Last reviewed 2026-04-20 · How we verify

Serzone (NEFAZODONE)

Serzone (Nefazodone) is a serotonin reuptake inhibitor developed by Bristol Myers Squibb, targeting the sodium-dependent serotonin transporter. It was approved by the FDA in 1994 for the treatment of major depressive disorder. As a small molecule, Serzone has a short half-life of 1.2 hours and 20% bioavailability. The drug is now off-patent with multiple generic manufacturers. Key safety considerations include its potential for liver toxicity and interactions with other medications.

At a glance

Approved indications

• Major depressive disorder

Boxed warnings

• Suicidality and Antidepressant Drugs 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 ). Warning Cases of life-threatening hepatic failure have been reported in patients treated with nefazodone hydrochloride tablets. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of nefazodone hydrochloride treatment. The total patient-years is a summation of each patient’s duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (see WARNINGS ). Ordinarily, treatment with nefazodone hydrochloride tablets should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring. Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur. Nefazodone hydrochloride tablets should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS, Information for Patients ). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels ≥ 3 times the upper limit of NORMAL, while on nefazodone hydrochloride tablets should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if nefazodone hydrochloride is reintroduced. Accordingly, such patients should not be considered for re-treatment.

Common side effects

• Somnolence
• Dry mouth
• Nausea
• Dizziness
• Constipation
• Asthenia
• Lightheadedness
• Blurred vision
• Confusion
• Abnormal vision
• Headache
• Infection

Drug interactions

• CYP3A4 Substrates
• P-glycoprotein Substrates
• alfentanil
• chlordiazepoxide
• clonazepam
• clorazepate
• diazepam
• flurazepam
• halazepam
• midazolam
• pimozide
• prazepam

Key clinical trials

• Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD (PHASE4)
• Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals (PHASE2)
• Effect of Nefazodone on Relapse in Females With Cocaine Abuse - 10 (PHASE3)
• Effects of Nefazodone on Treatment of Female Cocaine Abusers - 3 (PHASE2)
• Nefazodone in the Treatment of Cocaine Dependence and Depression - 4 (PHASE2)
• Nefazodone in the Treatment of Social Phobia (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Serzone CI brief — competitive landscape report
• Serzone updates RSS · CI watch RSS
• Bristol-Myers Squibb portfolio CI