FAM TRASTUZUMAB DERUXTECAN NXKI

N/A

Manufactured by Daiichi Sankyo Inc.

15,771 FDA adverse event reports analyzed

Last updated: 2026-04-14

About FAM TRASTUZUMAB DERUXTECAN NXKI

FAM TRASTUZUMAB DERUXTECAN NXKI is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Daiichi Sankyo Inc.. The most commonly reported adverse reactions for FAM TRASTUZUMAB DERUXTECAN NXKI include NAUSEA, INTERSTITIAL LUNG DISEASE, DISEASE PROGRESSION, DEATH, OFF LABEL USE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for FAM TRASTUZUMAB DERUXTECAN NXKI.

Top Adverse Reactions

NAUSEA1,092 reports
INTERSTITIAL LUNG DISEASE933 reports
DISEASE PROGRESSION900 reports
DEATH898 reports
OFF LABEL USE707 reports
FATIGUE691 reports
DIARRHOEA496 reports
VOMITING493 reports
PNEUMONITIS347 reports
DECREASED APPETITE335 reports
NO ADVERSE EVENT320 reports
ALOPECIA306 reports
ASTHENIA291 reports
DYSPNOEA266 reports
INTENTIONAL PRODUCT USE ISSUE245 reports
NEUTROPENIA228 reports
METASTASES TO CENTRAL NERVOUS SYSTEM225 reports
MALAISE221 reports
WEIGHT DECREASED216 reports
PNEUMONIA208 reports
ANAEMIA187 reports
CONSTIPATION187 reports
MYELOSUPPRESSION175 reports
PLATELET COUNT DECREASED168 reports
NEUTROPHIL COUNT DECREASED166 reports
DRUG INEFFECTIVE164 reports
PYREXIA149 reports
THROMBOCYTOPENIA145 reports
UNDERDOSE139 reports
ASCITES138 reports
GENERAL PHYSICAL HEALTH DETERIORATION136 reports
PLEURAL EFFUSION135 reports
COUGH128 reports
FEBRILE NEUTROPENIA126 reports
WHITE BLOOD CELL COUNT DECREASED125 reports
HEADACHE115 reports
TOXICITY TO VARIOUS AGENTS114 reports
MALIGNANT NEOPLASM PROGRESSION113 reports
METASTASES TO LIVER110 reports
EJECTION FRACTION DECREASED109 reports
PANCYTOPENIA104 reports
DEHYDRATION103 reports
SEPSIS103 reports
PAIN99 reports
COVID 1998 reports
ABDOMINAL PAIN87 reports
DIZZINESS87 reports
NEUROPATHY PERIPHERAL86 reports
PRODUCT DOSE OMISSION ISSUE85 reports
BACK PAIN81 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA79 reports
FALL75 reports
PULMONARY EMBOLISM75 reports
LUNG DISORDER70 reports
PULMONARY TOXICITY70 reports
GASTROINTESTINAL DISORDER64 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION64 reports
WEIGHT INCREASED64 reports
ADVERSE DRUG REACTION63 reports
RESPIRATORY FAILURE63 reports
THERAPY CHANGE62 reports
FEELING ABNORMAL61 reports
INCORRECT DOSE ADMINISTERED61 reports
CONDITION AGGRAVATED60 reports
METASTASES TO BONE60 reports
RASH59 reports
DRUG INTOLERANCE55 reports
SEIZURE54 reports
BLOOD BILIRUBIN INCREASED53 reports
HYPOKALAEMIA52 reports
HAEMOGLOBIN DECREASED51 reports
ADVERSE EVENT50 reports
METASTASES TO LYMPH NODES49 reports
ABDOMINAL PAIN UPPER48 reports
CARDIAC FAILURE48 reports
DYSPEPSIA48 reports
HYPONATRAEMIA48 reports
URINARY TRACT INFECTION48 reports
INFECTION47 reports
VISION BLURRED47 reports
METASTASES TO LUNG46 reports
ACUTE KIDNEY INJURY45 reports
HEPATIC FAILURE45 reports
SEPTIC SHOCK45 reports
STOMATITIS45 reports
HEPATIC CYTOLYSIS44 reports
ILLNESS44 reports
METASTASES TO MENINGES43 reports
UNEVALUABLE EVENT43 reports
SKIN FISSURES42 reports
CHEST PAIN41 reports
COLITIS41 reports
HYPOTENSION41 reports
INSOMNIA41 reports
SOMNOLENCE41 reports
RENAL IMPAIRMENT40 reports
ARTHRALGIA39 reports
C REACTIVE PROTEIN INCREASED39 reports
HEPATIC FUNCTION ABNORMAL39 reports
VASCULAR DEVICE INFECTION39 reports

Report Outcomes

Out of 8,380 classified reports for FAM TRASTUZUMAB DERUXTECAN NXKI:

Serious 72.2%Non-Serious 27.8%

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

Female6,433 (87.5%)
Male921 (12.5%)

Reports by Age

Age 52130 reports
Age 60117 reports
Age 62109 reports
Age 56107 reports
Age 72105 reports
Age 6199 reports
Age 6899 reports
Age 5598 reports
Age 6698 reports
Age 7098 reports
Age 5895 reports
Age 6593 reports
Age 792 reports
Age 6786 reports
Age 5784 reports
Age 7584 reports
Age 5483 reports
Age 5983 reports
Age 6383 reports
Age 6482 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 FAM TRASTUZUMAB DERUXTECAN NXKI?

This profile reflects 15,771 FDA FAERS reports that mention FAM TRASTUZUMAB DERUXTECAN NXKI. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for FAM TRASTUZUMAB DERUXTECAN NXKI?

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

Who manufactures FAM TRASTUZUMAB DERUXTECAN NXKI?

Labeling and FAERS entries often list Daiichi Sankyo Inc. in connection with FAM TRASTUZUMAB DERUXTECAN NXKI. 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.