Brand name · Ribociclib
Kisqali: adverse event reports filed with FDA
24,603 reports list it as a suspect or interacting product, 2014–2026. Class: Kinase inhibitor.
- 24,603
- reports as suspect product
- 0.1% of all reports · about 1,983 a year
- 3,413
- reports, 12 months to June 2026
- 2,975 in the 12 months before
- 79.2%
- marked serious by the reporter
- 70.8% across the class
- 15.3%
- record death among outcomes, as reported
- 3,774 reports · not verified by FDA
Between February 2014 and June 2026, 24,603 adverse event reports received by FDA list the brand name Kisqali (ribociclib) as a suspect or interacting product. Reports that mention it only as a concomitant medication (323) are left out of every figure here.
In the 12 months to June 2026, 3,413 reports listed it, up 15% from 2,975 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 1,983 reports a year and 0.1% of the 20,646,523 reports in the database, and 2.9% of the reports for the kinase inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded nausea (13.7%), fatigue (13.6%) and neutropenia (11.2%). A report can list several reactions, so shares add to more than 100%; 2,424 different terms appear across these reports. Nausea is recorded in 13.7% of these reports, a larger share than in the median kinase inhibitor drug (5.5%).
79.2% of the reports are marked serious by the reporter (70.8% across the class); 15.3% record death among the outcomes and 23.2% record hospitalisation, as reported. 45.3% of the reports came from consumers, and the largest patient age group is 45 to 64 (19.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Kisqali reports recording the termmedian drug in kinase inhibitor
- Nauseafeeling sick13.7%3,379
- Fatiguetiredness13.6%3,336
- Neutropenialow neutrophils, a type of white blood cell11.2%2,765
- Deaththe patient died; cause not stated by this term8.6%2,104
- Vomitingbeing sick7.8%1,911
- Malignant neoplasm progression7.6%1,877
- Diarrhoealoose or frequent stools7.3%1,785
- White blood cell count decreasedlow white cell count6.8%1,675
- Painpain, site not specified6.6%1,632
- Malaisegeneral feeling of being unwell6.1%1,496
- Alopeciahair loss5.3%1,315
- Dyspnoeashortness of breath5.3%1,315
- Astheniaweakness or lack of energy5.2%1,278
- Decreased appetitereduced appetite5%1,228
- Anaemialow red blood cells4.9%1,205
- Pruritusitching4.8%1,192
- Headachehead pain4.8%1,183
- Leukopenialow white blood cells4.8%1,181
- Arthralgiajoint pain4.7%1,168
- Breast cancer metastatic4.7%1,163
- Dizzinesslight-headedness or unsteadiness4.7%1,160
- Metastases to bone4.6%1,126
- Rashskin rash4.5%1,097
- Coughcough4.4%1,089
- Constipationconstipation4.2%1,043
- Pain in extremitypain in an arm or leg4.1%1,021
- Drug ineffectivethe medicine did not work as expected3.8%936
- Electrocardiogram QT prolongeda QT prolongation on the ECG3.8%936
- Pyrexiafever3.8%935
Top 30 of 2,424 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 36.2% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Breast cancer metastatic | 7,600 | 30.9% |
| Breast cancer | 5,344 | 21.7% |
| Hormone receptor positive her2 negative breast cancer | 2,114 | 8.6% |
| Breast cancer female | 765 | 3.1% |
| Neoplasm malignant | 127 | 0.5% |
| Her2 negative breast cancer | 74 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 24,603 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Kisqali reports |
|---|---|---|
| Letrozole | 6,189 | 25.2% |
| Fulvestrant | 2,911 | 11.8% |
| Anastrozole | 1,672 | 6.8% |
| Femara | 1,485 | 6% |
| Zoledronic acid | 706 | 2.9% |
| Zometa | 641 | 2.6% |
| Xgeva | 580 | 2.4% |
| Faslodex | 529 | 2.2% |
| Exemestane | 506 | 2.1% |
| Denosumab | 412 | 1.7% |
Other products listed in reports where Kisqali 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
| Measure | Kisqali | Kinase inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 24,603 | 849,161 | 20,646,523 |
| Share of that pool | — | 2.9% | 0.1% |
| Reports, latest 12 months | 3,413 | — | 1,332,454 |
| Marked serious | 79.2% | 70.8% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 153 | 190 | 91 |
| Hospitalisation recorded, per 1,000 reports | 232 | 264 | 213 |
| Consumer-filed share | 45.3% | 42.3% | 45.8% |
| Top term, share of reports | Nausea 13.7% | median 5.5% | 3.8% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Ibrance | brand | 81,912 | 2,380 | 47.1% |
| Imbruvica | brand | 67,039 | 2,283 | 74.4% |
| Cabometyx | brand | 41,818 | 4,904 | 40.4% |
| Sutent | brand | 33,215 | 175 | 74.5% |
| Afinitor | brand | 30,706 | 161 | 71.3% |
| Sprycel | brand | 27,255 | 557 | 49.7% |
| Tasigna | brand | 24,911 | 328 | 70.9% |
| Ofev | brand | 23,907 | 2,434 | 66.9% |
| Gleevec | brand | 23,132 | 81 | 74.7% |
| Tagrisso | brand | 23,085 | 1,410 | 92.3% |
| Lenvima | brand | 22,350 | 2,643 | 87.3% |
| Votrient | brand | 22,084 | 119 | 60.9% |
| Mekinist | brand | 17,070 | 916 | 64% |
| Inlyta | brand | 15,696 | 388 | 60.9% |
| Nexavar | brand | 15,449 | 67 | 87.5% |
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.
Questions about Kisqali reports
How many adverse event reports has FDA received for Kisqali?
24,603 reports list Kisqali as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 3,413 of them arrived in the latest 12 months. Another 323 list it only as a concomitant medication.
What reactions are recorded in Kisqali reports?
nausea (13.7%), fatigue (13.6%), neutropenia (11.2%), death (8.6%) and vomiting (7.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Kisqali was responsible.
How serious are the reports?
79.2% are marked serious by the reporter. Among the outcomes recorded, 15.3% of reports include death and 23.2% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (45.3%), physician (30.6%) and other health professional (18.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Kisqali rising?
3,413 reports in the 12 months to June 2026, up 15% from 2,975 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Kisqali was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Kisqali?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
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 Kisqali as a suspect or interacting product; reports listing it only as a concomitant medication (323) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.