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Ribociclib

Ribociclib is a targeted cancer medicine used to treat hormone receptor-positive, HER2-negative breast cancer — either early-stage or advanced/metastatic — always given in combination with other hormone-blocking therapies.

Brand name Kisqali
Drug classes Cytochrome P450 3a Inhibitors
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Ribociclib at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Ribociclib (Kisqali) is a targeted tablet for hormone receptor-positive, HER2-negative breast cancer, early or advanced, that blocks CDK4 and CDK6, enzymes cancer cells need to divide, and since about 2017 it has become a standard add-on to hormone-blocking therapy (an aromatase inhibitor or fulvestrant). Most people manage it reasonably well and notice mainly nausea, tiredness or hair thinning, while drops in white blood cells (which make infections riskier) and liver changes usually show up only on blood tests. The one thing to watch is QT prolongation, a change in the heart's electrical rhythm, so report a pounding heartbeat, fainting or dizziness right away.

Clinical pearls

  • Never take it with tamoxifen or St. John's wort, and run any new antibiotic, antifungal or heart medicine past your pharmacist.
  • Expect ECGs (heart tracings) before starting and around day 14, plus blood counts every two weeks for the first two cycles.
  • New breathlessness, cough, blistering rash or mouth sores can mean rare lung or skin reactions, so report them right away.
  • Swallow tablets whole; if you vomit or miss a dose, skip it and take the next one on time.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2017
Companies listing it with the FDA1
FDA label last updatedJul 1, 2026
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Ribociclib, written from its FDA label.

What Ribociclib is used for

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Ribociclib is a targeted oral cancer treatment always used in combination with other hormone-blocking medicines — never alone. Its approved uses include:

  • Kisqali combined with an aromatase inhibitor for adults with HR-positive, HER2-negative stage II or III early breast cancer at high risk of the cancer returning (adjuvant treatment after surgery)
  • Kisqali combined with an aromatase inhibitor as the first hormonal-based treatment for adults with HR-positive, HER2-negative advanced or metastatic breast cancer
  • Kisqali combined with fulvestrant as the first hormonal-based treatment for adults with HR-positive, HER2-negative advanced or metastatic breast cancer
  • Kisqali combined with fulvestrant for adults with HR-positive, HER2-negative advanced or metastatic breast cancer whose cancer progressed on prior hormone therapy

How Ribociclib works

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Ribociclib is a CDK4/6 inhibitor — it blocks two proteins called cyclin-dependent kinase 4 and 6 that breast cancer cells use to fuel their growth and division. When these proteins are blocked, cancer cells get stuck in a resting phase and can't copy themselves. Because hormone receptor-positive breast cancers are also driven by estrogen signaling, combining ribociclib with an aromatase inhibitor (which cuts estrogen production) or fulvestrant (which blocks estrogen receptors) hits the cancer through two pathways at once, shrinking tumors more effectively than either drug could alone.

Ribociclib dosage

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Kisqali tablets are taken by mouth once daily — with or without food — at roughly the same time each day, preferably in the morning. Treatment follows a repeating 28-day cycle: 21 days on followed by 7 days off. For early breast cancer, treatment is planned to continue for 3 years unless the cancer returns or side effects require stopping sooner. Swallow tablets whole — never chew, crush, or split them, and discard any broken or cracked tablet.

  • If you vomit after a dose or forget to take it, skip that dose — do not take an extra one. Resume your next dose at the normal time.
  • Your doctor may reduce or pause your dose based on side effects; always follow their updated instructions.

Dosing details from the FDA-approved label

From the Ribociclib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Early Breast Cancer
    • 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles, in combination with an aromatase inhibitor
    • Take with or without food; continue for 3 years or until disease recurrence or unacceptable toxicity. Dose reduction: 200 mg/day (one 200 mg tablet); if reduction below 200 mg/day is required, discontinue
  • Advanced or Metastatic Breast Cancer
    • 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles, in combination with endocrine therapy (fulvestrant or an aromatase inhibitor)
    • Take with or without food. First dose reduction 400 mg/day, second dose reduction 200 mg/day; if reduction below 200 mg/day is required, discontinue
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 swallowing). No tablet should be ingested if it is broken, cracked, or otherwise not intact. Early Breast Cancer The recommended dosage of KISQALI is 400 mg (two 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with an aromatase inhibitor. Refer to the Full Prescribing Information for the recommended dosage of the aromatase inhibitor. In patients with early breast cancer, treatment with KISQALI should continue for 3 years or until disease recurrence or unacceptable toxicity occurs. Advanced or Metastatic Breast Cancer The recommended dosage of KISQALI is 600 mg (three 200 mg film-coated tablets) taken orally, once daily for 21 consecutive days followed by 7 days off in 28-day treatment cycles. KISQALI should be given in combination with endocrine therapy (fulvestrant or an aromatase inhibitor).

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Ribociclib side effects

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The most commonly reported side effects with Kisqali include:

Common side effects

  • Low white blood cell count (neutropenia or leukopenia)
  • Nausea
  • Fatigue
  • Headache
  • Hair thinning or hair loss (alopecia)
  • Diarrhea
  • Infections (such as urinary tract or respiratory infections)
  • Abnormal liver enzyme levels on blood tests
  • Low blood cell counts — white cells (neutropenia, leukopenia), red cells (anemia), and platelets
  • Nausea, vomiting, diarrhea, and constipation
  • Fatigue and weakness
  • Increased liver enzymes on blood tests

When to get medical help

  • Call your doctor right away if you have new or worsening shortness of breath, cough, or low oxygen levels — these can be signs of lung inflammation (interstitial lung disease or pneumonitis)
  • Seek immediate help for severe skin reactions: widespread rash, blistering, peeling, or sores in the mouth — these may be signs of dangerous reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis
  • Tell your doctor immediately about heart pounding, fainting, or dizziness — Kisqali can lengthen the QT interval, an electrical change in the heart that can lead to serious arrhythmia
  • Watch for signs of liver problems: yellowing of the skin or eyes (jaundice), dark urine, upper right belly pain, or extreme tiredness
  • Report fever, chills, or signs of infection — low white blood cell counts make infections more dangerous
  • If you are pregnant or become pregnant while on Kisqali, contact your doctor immediately — this medicine can harm an unborn baby

Some side effects are serious and need prompt attention: difficulty breathing or new cough (possible lung inflammation), severe skin reactions with blistering or peeling, heart palpitations or fainting (possible heart rhythm changes), or yellowing of the skin or eyes (possible liver damage). Contact your care team immediately if any of these occur.

Ribociclib warnings and precautions

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  • Heart rhythm (QT prolongation): Kisqali can lengthen the QT interval on an ECG in a dose-dependent way, raising the risk of a dangerous arrhythmia. ECGs and electrolyte blood tests are done before starting and regularly during treatment. Avoid Kisqali with tamoxifen, QT-prolonging drugs, and strong CYP3A inhibitors. Avoid in patients with congenital long QT syndrome, significant heart disease, or uncorrected electrolyte abnormalities.
  • Low white blood cell count (neutropenia): Very common — affects the majority of patients. Serious infections can result. Blood counts are monitored every 2 weeks for the first 2 cycles, then at the start of each subsequent cycle.
  • Liver toxicity (hepatotoxicity): Significant rises in liver enzymes and rare drug-induced liver injury have occurred. Liver function tests are checked before starting and throughout treatment.
  • Lung inflammation (ILD/pneumonitis): Severe, life-threatening, or fatal cases have been reported. Report any new or worsening shortness of breath, cough, or low oxygen right away.
  • Severe skin reactions (SCARs): Rare but potentially life-threatening reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have occurred. Stop Kisqali and get urgent medical care for any widespread, blistering, or peeling rash.
  • Fetal harm: Kisqali can cause serious harm to an unborn baby. Reliable contraception is required during treatment and for at least 3 weeks after the last dose.

Ribociclib interactions

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Ribociclib is broken down mainly by the CYP3A4 liver enzyme system and can also affect how other drugs are processed. Key interactions to know:

  • Strong CYP3A inhibitors (e.g., certain antifungals, some HIV medications, clarithromycin) — significantly raise ribociclib blood levels, worsening side effects and QT risk; avoid if possible, or use a reduced Kisqali dose if unavoidable
  • Strong CYP3A inducers (e.g., rifampin, carbamazepine, St. John's Wort) — lower ribociclib levels and may reduce effectiveness; avoid
  • QT-prolonging drugs (e.g., anti-arrhythmic medicines) — combining with Kisqali further increases the risk of dangerous heart rhythm changes; avoid
  • Tamoxifen — dramatically increases QT prolongation risk when used with Kisqali; this combination should not be used
  • Sensitive CYP3A4 substrates (drugs processed by CYP3A4) — Kisqali can raise their levels, potentially increasing their side effects; dose adjustments of those medicines may be needed

Interactions listed in the FDA-approved label

From the Ribociclib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Strong CYP3A inhibitors: Coadministration increases ribociclib exposure, which may increase the incidence and severity of adverse reactions, including QTcF prolongation. Avoid concomitant use and consider alternative medications with less potential for CYP3A inhibition. If it cannot be avoided, reduce KISQALI to 200 mg once daily in early breast cancer, or to 400 mg once daily in advanced or metastatic breast cancer.
  • Strong CYP3A inducers: Coadministration decreases the plasma exposure of ribociclib. Avoid concomitant use and consider an alternate concomitant medication with no or minimal potential to induce CYP3A.
  • Sensitive CYP3A substrates: Coadministration with multiple doses of KISQALI increases the substrate exposure. Monitor for increased adverse reactions of the CYP3A substrate; the dose of the sensitive CYP3A substrate may need to be reduced.
  • Drugs known to prolong the QT interval (such as antiarrhythmic drugs): Coadministration with products with a known potential to prolong the QT interval is a concern for QT prolongation. Avoid coadministration. If concomitant use cannot be avoided, monitor ECG when initiating, during concomitant use, and as clinically indicated.
Read the label’s full interactions text

7 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)] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿178 supplements and herbs with documented Ribociclib interactions, ranked by severity Check Ribociclib against a supplement or herb →

Before taking Ribociclib

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  • Tell your doctor if you have any heart condition — especially a history of abnormal heart rhythms, congenital long QT syndrome, heart failure, recent heart attack, unstable angina, high-degree heart block, or severe aortic stenosis
  • Tell your doctor about any electrolyte problems (low potassium, calcium, magnesium, or phosphorus), uncontrolled high blood pressure, or uncontrolled hypothyroidism — these raise the risk of QT-related heart events
  • Tell your doctor if you have moderate-to-severe liver disease or severe kidney disease — dose adjustments or extra monitoring may be needed
  • Share a complete list of all medicines, vitamins, and supplements — especially anything that affects heart rhythm or the CYP3A4 enzyme system
  • If you are pregnant, planning to become pregnant, or are of childbearing potential, discuss this with your doctor before starting — Kisqali can harm a developing baby and reliable contraception is required during treatment and for at least 3 weeks after the last dose
  • Do not breastfeed during treatment or for at least 3 weeks after the last dose
  • If you are a man, be aware that Kisqali may affect fertility based on animal studies
  • Kisqali's safety and effectiveness in children has not been established

What Ribociclib does in the body

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Ribociclib affects heart electrical activity in a measurable way: it prolongs the QTc interval (the time it takes the heart to recharge between beats) in a concentration-dependent manner — meaning higher drug levels cause more prolongation. This effect is clinically significant and is why ECG monitoring is required before and during treatment. The drug does not fully characterize an exposure-response relationship for its cancer-fighting effects in patients, but its cell-cycle-blocking action is well documented in laboratory and animal models.

How your body processes Ribociclib

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After taking a Kisqali tablet, ribociclib is absorbed within 1 to 4 hours and has a bioavailability of about 66% — meaning roughly two-thirds of the dose reaches the bloodstream. Food does not meaningfully change how much drug is absorbed, so it can be taken with or without a meal. Ribociclib is extensively broken down by the liver, primarily through the CYP3A4 enzyme, and the drug and its breakdown products leave the body mainly in the feces (about 69%) and urine (about 23%). The drug's effective half-life is around 32 hours, meaning it stays active in the body for well over a day; steady levels in the blood are typically reached after about 8 days of daily dosing. Patients with severe kidney impairment or severe liver disease have notably higher drug exposure, which is why dosing may be adjusted in those groups.

How to store Ribociclib

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Store at room temperature at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F). Store in the original blister package in order to protect from moisture.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

178

Supplements & herbs that interact with Ribociclib

178 supplements and herbal products have documented interactions with Ribociclib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 11
  • Moderate · 132
  • Minor · 35
ACTIVATED CHARCOAL Major AMERICAN HELLEBORE Major ARSENIC Major BEER Major CESIUM Major EPHEDRA Major GRAPEFRUIT Major SIBERIAN COCKLEBUR Major +170 more
Every supplement checked against Ribociclib — ranked by severity The full interaction hub: 11 major · 132 moderate · 35 minor · every one linked to its full report. Check Ribociclib against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Ribociclib: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Ribociclib — the kind of thing our pharmacy team would talk through with you at the counter.

Why do I have to take Kisqali with another medicine — can't I just take it alone?

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Great question. Kisqali is designed to be used alongside a hormone-blocking medicine — either an aromatase inhibitor or fulvestrant — because your breast cancer is driven by both cell growth signals AND hormones. Ribociclib blocks the cell-division machinery, while the hormone medicine cuts off the fuel that feeds the cancer. Together they work better than either one on its own. Taking Kisqali without the partner medicine would leave a major driver of the cancer unchecked.

What's the deal with the 21-days-on, 7-days-off schedule? Why do I get a break?

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The week off is intentional — it gives your body, especially your bone marrow and blood cell counts, time to recover. Kisqali can significantly lower your white blood cell counts, and the rest period helps them bounce back before the next cycle starts. It also helps manage other side effects. Your doctor will check your blood counts regularly throughout treatment to make sure everything is recovering as expected during those 7 days off.

I've heard this medicine can affect my heart. What should I watch for?

▾
Kisqali can change an electrical measurement in your heart called the QT interval, which in rare cases can lead to a serious irregular heartbeat. Your doctor will do an ECG — a heart tracing — before you start and around day 14 of your first cycle. Contact your doctor right away if you feel your heart pounding or racing, feel faint or dizzy, or have an unexplained fainting episode. Also, some common medicines — including the heartburn drug tamoxifen — can make this risk worse when combined with Kisqali, so always tell every prescriber you're on this drug.

What side effects are most likely, and which ones should I call about right away?

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The most common things people notice are nausea, fatigue, headache, and low blood cell counts — the last one usually shows up on blood tests before you feel it. Hair thinning is also common. These are manageable. What you do need to call about immediately: new or worsening shortness of breath or cough (possible lung inflammation), severe skin reactions like widespread blistering or peeling, signs of liver trouble like yellowing of the skin or eyes, or any fever or chills while your blood counts are low. Don't wait — those need same-day attention.

Can I take my regular medications and supplements while on Kisqali?

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Some medicines interact seriously with Kisqali. Drugs that are strong inhibitors or inducers of the CYP3A4 liver enzyme — including certain antifungals, HIV medications, antibiotics, seizure medicines, and even St. John's Wort — can either raise Kisqali levels dangerously or make it less effective. Medicines that also affect heart rhythm are especially risky to combine. Always run any new prescription, over-the-counter drug, or supplement by your oncologist or pharmacist before starting it while you're on Kisqali.

Is it safe to get pregnant or breastfeed while taking this medicine?

▾
No — Kisqali can cause serious harm to an unborn baby based on animal studies and how the drug works. If you can become pregnant, you need to use reliable contraception (something with less than a 1% failure rate) throughout your entire treatment and for at least 3 weeks after your very last dose. A pregnancy test is done before starting. Breastfeeding is also not safe during treatment or for at least 3 weeks after the last dose. If you have any concerns about fertility or family planning, talk with your oncologist before starting.

Is Ribociclib available over the counter?

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No. Ribociclib is a prescription medicine: every Ribociclib product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Ribociclib first available?

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The earliest FDA record we hold for Ribociclib is from 2017: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Ribociclib was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Ribociclib on HelloPharmacist

📊Ribociclib supplement interactions178 checked — ranked by severity 🌿Drug & Supplement CheckerRibociclib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Ribociclib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Ribociclib Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Ribociclib forms and strengths (how it comes)

Ribociclib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Kisqali
How this form is used
What it may be used for
  • Kisqali tablets are used with an aromatase inhibitor for adults with HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence
  • Kisqali tablets are used with an aromatase inhibitor as an initial hormonal treatment for adults with HR-positive, HER2-negative advanced or metastatic breast cancer
  • Kisqali tablets are used with fulvestrant — either as an initial hormonal treatment or after prior hormone therapy has stopped working — for adults with HR-positive, HER2-negative advanced or metastatic breast cancer
Important instructions
  • Kisqali tablets are swallowed whole with or without food — do not chew, crush, or split them, and discard any tablet that is broken or cracked
  • Kisqali tablets are taken once daily, preferably in the morning, on a 21-days-on / 7-days-off schedule within a 28-day cycle
  • If you vomit after taking Kisqali or miss a dose, skip it and take your next dose at the usual time — never take a double dose
  • Pre- or perimenopausal women and men taking Kisqali with an aromatase inhibitor or fulvestrant should also receive an LHRH agonist as directed by their prescriber
Available strengths 1 strength
200 mg
12 FDA-listed product records ⓘ

Ribociclib on the U.S. market: products, makers and brands

How Ribociclib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 3 Ribociclib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Kisqali; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
3
FDA-listed product records ⓘ
2017
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (8) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Ribociclib is used (Medicaid data)

A general measure of how commonly Ribociclib is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Ribociclib is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

21,708
Medicaid prescriptions filled (Q1–Q4 2025)
$353M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Ribociclib prescribed? Of the 1,601 medications we measure, Ribociclib ranks #782 by Medicaid prescriptions — more than 51% of them.

Where Ribociclib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #782 of 1,601
#777 Fosfomycin 23,298 Rx #778 Valganciclovir 23,219 Rx #779 Cetirizine / Pseudoeph... 22,875 Rx #780 Levetiracetam Injectio... 22,631 Rx #781 Dextromethorphan and Q... 22,121 Rx #782 Ribociclib 21,708 Rx #783 Ambrisentan 21,600 Rx #784 Olopatadine Nasal Spra... 21,523 Rx #785 Diclofenac Transdermal... 21,190 Rx #786 Daridorexant 20,970 Rx #787 Amiloride 20,737 Rx

Utilization by Ribociclib product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

Other Ribociclib products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)

21,708 Medicaid prescriptions (Q1–Q4 2025) 100% of Ribociclib prescriptions shown $353M gross reimbursement (before rebates) ≈ $16,260 per prescription (gross)

Summed across the 3 of 15 listed NDC products with Medicaid activity.

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Ribociclib, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 3 of 15 listed Ribociclib NDCs with Medicaid activity.

Compare Ribociclib products

A representative set of FDA-listed product records for Ribociclib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
200 mg Oral Novartis Pharmaceuticals Corporation × 3 listings NDA View NDC →

Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Ribociclib NDCs →

Ribociclib recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Ribociclib recalls since July 2021.

✅No Ribociclib recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Ribociclib RxCUI 1873916 1 dose form · 1 strength
  1. Dose form (SCDF) Oral Tablet RxCUI 1873982 In current FDA listings
    Clinical drug / strength (SCD) 200 MG RxCUI 1873983

Look up RxCUI 1873916 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Ribociclib brand names

Ribociclib is sold under one brand name in the FDA directory — Kisqali. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Kisqali

Who makes Ribociclib: manufacturers and labelers

One company lists Ribociclib products with the FDA. By number of product records, the largest are Novartis Pharmaceuticals Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Novartis Pharmaceuticals Corporation 3

Ribociclib drug class (RxNorm)

Ribociclib belongs to the Kinase Inhibitor class.

Pharmacologic class Kinase Inhibitor
Drug family (ATC) Cyclin-dependent kinase (CDK) inhibitors
How it works Kinase Inhibitors, Cytochrome P450 3A Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Ribociclib page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

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FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jul 1, 2026
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Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Ribociclib.
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Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Ribociclib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
3
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
Novartis Pharmaceuticals Corporation
Linked label effective
Jul 1, 2026
Composite sections available
20
Linked SPL Set ID
aaeaef94-f3f5-4367-8ea2-b181d7be2da8
Linked SPL Document ID
9466e642-f230-43f3-b78e-5a432fa040ee
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →