Prescription medicine
Palbociclib Brand names: Ibrance
Palbociclib (Ibrance) is a prescription medicine with an FDA approval on record since 2015. No generic is listed in FDA's NDC Directory.
- No generic listed
- A presentation discontinued
Check it at the source: the palbociclib FDA label on DailyMed (effective July 2, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 207103 record on Drugs@FDA; every palbociclib label on DailyMed.
Highlights of the record
FDA label of July 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageIBRANCE is a kinase inhibitor indicated:
for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 );
Forms and strengths
- 75 mg
- 100 mg
- 125 mg
Film-coated tablet; capsule.
On the market
- Earliest approval on file
- February 3, 2015 Ibrance, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first June 5, 2024; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- February 19, 2037 Ibrance tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- None current 2 past records
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 94,825 through July 30, 2026
What is palbociclib used for?
From the label: indications and usageIBRANCE is a kinase inhibitor indicated:
for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with: o an aromatase inhibitor as initial endocrine-based therapy ( 1.1 ); or o fulvestrant in patients with disease progression following endocrine therapy. […]
Conditions named in the indications of palbociclib's FDA labels, with every medicine labeled for each:
From other palbociclib labelsBreast cancer: in combination with inavolisib and fulvestrant for the treatment of adult patients with endocrine-resistant, PIK3CA -mutated, HR-positive, HER2-negative, locally advanced or metastatic breast cancer, as detected by an FDA‑authorized test …
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Ibrance), Pfizer Laboratories Div Pfizer Inc, effective July 2, 2026 (SPL set fecbdd7d-b729-41b5-9872-231b8fe104ce), via openFDA; the full label on DailyMed
What does the patient leaflet for palbociclib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about IBRANCE?IBRANCE may cause serious side effects, including: • Low white blood cell counts (neutropenia). Low white blood cell counts are very common during treatment with IBRANCE and may cause serious infections that can lead to death. Your healthcare provider should check your white blood cell counts before and during treatment. If you develop low white blood cell counts during treatment with IBRANCE, your healthcare provider may stop your treatment, decrease your dose, or may tell you to wait to begin your treatment cycle. Tell your healthcare provider right away if you have signs and symptoms of low white blood cell counts or infections such as fever and chills. • Lung problems (pneumonitis). IBRANCE may cause severe or life-threatening inflammation of the lungs during treatment that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including: o chest pain o cough with or without mucus o trouble breathing or shortness of breath Your healthcare provider may interrupt or stop treatment with IBRANCE completely if your symptoms are severe. See " What are the possible side effects of IBRANCE? " for more information about side effects.
From the patient leaflet: How should I store IBRANCE?Store IBRANCE at 68 °F to 77 °F (20 °C to 25 °C) in the original blister pack. Keep IBRANCE and all medicines out of the reach of children.
Source: FDA drug label (Ibrance), Pfizer Laboratories Div Pfizer Inc, effective July 2, 2026 (SPL set fecbdd7d-b729-41b5-9872-231b8fe104ce), via openFDA; the full label on DailyMed
Is there a generic for palbociclib (Ibrance)?
The FDA approved the first generic palbociclib on June 5, 2024. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 10 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 3 patents for Ibrance tablets: the compound patent runs to February 8, 2034 (pediatric exclusivity to August 8, 2034), and the last listed entry to February 19, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2024 first generic approved
- 2037 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Is palbociclib in shortage?
No palbociclib presentation is listed as in shortage in the FDA Drug Shortage Database (read October 8, 2026); its 2 records are all marked to be discontinued, the latest updated April 22, 2026. ASHP keeps a separate shortage list, which can differ.
| Presentation | Company | Status | Updated |
|---|---|---|---|
| Ibrance, Capsule, 100 mg (NDC 0069-0188-21) | Pfizer Inc. | To Be Discontinued | April 22, 2026 |
| Ibrance, Capsule, 75 mg (NDC 0069-0187-21) | Pfizer Inc. | To Be Discontinued | April 22, 2026 |
Source: FDA Drug Shortage Database via openFDA, updated October 8, 2026
What does the palbociclib label say about other medicines?
The palbociclib label names 27 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name palbociclib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort) [see Clinical Pharmacology (12.3) ]. |
| Clarithromycin | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). |
| Cyclosporine | drug interactions | 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) ]. |
| Dihydroergotamine | drug interactions | 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) ]. |
| Enzalutamide | drug interactions | Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort) [see Clinical Pharmacology (12.3) ]. |
| Ergotamine | drug interactions | 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) ]. |
| Everolimus | drug interactions | 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) ]. |
| Fentanyl | drug interactions | 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) ]. |
| Fulvestrant | warnings and precautions | A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving IBRANCE plus letrozole in PALOMA-2 and 66% of patients receiving IBRANCE plus fulvestrant in PALOMA-3. |
| Itraconazole | drug interactions | Effect of CYP3A Inhibitors Coadministration of a strong CYP3A inhibitor (itraconazole) increased the plasma exposure of palbociclib in healthy subjects by 87%. |
| Ketoconazole | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). |
| Letrozole | warnings and precautions | A Grade ≥3 decrease in neutrophil counts was reported in 66% of patients receiving IBRANCE plus letrozole in PALOMA-2 and 66% of patients receiving IBRANCE plus fulvestrant in PALOMA-3. |
| Lopinavir and ritonavir | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). |
| Midazolam | drug interactions | 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. |
Every other medicine the palbociclib label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nefazodone | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir … |
| Nelfinavir | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir … |
| Pertuzumab | warnings and precautions | Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. |
| Phenytoin | drug interactions | Avoid concomitant use of strong CYP3A inducers (e.g., phenytoin, rifampin, carbamazepine, enzalutamide, and St John's Wort) [see Clinical Pharmacology (12.3) ]. |
| Pimozide | drug interactions | … cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as IBRANCE may increase its exposure [see Clinical … |
| Posaconazole | drug interactions | … itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). |
| Quinidine | drug interactions | … cyclosporine, dihydroergotamine, ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as IBRANCE may increase its exposure [see Clinical … |
| Rifampin | drug interactions | Effect of CYP3A Inducers Coadministration of a strong CYP3A inducer (rifampin) decreased the plasma exposure of palbociclib in healthy subjects by 85%. |
| Ritonavir | drug interactions | Avoid concomitant use of strong CYP3A inhibitors (e.g., clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir … |
| Sirolimus | drug interactions | … 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) ]. |
| Tacrolimus | drug interactions | … ergotamine, everolimus, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus) may need to be reduced, as IBRANCE may increase its exposure [see Clinical Pharmacology (12.3) ]. |
| Trastuzumab | warnings and precautions | Grade ≥3 neutropenia was reported in 61% of patients receiving IBRANCE in combination with trastuzumab, with or without pertuzumab, and endocrine therapy. |
| Voriconazole | drug interactions | … posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, and voriconazole). |
Other labels that name palbociclib
Source: FDA drug label (Ibrance), Pfizer Laboratories Div Pfizer Inc, effective July 2, 2026 (SPL set fecbdd7d-b729-41b5-9872-231b8fe104ce), via openFDA; the full label on DailyMed
What do FAERS reports show for palbociclib?
The FDA Adverse Event Reporting System holds 94,825 reports that list palbociclib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10,577 are coded as a death and 14,349 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as palbociclib?
17 other medicines are given the same way (oral) and in the same FDA class as palbociclib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Abemaciclib | Breast cancer | none listed | n/a | No current entry |
| Lapatinib ditosylate | Breast cancer | 3 labelers | n/a | No current entry |
| Ribociclib | Breast cancer | none listed | $289.72 per unit 600 mg daily dose | No current entry |
| Tucatinib | Breast cancer | none listed | n/a | No current entry |
| Neratinib | Breast cancer | none listed | n/a | No current entry |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
Every medicine labeled for the same conditions as palbociclib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to palbociclib
- 17 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Palbociclib side effects
- the label's list beside FAERS reports
- Palbociclib shortage record
- every presentation, company and date
- Check an interaction
- what two or more labels say about each other