What the label lists and what reports show
Belinostat side effects
Belinostat's FDA label: “The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting.” FAERS holds 347 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 nausea (58 reports).
- No generic listed
Check it at the source: the belinostat FDA label on DailyMed (effective April 7, 2025, Acrotech Biopharma Inc); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Beleodaq?Beleodaq may cause serious side effects, including: • Low blood cell counts. Your doctor will do blood tests to check your blood counts during your treatment with Beleodaq. o Low platelet counts can cause unusual bleeding or bruising under your skin. o Low red blood cell counts may make you feel weak, tired, or you get tired easily, you look pale, or you feel short of breath. o Low white blood cell counts can cause you to get infections, which may be serious. • Serious infections. People receiving Beleodaq may develop serious infections that can sometimes lead to death. You may have a greater risk of life-threatening infections if you have had chemotherapy in the past. Tell your doctor right away if you have any of the following signs or symptoms of an infection: fever, flu-like symptoms, cough, shortness of breath, burning with urination, muscle aches, or worsening skin problems. […]
Source: FDA drug label, Acrotech Biopharma Inc, effective April 7, 2025 (SPL set 2e8ef36b-71fa-4492-a16f-577d5f7d111d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting.
Table 3: Adverse Reactions Occurring in ≥ 10% of Patients with Relapsed or Refractory PTCL (NCI CTC Grade 1-4)
| Reaction | Adverse Reactions All Grades | Percentage of Patients (%) (N=129) Grade 3 or 4 |
|---|---|---|
| All Adverse Reactions | 97 | 61 |
| Nausea | 42 | 1 |
| Fatigue | 37 | 5 |
| Pyrexia | 35 | 2 |
| Anemia | 32 | 11 |
| Vomiting | 29 | 1 |
| Constipation | 23 | 1 |
| Diarrhea | 23 | 2 |
| Dyspnea | 22 | 6 |
| Rash | 20 | 1 |
| Peripheral Edema | 20 | 0 |
| Cough | 19 | 0 |
| Thrombocytopenia | 16 | 7 |
| Pruritus | 16 | 3 |
| Chills | 16 | 1 |
| Increased Blood Lactate Dehydrogenase | 16 | 2 |
| Decreased Appetite | 15 | 2 |
| Headache | 15 | 0 |
| Infusion Site Pain | 14 | 0 |
| Hypokalemia | 12 | 4 |
| Prolonged QT | 11 | 4 |
| Abdominal pain | 11 | 1 |
| Hypotension | 10 | 3 |
| Phlebitis | 10 | 1 |
| Dizziness | 10 | 0 |
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 in more detail in other sections of the prescribing information. • Hematologic Toxicity [see Warnings and Precautions ( 5.1 )] • Infection [see Warnings and Precautions ( 5.2 )] • Hepatotoxicity [see Warnings and Precautions ( 5.3 )] • Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] • Gastrointestinal Toxicity [see Warnings and Precautions ( 5.5 )] The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Acrotech Biopharma Inc at 1-888-292-9617 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 Beleodaq may not reflect the rates observed in practice. Adverse Reactions in Patients with Peripheral T-Cell Lymphoma The safety of Beleodaq was evaluated in 129 patients with relapsed or refractory PTCL in the single arm clinical trial in which patients were administered Beleodaq at a dosage of 1,000 mg/m 2 administered over 30 minutes by IV infusion once daily on Days 1 through 5 of a 21-day cycle [see Clinical Studies ( 14 ) ]. The median duration of treatment was 2 cycles (range 1 – 33 cycles). …
Source: FDA drug label, Acrotech Biopharma Inc, effective April 7, 2025 (SPL set 2e8ef36b-71fa-4492-a16f-577d5f7d111d), via openFDA; the full label on DailyMed
What do FAERS reports show?
347 reports list belinostat among the medicines taken, each a report of something that happened, not proof the medicine caused it; 116 are coded as a death and 153 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, 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.
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?
- Belinostat: 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