ALPELISIB

N/A

Manufactured by Novartis Pharmaceuticals Corporation

20,016 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ALPELISIB

ALPELISIB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for ALPELISIB include HYPERGLYCAEMIA, RASH, DIARRHOEA, BLOOD GLUCOSE INCREASED, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ALPELISIB.

Top Adverse Reactions

HYPERGLYCAEMIA1,495 reports
RASH1,377 reports
DIARRHOEA1,334 reports
BLOOD GLUCOSE INCREASED1,112 reports
DEATH888 reports
NAUSEA854 reports
FATIGUE837 reports
DECREASED APPETITE542 reports
WEIGHT DECREASED513 reports
MALIGNANT NEOPLASM PROGRESSION493 reports
VOMITING478 reports
DRUG INEFFECTIVE365 reports
ASTHENIA341 reports
STOMATITIS338 reports
PRURITUS273 reports
PYREXIA266 reports
DIABETES MELLITUS242 reports
PAIN239 reports
BREAST CANCER METASTATIC238 reports
DISEASE PROGRESSION224 reports
ALOPECIA219 reports
MALAISE213 reports
DRY MOUTH205 reports
DYSPNOEA196 reports
DEHYDRATION194 reports
HEADACHE186 reports
OFF LABEL USE180 reports
METASTASES TO BONE172 reports
METASTASES TO LIVER168 reports
HYPERSENSITIVITY149 reports
DIZZINESS147 reports
DRUG INTOLERANCE139 reports
ABDOMINAL DISCOMFORT136 reports
ILLNESS136 reports
DIABETIC KETOACIDOSIS133 reports
PNEUMONIA131 reports
ORAL PAIN128 reports
DRY SKIN123 reports
BREAST CANCER121 reports
PRODUCT DOSE OMISSION ISSUE121 reports
TASTE DISORDER118 reports
COVID 19115 reports
ABDOMINAL PAIN UPPER112 reports
CONSTIPATION109 reports
FEELING ABNORMAL109 reports
BLOOD CREATININE INCREASED103 reports
URTICARIA103 reports
BLOOD GLUCOSE ABNORMAL101 reports
ABDOMINAL PAIN100 reports
DYSPHAGIA96 reports
COUGH95 reports
ERYTHEMA95 reports
FEEDING DISORDER93 reports
BACK PAIN90 reports
PERIPHERAL SWELLING90 reports
EATING DISORDER85 reports
URINARY TRACT INFECTION85 reports
PRODUCT USE IN UNAPPROVED INDICATION83 reports
GENERAL PHYSICAL HEALTH DETERIORATION82 reports
MUCOSAL INFLAMMATION81 reports
NEUTROPENIA79 reports
TUMOUR MARKER INCREASED79 reports
PLEURAL EFFUSION75 reports
PAIN IN EXTREMITY74 reports
INSOMNIA72 reports
MUSCLE SPASMS71 reports
THIRST70 reports
ARTHRALGIA69 reports
CHILLS68 reports
NEOPLASM MALIGNANT67 reports
VISION BLURRED67 reports
DYSPEPSIA66 reports
SKIN EXFOLIATION66 reports
DYSGEUSIA64 reports
HYPOGLYCAEMIA64 reports
RASH PRURITIC64 reports
RENAL IMPAIRMENT62 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION61 reports
SWELLING FACE61 reports
COLITIS60 reports
GAIT DISTURBANCE59 reports
FALL57 reports
METASTASES TO LUNG57 reports
ADVERSE DRUG REACTION56 reports
PNEUMONITIS56 reports
CONDITION AGGRAVATED55 reports
HYPERTENSION55 reports
LIP SWELLING55 reports
NEUROPATHY PERIPHERAL55 reports
THERAPY INTERRUPTED55 reports
SOMNOLENCE54 reports
GLYCOSYLATED HAEMOGLOBIN INCREASED53 reports
ABDOMINAL DISTENSION51 reports
INCORRECT DOSE ADMINISTERED51 reports
CONFUSIONAL STATE50 reports
HYPOTENSION50 reports
SWELLING50 reports
ACUTE KIDNEY INJURY49 reports
INFECTION49 reports
NEOPLASM PROGRESSION49 reports

Report Outcomes

Out of 8,457 classified reports for ALPELISIB:

Serious 56.4%Non-Serious 43.6%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female7,240 (94.5%)
Male423 (5.5%)
Unknown2 (0.0%)

Reports by Age

Age 60126 reports
Age 66116 reports
Age 73109 reports
Age 65107 reports
Age 70106 reports
Age 72105 reports
Age 58104 reports
Age 67104 reports
Age 62102 reports
Age 6399 reports
Age 6999 reports
Age 6495 reports
Age 7495 reports
Age 6894 reports
Age 6179 reports
Age 5677 reports
Age 5776 reports
Age 7575 reports
Age 5574 reports
Age 5473 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ALPELISIB?

This profile reflects 20,016 FDA FAERS reports that mention ALPELISIB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ALPELISIB?

Frequently reported terms in FAERS include HYPERGLYCAEMIA, RASH, DIARRHOEA, BLOOD GLUCOSE INCREASED, DEATH, NAUSEA. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ALPELISIB?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with ALPELISIB. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.