ADO TRASTUZUMAB EMTANSINE

N/A

Manufactured by Genentech, Inc.

19,599 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ADO TRASTUZUMAB EMTANSINE

ADO TRASTUZUMAB EMTANSINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for ADO TRASTUZUMAB EMTANSINE include DISEASE PROGRESSION, FATIGUE, NAUSEA, OFF LABEL USE, DIARRHOEA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ADO TRASTUZUMAB EMTANSINE.

Top Adverse Reactions

DISEASE PROGRESSION771 reports
FATIGUE743 reports
NAUSEA726 reports
OFF LABEL USE632 reports
DIARRHOEA594 reports
DEATH536 reports
THROMBOCYTOPENIA467 reports
NEUROPATHY PERIPHERAL449 reports
PLATELET COUNT DECREASED430 reports
HEADACHE428 reports
DRUG INEFFECTIVE402 reports
METASTASES TO CENTRAL NERVOUS SYSTEM402 reports
VOMITING340 reports
PYREXIA321 reports
EPISTAXIS316 reports
WEIGHT DECREASED313 reports
DYSPNOEA297 reports
ASTHENIA296 reports
PAIN285 reports
PNEUMONIA277 reports
CONSTIPATION266 reports
COUGH242 reports
MALIGNANT NEOPLASM PROGRESSION242 reports
ANAEMIA230 reports
RASH229 reports
NO ADVERSE EVENT218 reports
NASOPHARYNGITIS208 reports
DECREASED APPETITE206 reports
EJECTION FRACTION DECREASED204 reports
NEUTROPENIA195 reports
ARTHRALGIA193 reports
DIZZINESS191 reports
BACK PAIN185 reports
ALANINE AMINOTRANSFERASE INCREASED177 reports
INFUSION RELATED REACTION172 reports
MALAISE170 reports
MYALGIA170 reports
MYELOSUPPRESSION168 reports
ASPARTATE AMINOTRANSFERASE INCREASED166 reports
URINARY TRACT INFECTION161 reports
PLEURAL EFFUSION160 reports
ABDOMINAL PAIN158 reports
METASTASES TO LYMPH NODES156 reports
SEIZURE152 reports
PARAESTHESIA151 reports
ALOPECIA149 reports
METASTASES TO LUNG147 reports
BREAST CANCER METASTATIC144 reports
HYPOAESTHESIA141 reports
METASTASES TO BONE139 reports
PAIN IN EXTREMITY137 reports
WHITE BLOOD CELL COUNT DECREASED133 reports
NEOPLASM PROGRESSION131 reports
STOMATITIS130 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME128 reports
BLOOD PRESSURE INCREASED126 reports
PRURITUS122 reports
BREAST CANCER121 reports
HYPERTENSION116 reports
INTENTIONAL PRODUCT USE ISSUE113 reports
FEBRILE NEUTROPENIA112 reports
INTERSTITIAL LUNG DISEASE111 reports
BLOOD ALKALINE PHOSPHATASE INCREASED110 reports
CHILLS110 reports
DRY SKIN110 reports
HYPOKALAEMIA110 reports
PNEUMONITIS110 reports
HEPATIC ENZYME INCREASED108 reports
PERIPHERAL SWELLING108 reports
WEIGHT INCREASED107 reports
HEPATOTOXICITY106 reports
ILL DEFINED DISORDER105 reports
INSOMNIA105 reports
METASTASES TO LIVER105 reports
BLOOD BILIRUBIN INCREASED104 reports
BLOOD LACTATE DEHYDROGENASE INCREASED101 reports
SEPSIS101 reports
GENERAL PHYSICAL HEALTH DETERIORATION100 reports
BONE PAIN98 reports
MUSCULAR WEAKNESS98 reports
SKIN FISSURES97 reports
COVID 1996 reports
CHEST PAIN93 reports
DRY MOUTH93 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED92 reports
MUCOSAL INFLAMMATION92 reports
HYPERSENSITIVITY91 reports
LIVER DISORDER88 reports
PALPITATIONS88 reports
HYPOTENSION87 reports
MUSCLE SPASMS84 reports
POLYNEUROPATHY84 reports
VISION BLURRED81 reports
C REACTIVE PROTEIN INCREASED80 reports
CELLULITIS78 reports
FALL78 reports
VASCULAR DEVICE INFECTION78 reports
CANDIDA INFECTION77 reports
NEUTROPHIL COUNT DECREASED76 reports
STRESS75 reports

Report Outcomes

Out of 8,158 classified reports for ADO TRASTUZUMAB EMTANSINE:

Serious 82.4%Non-Serious 17.6%

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 Breakdown

Reports by Sex

Female6,746 (97.3%)
Male179 (2.6%)
Unknown11 (0.2%)

Reports by Age

Age 58167 reports
Age 60166 reports
Age 52160 reports
Age 47156 reports
Age 54152 reports
Age 57152 reports
Age 55149 reports
Age 65149 reports
Age 63142 reports
Age 64141 reports
Age 56138 reports
Age 61138 reports
Age 62138 reports
Age 53133 reports
Age 66131 reports
Age 48130 reports
Age 59130 reports
Age 50118 reports
Age 42115 reports
Age 51112 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ADO TRASTUZUMAB EMTANSINE?

This profile reflects 19,599 FDA FAERS reports that mention ADO TRASTUZUMAB EMTANSINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ADO TRASTUZUMAB EMTANSINE?

Frequently reported terms in FAERS include DISEASE PROGRESSION, FATIGUE, NAUSEA, OFF LABEL USE, DIARRHOEA, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ADO TRASTUZUMAB EMTANSINE?

Labeling and FAERS entries often list Genentech, Inc. in connection with ADO TRASTUZUMAB EMTANSINE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.