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Frequency not reportedActivation of mania/hypomaniaaggressive reactionagitationsometimes exacerbating to deliriumanxietycognitive impairmentconfusional statedelusionsdiscontinuation syndromehallucinationshypomaniaincreased libidoinsomnialibido decreasedmanianightmaresrestlessnesssuicidal behaviorsuicidal ideationsuicidal thoughtswithdrawal syndrome.

Antidepressants increase the risk of suicidal thinking and behaviorsuicidalityin short-term studies in children and adolescents with Major Depressive DisorderMDDand other psychiatric disordersAnyone considering the use of Desyrel or any other antidepressant in a child or adolescent must balance this risk with the clinical needPatients who are started on therapy should be observed closely for clinical worseningsuicidalityor unusual changes in behaviorFamilies and caregivers should be advised of the need for close observation and communication with the prescriberDesyrel is not approved for use in pediatric patientsSee WARNINGS and PRECAUTIONSPediatric Use

Desyrel and/or its metabolites have been found in the milk of lactating ratssuggesting that the drug may be secreted in human milkCaution should be exercised when Desyrel is administered to a nursing woman.

Consideration should be given to changing the therapeutic regimenincluding possibly discontinuing the medicationin patients whose depression is persistently worseor who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidalityespecially if these symptoms are severeabrupt in onsetor were not part of the patient’s presenting 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.

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