INULIN: 73 Adverse Event Reports & Safety Profile
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73
Total FAERS Reports
0
Deaths Reported
47
Hospitalizations
73
As Primary/Secondary Suspect
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
FDA Application: 002282 ·
First Report: 201308 · Latest Report: 20240624
What Are the Most Common INULIN Side Effects?
#1 Most Reported
Somnolence
48 reports (65.8%)
#2 Most Reported
Pneumonia aspiration
47 reports (64.4%)
#3 Most Reported
Gastrooesophageal reflux disease
47 reports (64.4%)
All INULIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Somnolence | 48 | 65.8% | 0 | 47 |
| Coma | 47 | 64.4% | 0 | 47 |
| Gastrooesophageal reflux disease | 47 | 64.4% | 0 | 47 |
| Pneumonia aspiration | 47 | 64.4% | 0 | 47 |
| Off label use | 27 | 37.0% | 0 | 23 |
| Incorrect route of product administration | 22 | 30.1% | 0 | 22 |
| Underdose | 21 | 28.8% | 0 | 19 |
| Product use issue | 10 | 13.7% | 0 | 0 |
| Drug ineffective | 9 | 12.3% | 0 | 0 |
| Diarrhoea | 5 | 6.9% | 0 | 0 |
Who Reports INULIN Side Effects? Age & Gender Data
Gender: 82.9% female, 17.1% male. Average age: 64.0 years. Most reports from: CA. View detailed demographics →
Is INULIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2013 | 1 | 0 | 0 |
| 2014 | 2 | 0 | 0 |
| 2015 | 2 | 0 | 0 |
| 2016 | 5 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2020 | 2 | 0 | 0 |
| 2024 | 1 | 0 | 0 |
What Is INULIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 47 |
| Constipation | 5 |
Official FDA Label for INULIN
Official prescribing information from the FDA-approved drug label.