What the label lists and what reports show
Polatuzumab vedotin side effects
Polatuzumab vedotin's FDA label: “The most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with POLIVY in combination with R-CHP, excluding laboratory abnormalities, are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis.” FAERS holds 9,702 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is neutropenia (609 reports).
- No generic listed
Check it at the source: the polatuzumab vedotin FDA label on DailyMed (effective August 24, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with POLIVY in combination with R-CHP, excluding laboratory abnormalities, are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis.
Table 7 Select Adverse Reactions Occurring in ≥10% of Patients Treated with POLIVY Plus R-CHP in POLARIX
| Reaction | All Grades, % | Grade 3–4, % | All Grades, % | Grade 3–4, % |
|---|---|---|---|---|
| Lymphopenia | 80 | 44 | 77 | 44 |
| Anemia | 68 | 14 | 67 | 11 |
| Neutropenia | 60 | 39 | 60 | 42 |
| Thrombocytopenia | 32 | 8 | 33 | 6 |
| Febrile neutropenia Febrile neutropenia includes febrile neutropenia, febrile bone marrow… | 15 | 15 | 9 | 9 |
| Creatinine increased | 66 | 0.7 | 64 | 0.9 |
| Aspartate aminotransferase increased | 26 | 0.7 | 23 | 1.1 |
| Alanine aminotransferase increased | 25 | 1.4 | 27 | 0.5 |
| Alkaline phosphatase increased | 23 | 0 | 22 | 0.5 |
| Uric acid increased | 19 | 18 | 17 | 16 |
| Weight decreased | 13 | 0.9 | 12 | 0.2 |
| Peripheral neuropathy At last assessment, peripheral neuropathy was unresolved in 42% in… | 53 | 1.6 | 54 | 1.1 |
| Altered taste | 14 | 0 | 16 | 0 |
| Headache | 13 | 0.2 | 14 | 0.9 |
| Nausea | 42 | 1.1 | 37 | 0.5 |
| Diarrhea | 31 | 3.9 | 20 | 1.8 |
| Constipation | 29 | 1.1 | 29 | 0.2 |
| Mucositis Mucositis includes stomatitis, oropharyngeal pain, mucosal inflammation, mouth… | 22 | 1.4 | 19 | 0.5 |
| Abdominal pain Abdominal pain includes abdominal pain, abdominal discomfort,… | 16 | 1.1 | 14 | 1.6 |
| Vomiting | 15 | 1.1 | 14 | 0.7 |
| Fatigue | 37 | 2.5 | 38 | 3.0 |
| Pyrexia | 16 | 1.4 | 13 | 0 |
| Edema Edema includes edema, face edema, swelling face, edema peripheral, fluid overload,… | 14 | 0.5 | 11 | 0.2 |
| Infusion-related reaction Infusion related reaction is reflective of the combination… | 13 | 1.1 | 16 | 1.6 |
| Alopecia | 24 | 0 | 24 | 0.2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed in greater detail in other sections of the label: Peripheral Neuropathy [see Warnings and Precautions (5.1) ] Infusion-Related Reactions [see Warnings and Precautions (5.2) ] Myelosuppression [see Warnings and Precautions (5.3) ] Serious and Opportunistic Infections [see Warnings and Precautions (5.4) ] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.5) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.6) ] Hepatotoxicity [see Warnings and Precautions (5.7) ] Infusion Site Extravasation Injury [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥20%) in patients with large B-cell lymphoma treated with POLIVY in combination with R-CHP, excluding laboratory abnormalities, are peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. Grade 3 to 4 laboratory abnormalities (≥10%) are lymphopenia, neutropenia, hyperuricemia, and anemia. ( 6.1 ) The most common adverse reaction (≥20%) in patients with relapsed or refractory DLBCL treated with POLIVY in combination with BR are neutropenia, thrombocytopenia, anemia, peripheral neuropathy, fatigue, diarrhea, pyrexia, decreased appetite, and pneumonia.
Source: FDA drug label, Genentech, Inc., effective August 24, 2026 (SPL set 20a16ab2-f338-4abb-9dcd-254bd949a2bc), via openFDA; the full label on DailyMed
What do FAERS reports show?
9,702 reports list polatuzumab vedotin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,075 are coded as a death and 2,557 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2023 (2,266, against a median of 467 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Polatuzumab vedotin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions