CHOLINE: 34 Adverse Event Reports & Safety Profile
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34
Total FAERS Reports
8 (23.5%)
Deaths Reported
27
Hospitalizations
34
As Primary/Secondary Suspect
First Report: 201408 · Latest Report: 20250621
What Are the Most Common CHOLINE Side Effects?
#1 Most Reported
Somnolence
22 reports (64.7%)
#2 Most Reported
Gastrooesophageal reflux disease
18 reports (52.9%)
#3 Most Reported
Pneumonia aspiration
17 reports (50.0%)
All CHOLINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Somnolence | 22 | 64.7% | 4 | 21 |
| Gastrooesophageal reflux disease | 18 | 52.9% | 0 | 17 |
| Coma | 17 | 50.0% | 0 | 17 |
| Pneumonia aspiration | 17 | 50.0% | 0 | 17 |
| Off label use | 16 | 47.1% | 0 | 15 |
| Incorrect route of product administration | 14 | 41.2% | 0 | 14 |
| Underdose | 14 | 41.2% | 0 | 14 |
| Death | 7 | 20.6% | 7 | 6 |
| Vomiting | 6 | 17.7% | 4 | 4 |
| Pain | 5 | 14.7% | 4 | 4 |
| Syncope | 5 | 14.7% | 4 | 4 |
Who Reports CHOLINE Side Effects? Age & Gender Data
Gender: 70.6% female, 29.4% male. Average age: 58.3 years. Most reports from: CA. View detailed demographics →
Is CHOLINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 1 |
| 2017 | 1 | 1 | 1 |
| 2019 | 3 | 0 | 0 |
| 2021 | 4 | 4 | 4 |
| 2025 | 1 | 0 | 1 |
What Is CHOLINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 22 |
Official FDA Label for CHOLINE
Official prescribing information from the FDA-approved drug label.