Kisqali Side Effects

Generic name: ribociclib

Medically reviewed by Drugs.com. Last updated on Sep 30, 2023.

Note: This document provides detailed information about Kisqali Side Effects associated with ribociclib. Some dosage forms listed on this page may not apply specifically to the brand name Kisqali.

Applies to ribociclib: oral tablet.

Serious side effects of Kisqali

Along with its needed effects, ribociclib (the active ingredient contained in Kisqali) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ribociclib:

More common side effects

• black, tarry stools
• bladder pain
• bleeding gums
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• chest tightness
• chills
• cough
• difficult, burning, or painful urination
• fever
• frequent urge to urinate
• lower back or side pain
• pale skin
• pinpoint red spots on the skin
• sore throat
• tingling of the hands or feet
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss

Less common side effects

• chest pain
• confusion
• dark urine
• fainting
• general feeling of discomfort or illness
• irregular heartbeat
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• nausea
• numbness and tingling around the mouth, fingertips, or feet
• pain or tenderness in the upper stomach
• pale stools
• seizures
• stomach cramps
• thickening of bronchial secretions
• tremor
• vomiting
• yellow eyes or skin

Incidence not known

• blistering, peeling, loosening of skin
• diarrhea
• joint or muscle pain
• rash or itching skin
• red irritated eyes
• red skin lesions, often with a purple center
• swollen glands

Other side effects of Kisqali

Some side effects of ribociclib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• back pain
• constipation
• dry skin
• headache
• lack or loss of strength
• loss or thinning of the hair
• mouth or throat pain
• swelling or inflammation of the mouth
• trouble sleeping

Less common side effects

• belching
• dry eye
• heartburn
• increased tearing
• indigestion
• patchy loss of skin color

For healthcare professionals

Applies to ribociclib: oral tablet.

General adverse events

The most common adverse reactions reported in patients with early breast cancer included decreased lymphocytes, decreased leukocytes, decreased neutrophils, decreased hemoglobin, increased ALT, increased AST, infections, increased creatinine, decreased platelets, headache, nausea, and fatigue. The most common adverse reactions reported in patients with advanced/metastatic breast cancer included decreased leukocytes, decreased neutrophils, decreased hemoglobin, decreased lymphocytes, increased AST, increased GGT, increased ALT, infections, nausea, increased creatinine, fatigue, decreased platelets, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, back pain, and decreased serum glucose.^[Ref]

Cardiovascular

• Common (1% to 10%): ECG QT prolonged
• Uncommon (0.1% to 1%): Acute myocardial infarction, cardiac failure, ventricular arrhythmia, hemorrhagic shock

In patients with early breast cancer who received this drug plus a nonsteroidal aromatase inhibitor (NSAI), 8 of 2494 patients (0.3%) had greater than 500 milliseconds (ms) postbaseline QTcF interval (QT interval corrected for heart rate using Fridericia's formula) value and 50 of 2494 patients (2%) had greater than 60 ms QTcF increase from baseline. In patients with advanced/metastatic breast cancer who received this drug plus NSAI or fulvestrant, 15 of 1054 patients (1.4%) had greater than 500 ms postbaseline QTcF value and 61 of 1054 patients (6%) had greater than 60 ms QTcF increase from baseline. For both patient populations, QTcF prolongation was reversible with dose interruption and most occurred within the first 4 weeks of therapy.

Dermatologic

• Very common (10% or more): Alopecia (up to 35%), rash (up to 26%), pruritus (up to 22%)
• Common (1% to 10%): Dry skin, vitiligo, erythema
• Rare (0.01% to 0.1%): Erythema multiforme
• Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced hypersensitivity syndrome/drug reaction with eosinophilia and systemic symptoms

Rash included rash, maculopapular rash, and pruritic rash.

Gastrointestinal

• Very common (10% or more): Nausea (up to 55%), diarrhea (up to 41%), vomiting (up to 35%), constipation (up to 30%), abdominal pain (up to 21%), stomatitis (up to 16%), dry mouth (up to 14%), dyspepsia (up to 11%)

Abdominal pain included abdominal pain and upper abdominal pain.

Genitourinary

• Very common (10% or more): Urinary tract infections (up to 11%)

Hematologic

• Very common (10% or more): Decreased lymphocytes (up to 97%), decreased leukocytes (up to 95%), decreased neutrophils (up to 94%), decreased hemoglobin (up to 85%), neutropenia (up to 80%), leukopenia (up to 35%), decreased platelets (up to 35%), anemia (up to 24%), lymphopenia (up to 13%), thrombocytopenia (up to 11%)
• Common (1% to 10%): Febrile neutropenia

In patients with early breast cancer who received this drug plus NSAI, 94% (grade 3 or 4: 45%) had a decrease in neutrophil counts (based on laboratory findings), 63% had neutropenia, and 0.3% had febrile neutropenia. The median time to grade 2 or lower neutropenia was 18 days, and the median time to resolution to lower than grade 3 was 10 days. In patients with advanced/metastatic breast cancer who received this drug plus NSAI or fulvestrant, 75% had neutropenia, 62% had grade 3 or 4 decrease in neutrophil count (based on laboratory findings), and 1.7% had febrile neutropenia. The median time to grade 2 or lower neutropenia was 17 days, and the median time to resolution to less than grade 3 was 12 days. Treatment discontinuation due to neutropenia was required in 1.1% of patients with early breast cancer and 1% of patients with advanced/metastatic breast cancer.

Hepatic

• Very common (10% or more): Increased ALT (up to 59%), increased AST (up to 57%), increased GGT (up to 57%), hepatobiliary toxicity (up to 27.3%), abnormal liver function tests (up to 23%)
• Common (1% to 10%): Abnormal liver function, drug-induced liver injury, increased blood bilirubin, hepatotoxicity
• Rare (0.01% to 0.1%): Hy's law cases

Abnormal liver function tests included increased ALT, increased AST, and increased blood bilirubin.

Hepatotoxicity included hepatic cytolysis, hepatocellular injury, drug-induced liver injury, hepatotoxicity, hepatic failure, and autoimmune hepatitis.

In patients with advanced/metastatic breast cancer treated with this drug, grade 3 or 4 increases in ALT and AST occurred in 11% and 8%, respectively. Among the patients with grade 3 or higher ALT/AST elevation, the median time-to-onset was 92 days, and the median time to resolution to grade 2 or lower was 21 days. In 2 studies, concurrent elevations in ALT or AST greater than 3 times the upper limit of normal (3 x ULN) and total bilirubin greater than 2 x ULN (with normal alkaline phosphatase and without cholestasis) occurred in 6 (1%) patients; all patients recovered after discontinuation of this drug.

Drug-induced liver injury was reported in 9 patients (0.4%) with early breast cancer; 5 cases were grade 3 or higher, and 8 cases had resolved as of data cutoff. There were 8 (0.3%) clinically confirmed Hy's law cases (including 4 of the 9 drug-induced liver injury patients); 6 cases had resolved within 303 days and 2 were improving after discontinuation of this drug. Grade 3 or 4 increases in ALT and AST occurred in 8% and 4.7% respectively; grade 4 increases in ALT and AST occurred in 1.5% and 0.8% of patients, respectively.

Metabolic

• Very common (10% or more): Decreased serum glucose (up to 25%), decreased appetite (up to 22%)
• Common (1% to 10%): Hypocalcemia, hypokalemia, hypomagnesemia, hypophosphatemia

Musculoskeletal

• Very common (10% or more): Arthralgia (up to 43%), back pain (up to 27%), pain in extremity (up to 17%)

Nervous system

• Very common (10% or more): Headache (up to 29%), dizziness (up to 15%)
• Common (1% to 10%): Dysgeusia, vertigo, syncope

Ocular

• Very common (10% or more): Increased lacrimation (up to 12%)
• Common (1% to 10%): Dry eye

Other

• Very common (10% or more): Infections (up to 49%), fatigue (up to 43%), decreased phosphorus (up to 20%), pyrexia (up to 19%), peripheral edema (up to 19%), asthenia (up to 17%), decreased potassium (up to 17%), decreased albumin (up to 12%)
• Common (1% to 10%): On-treatment deaths

Infections included urinary tract infections, respiratory tract infections, gastroenteritis, and sepsis.

On-treatment deaths, regardless of causality, were reported in 8 cases (2.4%) of patients treated with this drug plus letrozole. Causes of death included 2 cases of progressive disease (0.6%), 2 cases of acute respiratory failure (0.6%), and 1 case each (0.3%) of the following: sudden death (in a patient with grade 3 hypokalemia and grade 2 QT prolongation that improved to grade 1 on the same day, both reported 10 days before the event), death due to unknown cause, acute myocardial infarction, and pneumonia.

On-treatment deaths, regardless of causality, were reported in 7 patients (1.4%) due to the underlying malignancy and 6 patients (1.2%) due to other causes during treatment with this drug plus fulvestrant. Causes of death included 1 pulmonary embolism, 1 acute respiratory distress syndrome, 1 cardiac failure, 1 pneumonia, 1 hemorrhagic shock, and 1 ventricular arrhythmia.

Psychiatric

• Very common (10% or more): Insomnia (up to 16%)

Renal

• Very common (10% or more): Increased creatinine (up to 68%)

Respiratory

• Very common (10% or more): Cough (up to 25%), dyspnea (up to 18%)
• Common (1% to 10%): Oropharyngeal pain, COVID-19, pneumonia, interstitial lung disease (ILD)/pneumonitis
• Uncommon (0.1% to 1%): Pulmonary embolism, COVID-19 pneumonia, acute respiratory failure, ILD, lung infiltration, pneumonitis, pulmonary fibrosis, acute respiratory distress syndrome, hypersensitivity pneumonitis
• Postmarketing reports: ILD/pneumonitis

In patients with early breast cancer who received this drug plus a NSAI, 1.5% of patients had ILD/pneumonitis (grade 1 to 2). In patients with advanced/metastatic breast cancer, 1.6% of patients had ILD/pneumonitis (any grade; grade 3 to 4: 0.4%; fatal outcome: 0.1%). Cases of ILD/pneumonitis (some resulting in death) have also been reported during postmarketing experience.

Frequently asked questions

• Does Kisqali improve survival / life expectancy for mBC?
• What are the benefits of taking Kisqali and Femara together?
• How do you take Kisqali?

Further information

Kisqali side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer