Nefazodone

Nefazodone
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Black Box Warning

Suicidality and Antidepressant Drugs See full prescribing information for complete Boxed Warning. 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 disorder

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 about FDA-labeled indications and dosage information of Nefazodone in pediatric patients.

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. 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

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Package and Label Display Panel

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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.