FLUOXETINE for Off label use: Side Effects & Safety Data
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There are 12 adverse event reports in the FDA FAERS database where FLUOXETINE was used for Off label use.
Most Reported Side Effects for FLUOXETINE
| Side Effect | Reports | % | Deaths | Hosp. |
|---|---|---|---|---|
| Toxicity to various agents | 3,172 | 10.2% | 1,830 | 1,573 |
| Drug ineffective | 2,471 | 7.9% | 23 | 817 |
| Completed suicide | 2,345 | 7.5% | 2,338 | 738 |
| Drug interaction | 2,054 | 6.6% | 248 | 1,053 |
| Intentional overdose | 2,026 | 6.5% | 173 | 1,570 |
| Foetal exposure during pregnancy | 1,670 | 5.4% | 73 | 469 |
| Off label use | 1,472 | 4.7% | 103 | 635 |
| Serotonin syndrome | 1,457 | 4.7% | 81 | 817 |
| Suicide attempt | 1,441 | 4.6% | 28 | 1,022 |
| Anxiety | 1,347 | 4.3% | 19 | 353 |
| Suicidal ideation | 1,298 | 4.2% | 58 | 489 |
| Drug abuse | 1,295 | 4.2% | 569 | 549 |
| Nausea | 1,171 | 3.8% | 133 | 313 |
| Fatigue | 1,150 | 3.7% | 167 | 309 |
| Insomnia | 1,150 | 3.7% | 187 | 160 |
Other Indications for FLUOXETINE
Product used for unknown indication (13,207)
Depression (7,035)
Anxiety (1,541)
Major depression (838)
Obsessive-compulsive disorder (637)
Suicide attempt (392)
Bipolar disorder (385)
Schizophrenia (351)
Antidepressant therapy (267)
Mixed anxiety and depressive disorder (198)
Other Drugs Used for Off label use
LENALIDOMIDE (5,767)
ECULIZUMAB (3,550)
CERTOLIZUMAB PEGOL (2,256)
ABOBOTULINUMTOXINA (2,170)
LEVETIRACETAM (2,161)
APREMILAST (1,995)
PROPRANOLOL (1,576)
CETIRIZINE (1,416)
HUMAN IMMUNOGLOBULIN G (1,129)
THALIDOMIDE (1,033)