duloxetine (cont.)
Combining duloxetine with aspirin,
nonsteroidal antiinflammatory
drugs (NSAIDs), warfarin
(Coumadin) or other drugs that are
associated with bleeding may increase the risk of bleeding, because duloxetine
is associated with bleeding.
PREGNANCY: In animal studies, duloxetine has been shown to have adverse
effects on fetal development. There are no adequate studies in pregnant women.
Duloxetine should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
NURSING MOTHERS: Duloxetine is excreted into the
milk of lactating women.
Because the safety of duloxetine in infants is not known, nursing while on
duloxetine is not recommended.
SIDE EFFECTS: The most common side effects noted with duloxetine are nausea,
dry mouth, constipation, diarrhea, fatigue, difficulty sleeping, and dizziness.
Increased blood pressure can occur and should be monitored.
Seizures have been
reported. Sexual dysfunction (decreased sex drive and delayed orgasm and
ejaculation) has been associated with duloxetine. Some patients may experience
withdrawal reactions upon stopping duloxetine. Symptoms of withdrawal include
anxiety, nausea, nervousness, and insomnia. The dose of duloxetine should be
gradually reduced when therapy is discontinued to prevent symptoms of
withdrawal.
Antidepressants increased the risk of
suicidal thinking and behavior
(suicidality) in short-term studies in children and adolescents with depression
and other psychiatric disorders. Anyone considering the use of duloxetine or any
other antidepressant in a child or adolescent must balance this risk with the
clinical need. Patients who are started on therapy should be closely observed
for clinical worsening, suicidality, or unusual changes in behavior.
Reference: Cymbalta Prescribing Information, February 2009
Last Editorial Review: 9/10/2009
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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