82/100 · Critical
Manufactured by Genentech, Inc.
Trastuzumab Adverse Events: High Seriousness and Diverse Reactions
130,352 FDA adverse event reports analyzed
Last updated: 2026-05-12
TRASTUZUMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. Based on analysis of 130,352 FDA adverse event reports, TRASTUZUMAB has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for TRASTUZUMAB include DIARRHOEA, ALOPECIA, NAUSEA, FATIGUE, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TRASTUZUMAB.
Trastuzumab has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 130,352 adverse event reports for this medication, which is primarily manufactured by Genentech, Inc..
The most commonly reported adverse events include Diarrhoea, Alopecia, Nausea. Of classified reports, 85.3% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Trastuzumab is associated with a high number of serious adverse events, particularly death and disease progression.
The most common reactions include diarrhea, alopecia, and nausea, indicating a broad range of potential side effects. Cardiotoxicity and pulmonary issues are significant concerns, with multiple reports of cardiac failure and interstitial lung disease.
Patients taking Trastuzumab should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Trastuzumab can cause cardiotoxicity and pulmonary issues, and patients should be monitored for these conditions. Drug interactions are not specifically noted in the data. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Trastuzumab received a safety concern score of 82/100 (high concern). This is based on a 85.3% serious event ratio across 66,263 classified reports. The score accounts for 130,352 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 53,225, Male: 3,942, Unknown: 472. The most frequently reported age groups are age 54 (1,335 reports), age 58 (1,317 reports), age 55 (1,311 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 66,263 classified reports for TRASTUZUMAB:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Trastuzumab can cause cardiotoxicity and pulmonary issues, and patients should be monitored for these conditions. Drug interactions are not specifically noted in the data.
If you are taking Trastuzumab, here are important things to know. The most commonly reported side effects include diarrhoea, alopecia, nausea, fatigue, off label use. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Monitor for signs of cardiotoxicity and pulmonary issues, such as shortness of breath and chest pain. Report any adverse events to your healthcare provider promptly. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA continues to monitor trastuzumab for safety, particularly for serious outcomes like death and disease progression. Patients should report any adverse events to their healthcare provider.
The FDA has received approximately 130,352 adverse event reports associated with Trastuzumab. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Trastuzumab include Diarrhoea, Alopecia, Nausea, Fatigue, Off Label Use. By volume, the top reported reactions are: Diarrhoea (6,558 reports), Alopecia (4,968 reports), Nausea (4,438 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Trastuzumab.
Out of 66,263 classified reports, 56,536 (85.3%) were classified as serious and 9,727 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Trastuzumab break down by patient sex as follows: Female: 53,225, Male: 3,942, Unknown: 472. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Trastuzumab adverse events are: age 54: 1,335 reports, age 58: 1,317 reports, age 55: 1,311 reports, age 60: 1,298 reports, age 52: 1,283 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Trastuzumab adverse event reports is Genentech, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Trastuzumab include: Death, Disease Progression, Vomiting, Dyspnoea, Myelosuppression. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Trastuzumab to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Trastuzumab has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Trastuzumab is associated with a high number of serious adverse events, particularly death and disease progression.
Key safety signals identified in Trastuzumab's adverse event data include: Death and disease progression are among the most serious outcomes reported.. Cardiotoxicity and pulmonary issues are key safety signals, with multiple reports of cardiac failure and interstitial lung disease.. Neurological issues, including peripheral neuropathy and polyneuropathy, are also notable.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Trastuzumab can cause cardiotoxicity and pulmonary issues, and patients should be monitored for these conditions. Drug interactions are not specifically noted in the data. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Trastuzumab.
Monitor for signs of cardiotoxicity and pulmonary issues, such as shortness of breath and chest pain. Report any adverse events to your healthcare provider promptly.
Trastuzumab has 130,352 adverse event reports on file with the FDA. The most common reactions include diarrhea, alopecia, and nausea, indicating a broad range of potential side effects. The volume of reports for Trastuzumab reflects both the drug's usage level and the vigilance of the reporting community.
The FDA continues to monitor trastuzumab for safety, particularly for serious outcomes like death and disease progression. Patients should report any adverse events to their healthcare provider. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
Explore other medications manufactured by Genentech, Inc. and compare their safety profiles:
The following drugs share commonly reported adverse reactions with TRASTUZUMAB:
Drugs related to TRASTUZUMAB based on therapeutic use, drug class, or shared indications: