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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

POLATUZUMAB VEDOTIN-PIIQ: 3,180 Adverse Event Reports & Safety Profile

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3,180
Total FAERS Reports
842 (26.5%)
Deaths Reported
557
Hospitalizations
3,180
As Primary/Secondary Suspect
94
Life-Threatening
13
Disabilities
Prescription
Status

FDA Application: 761121 ·

First Report: 20090101 · Latest Report: 20250917

What Are the Most Common POLATUZUMAB VEDOTIN-PIIQ Side Effects?

#1 Most Reported
Disease progression
753 reports (23.7%)
#2 Most Reported
Off label use
484 reports (15.2%)
#3 Most Reported
Death
367 reports (11.5%)

All POLATUZUMAB VEDOTIN-PIIQ Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Disease progression 753 23.7% 207 36
Off label use 484 15.2% 112 47
Death 367 11.5% 367 23
Covid-19 202 6.4% 66 50
Neutropenia 160 5.0% 44 25
Pyrexia 119 3.7% 34 38
Drug ineffective 118 3.7% 44 10
No adverse event 109 3.4% 1 0
Blood lactate dehydrogenase increased 108 3.4% 29 10
Febrile neutropenia 107 3.4% 26 41
Platelet count decreased 103 3.2% 29 36
Diarrhoea 95 3.0% 28 23
Lymphoma 91 2.9% 10 5
Neutrophil count decreased 90 2.8% 12 27
Neuropathy peripheral 87 2.7% 4 8
Diffuse large b-cell lymphoma 82 2.6% 29 2
White blood cell count decreased 82 2.6% 15 29
Diffuse large b-cell lymphoma recurrent 81 2.6% 7 5
Anaemia 80 2.5% 29 30
Malignant neoplasm progression 80 2.5% 20 13

Who Reports POLATUZUMAB VEDOTIN-PIIQ Side Effects? Age & Gender Data

Gender: 41.3% female, 58.7% male. Average age: 67.3 years. Most reports from: JP. View detailed demographics →

Is POLATUZUMAB VEDOTIN-PIIQ Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 0
2015 1 0 0
2016 6 0 1
2017 3 0 3
2018 4 1 0
2019 14 3 0
2020 56 11 16
2021 107 42 29
2022 277 68 43
2023 375 89 93
2024 289 101 100
2025 102 33 44

View full timeline →

What Is POLATUZUMAB VEDOTIN-PIIQ Used For?

IndicationReports
Diffuse large b-cell lymphoma 2,228
Product used for unknown indication 395
Diffuse large b-cell lymphoma refractory 158
Diffuse large b-cell lymphoma recurrent 107
Non-hodgkin's lymphoma 57
B-cell lymphoma 51
Follicular lymphoma 32
Lymphoma 32
Diffuse large b-cell lymphoma stage iv 22
Richter's syndrome 15

POLATUZUMAB VEDOTIN-PIIQ vs Alternatives: Which Is Safer?

POLATUZUMAB VEDOTIN-PIIQ vs POLIDOCANOL POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 3350 POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM\SODIUM POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 3350\POTASSIUM\SODIUM BICARBONATE\SODIUM\SODIUM ANHYDROUS POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 400 POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 4000 POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL 400\PROPYLENE GLYCOL POLATUZUMAB VEDOTIN-PIIQ vs POLYETHYLENE GLYCOL\POTASSIUM\SODIUM BICARBONATE

Official FDA Label for POLATUZUMAB VEDOTIN-PIIQ

Official prescribing information from the FDA-approved drug label.