SIBUTRAMINE: 140 Adverse Event Reports & Safety Profile
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140
Total FAERS Reports
9 (6.4%)
Deaths Reported
27
Hospitalizations
140
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities
Nov 22, 1997
FDA Approved
Discontinued
Status
FDA Application: 020632 ·
First Report: 2006 · Latest Report: 20230915
What Are the Most Common SIBUTRAMINE Side Effects?
#1 Most Reported
Weight decreased
48 reports (34.3%)
#2 Most Reported
Headache
27 reports (19.3%)
#3 Most Reported
Tachycardia
25 reports (17.9%)
All SIBUTRAMINE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Weight decreased | 48 | 34.3% | 0 | 0 |
| Headache | 27 | 19.3% | 0 | 9 |
| Tachycardia | 25 | 17.9% | 0 | 0 |
| Suspected counterfeit product | 20 | 14.3% | 0 | 3 |
| Toxicity to various agents | 19 | 13.6% | 3 | 0 |
| Palpitations | 18 | 12.9% | 0 | 5 |
| Off label use | 17 | 12.1% | 1 | 1 |
| Intentional product misuse | 16 | 11.4% | 1 | 1 |
| Asthenia | 15 | 10.7% | 0 | 4 |
| Hypertension | 13 | 9.3% | 2 | 2 |
| Nausea | 13 | 9.3% | 0 | 1 |
| Chest pain | 12 | 8.6% | 0 | 5 |
| Dyspnoea | 12 | 8.6% | 0 | 6 |
| Decreased appetite | 11 | 7.9% | 0 | 0 |
| Insomnia | 11 | 7.9% | 0 | 6 |
| Constipation | 9 | 6.4% | 0 | 4 |
| Dizziness | 9 | 6.4% | 0 | 2 |
| Amnesia | 7 | 5.0% | 0 | 6 |
| Anxiety | 7 | 5.0% | 0 | 2 |
| Sleep disorder | 7 | 5.0% | 0 | 1 |
Who Reports SIBUTRAMINE Side Effects? Age & Gender Data
Gender: 84.5% female, 15.5% male. Average age: 36.2 years. Most reports from: FR. View detailed demographics →
Is SIBUTRAMINE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 3 | 0 | 0 |
| 2010 | 3 | 0 | 2 |
| 2013 | 1 | 1 | 0 |
| 2014 | 3 | 0 | 1 |
| 2015 | 2 | 0 | 1 |
| 2017 | 2 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 0 |
| 2022 | 20 | 0 | 1 |
| 2023 | 50 | 0 | 11 |
What Is SIBUTRAMINE Used For?
| Indication | Reports |
|---|---|
| Weight decreased | 80 |
| Product used for unknown indication | 20 |
| Obesity | 9 |
| Drug therapy | 7 |
SIBUTRAMINE vs Alternatives: Which Is Safer?
SIBUTRAMINE vs SILDENAFIL
SIBUTRAMINE vs SILODOSIN
SIBUTRAMINE vs SILTUXIMAB
SIBUTRAMINE vs SILVER SULFADIAZINE
SIBUTRAMINE vs SIMEPREVIR
SIBUTRAMINE vs SIMPONI
SIBUTRAMINE vs SIMVASTATIN
SIBUTRAMINE vs SINGULAIR
SIBUTRAMINE vs SINTILIMAB
SIBUTRAMINE vs SIPONIMOD
Official FDA Label for SIBUTRAMINE
Official prescribing information from the FDA-approved drug label.