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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

INOSITOL: 79 Adverse Event Reports & Safety Profile

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79
Total FAERS Reports
17 (21.5%)
Deaths Reported
30
Hospitalizations
79
As Primary/Secondary Suspect
12
Life-Threatening
12
Disabilities

First Report: 20140101 · Latest Report: 20250621

What Are the Most Common INOSITOL Side Effects?

#1 Most Reported
Off label use
31 reports (39.2%)
#2 Most Reported
Exposure during pregnancy
27 reports (34.2%)
#3 Most Reported
Incorrect route of product administration
18 reports (22.8%)

All INOSITOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 31 39.2% 11 19
Exposure during pregnancy 27 34.2% 0 0
Incorrect route of product administration 18 22.8% 9 18
Product use issue 15 19.0% 10 10
Dyspnoea 14 17.7% 12 14
Normal newborn 14 17.7% 0 0
Drug hypersensitivity 13 16.5% 10 11
Nausea 13 16.5% 10 11
C-reactive protein abnormal 12 15.2% 12 12
Chest pain 12 15.2% 12 12
Contusion 12 15.2% 12 12
Drug intolerance 12 15.2% 12 12
Gait inability 12 15.2% 12 12
Injury 12 15.2% 12 12
Maternal exposure during pregnancy 12 15.2% 1 1
Arthralgia 11 13.9% 11 11
Arthropathy 11 13.9% 11 11
Coma 11 13.9% 0 11
Condition aggravated 11 13.9% 11 11
Decreased appetite 11 13.9% 10 10

Who Reports INOSITOL Side Effects? Age & Gender Data

Gender: 97.3% female, 2.7% male. Average age: 42.3 years. Most reports from: CA. View detailed demographics →

Is INOSITOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 0
2016 2 0 2
2022 1 1 0
2025 1 0 1

View full timeline →

What Is INOSITOL Used For?

IndicationReports
Product used for unknown indication 39
Polycystic ovaries 13

Official FDA Label for INOSITOL

Official prescribing information from the FDA-approved drug label.