Ibrance Side Effects
Generic name: palbociclib
Note: This document provides detailed information about Ibrance.
Applies to palbociclib: capsule oral, oral capsule, oral tablet Side Effects associated with palbociclib. Some dosage forms listed on this page may not apply specifically to the brand name Ibrance.
Applies to palbociclib: capsule oral, oral capsule, oral tablet.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Women must have a pregnancy test before using this medicine. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 3 weeks after your last dose. Males who are using this medicine with female partners who can become pregnant must use effective birth control during treatment and for at least 3 months after the last dose. If you think you or your partner have become pregnant while using the medicine, tell your doctor right away.
If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
Palbociclib can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
Interstitial lung disease or pneumonitis can occur while using this medicine. This can be life-threatening and requires immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty with breathing, fever or chills while using this medicine.
Do not change your dose or stop using this medicine without checking first with your doctor.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Ibrance
Along with its needed effects, palbociclib (the active ingredient contained in Ibrance) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking palbociclib:
More common side effects
- black, tarry stools
- bleeding gums
- blood in the urine or stools
- chest pain
- chills
- cough
- difficulty breathing
- fever
- hoarseness
- loss of voice
- lower back or side pain
- nosebleeds
- painful or difficult urination
- pale skin
- pinpoint red spots on the skin
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swelling or inflammation of the mouth
- swollen glands
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
Incidence not known
- general feeling of discomfort or illness
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- thickening of bronchial secretions
- tingling of the hands and feet
- ulceration of the skin
Other side effects of Ibrance
Some side effects of palbociclib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
Less common side effects
- dry eye
For healthcare professionals
Applies to palbociclib: oral capsule, oral tablet.
General adverse events
Most common adverse reactions (10% or greater incidence): Neutropenia, leukopenia, fatigue, anemia, infections, nausea, stomatitis, alopecia, diarrhea, thrombocytopenia, decreased appetite, vomiting, asthenia, peripheral neuropathy, and epistaxis.[Ref]
Respiratory
- Very common (10% or more): Upper respiratory infection (up to 31%), epistaxis (up to 11%)
- Common (1% to 10%): Pulmonary embolism, interstitial lung disease, pneumonitis[Ref]
Other
- Very common (10% or more): Fatigue (37%), asthenia (17%), pyrexia (12%)[Ref]
Hematologic
- Very common (10% or more): Decreased white blood cells (95%), decreased neutrophils (94%), decreased hemoglobin (83%), decreased lymphocytes (81%), neutropenia (80%), decreased platelets (61%), leukopenia (39%), anemia (24%), thrombocytopenia (16%)
- Frequency not reported: Febrile neutropenia[Ref]
Gastrointestinal
- Very common (10% or more): Nausea (35%), stomatitis (30%), diarrhea (26%), vomiting (16%)[Ref]
Dermatologic
- Very common (10% or more): Alopecia (33%), rash (18%), dry skin (12%)[Ref]
Metabolic
- Very common (10% or more): Decreased appetite (16%)[Ref]
Nervous system
- Very common (10% or more): Peripheral neuropathy (13%), dysgeusia (10%)[Ref]
Immunologic
- Very common (10% or more): Infections (e.g., nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, folliculitis) (60%)[Ref]
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References
1. (2015) "Product Information. Ibrance (palbociclib)." Pfizer U.S. Pharmaceuticals Group
Frequently asked questions
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Further information
Ibrance side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.