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Serzone Side Effects

Generic name: nefazodone

Medically reviewed by Drugs.com. Last updated on Jan 16, 2024.

Note: This document contains side effect information about nefazodone. Some dosage forms listed on this page may not apply to the brand name Serzone.

Applies to nefazodone: oral tablet.

Warning

Oral route (Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients. Cases of life-threatening hepatic failure have been reported. Treatment should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. Patients should be advised to be alert for signs and symptoms of liver dysfunction and to report them to their doctor immediately if they occur. Patients who develop evidence of hepatocellular injury should be withdrawn from the drug .

Serious side effects of Serzone

Along with its needed effects, nefazodone (the active ingredient contained in Serzone) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking nefazodone:

More common

Less common

Rare

Incidence not known

Other side effects of Serzone

Some side effects of nefazodone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common or rare

Incidence not known

For Healthcare Professionals

Applies to nefazodone: oral tablet.

General

The most commonly reported side effects were headache, somnolence, dry mouth, and nausea.[Ref]

Nervous system

Very common (10% or more): Headache (up to 36%), somnolence (up to 28%), dizziness (up to 22%), lightheadedness (up to 10%)

Common (1% to 10%): Ataxia, decreased concentration, hypertonia, incoordination, memory impairment, paresthesia, taste perversion, tremor

Uncommon (0.1% to 1%): Abnormal gait, decreased attention, dysarthria, hangover effect, myoclonus, neuralgia, twitching, vertigo

Rare (less than 0.1%): Cerebrovascular accident, hyperesthesia, hyperkinesia, hypotonia, neuroleptic malignant syndrome, taste loss

Frequency not reported: Central nervous system stimulation, hypesthesia, migraine

Postmarketing reports: Convulsions, grand mal seizures, serotonin syndrome[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (up to 25%), nausea (up to 23%), constipation (up to 17%)

Common (1% to 10%): Diarrhea, dyspepsia, gastroenteritis, vomiting

Uncommon (0.1% to 1%): Colitis, enlarged abdomen, eructation, esophagitis, gastritis, gingivitis, halitosis, mouth ulceration, peptic ulcer, periodontal abscess, rectal hemorrhage, stomatitis

Rare (less than 0.1%): Dysphagia, gastrointestinal hemorrhage, glossitis, increased salivation, oral moniliasis, ulcerative colitis

Frequency not reported: Abdominal pain, flatulence, tooth disorder[Ref]

Other

Very common (10% or more): Asthenia (up to 11%)

Common (1% to 10%): Chills, fever, tinnitus

Uncommon (0.1% to 1%): Ear pain, hernia, malaise

Rare (less than 0.1%): Deafness

Frequency not reported: Accidental injury, pain[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 11%)

Common (1% to 10%): Abnormal dreams, agitation, confusion, decreased libido, psychomotor retardation

Uncommon (0.1% to 1%): Abnormal thinking, apathy, depersonalization, derealization, euphoria, hallucinations, hostility, increased libido, paranoid reaction, suicidal thoughts, suicide, suicide attempt

Rare (less than 0.1%): Anorgasmia

Frequency not reported: Anxiety, depression, dysphoria, emotional lability[Ref]

Ocular

In clinical trials, scotomata and visual trails did not occur in patients given doses below 300 mg/day; however, these events were reported at doses below 300 mg/day in postmarketing experience.[Ref]

Very common (10% or more): Abnormal vision (up to 10%)

Common (1% to 10%): Blurred vision, eye pain, scotoma, visual field defect, visual trails

Uncommon (0.1% to 1%): Abnormality of accommodation, conjunctivitis, diplopia, dry eye, hyperacusis, keratoconjunctivitis, mydriasis, photophobia

Rare (less than 0.1%): Angle-closure glaucoma, night blindness, ptosis[Ref]

Cardiovascular

Common (1% to 10%): Feeling warm, flushing, hypotension, peripheral edema, postural hypotension, sinus bradycardia, vasodilatation

Uncommon (0.1% to 1%): Angina pectoris, hypertension, syncope, tachycardia, ventricular extrasystoles

Rare (less than 0.1%): Atrioventricular (AV) block, congestive heart failure, hemorrhage, pallor, varicose veins

Frequency not reported: Chest pain, edema, palpitation[Ref]

Genitourinary

Common (1% to 10%): Breast pain, impotence, urinary frequency, urinary retention, urinary tract infection, vaginitis

Uncommon (0.1% to 1%): Abnormal ejaculation, amenorrhea, breast enlargement, hematuria, menorrhagia, metrorrhagia, nocturia, pelvic pain, polyuria, urinary incontinence, urinary urgency, vaginal hemorrhage

Rare (less than 0.1%): Enlarged uterine fibroids, oliguria, uterine hemorrhage

Frequency not reported: Dysmenorrhea, dysuria

Postmarketing reports: Galactorrhea, priapism[Ref]

Respiratory

Common (1% to 10%): Bronchitis, dyspnea, increased cough, pharyngitis

Uncommon (0.1% to 1%): Asthma, epistaxis, hiccup, laryngitis, pneumonia, voice alteration

Rare (less than 0.1%): Hyperventilation, yawn

Frequency not reported: Rhinitis, sinusitis[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Acne, alopecia, dry skin, ecchymosis, eczema, face edema, maculopapular rash, photosensitivity reaction, urticaria, vesiculobullous rash

Rare (less than 0.1%): Cellulitis

Frequency not reported: Sweating

Postmarketing reports: Stevens-Johnson syndrome[Ref]

Metabolic

Common (1% to 10%): Increased appetite, thirst

Uncommon (0.1% to 1%): Dehydration, gout, increased lactic dehydrogenase, weight loss

Rare (less than 0.1%): Hypercholesteremia, hypoglycemia

Frequency not reported: Anorexia, weight gain

Postmarketing reports: Hyponatremia[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia, neck rigidity

Uncommon (0.1% to 1%): Arthritis, bursitis, muscle stiffness, tenosynovitis

Rare (less than 0.1%): Tendinous contracture

Frequency not reported: Back pain, cramp, myalgia, neck pain

Postmarketing reports: Rhabdomyolysis[Ref]

Rhabdomyolysis occurred in patients receiving this drug with lovastatin or simvastatin.[Ref]

Immunologic

Common (1% to 10%): Flu syndrome, infection[Ref]

Hematologic

Common (1% to 10%): Decreased hematocrit

Uncommon (0.1 to 1%): Anemia, leukopenia, lymphadenopathy

Postmarketing reports: Thrombocytopenia[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests, increased ALT, increased AST

Rare (less than 0.1%): Hepatitis

Postmarketing reports: Liver failure (in some cases leading to liver transplantation and/or death), liver necrosis[Ref]

Renal

Uncommon (0.1% to 1%): Cystitis, kidney calculus[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction

Postmarketing reports: Anaphylactic reactions, angioedema[Ref]

Endocrine

Postmarketing reports: Gynecomastia, increased prolactin[Ref]

References

1. Product Information. Serzone (nefazodone). Bristol-Myers Squibb. 2001;PROD.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.