5.0%	0	0
Chills	58	4.2%	0	27
Dyspnoea	52	3.8%	1	16
Nausea	49	3.6%	1	10
Diarrhoea	48	3.5%	2	7
Rash	45	3.3%	0	1
Fatigue	42	3.1%	1	3
Intercepted product preparation error	42	3.1%	0	0
Product preparation error	40	2.9%	0	0
Accidental exposure to product	39	2.8%	0	0
Infusion related reaction	34	2.5%	0	2
Asthenia	31	2.3%	1	3
Vomiting	30	2.2%	1	12
Dizziness	28	2.0%	0	3
Unevaluable event	28	2.0%	1	0
Malaise	27	2.0%	0	1

Gender: 92.4% female, 7.6% male. Average age: 59.0 years. Most reports from: US. View detailed demographics →

Year	Reports	Deaths	Hosp.
2016	2	0	1
2017	1	1	1
2018	2	0	0
2019	59	2	15
2020	136	1	19
2021	92	2	7
2022	141	0	5
2023	165	2	9
2024	100	1	8
2025	33	0	5

Indication	Reports
Product used for unknown indication	871
Breast cancer	297
Breast cancer metastatic	36
Her2 positive breast cancer	34
Breast cancer female	25
Her-2 positive breast cancer	10
Endometrial cancer	9
Invasive ductal breast carcinoma	8
Off label use	8
Gastric cancer	7

Official prescribing information from the FDA-approved drug label.