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Ribociclib Side Effects

For the Consumer

Applies to ribociclib: oral tablet

Along with its needed effects, ribociclib 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
  • Black, tarry, stools
  • bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • chills
  • cough
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • fever
  • frequent urge to urinate
  • lower back or side pain
  • pale skin
  • rapid weight gain
  • sore throat
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Fainting
  • irregular heartbeat recurrent

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
  • Abdominal or stomach pain
  • back pain
  • decreased appetite
  • diarrhea
  • difficulty having a bowel movement (stool)
  • hair loss or thinning of the hair
  • headache
  • nausea
  • rash or itching skin
  • swelling or inflammation of the mouth
  • trouble sleeping
  • vomiting

For Healthcare Professionals

Applies to ribociclib: oral tablet

General

-The most common adverse reactions (reported at a frequency 20% or more) were neutropenia, nausea, fatigue, diarrhea, leukopenia, alopecia, vomiting, constipation, headache, and back pain.
-The most common laboratory abnormalities (reported at a frequency 20% or more) were decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, increased ALT, increased AST, decreased platelet count, and increased creatinine.[Ref]

Hematologic

Very common (10% or more): Decreased leukocyte count (93%), decreased neutrophil count (93%), neutropenia (75%), decreased hemoglobin (57%), decrease lymphocyte count (51%), leukopenia (33%), decreased platelet count (29%), anemia (18%), lymphopenia (11%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (52%), diarrhea (35%), vomiting (29%), constipation (25%), stomatitis (12%), abdominal pain (11%)[Ref]

Hepatic

Very common (10% or more): Increased ALT (46%), increased AST (44%), abnormal liver function tests (18%)
Frequency not reported: Increased blood bilirubin[Ref]

Other

Very common (10% or more): Fatigue (37%), pyrexia (13%), peripheral edema (12%)
Uncommon (0.1% to 1%): On-treatment deaths, sudden death[Ref]

Dermatologic

Very common (10% or more): Alopecia (33%), rash (17%), pruritus (14%)[Ref]

Nervous system

Very common (10% or more): Headache (22%), insomnia (12%)
Common (1% to 10%): Syncope

Metabolic

Very common (10% or more): Increased creatinine (20%), decreased appetite (19%), decreased phosphorous (13%), decreased potassium (11%)[Ref]

Musculoskeletal

Very common (10% or more): Back pain (20%)

Respiratory

Very common (10% or more): Dyspnea (12%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (11%)[Ref]

Cardiovascular

Frequency not reported: QT interval prolongation[Ref]

References

1. "Product Information. Kisqali (ribociclib)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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.

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