Jaypirca: adverse event reports filed with FDA

503

reports as suspect product

0% of all reports · about 151 a year

272

reports, 12 months to June 2026

135 in the 12 months before

56.1%

marked serious by the reporter

70.8% across the class

22.7%

record death among outcomes, as reported

114 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 Jaypirca reports recording the termmedian drug in kinase inhibitor

1. Deaththe patient died; cause not stated by this term15.1%76
2. Malignant neoplasm progression8.3%42
3. Pneumonialung infection5.6%28
4. White blood cell count increased4%20
5. Hospitalisationadmission to hospital3.6%18
6. Rashskin rash3.2%16
7. Therapy interrupted3.2%16
8. Fatiguetiredness3%15
9. Painpain, site not specified3%15
10. Off label useused for a purpose or in a way not on the label2.8%14
11. Diarrhoealoose or frequent stools2.6%13
12. Astheniaweakness or lack of energy2%10
13. Drug ineffectivethe medicine did not work as expected2%10
14. Acute kidney injurysudden loss of kidney function1.8%9
15. Peripheral swellingswelling of the arms or legs1.8%9
16. Platelet count decreasedlow platelet count1.8%9
17. Dyspnoeashortness of breath1.6%8
18. Illness1.6%8
19. Pyrexiafever1.6%8
20. Cardiac failureheart failure1.4%7
21. Sinus node dysfunction1.4%7
22. Contusiona bruise1.2%6
23. Haemoglobin decreasedlow haemoglobin1.2%6
24. Pericardial effusionfluid around the heart1.2%6
25. Pleural effusionfluid around the lung1.2%6
26. Anaemialow red blood cells1%5
27. Arthralgiajoint pain1%5
28. Dysphagiadifficulty swallowing1%5
29. Neutropenialow neutrophils, a type of white blood cell1%5
30. Sepsisa severe body-wide response to infection1%5

Top 30 of 107 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 100 drugs in the 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 849,161 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. 76.3% 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 503 reports.

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 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 Jaypirca as a suspect or interacting product; reports listing it only as a concomitant medication (37) 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.