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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2016 | 2 | 0 | 2 |
| 2022 | 1 | 1 | 0 |
| 2025 | 1 | 0 | 1 |
What Is INOSITOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 39 |
| Polycystic ovaries | 13 |
Official FDA Label for INOSITOL
Official prescribing information from the FDA-approved drug label.