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The following adverse reactions have been identified during post approval use of fluoxetineBecause these reactions are reported voluntarily from a population of uncertain sizeit is difficult to reliably estimate their frequency or evaluate a causal relationship to drug exposure.
Patients should be advised of the signs and symptoms associated with serotonin syndrome that may include mental status changesfor exampleagitationhallucinationsdeliriumand comaautonomic instabilityfor exampletachycardialabile blood pressuredizzinessdiaphoresisflushinghyperthermianeuromuscular changesfor exampletremorrigiditymyoclonushyperreflexiaincoordinationseizuresand/or gastrointestinal symptomsfor examplenauseavomitingdiarrheaPatients should be cautioned to seek medical care immediately if they experience these symptoms.
Report any new or worsening symptoms to your doctorsuch asmood or behavior changesanxietypanic attackstrouble sleepingor if you feel impulsiveirritableagitatedhostileaggressiverestlesshyperactivementally or physicallymore depressedor have thoughts about suicide or hurting yourself.
Some products that may interact with this drug includedrugs removed from your body by certain liver enzymes including vinblastineantiarrhythmics such as propafenone/flecainidetricyclic antidepressants such as desipramine/imipramineother drugs that can cause bleeding/bruising including antiplatelet drugs such as clopidogrelNSAIDs such as ibuprofenblood thinnerssuch as warfarin.
Safety and effectiveness of SARAFEM in the pediatric population have not been establishedsee BOXED WARNING and WARNINGS AND PRECAUTIONSWhen considering the use of SARAFEM in a child or adolescentthe potential risks must be balanced with the clinical needSignificant toxicityincluding myotoxicitylong-term neurobehavioral and reproductive toxicityand impaired bone developmenthas been observed following exposure of juvenile animals to fluoxetineSome of these effects occurred at clinically relevant exposures.
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