Palbociclib: uses, dosing, side effects & brands
Palbociclib 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 (across its forms)
- Breast Neoplasms
- Available as
- Capsule · Tablet
- Sold as
- Ibrance
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How palbociclib is dosed
From the FDA label for Ibrance (application NDA212436). Other palbociclib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 Dosage The recommended dosage 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) ] . 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, IBRANCE plus inavolisib and fulvestrant therapy, or IBRANCE plus trastuzumab, with or without pertuzumab, plus endocrine therapy 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, IBRANCE plus inavolisib and…
Palbociclib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Neutropenia [see Warnings and Precautions (5.1) ] • ILD/Pneumonitis [see Warnings and Precautions (5.2) ] Most common adverse reactions (incidence ≥20%) in combination with either letrozole or fulvestrant, including laboratory abnormalities, were white blood cell count decreased, neutrophils decreased, blood creatinine increased, hemoglobin decreased, platelets decreased, infections, aspartate aminotransferase increased, alanine aminotransferase increased, fatigue, nausea, stomatitis, diarrhea, and alopecia. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with inavolisib and fulvestrant, including laboratory abnormalities, were neutrophils decreased, hemoglobin decreased, fasting glucose increased, platelets decreased, lymphocytes decreased, stomatitis, diarrhea, calcium decreased, fatigue, potassium decreased, creatinine increased, alanine aminotransferase (ALT) increased, nausea, sodium decreased, magnesium decreased, rash, decreased appetite, COVID-19 infection, and headache. ( 6.1 ) The most common adverse reactions (incidence ≥20%) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy, including laboratory abnormalities, were white blood cell decreased, neutrophil count decreased, creatinine increased, hemoglobin…
Who shouldn’t take palbociclib
None. None. ( 4 )
Palbociclib 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. The dose of the sensitive CYP3A substrate with a narrow therapeutic index (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as IBRANCE may increase its exposure [see Clinical Pharmacology (12.3) ] .
Every palbociclib 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: Ibrance.
What palbociclib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| PBC;75;Pfizer | 75 mg | orange | capsule | — |
| PBC;100;Pfizer | 100 mg | orange, brown | capsule | — |
| PBC;125;Pfizer | 125 mg | brown | capsule | — |
| Pfizer;PBC;75 | 75 mg | purple | round | — |
| Pfizer;PBC;100 | 100 mg | green | oval | — |
| Pfizer;PBC;125 | 125 mg | purple | oval | — |
| Pfizer;PBC;75 | 75 mg | purple | round | — |
| Pfizer;PBC;100 | 100 mg | green | oval | — |
| Pfizer;PBC;125 | 125 mg | purple | oval | — |
Can you crush or split palbociclib?
At least one palbociclibproduct 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 palbociclib label says about crushing, splitting and chewingHow long palbociclib keeps
No palbociclib label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does palbociclib expire? The in-use limits and storage rules from its labelsPalbociclib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for palbociclib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of palbociclib during breastfeeding. Because palbociclib is 85% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 29 hours and the manufacturer recommends that breastfeeding be discontinued during palbociclib therapy and for 3 weeks after the last dose. Palbociclib is also given in combination with letrozole or 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 palbociclib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 11,048 reports naming palbociclib, and the FDA flagged 95% 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:
- neutropenia1,767 reports
- neoplasm progression1,113 reports
- malignant neoplasm progression1,112 reports
- fatigue908 reports
- nausea650 reports
- white blood cell count decreased650 reports
- asthenia633 reports
- metastases to bone605 reports
Read these as a signal, not a rate. A report does not mean palbociclib 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 25, 2026.
Related calculators
Frequently asked questions
What is palbociclib?
Ibrance (Palbociclib) is a kinase inhibitor used to treat Breast Neoplasms.
What kind of drug is palbociclib?
The FDA classifies palbociclib 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 palbociclib 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 palbociclib 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 palbociclib come in?
Across the brands we track, palbociclib is currently marketed as capsule and 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 palbociclib?
We do not currently list a generic-labelled palbociclib 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). Palbociclib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/palbociclib
- MLA
- “Palbociclib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/palbociclib.
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 palbociclib on DailyMed (NIH) ↗.