TANDOSPIRONE: 53 Adverse Event Reports & Safety Profile
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53
Total FAERS Reports
2 (3.8%)
Deaths Reported
30
Hospitalizations
53
As Primary/Secondary Suspect
6
Life-Threatening
1
Disabilities
First Report: 20110808 · Latest Report: 20241125
What Are the Most Common TANDOSPIRONE Side Effects?
#1 Most Reported
Drug interaction
10 reports (18.9%)
#2 Most Reported
Serotonin syndrome
9 reports (17.0%)
#3 Most Reported
Altered state of consciousness
6 reports (11.3%)
All TANDOSPIRONE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug interaction | 10 | 18.9% | 0 | 6 |
| Serotonin syndrome | 9 | 17.0% | 0 | 5 |
| Altered state of consciousness | 6 | 11.3% | 0 | 1 |
| Intentional overdose | 5 | 9.4% | 0 | 4 |
| Somnolence | 5 | 9.4% | 0 | 3 |
Who Reports TANDOSPIRONE Side Effects? Age & Gender Data
Gender: 72.5% female, 27.5% male. Average age: 38.5 years. Most reports from: JP. View detailed demographics →
Is TANDOSPIRONE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 1 | 0 | 1 |
| 2014 | 4 | 0 | 4 |
| 2015 | 2 | 1 | 2 |
| 2016 | 4 | 0 | 1 |
| 2017 | 3 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 4 | 1 | 1 |
| 2022 | 4 | 0 | 4 |
| 2023 | 4 | 0 | 1 |
| 2024 | 2 | 0 | 0 |
What Is TANDOSPIRONE Used For?
| Indication | Reports |
|---|---|
| Depression | 16 |
| Product used for unknown indication | 9 |
| Anxiety | 8 |
| Major depression | 5 |
Official FDA Label for TANDOSPIRONE
Official prescribing information from the FDA-approved drug label.