What the label lists and what reports show
Ibritumomab tiuxetan side effects
Ibritumomab tiuxetan's FDA label: “The most common adverse reactions of Zevalin are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.” FAERS holds 1,521 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 thrombocytopenia (174 reports).
- No generic listed
- Boxed warning
Check it at the source: the ibritumomab tiuxetan FDA label on DailyMed (effective April 25, 2023, Acrotech Biopharma Inc); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions of Zevalin are cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia.
Table 2. Per-Patient Incidence (%) of Selected Between-group difference of ≥5% Adverse Reactions Occurring in ≥ 5% of Patients with Previously Untreated Follicular NHL Treated with the Zevalin Therapeutic Regimen
| Reaction | All Grades NCI CTCAE version 2.0 % | Grade 3-4 % | All Grades % | Grade 3-4 % |
|---|---|---|---|---|
| Abdominal pain | 17 | 2 | 13 | <1 |
| Diarrhea | 11 | 0 | 3 | 0 |
| Nausea | 18 | 0 | 2 | 0 |
| Asthenia | 15 | 1 | 8 | <1 |
| Fatigue | 33 | 1 | 9 | 0 |
| Influenza-like illness | 8 | 0 | 3 | 0 |
| Pyrexia | 10 | 3 | 4 | 0 |
| Myalgia | 9 | 0 | 3 | 0 |
| Anorexia | 8 | 0 | 2 | 0 |
| Cough | 11 | <1 | 5 | 0 |
| Pharyngolaryngeal pain | 7 | 0 | 2 | 0 |
| Epistaxis | 5 | 2 | <1 | 0 |
| Dizziness | 7 | 0 | 2 | 0 |
| Hypertension | 7 | 3 | 2 | <1 |
| Night sweats | 8 | 0 | 2 | 0 |
| Petechiae | 8 | 2 | 0 | 0 |
| Pruritus | 7 | 0 | 1 | 0 |
| Rash | 7 | 0 | <1 | 0 |
| Bronchitis | 8 | 0 | 3 | 0 |
| Nasopharyngitis | 19 | 0 | 10 | 0 |
| Rhinitis | 8 | 0 | 2 | 0 |
| Sinusitis | 7 | <1 | <1 | 0 |
| Urinary tract infection | 7 | <1 | 3 | 0 |
| Thrombocytopenia | 62 | 51 | 1 | 0 |
| Neutropenia | 45 | 41 | 3 | 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 serious adverse reactions are discussed in greater detail in other sections of the label: Serious Infusion Reactions [ see Boxed Warning and Warnings and Precautions ( 5.1 ) ]. Prolonged and Severe Cytopenias [ see Boxed Warning and Warnings and Precautions ( 5.2 ) ]. Severe Cutaneous and Mucocutaneous Reactions [ see Boxed Warning and Warnings and Precautions ( 5.3 ) ]. Leukemia and Myelodysplastic Syndrome [ see Warnings and Precautions ( 5.4 ) ]. Common adverse reactions ( > 10%) in clinical trials were: cytopenias, fatigue, nasopharyngitis, nausea, abdominal pain, asthenia, cough, diarrhea, and pyrexia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc. at 1-866-298-8433 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, BLA125019 (Spectrum Pharms), as published by Acrotech Biopharma Inc, effective April 25, 2023 (SPL set 25d367dc-da65-44c9-a844-1bf15339c285), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,521 reports list ibritumomab tiuxetan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 551 are coded as a death and 609 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 23 reactions below, 11 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?
- Ibritumomab tiuxetan: 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