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Fedratinib Side Effects

The most commonly reported side effects of fedratinib include diarrhoea, death, and nausea, based on 1,531 FDA adverse event reports from 2010 to 2025. 3.1% of reports found the drug to be ineffective.

Fedratinib side effects

Percentages show how often each reaction appears relative to total reports for fedratinib.

1
Diarrhoea9.8%150
2
Death9.5%146
3
Nausea8.0%122
4
Fatigue7.5%115
5
Vomiting5.0%76
6
Constipation4.0%62
7
Platelet Count Decreased3.7%56
8
Off Label Use3.6%55
9
Haemoglobin Decreased3.4%52
10
Anaemia3.3%51
11
Asthenia3.3%50
12
Drug Ineffective3.1%47
13
Full Blood Count Decreased2.9%45
14
Splenomegaly2.7%42
15
Pruritus2.7%42

These are voluntary reports and do not establish that fedratinib caused these reactions.

Report severity

52.8%Serious808 reports
21.4%Hospitalizations328 reports
14.6%Fatal223 reports

Seriousness is determined by the reporter, not by OpenClaim.

Fedratinib drug interactions

Other drugs that appear in adverse event reports alongside fedratinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ruxolitinib9.3%143
2
Pacritinib-citrate1.4%22
3
Hydroxyurea1.2%19
4
Levothyroxine-sodium0.7%11
5
Allopurinol0.7%11
6
Azacitidine0.6%9
7
Spironolactone0.6%9
8
Tramadol-hydrochloride0.6%9
9
Acyclovir0.6%9
10
Rituximab0.4%6
11
Doxorubicin-hydrochloride0.4%6
12
Cyclophosphamide0.4%6
13
Prednisone0.4%6
14
Vincristine-sulfate0.4%6
15
Ketoconazole0.4%6

Taken alongside

1
Allopurinol9.1%140
2
Aspirin8.8%134
3
Levothyroxine-sodium7.8%120
4
Ergocalciferol7.3%112
5
Ruxolitinib6.6%101
6
Ondansetron5.7%87
7
Omeprazole5.6%86
8
Acetaminophen5.3%81
9
Hydroxyurea4.9%75
10
Furosemide4.4%68
11
Acyclovir4.2%65
12
Losartan-potassium4.1%63
13
Metoprolol3.7%57
14
Pantoprazole-sodium3.7%57
15
Thiamine3.3%50

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports fedratinib side effects

43.1% of fedratinib adverse event reports involve female patients and 46.7% involve male patients. The largest age group is elderly at 76%. These figures reflect who reports side effects, not underlying risk.

Sex

Female43.1%
Male46.7%
Unknown10.2%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6423.6%
65+76.4%

What is fedratinib used for

Conditions and purposes for which patients were taking fedratinib when the adverse event was reported.

Acute Myeloid LeukaemiaAnaemiaAnaemiaB-cell LymphomaBlood Product Transfusion DependentBreast CancerBreast Cancer FemaleBreast NeoplasmBenign Prostatic HyperplasiaBladder CancerBlood DisorderBreast NeoplasmCarcinoid TumourChronic Myeloid LeukaemiaCongenital Methaemoglobinaemia

Showing 15 of 87 indications

Fedratinib brand names and reporting trend

Fedratinib is sold under the brand name Inrebic.

Brand names

Inrebic352

Quarterly reports (20102025)

20102016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking fedratinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.