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Ribociclib Side Effects

The most commonly reported side effects of ribociclib include neutropenia, nausea, and fatigue, based on 29,916 FDA adverse event reports from 2004 to 2025.

Ribociclib side effects

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

1
Neutropenia12.6%3,771
2
Nausea12.0%3,600
3
Fatigue11.9%3,570
4
Malignant Neoplasm Progression8.6%2,559
5
Death8.4%2,505
6
Vomiting6.8%2,046
7
Diarrhoea6.5%1,957
8
White Blood Cell Count Decreased6.1%1,815
9
Pain5.8%1,750
10
Metastases To Bone5.5%1,649
11
Dyspnoea5.1%1,540
12
Malaise5.1%1,518
13
Asthenia5.0%1,506
14
Breast Cancer Metastatic5.0%1,505
15
Anaemia4.8%1,440

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

Report severity

82.0%Serious24,541 reports
23.0%Hospitalizations6,895 reports
15.3%Fatal4,573 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ribociclib drug interactions

Other drugs that appear in adverse event reports alongside ribociclib. 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
Letrozole30.9%9,251
2
Fulvestrant12.9%3,860
3
Zoledronic-acid5.4%1,610
4
Anastrozole4.9%1,470
5
Denosumab2.2%658
6
Palbociclib1.9%577
7
Goserelin1.8%539
8
Exemestane1.8%531
9
Everolimus1.6%471
10
Tamoxifen-citrate1.3%395
11
Capecitabine1.0%292
12
Paclitaxel1.0%291
13
Alpelisib0.8%246
14
Cyclophosphamide0.7%199
15
Doxorubicin-hydrochloride0.7%199

Taken alongside

1
Letrozole5.2%1,550
2
Fulvestrant3.2%957
3
Denosumab3.0%902
4
Levothyroxine-sodium2.1%623
5
Anastrozole2.0%609
6
Ergocalciferol1.9%556
7
Goserelin1.8%545
8
Acetaminophen1.7%503
9
Calcium1.6%483
10
Omeprazole1.6%465
11
Zoledronic-acid1.4%426
12
Amlodipine1.3%378
13
Aspirin1.3%378
14
Metformin1.2%369
15
Pantoprazole-sodium1.1%344

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 ribociclib side effects

91.2% of ribociclib adverse event reports involve female patients and 1.7% involve male patients. The largest age group is adult at 59%. These figures reflect who reports side effects, not underlying risk.

Sex

Female91.2%
Male1.7%
Unknown7.1%

Age group

< 2<0.1%
2–110.3%
12–17<0.1%
18–6458.7%
65+40.9%

What is ribociclib used for

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

Acinar Cell Carcinoma Of PancreasAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAcute Promyelocytic LeukaemiaAcute Undifferentiated LeukaemiaAdenocarcinomaAdrenal Gland CancerAgranulocytosisAllogenic Stem Cell TransplantationAnaplastic Large-cell LymphomaAngiosarcomaAntioestrogen TherapyAromatase Inhibition Therapy

Showing 15 of 408 indications

Ribociclib brand names and reporting trend

Ribociclib is sold under brand names including Ribociclib, Letrozole;vribociclib Succinate.

Brand names

Ribociclib10,471
Letrozole;vribociclib Succinate131

Quarterly reports (20042025)

200420202025

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

Taking ribociclib with another medication?

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