Skip to content

Nefazodone

    DEA Class;  Rx

    Common Brand Names; Serzone, Nefazodone 5HT2, Serzone 5HT2

    • Antidepressants, Other; 
    • Antidepressants, SSRI/Antagonist

    Synthetic phenylpiperazine antidepressant; structurally similar to trazodone but exhibits less sedation and orthostasis
    Used for treating major depression in adults
    Boxed warning warns of risk of hepatotoxicity
    Requires close monitoring in pediatrics and young adults due to an increased risk of suicidality during the initial stages of treatment

    Indicated For the treatment of major depression.

    For the treatment of panic disorder or for social phobia (social anxiety disorder).
    For the treatment of posttraumatic stress disorder (PTSD).
    For the treatment of premenstrual dysphoric disorder (PMDD).

    Co-administration with terfenadine (discontinued), astemizole (discontinued), cisapride, pimozide, carbamazepine

    Concurrent administration with triazolam (75% dose reduction may be needed but not all commercially available dosage forms of triazolam may permit sufficient dosage reduction)

    Hypersensitivity to nefazadone or other phenylpiperazine antidepressants

    Co-administration with MAO inhibitors or within 14 days of administration

    Liver injury resulting from previous nefazodone treatment

    • Headache (31-35%)
    • Somnolence (21-25%)
    • Nausea (21-25%)
    • Xerostomia (21-25%)
    • Dizziness (15-20%)
    • Asthenia (11-15%)
    • Constipation (11-15%)
    • Insomnia (11-15%)
    • Infection (6-10%)
    • Dyspepsia (6-10%)
    • Lightheadedness (6-10%)
    • Confusion (6-10%)
    • Blurred vision (6-10%)
    • Abnormal vision (6-10%)
    • Increased appetite (1-5%)
    • Memory loss (1-5%)
    • Paresthesia (1-5%)
    • Vasodilation (1-5%)
    • Decreased concentration (1-5%)
    • Ataxia (1-5%)
    • Decreased libido (1-5%)
    • Breast pain (1-5%)
    • Decreased hematocrit (1-5%)
    • Agitation with discontinuation (1-5%)
    • Orthostatic hypotension (2.6%)
    • Bradycardia (1.5%)
    • Hypomania
    • Mania
    • Seizure
    • Suicidal thoughts
    • Suicide
    • Worsening depression
    • Liver failure (rare, 1 in 250,000-300,000)

    Clinical worsening & suicide ideation may occur despite medication in adolescents & young adults (18-24 yo)

    May take several weeks to achieve full response

    May cause anticholinergic effects

    Use caution in patients experiencing xerostomia, visual problems, paralytic ileus, BPH, urinary retention, or decreased motility

    The pupillary dilation that occurs following use of many antidepressant drugs may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy

    Postural hypotension reported; the prescriber should be aware that there is some risk of postural hypotension in association with this therapy; it should be used with caution in patients with known cardiovascular or cerebrovascular disease that could be exacerbated by hypotension (history of myocardial infarction, angina, or ischemic stroke) and conditions that would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medication)

    Rare occurrences of convulsions (including grand mal seizures) following administration of this drug reported since market introduction; a causal relationship has not been established

    While priapism did not occur during premarketing experience, rare reports of priapism have been received since market introduction; a causal relationship to this drug has not been established; if patients present with prolonged or inappropriate erections, they should discontinue therapy immediately and consult their physicians; if the condition persists for more than 24 hours, a urologist should be consulted to determine appropriate management

    Sinus bradycardia, defined as heart rate ≤ 50 bpm and a decrease of at least 15 bpm from baseline, reported with therapy; because patients with a recent history of myocardial infarction or unstable heart disease were excluded from clinical trials, such patients should be treated with caution

    There are no adequate and well-controlled studies in pregnant women; therapy should be administered during pregnancy only if potential benefit justifies potential risk to fetus

    Not known whether nefazodone or its metabolites are excreted in human milk; because many drugs are excreted in human milk, caution should be exercised when this drug is administered to a nursing woman

    Adults

    600 mg/day PO.

    Elderly

    600 mg/day PO.

    Adolescents

    600 mg/day PO.

    Children

    >= 7 years: 300 mg/day PO has been suggested; limited data are available; not FDA-approved.
    <= 6 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Nefazodone hydrochloride

    tablet

    • 50mg
    • 100mg
    • 150mg
    • 200mg
    • 250mg