Drug Notebook

FDA Alerts

    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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(ne FAZ oh done)

What is the most important information I should know about nefazodone?

Do not take nefazodone together with carbamazepine (Tegretol), cisapride (Propulsid), pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

These drugs are no longer available in the U.S. but should also not be taken together with nefazodone: astemizole (Hismanal), or terfenadine (Seldane).

There are many other medicines that can interact with nefazodone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

What is nefazodone?

Nefazodone is an antidepressant. It is used to treat depression, including major depressive disorder.

Nefazodone is not chemically similar to other groups of antidepressants, such as selective serotonin reuptake inhibitors or "SSRIs", tricyclic antidepressants, or monoamine oxidase inhibitors or "MAOIs."

Nefazodone may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking nefazodone?

You should not take this medication if you are allergic to nefazodone or trazodone (Desyrel), or if you have ever had liver problems caused by taking nefazodone.

Do not take nefazodone if you are using any of the following drugs:

  • carbamazepine (Tegretol);

  • cisapride (Propulsid);

  • pimozide (Orap);

  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam); or

  • (these drugs are no longer available in the U.S.) astemizole (Hismanal) or terfenadine (Seldane).

Serious and sometimes fatal reactions can occur when these medicines are taken with nefazodone. You must wait at least 14 days after stopping an MAO inhibitor before you can take nefazodone. You must wait 7 days after stopping nefazodone before you can take an MAOI.

Before taking nefazodone, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may need a dose adjustment or special tests to safely take nefazodone.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether nefazodone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
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