BRENTUXIMAB VEDOTIN

N/A

Manufactured by SEAGEN INC.

18,008 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BRENTUXIMAB VEDOTIN

BRENTUXIMAB VEDOTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by SEAGEN INC.. The most commonly reported adverse reactions for BRENTUXIMAB VEDOTIN include OFF LABEL USE, FEBRILE NEUTROPENIA, NEUROPATHY PERIPHERAL, PYREXIA, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BRENTUXIMAB VEDOTIN.

Top Adverse Reactions

OFF LABEL USE1,303 reports
FEBRILE NEUTROPENIA713 reports
NEUROPATHY PERIPHERAL673 reports
PYREXIA666 reports
NEUTROPENIA561 reports
DEATH519 reports
HODGKIN^S DISEASE445 reports
NAUSEA381 reports
ANAEMIA376 reports
DIARRHOEA374 reports
THROMBOCYTOPENIA366 reports
DRUG INEFFECTIVE352 reports
DISEASE PROGRESSION331 reports
PNEUMONIA316 reports
WEIGHT DECREASED314 reports
VOMITING292 reports
RASH263 reports
SEPSIS254 reports
FATIGUE250 reports
WHITE BLOOD CELL COUNT DECREASED244 reports
DYSPNOEA230 reports
MYELOSUPPRESSION227 reports
ABDOMINAL PAIN217 reports
MALIGNANT NEOPLASM PROGRESSION216 reports
ASTHENIA202 reports
PRODUCT USE IN UNAPPROVED INDICATION192 reports
POLYNEUROPATHY191 reports
NEUTROPHIL COUNT DECREASED190 reports
HYPOTENSION185 reports
PANCYTOPENIA173 reports
ACUTE KIDNEY INJURY169 reports
DECREASED APPETITE168 reports
INFECTION168 reports
PLATELET COUNT DECREASED168 reports
GENERAL PHYSICAL HEALTH DETERIORATION162 reports
CONDITION AGGRAVATED157 reports
MALAISE156 reports
LEUKOPENIA148 reports
PERIPHERAL SENSORY NEUROPATHY144 reports
ALANINE AMINOTRANSFERASE INCREASED142 reports
PNEUMONITIS137 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA136 reports
CONSTIPATION134 reports
PRURITUS134 reports
COUGH132 reports
NEOPLASM PROGRESSION129 reports
RESPIRATORY FAILURE129 reports
SEPTIC SHOCK126 reports
CHILLS121 reports
MUCOSAL INFLAMMATION121 reports
INFUSION RELATED REACTION119 reports
COLITIS114 reports
COVID 19111 reports
ASPARTATE AMINOTRANSFERASE INCREASED109 reports
HODGKIN^S DISEASE RECURRENT108 reports
DEHYDRATION104 reports
CARDIAC FAILURE99 reports
TOXICITY TO VARIOUS AGENTS98 reports
ERYTHEMA96 reports
HAEMOGLOBIN DECREASED95 reports
PAIN94 reports
PRODUCT TEMPERATURE EXCURSION ISSUE94 reports
PRODUCT USE ISSUE94 reports
HYPOKALAEMIA93 reports
ANAPHYLACTIC REACTION91 reports
PLEURAL EFFUSION89 reports
ANAPLASTIC LARGE CELL LYMPHOMA86 reports
HYPERSENSITIVITY85 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME85 reports
PERIPHERAL T CELL LYMPHOMA UNSPECIFIED85 reports
TACHYCARDIA85 reports
CYTOMEGALOVIRUS INFECTION84 reports
HYPERGLYCAEMIA84 reports
ALOPECIA82 reports
HEADACHE82 reports
HYPOAESTHESIA82 reports
BLOOD LACTATE DEHYDROGENASE INCREASED80 reports
CYTOPENIA80 reports
INTERSTITIAL LUNG DISEASE80 reports
WEIGHT INCREASED80 reports
FALL76 reports
STOMATITIS75 reports
ARTHRALGIA74 reports
HYPONATRAEMIA71 reports
LYMPHADENOPATHY71 reports
HODGKIN^S DISEASE REFRACTORY70 reports
PANCREATITIS70 reports
PARAESTHESIA70 reports
URTICARIA70 reports
RENAL FAILURE69 reports
C REACTIVE PROTEIN INCREASED65 reports
LYMPHOCYTE COUNT DECREASED65 reports
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY63 reports
THERAPY PARTIAL RESPONDER63 reports
ACUTE MYELOID LEUKAEMIA62 reports
CYTOMEGALOVIRUS CHORIORETINITIS62 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED62 reports
NEUROTOXICITY62 reports
PERIPHERAL MOTOR NEUROPATHY62 reports
BLINDNESS61 reports

Report Outcomes

Out of 9,731 classified reports for BRENTUXIMAB VEDOTIN:

Serious 90.6%Non-Serious 9.4%

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

Male4,353 (57.5%)
Female3,178 (42.0%)
Unknown42 (0.6%)

Reports by Age

Age 35126 reports
Age 72126 reports
Age 60112 reports
Age 8111 reports
Age 36109 reports
Age 64109 reports
Age 30107 reports
Age 69107 reports
Age 40106 reports
Age 70106 reports
Age 71106 reports
Age 67105 reports
Age 33104 reports
Age 44103 reports
Age 51102 reports
Age 26100 reports
Age 5498 reports
Age 6898 reports
Age 6697 reports
Age 5996 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 BRENTUXIMAB VEDOTIN?

This profile reflects 18,008 FDA FAERS reports that mention BRENTUXIMAB VEDOTIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BRENTUXIMAB VEDOTIN?

Frequently reported terms in FAERS include OFF LABEL USE, FEBRILE NEUTROPENIA, NEUROPATHY PERIPHERAL, PYREXIA, NEUTROPENIA, DEATH. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BRENTUXIMAB VEDOTIN?

Labeling and FAERS entries often list SEAGEN INC. in connection with BRENTUXIMAB VEDOTIN. 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.