Ribociclib: uses, dosing, side effects & brands
Ribociclib is a kinase inhibitor sold in the U.S. under one brand, for breast neoplasms. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats
- Breast Neoplasms
- Available as
- Tablet
- Sold as
- Kisqali
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How ribociclib is dosed
From the FDA label for Kisqali (application NDA209092). Other ribociclib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
KISQALI tablets are taken orally with or without food in combination with an aromatase inhibitor or fulvestrant. ( 2 ) Early Breast Cancer Recommended starting dose: 400 mg orally (two 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment. ( 2.1 ) Advanced or Metastatic Breast Cancer Recommended starting dose: 600 mg orally (three 200 mg tablets) taken once daily with or without food for 21 consecutive days followed by 7 days off treatment. ( 2.1 ) Dose interruption, reduction, and/or discontinuation may be required based on individual safety and tolerability. ( 2.2 ) 2.1 Recommended Dosage Important Administration Instructions KISQALI can be taken with or without food [see Clinical Pharmacology (12.3)] . Pre/perimenopausal women, or men, treated with the combination KISQALI plus an aromatase inhibitor or fulvestrant, should be treated with a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards. Patients should take their dose of KISQALI at approximately the same time each day, preferably in the morning. If the patient vomits after taking the dose, or misses a dose, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time. KISQALI tablets should be swallowed whole (tablets should not be chewed, crushed or split prior to…
Ribociclib side effects
The following adverse reactions are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease/Pneumonitis [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] QT Interval Prolongation [see Warnings and Precautions (5.3, 5.4)] Hepatotoxicity [see Warnings and Precautions (5.5)] Neutropenia [see Warnings and Precautions (5.6)] In patients with early breast cancer, the most common (incidence ≥ 20%) adverse reactions, including laboratory abnormalities, are lymphocytes decreased, leukocytes decreased, neutrophils decreased, hemoglobin decreased, alanine aminotransferase increased, aspartate aminotransferase increased, infections, creatinine increased, platelets decreased, headache, nausea, and fatigue. ( 6 ) In patients with advanced or metastatic breast cancer, the most common (incidence ≥ 20%) adverse reactions, including laboratory abnormalities, are leukocytes decreased, neutrophils decreased, hemoglobin decreased, lymphocytes decreased, aspartate aminotransferase increased, gamma glutamyl transferase increased, alanine aminotransferase increased, infections, nausea, creatinine increased, fatigue, platelets decreased, diarrhea, vomiting, headache, constipation, alopecia, cough, rash, back pain, and glucose serum decreased. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis…
Who shouldn’t take ribociclib
None. None. ( 4 )
Ribociclib drug interactions
CYP3A Inhibitors: Avoid concomitant use of KISQALI with strong CYP3A inhibitors. If strong inhibitors cannot be avoided, reduce KISQALI dose. ( 2.2 , 7.1 ) CYP3A4 Inducers: Avoid concomitant use of KISQALI with strong CYP3A inducers. ( 7.2 ) CYP3A Substrates: The dose of CYP3A substrates may need to be reduced when given concurrently with KISQALI. ( 7.3 ) Drugs Known to Prolong QT Interval: Avoid concomitant use of drugs known to prolong QT interval, such as anti-arrhythmic medicines. ( 7.4 ) 7.1 Drugs That May Increase Ribociclib Plasma Concentrations CYP3A4 Inhibitors Coadministration of strong CYP3A inhibitors increases ribociclib exposure [see Clinical Pharmacology (12.3)] . Increased ribociclib concentrations may increase the incidence and severity of adverse reactions, including QTcF prolongation [see Warnings and Precautions (5.3)] . Avoid concomitant use of strong CYP3A inhibitors with KISQALI and consider alternative concomitant medications with less potential for CYP3A inhibition. In patients with early breast cancer, if coadministration of KISQALI with a strong CYP3A inhibitor cannot be avoided, reduce the dose of KISQALI to 200 mg once daily. In patients with advanced or metastatic breast cancer, if coadministration of KISQALI with a strong CYP3A inhibitor cannot be avoided, reduce the dose of KISQALI to 400 mg once daily [see Dosage and Administration (2.2)] . 7.2 Drugs That May Decrease Ribociclib Plasma Concentrations CYP3A Inducers Coadministration of strong CYP3A inducers decreases the plasma exposure of ribociclib [see Clinical Pharmacology (12.3)] . Avoid concomitant use of strong CYP3A inducers and consider an alternate concomitant medication with no or minimal potential to induce CYP3A. 7.3 Effect of KISQALI on Other Drugs CYP3A Substrates Coadministration of sensitive CYP3A4 substrates with multiple doses of KISQALI increases the substrate exposure [see Clinical Pharmacology (12.3)] . For CYP3A substrates where minimal increases in the concentration may increase CYP3A substrate adverse reactions, monitor for increased adverse reactions of the CYP3A substrate during treatment with KISQALI. The dose of the sensitive CYP3A substrate may need to be reduced as KISQALI can increase its exposure. 7.4 Drugs That Prolong the QT Interval Avoid coadministration of KISQALI with products with a known potential to prolong QT interval, such as antiarrhythmic drugs and other drugs that are known to prolong the QT interval. If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated [see Warnings and Precautions (5.3), Clinical Pharmacology (12.2)] .
Every ribociclib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Kisqali.
Combination products containing ribociclib
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Can you crush or split ribociclib?
At least one ribociclibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each ribociclib label says about crushing, splitting and chewingRibociclib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ribociclib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of ribociclib during breastfeeding. Because protein binding of ribociclib is 70%, clinically important amounts of the drug might pass into breastmilk. The manufacturer recommends that breastfeeding be discontinued during ribociclib therapy and for at least 3 weeks after the final dose. Ribociclib is also given in combination with fulvestrant, which may increase the risk to the infant.
National Institute of Child Health and Human Development, record revised March 15, 2025. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ribociclib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 90 reports naming ribociclib, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- neutropenia18 reports
- asthenia11 reports
- metastases to liver9 reports
- white blood cell count decreased9 reports
- metastases to bone8 reports
- leukopenia7 reports
- dyspnoea6 reports
- laboratory test abnormal6 reports
Read these as a signal, not a rate. A report does not mean ribociclib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is ribociclib?
Kisqali (Ribociclib Succinate) is a kinase inhibitor used to treat Breast Neoplasms.
What kind of drug is ribociclib?
The FDA classifies ribociclib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ribociclib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ribociclib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ribociclib come in?
Across the brands we track, ribociclib is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ribociclib?
We do not currently list a generic-labelled ribociclib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ribociclib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ribociclib
- MLA
- “Ribociclib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ribociclib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ribociclib on DailyMed (NIH) ↗.