What the label lists and what reports show
Alpelisib side effects
Alpelisib's FDA label: “Most common adverse reactions (Grades 1 to 4, incidence ≥ 10%) were diarrhea, stomatitis, and hyperglycemia.” FAERS holds 8,666 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is hyperglycaemia (1,509 reports).
- No generic listed
Check it at the source: the alpelisib FDA label on DailyMed (effective November 4, 2025, Novartis Pharmaceuticals Corporation); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VIJOICE?VIJOICE may cause serious side effects, including: Severe allergic reactions. Tell your healthcare provider or get medical help right away if you have trouble breathing, swelling of the face or throat, flushing, rash, fever, or fast heart rate during treatment with VIJOICE. Severe skin reactions. Tell your healthcare provider or get medical help right away if you get severe rash or rash that keeps getting worse, reddened skin, flu-like symptoms, blistering of the lips, eyes or mouth, blisters on the skin or skin peeling, with or without fever. High blood sugar levels (hyperglycemia). Hyperglycemia is common with VIJOICE and may be severe. Your healthcare provider will monitor your sugar levels before you start and during treatment with VIJOICE. Your healthcare provider may monitor your sugar levels more often if you have a history of diabetes. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective November 4, 2025 (SPL set 638069a4-aee0-46c9-9e21-54ad449c163c), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (Grades 1 to 4, incidence ≥ 10%) were diarrhea, stomatitis, and hyperglycemia.
Table 10: Adverse Reactions (≥ 5%) in Patients with PROS Who Received VIJOICE in EPIK-P1
| Reaction | All Grades (%) | Grade 3 or 4 (%) |
|---|---|---|
| Diarrhea | 16 | 0 |
| Stomatitis a | 16 | 0 |
| Hyperglycemia | 12 | 0 |
| Eczema | 7 | 0 |
| Dry skin | 7 | 0 |
| Alopecia | 5 | 0 |
| Headache | 5 | 0 |
| Cellulitis | 5 | 3.5 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are discussed elsewhere in the labeling: Severe Hypersensitivity [see Warnings and Precautions (5.1)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.2)] Hyperglycemia [see Warnings and Precautions (5.3)] Pneumonitis [see Warnings and Precautions (5.4)] Diarrhea or Colitis [see Warnings and Precautions (5.5)] Most common adverse reactions (Grades 1 to 4, incidence ≥ 10%) were diarrhea, stomatitis, and hyperglycemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of VIJOICE was evaluated in EPIK-P1 (NCT04285723), a single-arm clinical study in patients who were treated as part of an expanded access program for compassionate use. Fifty-seven patients 2 years of age and older with severe or life-threatening PIK3CA-Related Overgrowth Spectrum (PROS) received VIJOICE based on age at dosages ranging from 50 mg to 250 mg orally once daily [see Clinical Studies (14)]. …
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective November 4, 2025 (SPL set 638069a4-aee0-46c9-9e21-54ad449c163c), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,666 reports list alpelisib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,224 are coded as a death and 1,686 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 rose sharply in 2022 (1,783, against a median of 555 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Alpelisib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions