TOLPERISONE: 98 Adverse Event Reports & Safety Profile
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98
Total FAERS Reports
2 (2.0%)
Deaths Reported
67
Hospitalizations
98
As Primary/Secondary Suspect
29
Life-Threatening
1
Disabilities
First Report: 200308 · Latest Report: 20241021
What Are the Most Common TOLPERISONE Side Effects?
#1 Most Reported
Serotonin syndrome
20 reports (20.4%)
#2 Most Reported
Suicide attempt
19 reports (19.4%)
#3 Most Reported
Hallucination
17 reports (17.3%)
All TOLPERISONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Serotonin syndrome | 20 | 20.4% | 1 | 20 |
| Suicide attempt | 19 | 19.4% | 0 | 11 |
| Hallucination | 17 | 17.4% | 1 | 17 |
| Blood glucose increased | 16 | 16.3% | 1 | 16 |
| Intentional overdose | 16 | 16.3% | 0 | 6 |
| Urinary tract infection | 16 | 16.3% | 1 | 16 |
| Blood pressure decreased | 15 | 15.3% | 1 | 15 |
| Coordination abnormal | 15 | 15.3% | 1 | 15 |
| Dementia | 15 | 15.3% | 1 | 15 |
| Hypothyroidism | 15 | 15.3% | 1 | 15 |
| Tooth loss | 15 | 15.3% | 1 | 15 |
| Withdrawal syndrome | 15 | 15.3% | 1 | 15 |
| Contraindicated product administered | 13 | 13.3% | 1 | 13 |
| Skin disorder | 13 | 13.3% | 1 | 13 |
| Wound | 13 | 13.3% | 1 | 13 |
| Electrocardiogram qt prolonged | 12 | 12.2% | 1 | 12 |
| Staring | 12 | 12.2% | 1 | 12 |
| Infection | 11 | 11.2% | 1 | 11 |
| Gaze palsy | 10 | 10.2% | 0 | 10 |
| Lactic acidosis | 9 | 9.2% | 0 | 9 |
Who Reports TOLPERISONE Side Effects? Age & Gender Data
Gender: 57.3% female, 42.7% male. Average age: 56.6 years. Most reports from: DE. View detailed demographics →
Is TOLPERISONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 3 | 0 | 0 |
| 2006 | 3 | 0 | 3 |
| 2014 | 4 | 0 | 3 |
| 2015 | 14 | 0 | 6 |
| 2016 | 5 | 0 | 3 |
| 2017 | 14 | 1 | 11 |
| 2018 | 1 | 0 | 1 |
| 2019 | 5 | 0 | 5 |
| 2021 | 4 | 0 | 4 |
| 2022 | 4 | 0 | 4 |
| 2023 | 11 | 0 | 11 |
| 2024 | 1 | 0 | 1 |
What Is TOLPERISONE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 53 |
| Pain | 5 |
Official FDA Label for TOLPERISONE
Official prescribing information from the FDA-approved drug label.