Ruxolitinib: adverse event reports filed with FDA

8,815

reports as suspect product

0% of all reports · about 634 a year

1,361

reports, 12 months to June 2026

1,347 in the 12 months before

98%

marked serious by the reporter

53.1% across the class

25.4%

record death among outcomes, as reported

2,236 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Ruxolitinib reports recording the termmedian drug in janus kinase inhibitor

1. Off label useused for a purpose or in a way not on the label11.5%1,010
2. Drug ineffectivethe medicine did not work as expected9%790
3. Deaththe patient died; cause not stated by this term8.1%710
4. Anaemialow red blood cells7.6%669
5. Product use in unapproved indicationused for a purpose not on the label7.6%668
6. Pyrexiafever6%530
7. Thrombocytopenialow platelets5.8%508
8. Platelet count decreasedlow platelet count5.7%500
9. Pneumonialung infection5.5%486
10. Haemoglobin decreasedlow haemoglobin5.4%478
11. Febrile neutropeniafever with low white blood cells4.7%410
12. Splenomegaly4.5%394
13. Diarrhoealoose or frequent stools4%352
14. Astheniaweakness or lack of energy4%351
15. Fatiguetiredness3.9%347
16. Inappropriate schedule of product administrationthe product was taken at the wrong times3.8%339
17. Condition aggravatedthe condition being treated got worse3%267
18. Sepsisa severe body-wide response to infection2.8%251
19. Disease progressionthe disease advanced2.8%247
20. Neutropenialow neutrophils, a type of white blood cell2.8%247
21. Nauseafeeling sick2.8%246
22. Vomitingbeing sick2.6%231
23. Myelofibrosis2.6%225
24. Covid-19COVID-19 infection2.5%224
25. Infectionan infection, type not specified2.5%219
26. Abdominal painstomach or belly pain2.5%218
27. Dyspnoeashortness of breath2.4%215
28. Malignant neoplasm progression2.4%211
29. Pancytopenialow counts of all blood cells2.3%206
30. Acute kidney injurysudden loss of kidney function2.3%205

Top 30 of 1,686 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the janus kinase inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 323,323 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 19% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,815 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ruxolitinib is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the janus kinase inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Ruxolitinib as a suspect or interacting product; reports listing it only as a concomitant medication (1,468) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.