Alpelisib Side Effects

Medically reviewed by Drugs.com. Last updated on May 13, 2024.

Applies to alpelisib: 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.

It is unlikely that a postmenopausal woman may become pregnant. But, using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control to keep from getting pregnant during treatment and for 1 week after your last dose. Male patients who have female partners should use effective birth control during treatment and for 1 week after the last dose. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, and anaphylactic shock, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

This medicine may affect your blood sugar levels. Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention. The symptoms may be similar to the symptoms from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.

This medicine may cause diarrhea (colitis), and in some cases it can be severe. Your doctor may give you medicine to treat diarrhea. Drink plenty of fluids to prevent dehydration and kidney problems. If you have any questions about this or if mild diarrhea continues, or gets worse, check with your doctor. Call your doctor right away if you have stomach pain, or mucus or blood in your stool.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

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 or vitamin supplements.

Serious side effects of alpelisib

Along with its needed effects, alpelisib 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 alpelisib:

Other side effects of alpelisib

Some side effects of alpelisib 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:

For healthcare professionals

Applies to alpelisib: oral granule, oral tablet.

General adverse events

The most common adverse reactions including laboratory abnormalities (all Grades, incidence 20% or greater) were glucose increased, creatinine increased, diarrhea, rash, lymphocyte count decreased, GGT increased, nausea, ALT increased, fatigue, hemoglobin decreased, lipase increased, decreased appetite, stomatitis, vomiting, weight decreased, calcium decreased, glucose decreased, activated partial thromboplastin time (aPTT) prolonged, and alopecia.^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Severe hypersensitivity (e.g., anaphylaxis, anaphylactic shock, dyspnea, flushing, rash, fever, tachycardia)^[Ref]

Musculoskeletal

• Common (1% to 10%): Osteonecrosis of the jaw (ONJ)^[Ref]

Metabolic

• Very common (10% or more): Glucose increased (79%), hyperglycemia (65%), weight loss (27%), calcium (corrected) decreased (27%), glucose decreased (26%), potassium decreased (14%), albumin decreased (14%), magnesium decreased (11%)^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (10%)^[Ref]

Hepatic

• Very common (10% or more): Gamma glutamyl transferase (GGT) increased (52%), alanine aminotransferase (ALT) increased (44%)^[Ref]

Respiratory

• Common (1% to 10%): Pneumonitis (including acute interstitial pneumonitis and interstitial lung disease)^[Ref]

Other

• Very common (10% or more): Fatigue (42%), lipase increased (42%), edema peripheral (15%), pyrexia (14%)^[Ref]

Hematologic

• Very common (10% or more): Lymphocyte count decreased (52%), hemoglobin decreased (42%), activated partial thromboplastin time (aPTT) prolonged (21%), platelet count decreased (14%)^[Ref]

Nervous system

• Very common (10% or more): Headache (18%), dysgeusia/ageusia/hypogeusia (18%)^[Ref]

Renal

• Very common (10% or more): Creatinine increased (79%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (e.g., maculopapular, macular, generalized, papular, pruritic) (52%), alopecia (20%), pruritus (18%), dry skin/skin fissures/xerosis/xeroderma (18%)
• Uncommon (0.1% to 1%): Stevens-Johnson syndrome (SJS), erythema multiforme (EM)^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (58%), nausea (45%), stomatitis/aphthous ulcer/mouth ulceration (30%), vomiting (27%), mucosal inflammation (19%), abdominal pain/abdominal pain upper/abdominal pain lower (17%), mucosal dryness (12%), dyspepsia (11%)^[Ref]

See also:

Further information

Alpelisib 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.

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