LACTITOL: 47 Adverse Event Reports & Safety Profile
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47
Total FAERS Reports
3 (6.4%)
Deaths Reported
34
Hospitalizations
47
As Primary/Secondary Suspect
7
Life-Threatening
5
Disabilities
Feb 12, 2020
FDA Approved
Discontinued
Status
FDA Application: 211281 ·
Patent Expires: May 12, 2037 · First Report: 200806 · Latest Report: 20241216
What Are the Most Common LACTITOL Side Effects?
#1 Most Reported
Myalgia
12 reports (25.5%)
#2 Most Reported
Headache
10 reports (21.3%)
#3 Most Reported
General physical health deterioration
9 reports (19.1%)
All LACTITOL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Myalgia | 12 | 25.5% | 0 | 5 |
| Headache | 10 | 21.3% | 2 | 9 |
| General physical health deterioration | 9 | 19.2% | 0 | 9 |
| Drug dependence | 8 | 17.0% | 0 | 0 |
| Interstitial lung disease | 8 | 17.0% | 0 | 8 |
| Anxiety | 7 | 14.9% | 0 | 0 |
| Apathy | 7 | 14.9% | 0 | 0 |
| Dehydration | 7 | 14.9% | 0 | 0 |
| Drug ineffective | 7 | 14.9% | 0 | 0 |
| Feeling cold | 7 | 14.9% | 0 | 0 |
| Insomnia | 7 | 14.9% | 0 | 0 |
| Myoclonus | 7 | 14.9% | 0 | 0 |
| Renal failure | 7 | 14.9% | 0 | 0 |
| Restlessness | 7 | 14.9% | 0 | 0 |
| Somnolence | 7 | 14.9% | 0 | 0 |
| Yawning | 7 | 14.9% | 0 | 0 |
| Acute kidney injury | 6 | 12.8% | 0 | 2 |
| Coma | 6 | 12.8% | 0 | 6 |
| Drug abuse | 6 | 12.8% | 0 | 6 |
| Suicide attempt | 6 | 12.8% | 0 | 6 |
Who Reports LACTITOL Side Effects? Age & Gender Data
Gender: 66.7% female, 33.3% male. Average age: 60.9 years. Most reports from: FR. View detailed demographics →
Is LACTITOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2008 | 5 | 0 | 5 |
| 2009 | 1 | 0 | 1 |
| 2013 | 1 | 0 | 1 |
| 2014 | 2 | 0 | 2 |
| 2016 | 5 | 0 | 1 |
| 2017 | 6 | 3 | 6 |
| 2019 | 6 | 0 | 6 |
| 2021 | 3 | 0 | 3 |
| 2023 | 2 | 0 | 1 |
| 2024 | 8 | 0 | 8 |
What Is LACTITOL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 27 |
| Constipation | 8 |
Official FDA Label for LACTITOL
Official prescribing information from the FDA-approved drug label.