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Ruxolitinib Side Effects

The most commonly reported side effects of ruxolitinib include off label use, death, and fatigue, based on 67,644 FDA adverse event reports from 2011 to 2025. 3.0% of reports found the drug to be ineffective.

Ruxolitinib side effects

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

1
Off Label Use19.7%13,342
2
Death9.0%6,086
3
Fatigue8.7%5,859
4
Anaemia4.4%2,987
5
Haemoglobin Decreased4.3%2,913
6
Platelet Count Decreased3.9%2,632
7
Diarrhoea3.8%2,583
8
Asthenia3.6%2,446
9
Dizziness3.6%2,435
10
Headache3.4%2,328
11
Product Dose Omission Issue3.4%2,316
12
Product Availability Issue3.2%2,179
13
Pneumonia3.1%2,075
14
Nausea3.1%2,064
15
Drug Ineffective3.0%2,004

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

Report severity

48.8%Serious33,002 reports
19.2%Hospitalizations13,000 reports
13.9%Fatal9,420 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ruxolitinib drug interactions

Other drugs that appear in adverse event reports alongside ruxolitinib. 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
Methotrexate2.0%1,375
2
Tacrolimus1.9%1,281
3
Prednisone1.8%1,198
4
Cyclosporine1.7%1,151
5
Mycophenolate1.7%1,129
6
Cyclophosphamide1.2%812
7
Methylprednisolone1.1%755
8
Dupilumab1.1%730
9
Vincristine-sulfate1.0%704
10
Hydroxyurea1.0%698
11
Dexamethasone0.8%517
12
Rituximab0.8%514
13
Fludarabine-phosphate0.7%474
14
Cytarabine0.7%446
15
Mercaptopurine0.7%445

Taken alongside

1
Aspirin12.8%8,689
2
Ergocalciferol7.8%5,274
3
Levothyroxine-sodium7.0%4,745
4
Acetaminophen5.9%4,017
5
Metoprolol5.9%4,006
6
Allopurinol5.8%3,922
7
Omeprazole5.6%3,797
8
Amlodipine5.3%3,604
9
Furosemide5.2%3,503
10
Hydroxyurea4.7%3,181
11
Atorvastatin-calcium4.7%3,169
12
Acyclovir4.4%3,006
13
Prednisone4.3%2,920
14
Lisinopril4.0%2,693
15
Gabapentin4.0%2,692

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 ruxolitinib side effects

14.6% of ruxolitinib adverse event reports involve female patients and 15.6% involve male patients. The largest age group is elderly at 54%. These figures reflect who reports side effects, not underlying risk.

Sex

Female14.6%
Male15.6%
Unknown69.8%

Age group

< 20.8%
2–114.3%
12–173.9%
18–6436.9%
65+54.1%

What is ruxolitinib used for

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

3m Syndrome5q Minus SyndromeAbdominal PainAbdominal Pain UpperActinomycosisActivated Protein C ResistanceAcute Biphenotypic LeukaemiaAcute Graft Versus Host DiseaseAcute Graft Versus Host Disease In IntestineAcute Graft Versus Host Disease In LiverAcute Graft Versus Host Disease In SkinAcute Hepatitis BAcute Kidney InjuryAcute Left Ventricular FailureAcute Leukaemia

Showing 15 of 1,339 indications

Ruxolitinib brand names and reporting trend

Ruxolitinib is sold under brand names including Ruxolitinib, Jakafi.

Brand names

Ruxolitinib16,484
Jakafi356

Quarterly reports (20112025)

20122016202020242025

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

Taking ruxolitinib with another medication?

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