Ribociclib: adverse event reports filed with FDA

6,223

reports as suspect product

0% of all reports · about 656 a year

1,075

reports, 12 months to June 2026

1,019 in the 12 months before

97.3%

marked serious by the reporter

70.8% across the class

13%

record death among outcomes, as reported

810 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 Ribociclib reports recording the termmedian drug in kinase inhibitor

1. Neutropenialow neutrophils, a type of white blood cell20.6%1,281
2. Malignant neoplasm progression13.5%843
3. Metastases to bone9.8%607
4. Breast cancer metastatic7%437
5. Fatiguetiredness6.9%427
6. Metastases to liver6.6%411
7. Deaththe patient died; cause not stated by this term6.2%387
8. Nauseafeeling sick6.1%377
9. Off label useused for a purpose or in a way not on the label5.2%326
10. Astheniaweakness or lack of energy5.1%317
11. Anaemialow red blood cells4.8%297
12. White blood cell count decreasedlow white cell count4.5%279
13. Dyspnoeashortness of breath4.3%265
14. Leukopenialow white blood cells4.2%261
15. Hepatotoxicityliver injury3.9%242
16. Diarrhoealoose or frequent stools3.9%241
17. Metastases to lung3.9%240
18. Electrocardiogram QT prolongeda QT prolongation on the ECG3.8%238
19. Alanine aminotransferase increasedraised liver enzyme (ALT)3.8%236
20. Breast cancerbreast cancer3.7%232
21. Aspartate aminotransferase increasedraised liver enzyme (AST)3.6%224
22. Painpain, site not specified3.6%221
23. Vomitingbeing sick3.5%215
24. Pleural effusionfluid around the lung3.4%211
25. Arthralgiajoint pain3.4%210
26. Pyrexiafever3.3%207
27. Rashskin rash3.1%192
28. Thrombocytopenialow platelets3.1%190
29. Disease progressionthe disease advanced3%185
30. Drug ineffectivethe medicine did not work as expected2.9%178

Top 30 of 1,105 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. 6.8% 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 6,223 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ribociclib 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 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 Ribociclib as a suspect or interacting product; reports listing it only as a concomitant medication (309) 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.