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Alpelisib Side Effects

The most commonly reported side effects of alpelisib include hyperglycaemia, rash, and diarrhoea, based on 8,471 FDA adverse event reports from 2018 to 2025. 4.3% of reports found the drug to be ineffective.

Alpelisib side effects

Percentages show how often each reaction appears relative to total reports for alpelisib.

1
Hyperglycaemia17.7%1,497
2
Rash16.3%1,379
3
Diarrhoea15.8%1,335
4
Blood Glucose Increased13.2%1,114
5
Death10.5%891
6
Nausea10.1%854
7
Fatigue9.9%839
8
Decreased Appetite6.4%544
9
Weight Decreased6.1%515
10
Malignant Neoplasm Progression5.8%493
11
Vomiting5.6%478
12
Drug Ineffective4.3%365
13
Asthenia4.0%341
14
Stomatitis4.0%339
15
Pruritus3.2%273

These are voluntary reports and do not establish that alpelisib caused these reactions.

Report severity

56.5%Serious4,783 reports
19.5%Hospitalizations1,649 reports
14.4%Fatal1,217 reports

Seriousness is determined by the reporter, not by OpenClaim.

Alpelisib drug interactions

Other drugs that appear in adverse event reports alongside alpelisib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Fulvestrant10.1%852
2
Ribociclib2.9%248
3
Letrozole2.7%227
4
Everolimus2.1%176
5
Metformin2.0%166
6
Palbociclib1.8%152
7
Paclitaxel1.1%93
8
Capecitabine1.0%82
9
Denosumab0.9%74
10
Zoledronic-acid0.8%65
11
Anastrozole0.7%63
12
Olaparib0.6%55
13
Dexamethasone0.6%47
14
Elacestrant-hydrochloride0.6%47
15
Pantoprazole-sodium0.5%42

Taken alongside

1
Fulvestrant5.9%504
2
Metformin3.6%304
3
Ergocalciferol3.0%252
4
Acetaminophen2.8%236
5
Denosumab2.1%179
6
Ondansetron2.0%172
7
Levothyroxine-sodium2.0%172
8
Omeprazole1.9%161
9
Cetirizine-hydrochloride1.5%128
10
Calcium1.5%125
11
Gabapentin1.5%125
12
Letrozole1.4%121
13
Insulin1.4%117
14
Oxycodone1.4%115
15
Aspirin1.3%112

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports alpelisib side effects

85.6% of alpelisib adverse event reports involve female patients and 5.0% involve male patients. The largest age group is adult at 52%. These figures reflect who reports side effects, not underlying risk.

Sex

Female85.6%
Male5.0%
Unknown9.4%

Age group

< 20.2%
2–112.7%
12–171.3%
18–6452.4%
65+43.3%

What is alpelisib used for

Conditions and purposes for which patients were taking alpelisib when the adverse event was reported.

Abdominal Pain UpperAgranulocytosisAcquired Gene MutationActivated Pi3 Kinase Delta SyndromeAdenocarcinomaAdenocarcinoma Of ColonAdenoid Cystic CarcinomaAdrenal Gland CancerAlveolar RhabdomyosarcomaAnal CancerAnaplastic Thyroid CancerArteriovenous MalformationAscitesAutonomic NeuropathyBladder Cancer

Showing 15 of 309 indications

Alpelisib brand names and reporting trend

Alpelisib is sold under the brand name Vijoice.

Brand names

Vijoice1,989

Quarterly reports (20182025)

20182020202220242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking alpelisib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.