Skip to the answer

Palbociclib

Palbociclib is a targeted cancer medicine used to treat certain types of advanced or metastatic breast cancer in adults.

Brand name Ibrance
Drug class Kinase Inhibitor
Rx Forms 2
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 3 clinical label sets 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 →

Palbociclib 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

Palbociclib (Ibrance) is a targeted oral medicine that blocks two growth proteins, CDK4 and CDK6, to slow certain advanced breast cancers. Always paired with hormonal therapy, it was the first of its kind and, after about a decade on the market, is a standard first choice for hormone-sensitive, HER2-negative disease. It is not traditional chemotherapy and is usually easier to tolerate, though fatigue, mouth sores and thinning hair are common, and low white blood cell counts (neutropenia) are very common but mostly show up on blood tests. Call right away for fever, a possible sign of serious infection, or a new cough or breathlessness, which can signal serious lung inflammation.

Clinical pearls

  • Take it with food at about the same time each day, and swallow tablets whole, never chewed, crushed, split or cracked.
  • Each cycle is 21 days on and 7 days off, with blood counts checked before every new cycle starts.
  • Skip grapefruit and St. John’s wort, and double-check any new antibiotic, antifungal, seizure or HIV medicine before starting it.
  • Use effective contraception during treatment and at least 3 weeks after (3 months for men with partners who could become pregnant).
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record2013
Companies listing it with the FDA2
FDA label last updatedJul 6, 2026
FDA’s strongest warning (boxed)None on the label

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

What Palbociclib is used for

▾

Palbociclib (Ibrance) is a targeted oral medicine used to treat certain advanced or metastatic breast cancers in adults. It is always used in combination with other medicines, never alone.

  • Ibrance treats HR-positive (hormone receptor-positive), HER2-negative advanced or metastatic breast cancer — combined with an aromatase inhibitor as a first hormonal treatment, or with fulvestrant after disease has progressed on prior hormonal therapy
  • Ibrance is used with inavolisib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (confirmed by an FDA-authorized test) that has come back during or after completing adjuvant endocrine therapy
  • Ibrance is used with trastuzumab, with or without pertuzumab, plus endocrine therapy for maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer, following initial induction treatment

How Palbociclib works

▾

Palbociclib targets two enzymes — CDK4 and CDK6 (cyclin-dependent kinases 4 and 6) — that act like switches telling cancer cells when to divide. By blocking these switches, palbociclib stalls cancer cells in an early part of their division cycle (called the G1 phase) so they cannot replicate. When combined with anti-estrogen medicines, the effect is amplified: cancer cells are more likely to enter a permanent state of growth arrest (senescence), and tumor growth slows more than with either drug alone.

Importantly, normal bone marrow cells do not appear to permanently stop growing in response to palbociclib the way cancer cells do — they resume normal activity once the drug is withdrawn, which is relevant to understanding the manageable (though significant) impact on blood counts.

Palbociclib dosage

▾

Palbociclib is taken by mouth once a day for 21 days in a row, then 7 days off — a repeating 28-day cycle. Try to take it at the same time each day.

  • Ibrance capsules: should be taken with food
  • Ibrance tablets: may be taken with or without food; swallow whole — never chew, crush, or split; discard any broken or cracked tablet
  • If you vomit or miss a dose, skip it and take the next dose at the usual time — never double up
  • Your prescriber may adjust your dose based on side effects or drug interactions

Dosing details from the FDA-approved label

From the Palbociclib 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.

  • Recommended dosage (starting dose)
    • 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
    • May be taken with or without food; swallow tablets whole; if the patient vomits or misses a dose, do not take an additional dose
  • Dose modification for adverse reactions - first dose reduction
    • 100 mg/day
    • Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability
  • Dose modification for adverse reactions - second dose reduction
    • 75 mg/day
    • If further dose reduction below 75 mg/day is required, discontinue
  • Pre/perimenopausal women treated with IBRANCE plus an aromatase inhibitor or fulvestrant, IBRANCE plus inavolisib and fulvestrant, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy
    • Same IBRANCE regimen, and should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards
  • Men treated with IBRANCE plus aromatase inhibitor, IBRANCE plus inavolisib and fulvestrant, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy
    • Same IBRANCE regimen
    • Consider treatment with an LHRH agonist according to current clinical practice standards
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION IBRANCE tablets are taken orally with or without food in combination with an aromatase inhibitor, fulvestrant, or inavolisib and fulvestrant. ( 2 ) • Recommended starting dose: 125 mg once daily taken with or without food for 21 days followed by 7 days off treatment. ( 2.1 ) • Dosing interruption and/or dose reductions are recommended based on individual safety and tolerability. ( 2.2 ) 2.1 Recommended Dose and Schedule The recommended dose of IBRANCE is a 125 mg tablet taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. IBRANCE tablet may be taken with or without food [see Clinical Pharmacology (12.3) ] . Administer the recommended dose of an aromatase inhibitor when given with IBRANCE. Please refer to the Full Prescribing Information for the aromatase inhibitor being used. When given with IBRANCE, the recommended dose of fulvestrant is 500 mg administered on Days 1, 15, 29, and once monthly thereafter. Please refer to the Full Prescribing Information of fulvestrant. Refer to the Full Prescribing Information for inavolisib and fulvestrant for dosing information . Advise patients to take their dose of IBRANCE at approximately the same time each day. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time. IBRANCE tablets should be swallowed whole (do not chew, crush, or split them prior to swallowing). Tablets should not be ingested if they are broken, cracked, or otherwise not intact. Pre/perimenopausal women treated with the combination IBRANCE plus an aromatase inhibitor or fulvestrant therapy or IBRANCE plus inavolisib and fulvestrant should also be treated with luteinizing hormone-releasing hormone (LHRH) agonists according to current clinical practice standards. For men treated with combination IBRANCE plus aromatase inhibitor or IBRANCE plus inavolisib and fulvestrant therapy, consider treatment with an LHRH agonist according to current clinical practice standards. 2.2 Dose Modification The recommended dose modifications for adverse reactions are listed in Tables 1, 2, and 3. Table 1.

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

Palbociclib side effects

▾

Palbociclib commonly causes a range of side effects, most often related to its effect on blood cells. The most frequently reported include:

Common side effects

  • Low white blood cell count (neutropenia) — very common
  • Fatigue or weakness
  • Nausea
  • Mouth sores (stomatitis)
  • Diarrhea
  • Hair thinning or hair loss
  • Infections (colds, respiratory, urinary tract, and others)
  • Low platelet or red blood cell counts
  • Infections of various types (respiratory, urinary, skin, and others)
  • Decreased appetite

When to get medical help

  • Call your doctor right away if you develop a fever — it could signal a dangerous drop in infection-fighting white blood cells (febrile neutropenia)
  • Seek urgent care for new or worsening cough, shortness of breath, or difficulty breathing — these could be signs of serious lung inflammation (ILD/pneumonitis)
  • Tell your doctor immediately if you are pregnant or think you might be — this medicine can seriously harm a developing baby
  • Report any signs of severe or unusual infection promptly, as some infections linked to low white blood cell counts can be life-threatening

Fever during treatment is a serious warning sign of a dangerous infection and requires immediate medical attention. New or worsening shortness of breath or cough should also be reported to your doctor right away, as these could signal lung inflammation.

Palbociclib warnings and precautions

▾
  • Neutropenia (low infection-fighting white blood cells): This is the most common serious risk. Blood counts must be checked before treatment starts, at the beginning of every cycle, and at Day 15 for the first two cycles. Fever during treatment is a medical emergency. One death from neutropenic sepsis was reported in clinical trials.
  • Interstitial lung disease (ILD) / Pneumonitis (lung inflammation): Severe, life-threatening, and fatal cases have been reported, including after the drug was approved. Report any new or worsening cough, shortness of breath, or low oxygen levels immediately. Ibrance must be stopped right away if pneumonitis is suspected and permanently discontinued if it is severe.
  • Embryo-fetal toxicity (harm to an unborn baby): Animal studies show palbociclib can cause serious fetal harm. Women of childbearing age must use effective contraception during treatment and for at least 3 weeks after the last dose. Men should use contraception during treatment and for 3 months after. A pregnancy test is required before starting treatment.

Palbociclib interactions

▾

Palbociclib is broken down mainly by the liver enzyme CYP3A, and it also affects that same enzyme pathway in other drugs — so several important interactions exist.

  • Strong CYP3A inhibitors (e.g., itraconazole, ketoconazole, clarithromycin, ritonavir, voriconazole, posaconazole): Can nearly double palbociclib levels in the blood — avoid if possible; if unavoidable, a dose reduction is required
  • Strong CYP3A inducers (e.g., rifampin, phenytoin, carbamazepine, enzalutamide, St. John's Wort): Can cut palbociclib blood levels by about 85%, making it far less effective — avoid these combinations
  • Grapefruit and grapefruit juice: Can raise palbociclib exposure — avoid during treatment
  • Sensitive CYP3A4 substrates with a narrow safety margin (e.g., cyclosporine, everolimus, fentanyl, sirolimus, tacrolimus, pimozide, quinidine): Palbociclib can increase their blood levels, potentially causing toxicity — doses of those drugs may need to be reduced

Interactions listed in the FDA-approved label

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

  • Strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole): Coadministration of a strong CYP3A inhibitor (itraconazole) increased the plasma exposure of palbociclib in healthy subjects by 87%. Avoid concomitant use; if coadministration cannot be avoided, reduce the dose of IBRANCE.
  • Grapefruit or grapefruit juice: Listed with strong CYP3A inhibitors under agents that may increase palbociclib plasma concentrations. Avoid grapefruit or grapefruit juice during IBRANCE treatment.
  • Strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, St John's Wort): Coadministration of a strong CYP3A inducer (rifampin) decreased the plasma exposure of palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers.
  • Sensitive CYP3A substrates with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, tacrolimus): IBRANCE may increase their exposure; coadministration of midazolam with multiple doses of IBRANCE increased midazolam plasma exposure by 61% in healthy subjects. The dose of the sensitive CYP3A substrate may need to be reduced.
Read the label’s full interactions text

7 DRUG INTERACTIONS Palbociclib is primarily metabolized by CYP3A and sulfotransferase (SULT) enzyme SULT2A1. In vivo, palbociclib is a time-dependent inhibitor of CYP3A. • CYP3A Inhibitors: Avoid concurrent use of IBRANCE with strong CYP3A inhibitors. If the strong inhibitor cannot be avoided, reduce the IBRANCE dose. ( 2.2 , 7.1 ) • CYP3A Inducers: Avoid concurrent use of IBRANCE with strong CYP3A inducers. ( 7.2 ) • CYP3A Substrates: The dose of sensitive CYP3A4 substrates with narrow therapeutic indices may need to be reduced when given concurrently with IBRANCE. ( 7.3 ) 7.1 Agents That May Increase Palbociclib Plasma Concentrations Effect of CYP3A Inhibitors Coadministration of a strong CYP3A inhibitor (itraconazole) increased the plasma exposure of palbociclib in healthy subjects by 87%. Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). Avoid grapefruit or grapefruit juice during IBRANCE treatment. If coadministration of IBRANCE with a strong CYP3A inhibitor cannot be avoided, reduce the dose of IBRANCE [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] . 7.2 Agents That May Decrease Palbociclib Plasma Concentrations Effect of CYP3A Inducers Coadministration of a strong CYP3A inducer (rifampin) decreased the plasma exposure of palbociclib in healthy subjects by 85%. Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort) [see Clinical Pharmacology (12.3) ] . 7.3 Drugs That May Have Their Plasma Concentrations Altered by Palbociclib Coadministration of midazolam with multiple doses of IBRANCE increased the midazolam plasma exposure by 61%, in healthy subjects, compared to administration of midazolam alone.

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.

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

Before taking Palbociclib

▾
  • Pregnancy: Palbociclib can seriously harm a fetus — do not use during pregnancy; inform your doctor immediately if you become pregnant
  • Breastfeeding: Do not breastfeed during treatment or for 3 weeks after the last dose
  • Women of childbearing age: Requires a negative pregnancy test before starting; effective contraception must be used during treatment and for at least 3 weeks after stopping
  • Men with partners who can become pregnant: Use effective contraception during treatment and for 3 months after the last dose; palbociclib may affect male fertility
  • Liver problems: Moderate or severe liver impairment increases drug exposure — discuss with your doctor; dose adjustments may be needed
  • Children: Safety and effectiveness have not been established in pediatric patients
  • All medicines and supplements: Tell your prescriber and pharmacist about every drug, herbal product, or supplement you take, especially antifungals, antibiotics, HIV medicines, seizure drugs, or St. John's Wort

What Palbociclib does in the body

▾

Palbociclib does not appear to cause large changes in the heart's electrical rhythm (QT interval) at therapeutic doses — studies in breast cancer patients showed no clinically meaningful QT prolongation. Its main measurable effect on the body is suppression of blood cell production in the bone marrow, which is why regular blood count monitoring is essential throughout treatment.

How your body processes Palbociclib

▾

After a dose by mouth, palbociclib reaches peak blood levels roughly 6 to 12 hours later, and steady blood levels are established within about 8 days of daily dosing. The drug has a half-life of about 29 hours, meaning it takes a little over a day for blood levels to fall by half after stopping. Palbociclib is processed mainly in the liver (via CYP3A and a sulfotransferase enzyme called SULT2A1) and is eliminated mostly through the stool (about 74%) with a smaller amount in urine (about 18%). Taking palbociclib with food helps reduce variability in how much drug is absorbed from person to person, which is why taking it with food is recommended — particularly for the capsule form.

How to store Palbociclib

▾

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) . Store in the original blister pack.

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

185

Supplements & herbs that interact with Palbociclib

185 supplements and herbal products have documented interactions with Palbociclib 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 · 3
  • Moderate · 145
  • Minor · 37
ACTIVATED CHARCOAL Major GRAPEFRUIT Major ST. JOHN'S WORT Major ACACIA RIGIDULA Moderate ACTIVE HEXOSE CORRELATED COMPOUND (AHCC) Moderate ADRAFINIL Moderate AFRICAN WILD POTATO Moderate ALFALFA Moderate +177 more
Every supplement checked against Palbociclib — ranked by severity The full interaction hub: 3 major · 145 moderate · 37 minor · every one linked to its full report. Check Palbociclib 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.

Palbociclib: pharmacist answers to common questions

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

What exactly is palbociclib (Ibrance) treating — is it a chemotherapy?

▾
Palbociclib is not traditional chemotherapy. It's a targeted therapy that works specifically on proteins called CDK4 and CDK6, which breast cancer cells need in order to divide and grow. It only works for certain types of breast cancer — specifically those that are hormone receptor-positive (HR-positive). It is always used together with hormonal medicines, not on its own. Your doctor will have confirmed your cancer type before prescribing it.

Why do I need blood tests so often while taking this medicine?

▾
Palbociclib very commonly lowers your white blood cell count — especially the neutrophils that fight bacterial infections. Low neutrophils can leave you vulnerable to serious infections. Blood tests let your care team catch this early and adjust your dose if needed. You'll typically need counts checked before starting, at the beginning of every cycle, and at Day 15 of your first two cycles. If your counts stay stable, the monitoring frequency can ease up after the first six cycles.

What side effects should I be worried about versus the ones I can manage at home?

▾
Fatigue, nausea, mouth sores, diarrhea, and some hair thinning are common and manageable — your team can help with those. But fever is a medical emergency while you're on this drug, because it can signal a dangerous infection when your white blood cells are low. Likewise, if you develop a new cough, shortness of breath, or feel like you can't get enough air, call your doctor right away — that could be a rare but serious lung problem. Don't wait and see with those two in particular.

Can I eat normally while taking Ibrance? What about grapefruit?

▾
Yes, you can eat normally — and actually, taking Ibrance with food helps your body absorb the medicine more consistently, especially the capsule form. The tablet form can be taken with or without food. One important food to avoid entirely during treatment is grapefruit and grapefruit juice. Grapefruit interferes with the enzyme that breaks down palbociclib and can raise drug levels in your blood to potentially unsafe levels.

I'm a woman who could get pregnant — what do I need to know?

▾
This is really important: palbociclib can seriously harm a developing baby, so you'll need a pregnancy test before starting and you must use reliable contraception throughout treatment and for at least 3 weeks after your last dose. If you become pregnant during treatment, tell your doctor immediately. You also shouldn't breastfeed while taking Ibrance or for 3 weeks after stopping, because of the potential risk to a nursing infant.

Are there medicines or supplements I should avoid while taking palbociclib?

▾
Yes — a few important ones. Strong antifungals like itraconazole or ketoconazole, certain antibiotics like clarithromycin, and some HIV medicines can raise palbociclib to dangerously high levels. On the flip side, drugs like rifampin, phenytoin, carbamazepine, enzalutamide, and the herbal supplement St. John's Wort can drop palbociclib levels so low it may stop working. Always give your pharmacist and doctor a complete list of everything you take — including vitamins and herbals — before starting.

Is Palbociclib available over the counter?

▾
No. Palbociclib is a prescription medicine: every Palbociclib 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 Palbociclib first available?

▾
The earliest FDA record we hold for Palbociclib is from 2013: 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 Palbociclib was first used.

Who makes Palbociclib?

▾
2 companies currently list Palbociclib products in the FDA's NDC Directory, including Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

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

More about Palbociclib on HelloPharmacist

📊Palbociclib supplement interactions185 checked — ranked by severity 🌿Drug & Supplement CheckerPalbociclib vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Palbociclib NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Palbociclib 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.

Palbociclib forms and strengths (how it comes)

Palbociclib is available in 2 forms. 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.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Palbociclib inactive ingredients by manufacturer.

Tablet

By mouth
Brands Ibrance
How this form is used
What it may be used for
  • Ibrance tablets are used for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant
  • Ibrance tablets are used in combination with inavolisib and fulvestrant for PIK3CA-mutated, endocrine-resistant, HR-positive, HER2-negative locally advanced or metastatic breast cancer
  • Ibrance tablets are used in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer
Important instructions
  • Ibrance tablets are taken once daily for 21 days followed by 7 days off, completing a 28-day cycle
  • Ibrance tablets may be taken with or without food
  • Ibrance tablets must be swallowed whole — do not chew, crush, or split them; do not take a tablet that is broken or cracked
  • If you miss a dose or vomit after taking Ibrance, skip that dose and take the next one at the usual time — never take two doses to make up for a missed one
Available strengths 3 strengths
75 mg 100 mg 125 mg
24 FDA-listed product records ⓘ

Capsule

By mouth
Brands Ibrance
How this form is used
What it may be used for
  • Ibrance capsules are used for HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant
  • Ibrance capsules are used in combination with inavolisib and fulvestrant for PIK3CA-mutated, endocrine-resistant, HR-positive, HER2-negative locally advanced or metastatic breast cancer
  • Ibrance capsules are used in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for maintenance treatment of HR-positive, HER2-positive locally advanced or metastatic breast cancer
Important instructions
  • Ibrance capsules are taken once daily for 21 days followed by 7 days off, in a 28-day cycle
  • Ibrance capsules should be taken with food to support consistent drug absorption
  • If you miss a dose or vomit after taking Ibrance, do not take an extra dose — take the next dose at the regular scheduled time
  • Follow your prescriber's instructions for any dose adjustments needed based on side effects or other medicines you take
Available strengths 3 strengths
75 mg 100 mg 125 mg
15 FDA-listed product records ⓘ

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

How Palbociclib 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.

2 companies list 9 Palbociclib product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 2013. Brand names on the directory include Ibrance; the rest are generics.

2
Dose forms ⓘ
2
Labelers (makers, repackagers, distributors)
1
Brand names
9
FDA-listed product records ⓘ
2013
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (15) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Pfizer Laboratories Div Pfizer Inc67%
U.S. Pharmaceuticals33%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Palbociclib is used (Medicaid data)

A general measure of how commonly Palbociclib 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 Palbociclib 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.

11,110
Medicaid prescriptions filled (Q1–Q4 2025)
$185.3M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Palbociclib prescribed? Of the 1,601 medications we measure, Palbociclib ranks #915 by Medicaid prescriptions — more than 43% of them.

Where Palbociclib ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #915 of 1,601
#910 Chlorothiazide 11,327 Rx #911 Magnesium Chloride / P... 11,275 Rx #912 Deferasirox 11,233 Rx #913 Tavaborole Topical 11,126 Rx #914 Eltrombopag 11,114 Rx #915 Palbociclib 11,110 Rx #916 Rivastigmine 11,022 Rx #917 Drospirenone / Ethinyl... 10,895 Rx #918 Dronedarone 10,844 Rx #919 Pyrethrin and Piperony... 10,703 Rx #920 Ertugliflozin / Metfor... 10,690 Rx

Utilization by Palbociclib 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.

The 125 mg oral tablet is the most-dispensed Palbociclib product — about 52% of these Medicaid prescriptions.

palbociclib 125 MG Oral Tablet Most dispensed

5,791 Medicaid prescriptions (Q1–Q4 2025) 52% of Palbociclib prescriptions shown $95.8M gross reimbursement (before rebates) ≈ $16,538 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2284105

palbociclib 100 MG Oral Tablet

2,175 Medicaid prescriptions (Q1–Q4 2025) 20% of Palbociclib prescriptions shown $36.8M gross reimbursement (before rebates) ≈ $16,912 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2284102

palbociclib 75 MG Oral Tablet

1,722 Medicaid prescriptions (Q1–Q4 2025) 15% of Palbociclib prescriptions shown $28M gross reimbursement (before rebates) ≈ $16,239 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2284107

palbociclib 125 MG Oral Capsule

839 Medicaid prescriptions (Q1–Q4 2025) 8% of Palbociclib prescriptions shown $14.7M gross reimbursement (before rebates) ≈ $17,506 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1601388

palbociclib 100 MG Oral Capsule

364 Medicaid prescriptions (Q1–Q4 2025) 3% of Palbociclib prescriptions shown $6.7M gross reimbursement (before rebates) ≈ $18,366 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1601380

palbociclib 75 MG Oral Capsule

219 Medicaid prescriptions (Q1–Q4 2025) 2% of Palbociclib prescriptions shown $3.4M gross reimbursement (before rebates) ≈ $15,743 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1601392

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 Palbociclib, 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 6 of 15 listed Palbociclib NDCs with Medicaid activity.

Compare Palbociclib products

A representative set of FDA-listed product records for Palbociclib — 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
💊Capsule
75 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
100 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
125 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
💊Tablet
75 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
100 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
125 mg Oral Pfizer Laboratories Div Pfizer Inc NDA View NDC →
75 mg Oral U.S. Pharmaceuticals NDA View NDC →
100 mg Oral U.S. Pharmaceuticals NDA View NDC →
125 mg Oral U.S. Pharmaceuticals NDA View NDC →

Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Palbociclib NDCs →

Palbociclib 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 Palbociclib recalls since July 2021.

✅No Palbociclib 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) Palbociclib RxCUI 1601374 2 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 1601379 In current FDA listings
    Clinical drug / strength (SCD) 75 MG RxCUI 1601392 100 MG RxCUI 1601380 125 MG RxCUI 1601388
  2. Dose form (SCDF) Oral Tablet RxCUI 2284101 In current FDA listings
    Clinical drug / strength (SCD) 75 MG RxCUI 2284107 100 MG RxCUI 2284102 125 MG RxCUI 2284105

Look up RxCUI 1601374 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.

Palbociclib brand names

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

Ibrance

Who makes Palbociclib: manufacturers and labelers

2 companies list Palbociclib products with the FDA. By number of product records, the largest are Pfizer Laboratories Div Pfizer Inc, U.S. Pharmaceuticals. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Pfizer Laboratories Div Pfizer Inc 6 U.S. Pharmaceuticals 3

Palbociclib drug class (RxNorm)

Palbociclib 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 Palbociclib 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.

📄
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 6, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Palbociclib.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Palbociclib after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
3
Finished products in the current FDA directory
9
Companies listing them (makers, repackagers, distributors)
2
FDA labeler codes behind them ⓘ
2
Linked representative label ⓘ
US Pharmaceuticals
Linked label effective
Jul 6, 2026
Composite sections available
21
Linked SPL Set ID
89a142d5-7e61-48bf-9e77-e2cd124c4792
Linked SPL Document ID
342c459f-fe40-4422-bc31-88d16fbbd4df
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. US Pharmaceuticals 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 →