What the label lists and what reports show
Fedratinib side effects
Fedratinib's FDA label: “The most common adverse reactions (≥20%) are diarrhea, nausea, anemia, and vomiting ( 6.1 ).” FAERS holds 1,322 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 diarrhoea (143 reports).
- No generic listed
- Boxed warning
Check it at the source: the fedratinib FDA label on DailyMed (effective July 20, 2026, Celgene Corporation); 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 INREBIC?INREBIC may cause serious side effects, including: • See "What is the most important information I should know about INREBIC?" • Low blood cell counts. INREBIC may cause new or worsening low red blood cell counts (anemia) and low platelet counts (thrombocytopenia) in some people. You may need a blood transfusion if your blood counts drop too low. Your healthcare provider will do blood tests to check your blood counts before you start and during treatment with INREBIC. Tell your healthcare provider if you develop any bleeding or bruising during treatment with INREBIC. • Diarrhea, nausea, and vomiting. Your healthcare provider may give you certain medicines to help treat your diarrhea, nausea, and vomiting. Call your healthcare provider or get emergency medical help right away if you have diarrhea, nausea, or vomiting that does not get better with treatment. • Liver problems. […]
Source: FDA drug label, NDA212327 (Bristol-Myers), as published by Celgene Corporation, effective July 20, 2026 (SPL set f0f55a2a-4e0c-4cba-8571-03e1424486d7), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥20%) are diarrhea, nausea, anemia, and vomiting ( 6.1 ).
Table 3: Adverse Reactions Reported in ≥5% Patients Receiving INREBIC 400 mg with a Difference between Arms of >5% during Randomized Treatment
| Reaction | All Grades % | Grade ≥3 b % | All Grades % | Grade ≥3 % |
|---|---|---|---|---|
| Diarrhea | 66 | 5 | 16 | 0 |
| Nausea | 62 | 0 | 15 | 0 |
| Anemia | 40 | 30 | 14 | 7 |
| Vomiting | 39 | 3.1 | 5 | 0 |
| Fatigue or asthenia | 19 | 5 | 16 | 1.1 |
| Muscle spasms | 12 | 0 | 1.1 | 0 |
| Blood creatinine increased | 10 | 1 | 1.1 | 0 |
| Pain in extremity | 10 | 0 | 4.2 | 0 |
| Alanine aminotransferase Increased | 9 | 0 | 1.1 | 0 |
| Headache | 9 | 0 | 1.1 | 0 |
| Weight increased | 9 | 0 | 4.2 | 0 |
| Dizziness | 8 | 0 | 3.2 | 0 |
| Bone pain | 8 | 0 | 2.1 | 0 |
| Urinary tract infection c | 6 | 0 | 1.1 | 0 |
| Dysuria | 6 | 0 | 0 | 0 |
| Aspartate aminotransferase increased | 5 | 0 | 1.1 | 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 elsewhere in the labeling: • Encephalopathy, including Wernicke's [see Warnings and Precautions (5.1) ] • Anemia and Thrombocytopenia [see Warnings and Precautions (5.2) ] • Gastrointestinal Toxicity [see Warnings and Precautions (5.3) ] • Hepatic Toxicity [see Warnings and Precautions (5.4) ] • Amylase and Lipase Elevation [see Warnings and Precautions (5.5) ] • Uveitis [see Warnings and Precautions (5.6) ] • Major Adverse Cardiac Events [see Warnings and Precautions (5.7) ] • Thrombosis [see Warnings and Precautions (5.8) ] • Secondary Malignancies [see Warnings and Precautions (5.9) ] • Symptom Exacerbation Following Interruption or Discontinuation of Treatment [see Warnings and Precautions (5.10) ] The most common adverse reactions (≥20%) are diarrhea, nausea, anemia, and vomiting ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 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, NDA212327 (Bristol-Myers), as published by Celgene Corporation, effective July 20, 2026 (SPL set f0f55a2a-4e0c-4cba-8571-03e1424486d7), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,322 reports list fedratinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 189 are coded as a death and 258 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, 8 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?
- Fedratinib: 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