POLATUZUMAB VEDOTIN

N/A

Manufactured by Genentech, Inc.

19,009 FDA adverse event reports analyzed

Last updated: 2026-04-14

About POLATUZUMAB VEDOTIN

POLATUZUMAB VEDOTIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Genentech, Inc.. The most commonly reported adverse reactions for POLATUZUMAB VEDOTIN include DISEASE PROGRESSION, OFF LABEL USE, DEATH, NEUTROPENIA, COVID-19. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POLATUZUMAB VEDOTIN.

Top Adverse Reactions

DISEASE PROGRESSION1,934 reports
OFF LABEL USE1,230 reports
DEATH724 reports
NEUTROPENIA540 reports
COVID 19514 reports
ANAEMIA498 reports
FEBRILE NEUTROPENIA468 reports
DRUG INEFFECTIVE460 reports
PYREXIA440 reports
BLOOD LACTATE DEHYDROGENASE INCREASED414 reports
PLATELET COUNT DECREASED404 reports
NEUTROPHIL COUNT DECREASED385 reports
WHITE BLOOD CELL COUNT DECREASED366 reports
CYTOKINE RELEASE SYNDROME365 reports
THROMBOCYTOPENIA359 reports
DIFFUSE LARGE B CELL LYMPHOMA358 reports
LYMPHOMA354 reports
PNEUMONIA335 reports
DIFFUSE LARGE B CELL LYMPHOMA RECURRENT299 reports
DIARRHOEA291 reports
MALIGNANT NEOPLASM PROGRESSION278 reports
NEUROPATHY PERIPHERAL267 reports
INFECTION235 reports
MYELOSUPPRESSION232 reports
SEPSIS221 reports
LYMPHOCYTE COUNT DECREASED208 reports
NAUSEA171 reports
CYTOPENIA168 reports
ASPARTATE AMINOTRANSFERASE INCREASED163 reports
PANCYTOPENIA158 reports
DECREASED APPETITE148 reports
PRODUCT USE ISSUE148 reports
HYPOKALAEMIA147 reports
PRODUCT USE IN UNAPPROVED INDICATION145 reports
SEPTIC SHOCK143 reports
CYTOMEGALOVIRUS INFECTION142 reports
NO ADVERSE EVENT141 reports
ALANINE AMINOTRANSFERASE INCREASED137 reports
LEUKOPENIA136 reports
ASTHENIA135 reports
NEOPLASM PROGRESSION134 reports
FATIGUE129 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION121 reports
LYMPHADENOPATHY119 reports
ILL DEFINED DISORDER117 reports
WEIGHT DECREASED114 reports
ABDOMINAL PAIN110 reports
THERAPY NON RESPONDER109 reports
GENERAL PHYSICAL HEALTH DETERIORATION108 reports
DISEASE RECURRENCE107 reports
ACUTE KIDNEY INJURY106 reports
RENAL FAILURE106 reports
DIFFUSE LARGE B CELL LYMPHOMA REFRACTORY105 reports
C REACTIVE PROTEIN INCREASED102 reports
DYSPNOEA101 reports
DEEP VEIN THROMBOSIS95 reports
URINARY TRACT INFECTION94 reports
HAEMOGLOBIN DECREASED93 reports
IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY SYNDROME93 reports
TUMOUR LYSIS SYNDROME91 reports
VOMITING91 reports
HYPOGAMMAGLOBULINAEMIA86 reports
CARDIAC FAILURE80 reports
CONSTIPATION80 reports
PULMONARY EMBOLISM80 reports
HYPOALBUMINAEMIA79 reports
HEPATIC FUNCTION ABNORMAL76 reports
HYPOCALCAEMIA76 reports
BLOOD CREATININE INCREASED75 reports
HAEMATOTOXICITY72 reports
MUCOSAL INFLAMMATION71 reports
INFUSION RELATED REACTION70 reports
ATRIAL FIBRILLATION69 reports
HYPOTENSION69 reports
COVID 19 PNEUMONIA68 reports
INTENTIONAL PRODUCT USE ISSUE67 reports
PAIN66 reports
PNEUMONITIS66 reports
TOXICITY TO VARIOUS AGENTS66 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED64 reports
MALAISE63 reports
RASH63 reports
BACTERAEMIA61 reports
BLOOD BILIRUBIN INCREASED60 reports
RESPIRATORY FAILURE60 reports
NEOPLASM59 reports
RENAL IMPAIRMENT58 reports
STOMATITIS58 reports
FALL57 reports
INTERSTITIAL LUNG DISEASE57 reports
POLYNEUROPATHY55 reports
THERAPY PARTIAL RESPONDER55 reports
THERAPEUTIC RESPONSE DECREASED54 reports
COUGH53 reports
HYPOMAGNESAEMIA53 reports
AGRANULOCYTOSIS52 reports
GASTROINTESTINAL HAEMORRHAGE52 reports
PLEURAL EFFUSION52 reports
NEUROTOXICITY51 reports
BLOOD ALKALINE PHOSPHATASE INCREASED50 reports

Report Outcomes

Out of 8,715 classified reports for POLATUZUMAB VEDOTIN:

Serious 94.8%Non-Serious 5.2%

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

Male4,065 (58.5%)
Female2,879 (41.5%)

Reports by Age

Age 70222 reports
Age 67221 reports
Age 74214 reports
Age 68206 reports
Age 72185 reports
Age 69184 reports
Age 60178 reports
Age 66174 reports
Age 64162 reports
Age 73162 reports
Age 76158 reports
Age 75151 reports
Age 77144 reports
Age 65142 reports
Age 63141 reports
Age 56140 reports
Age 80137 reports
Age 8136 reports
Age 78136 reports
Age 59124 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 POLATUZUMAB VEDOTIN?

This profile reflects 19,009 FDA FAERS reports that mention POLATUZUMAB VEDOTIN. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for POLATUZUMAB VEDOTIN?

Frequently reported terms in FAERS include DISEASE PROGRESSION, OFF LABEL USE, DEATH, NEUTROPENIA, COVID-19, ANAEMIA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures POLATUZUMAB VEDOTIN?

Labeling and FAERS entries often list Genentech, Inc. in connection with POLATUZUMAB 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.