Nefazodone
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Black Box Warning
|
Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
Condition Name: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nefazodone hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nefazodone hydrochloride tablets are not approved for use in pediatric patients. (See Warnings, Clinical Worsening and Suicide Risk; Precautions, Information for Patients; and Precautions, Pediatric Use.)
|
Overview
Nefazodone is a 5-HT2 Antagonists that is FDA approved for the {{{indicationType}}} of major depressive disorder. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cardiovascular: orthostatic hypotension (2.8% to 4), gastrointestinal: constipation (10% to 17% ), nausea (14% to 23% ), xerostomia (25% ), neurologic: asthenia (7% to 13% ), confusion (7% ), dizziness (11% to 22% ), headache (26% to 52% ), lightheadedness (10% ), somnolence (16% to 32% ),ophthalmic: blurred vision (3% to 9% ).
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Major depressive disorde
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Nefazodone in adult patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Nefazodone in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Nefazodone FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Nefazodone in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Nefazodone in pediatric patients.
Contraindications
There is limited information regarding Nefazodone Contraindications in the drug label.
Warnings
|
Suicidality and Antidepressant Drugs
See full prescribing information for complete Boxed Warning.
Condition Name: Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of nefazodone hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Nefazodone hydrochloride tablets are not approved for use in pediatric patients. (See Warnings, Clinical Worsening and Suicide Risk; Precautions, Information for Patients; and Precautions, Pediatric Use.)
|
There is limited information regarding Nefazodone Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Nefazodone Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Nefazodone Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Nefazodone Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Nefazodone in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Nefazodone in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Nefazodone during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Nefazodone in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Nefazodone in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Nefazodone in geriatric settings.
Gender
There is no FDA guidance on the use of Nefazodone with respect to specific gender populations.
Race
There is no FDA guidance on the use of Nefazodone with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Nefazodone in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Nefazodone in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Nefazodone in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Nefazodone in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Nefazodone Administration in the drug label.
Monitoring
There is limited information regarding Nefazodone Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Nefazodone and IV administrations.
Overdosage
There is limited information regarding Nefazodone overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Nefazodone Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Nefazodone Mechanism of Action in the drug label.
Structure
There is limited information regarding Nefazodone Structure in the drug label.
Pharmacodynamics
There is limited information regarding Nefazodone Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Nefazodone Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Nefazodone Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Nefazodone Clinical Studies in the drug label.
How Supplied
There is limited information regarding Nefazodone How Supplied in the drug label.
Storage
There is limited information regarding Nefazodone Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Nefazodone |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Nefazodone |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Nefazodone Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Nefazodone interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Nefazodone Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Nefazodone Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.