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nefazodone Images

Generic Name: nefazodone

Brand Names: Serzone

There is an FDA Alert for this drug. Click here to view it.

    Hepatic Effects
  • Severe, life-threatening, sometimes fatal hepatic failure reported. (See Hepatic Effects under Cautions.)
  • Avoid use in patients with active liver disease or elevated serum transaminase concentrations.
  • Discontinue and do not reinitiate therapy in patients who develop evidence of hepatocellular injury (e.g., AST or ALT concentrations ≥3 times the ULN).
    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Nefazodone is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on nefazodone therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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