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Nefazodone hydrochloride Information

5/2007: The issues described below have been addressed in product labeling.  Please see Antidepressant Use in Children, Adolescents, and Adults


FDA ALERT [7/2005] – Suicidal Thoughts or Actions in Children and Adults

Patients with depression or other mental illnesses often think about or attempt suicide. Closely watch anyone taking antidepressants, especially early in treatment or when the dose is changed. Patients who become irritable or anxious, or have new or increased thoughts of suicide or other changes in mood or behavior (or their care givers) should contact their healthcare professional right away.

Children

Taking antidepressants may increase suicidal thoughts and actions in about 1 out of 50 people 18 years or younger. Although nefazodone is prescribed for children, FDA has not approved nefazodone for use in children.

Adults

Several recent scientific publications report the possibility of an increased risk for suicidal behavior in adults who are being treated with antidepressant medications. Even before these reports became available, FDA began a complete review of all available data to determine whether there is an increased risk of suicidal thinking or behavior in adults being treated with antidepressant medications. It is expected that this review will take a year or longer to complete. In the meantime, FDA is highlighting that adults being treated with antidepressant medication, particularly those being treated for depression, should be watched closely for worsening of depression and for increased suicidal thinking or behavior.

  • Nefazodone is marketed under these names:
    • Nefazodone HCL
    • Nefazodone hydrochloride

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program using the contact information at the bottom of this page.

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Regulatory History and Labeling from Drugs@FDA

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