TIANEPTINE: 427 Adverse Event Reports & Safety Profile
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427
Total FAERS Reports
44 (10.3%)
Deaths Reported
236
Hospitalizations
427
As Primary/Secondary Suspect
74
Life-Threatening
21
Disabilities
First Report: 2004 · Latest Report: 20250715
What Are the Most Common TIANEPTINE Side Effects?
#1 Most Reported
Intentional overdose
46 reports (10.8%)
#2 Most Reported
Suicide attempt
40 reports (9.4%)
#3 Most Reported
Persistent genital arousal disorder
38 reports (8.9%)
All TIANEPTINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Intentional overdose | 46 | 10.8% | 3 | 7 |
| Suicide attempt | 40 | 9.4% | 0 | 11 |
| Persistent genital arousal disorder | 38 | 8.9% | 0 | 37 |
| Anxiety | 37 | 8.7% | 0 | 28 |
| Toxicity to various agents | 36 | 8.4% | 4 | 31 |
| Serotonin syndrome | 33 | 7.7% | 0 | 17 |
| Drug dependence | 31 | 7.3% | 1 | 14 |
| Somnolence | 31 | 7.3% | 1 | 2 |
| Condition aggravated | 27 | 6.3% | 0 | 24 |
| Drug abuse | 27 | 6.3% | 0 | 12 |
| Drug ineffective | 27 | 6.3% | 0 | 19 |
| Loss of consciousness | 27 | 6.3% | 1 | 13 |
| Confusional state | 23 | 5.4% | 0 | 16 |
| Hypotension | 21 | 4.9% | 0 | 14 |
| Withdrawal syndrome | 21 | 4.9% | 3 | 12 |
| Lethargy | 20 | 4.7% | 0 | 20 |
| Coma | 19 | 4.5% | 10 | 17 |
| Overdose | 19 | 4.5% | 4 | 13 |
| Depression | 18 | 4.2% | 2 | 7 |
| Agitation | 17 | 4.0% | 0 | 13 |
Who Reports TIANEPTINE Side Effects? Age & Gender Data
Gender: 48.9% female, 51.1% male. Average age: 47.9 years. Most reports from: US. View detailed demographics →
Is TIANEPTINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2004 | 1 | 0 | 1 |
| 2005 | 1 | 0 | 1 |
| 2009 | 4 | 3 | 3 |
| 2010 | 2 | 0 | 2 |
| 2011 | 2 | 0 | 2 |
| 2012 | 7 | 0 | 0 |
| 2013 | 5 | 0 | 1 |
| 2014 | 9 | 0 | 8 |
| 2015 | 22 | 0 | 10 |
| 2016 | 5 | 0 | 3 |
| 2017 | 21 | 0 | 13 |
| 2018 | 10 | 2 | 3 |
| 2019 | 12 | 1 | 2 |
| 2020 | 22 | 0 | 15 |
| 2021 | 21 | 1 | 11 |
| 2022 | 28 | 2 | 8 |
| 2023 | 39 | 16 | 20 |
| 2024 | 14 | 1 | 9 |
| 2025 | 4 | 0 | 3 |
What Is TIANEPTINE Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 164 |
| Depression | 70 |
| Persistent genital arousal disorder | 15 |
| Anxiety | 14 |
| Generalised anxiety disorder | 9 |
| Major depression | 8 |
| Intentional overdose | 7 |
| Suicide attempt | 7 |
| Asthenia | 6 |
| Drug use disorder | 6 |
TIANEPTINE vs Alternatives: Which Is Safer?
TIANEPTINE vs TIAPRIDE
TIANEPTINE vs TIAPROFENIC ACID
TIANEPTINE vs TICAGRELOR
TIANEPTINE vs TICLOPIDINE
TIANEPTINE vs TIGECYCLINE
TIANEPTINE vs TIKOSYN
TIANEPTINE vs TILDRAKIZUMAB
TIANEPTINE vs TILDRAKIZUMAB-ASMN
TIANEPTINE vs TILIDINE
TIANEPTINE vs TIMOLOL
Official FDA Label for TIANEPTINE
Official prescribing information from the FDA-approved drug label.