What the label lists and what reports show
Brentuximab vedotin side effects
Brentuximab vedotin's FDA label: “The most common adverse reactions (≥20%) are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash.” FAERS holds 10,190 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 febrile neutropenia (758 reports).
- No generic listed
- Boxed warning
Check it at the source: the brentuximab vedotin FDA label on DailyMed (effective November 11, 2025, SEAGEN INC.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash.
Table 7: Adverse Reactions Reported in ≥10% of Patients with Relapsed Classical Hodgkin Lymphoma (Study 1)
| Body System Adverse Reaction | Any Grade | Grade 3 | Grade 4 |
|---|---|---|---|
| Neutropenia Derived from laboratory values and adverse reaction data | 54 | 15 | 6 |
| Anemia | 33 | 8 | 2 |
| Thrombocytopenia | 28 | 7 | 2 |
| Lymphadenopathy | 11 | - | - |
| Peripheral sensory neuropathy | 52 | 8 | - |
| Peripheral motor neuropathy | 16 | 4 | - |
| Headache | 19 | - | - |
| Dizziness | 11 | - | - |
| Fatigue | 49 | 3 | - |
| Pyrexia | 29 | 2 | - |
| Chills | 13 | - | - |
| Upper respiratory tract infection | 47 | - | - |
| Nausea | 42 | - | - |
| Diarrhea | 36 | 1 | - |
| Abdominal pain | 25 | 2 | 1 |
| Vomiting | 22 | - | - |
| Constipation | 16 | - | - |
| Rash | 27 | - | - |
| Pruritus | 17 | - | - |
| Alopecia | 13 | - | - |
| Night sweats | 12 | - | - |
| Cough | 25 | - | - |
| Dyspnea | 13 | 1 | - |
| Oropharyngeal pain | 11 | - | - |
| Arthralgia | 19 | - | - |
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 described elsewhere in the labeling: • Peripheral Neuropathy [see Warnings and Precautions (5.1) ] • Anaphylaxis and Infusion Reactions [see Warnings and Precautions (5.2) ] • Hematologic Toxicities [see Warnings and Precautions (5.3) ] • Serious Infections and Opportunistic Infections [see Warnings and Precautions (5.4) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.5) ] o Increased Toxicity in the Presence of Severe Renal Impairment [see Warnings and Precautions (5.6) ] • Increased Toxicity in the Presence of Moderate or Severe Hepatic Impairment [see Warnings and Precautions (5.7) ] • Hepatotoxicity [see Warnings and Precautions (5.8) ] • Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.9) ] • Pulmonary Toxicity [see Warnings and Precautions (5.10) ] • Serious Dermatologic Reactions [see Warnings and Precautions (5.11) ] • Gastrointestinal Complications [see Warnings and Precautions (5.12) ] • Hyperglycemia [see Warnings and Precautions (5.13) ] The most common adverse reactions (≥20%) are peripheral neuropathy, nausea, fatigue, musculoskeletal pain, constipation, diarrhea, vomiting, pyrexia, upper respiratory tract infection, mucositis, abdominal pain, and rash. …
Source: FDA drug label, BLA125388 (Seattle Genetics), as published by SEAGEN INC., effective November 11, 2025 (SPL set 3904f8dd-1aef-3490-e48f-bd55f32ed67f), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,190 reports list brentuximab vedotin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,938 are coded as a death and 3,848 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. Of the 21 reactions below, 16 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?
- Brentuximab 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