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Inavolisib Side Effects

The most commonly reported side effects of inavolisib include hyperglycaemia, blood glucose increased, and diarrhoea, based on 315 FDA adverse event reports from 2019 to 2025.

Inavolisib side effects

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

1
Hyperglycaemia28.3%89
2
Blood Glucose Increased14.6%46
3
Diarrhoea14.3%45
4
Fatigue11.1%35
5
Stomatitis8.3%26
6
Neutropenia8.3%26
7
Nausea7.9%25
8
Off Label Use6.7%21
9
Thrombocytopenia6.7%21
10
White Blood Cell Count Decreased5.7%18
11
Diabetic Ketoacidosis4.8%15
12
Death4.4%14
13
Decreased Appetite3.8%12
14
Asthenia3.8%12
15
Dry Mouth3.2%10

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

Report severity

57.5%Serious181 reports
29.2%Hospitalizations92 reports
5.1%Fatal16 reports

Seriousness is determined by the reporter, not by OpenClaim.

Inavolisib drug interactions

Other drugs that appear in adverse event reports alongside inavolisib. 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
Palbociclib53.0%167
2
Fulvestrant24.4%77
3
Letrozole1.6%5
4
Metformin1.6%5
5
Bevacizumab0.6%2
6
Abemaciclib0.6%2
7
Capecitabine0.6%2
8
Denosumab0.3%1
9
Insulin0.3%1
10
Vismodegib0.3%1
11
Ciprofloxacin0.3%1
12
Alpelisib0.3%1
13
Capivasertib0.3%1
14
Goserelin0.3%1
15
Olaparib0.3%1

Taken alongside

1
Fulvestrant14.0%44
2
Metformin9.5%30
3
Palbociclib6.7%21
4
Acetaminophen5.7%18
5
Ondansetron5.1%16
6
Ergocalciferol5.1%16
7
Omeprazole5.1%16
8
Atorvastatin-calcium4.4%14
9
Prochlorperazine4.1%13
10
Oxycodone3.8%12
11
Zoledronic-acid3.8%12
12
Levothyroxine-sodium3.5%11
13
Loperamide-hydrochloride3.2%10
14
Amlodipine3.2%10
15
Aspirin3.2%10

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 inavolisib side effects

78.1% of inavolisib adverse event reports involve female patients and 1.0% involve male patients. The largest age group is adult at 62%. These figures reflect who reports side effects, not underlying risk.

Sex

Female78.1%
Male1.0%
Unknown21.0%

Age group

< 20.0%
2–110.0%
12–170.0%
18–6461.5%
65+38.5%

What is inavolisib used for

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

Breast CancerBreast Cancer MetastaticBladder CancerBreast CancerBreast Cancer FemaleBreast Cancer MetastaticBreast Cancer RecurrentCervix CarcinomaColon CancerDiabetes MellitusDrug ResistanceEndometrial CancerGene MutationGenitourinary SymptomGenitourinary Tract Infection

Showing 15 of 27 indications

Inavolisib brand names and reporting trend

Inavolisib is sold under the brand name Itovebi.

Brand names

Itovebi128

Quarterly reports (20192025)

20192025

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

Taking inavolisib with another medication?

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