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Serzone Side Effects

Generic Name: nefazodone

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

For the Consumer

Applies to nefazodone: oral tablet

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
  • Blurred vision or other changes in vision
  • clumsiness or unsteadiness
  • lightheadedness or fainting
  • ringing in the ears
  • skin rash or itching
Less common
  • Bladder pain
  • bloody or cloudy
  • cough or hoarseness
  • diarrhea
  • excessive muscle tone
  • eye pain
  • feeling dizzy
  • frequent urge to urinate
  • itching of the vagina or genital area
  • muscle stiffness
  • muscle tension or tightness
  • nausea
  • pain during sexual intercourse
  • painful, burning, or difficult urination
  • shortness of breath, tightness in chest, or wheezing
  • stomach pain
  • thick, white vaginal discharge with no odor or with a mild odor
  • troubled breathing
Rare
  • Asthma
  • bleeding from the rectum
  • bloody or black, tarry stools
  • change in sexual desire or performance
  • chest pain
  • double vision
  • dryness of eye
  • ear pain
  • fainting
  • fast heartbeat
  • fever, chills, or sore throat
  • hallucinations (seeing, hearing, or feeling things that are not there)
  • hives
  • increased sense of hearing
  • increased sensitivity to sun
  • irritation or soreness of mouth
  • joint or muscle pain or stiffness
  • kidney stones
  • large pupils of eyes
  • lower back, side, or stomach pain
  • menstrual changes
  • mood or mental changes
  • nerve pain or twitching
  • pelvic pain
  • problems in speaking
  • problems with urination
  • prolonged, painful, inappropriate penile erection
  • red or irritated eyes
  • sensitivity of eyes to light
  • swelling of face
  • swollen glands
  • talking, feeling, and acting with excitement and activity you cannot control
  • unusual bleeding or bruising
  • unusual feeling of well-being
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
Incidence not known
  • Blistering, peeling, or loosening of skin
  • light-colored stools
  • confusion
  • dark urine
  • decreased urine output
  • fever
  • increased thirst
  • itching
  • lack of appetite
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle pain or cramps
  • muscle spasm or jerking of all extremities
  • muscle stiffness
  • pain, warmth, or burning in fingers, toes, and legs
  • red skin lesions, often with a purple center
  • sore throat
  • sudden loss of consciousness
  • sweating
  • vomiting

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
  • Abnormal dreams
  • agitation
  • confusion
  • constipation
  • diarrhea
  • dizziness
  • drowsiness
  • dryness of mouth
  • flushing or feeling of warmth
  • headache
  • heartburn
  • increased appetite
  • increased cough
  • memory problems
  • nausea
  • swelling of arms or legs
  • tingling, burning, or prickly sensations
  • tremor
  • trouble in sleeping
  • vomiting
Less common or rare
  • Breast pain
  • generalized slowing of mental and physical activity
  • increased thirst
  • loss of strength or energy
  • muscle weakness
Incidence not known
  • Unexpected or excess milk flow from breasts
  • swelling of the breasts or breast soreness in males

For Healthcare Professionals

Applies to nefazodone: oral tablet

General

The most commonly reported side effects were somnolence, dry mouth, nausea, dizziness, constipation, asthenia, lightheadedness, blurred vision, confusion, and abnormal vision.[Ref]

Hepatic

Uncommon (0.1% to 1%): Abnormal liver function tests, increased SGOT, increased SGPT
Postmarketing reports: Liver necrosis, liver failure (in some cases leading to liver transplantation and/or death)[Ref]

Psychiatric

Very common (10% or more): Insomnia
Uncommon (0.1% to 1%): Depersonalization, hallucinations, suicide attempt, suicidal thoughts, derealization, paranoid reaction, suicide[Ref]

Nervous system

Very common (10% or more): Headache (36%), somnolence (up to 28%), dizziness (up to 22%), lightheadedness (10%)
Common (1% to 10%): Confusion, memory impairment, paraesthesia, decreased concentration, ataxia, incoordination, psychomotor retardation, tremor, hypertonia, tinnitus, taste perversion
Uncommon (0.1% to 1%): Vertigo, twitching, apathy, euphoria, hostility, abnormal thinking, decreased attention, abnormal gait, neuralgia, dysarthria, myoclonus
Rare (less than 0.1%): Hyperkinesia, increased salivation, cerebrovascular accident, hyperesthesia, hypotonia, ptosis, neuroleptic malignant syndrome
Postmarketing reports: Convulsions (including grand mal seizures), serotonin syndrome[Ref]

Gastrointestinal

Very common (10% or more): Dry mouth (25%), nausea (up to 23%), constipation (up to 17%)
Common (1% to 10%): Dyspepsia, diarrhea, vomiting, gastroenteritis
Uncommon (0.1% to 1%): Enlarged abdomen, halitosis, eructation, periodontal abscess, gingivitis, colitis, gastritis, mouth ulceration, stomatitis, esophagitis, peptic ulcer, rectal hemorrhage
Rare (less than 0.1%): Glossitis, hepatitis, dysphagia, gastrointestinal hemorrhage, oral moniliasis, ulcerative colitis[Ref]

Ocular

Very common (10% or more): Abnormal vision
Common (1% to 10%): Blurred vision, visual field defect, eye pain
Uncommon (0.1% to 1%): Dry eye, abnormality of accommodation, diplopia, conjunctivitis, mydriasis, keratoconjunctivitis, hyperacusis, photophobia
Rare (less than 0.1%): Angle-closure glaucoma, night blindness[Ref]

Cardiovascular

Common (1% to 10%): Postural hypotension, hypotension, vasodilatation
Uncommon (0.1% to 1%): Tachycardia, hypertension, syncope, ventricular extrasystoles, angina pectoris
Rare (less than 0.1%): AV block, congestive heart failure, hemorrhage, pallor, varicose veins[Ref]

Genitourinary

Common (1% to 10%): Decreased libido, urinary frequency, urinary tract infection, urinary retention, vaginitis, breast pain, impotence
Uncommon (0.1% to 1%): Pelvic pain, increased libido, cystitis, urinary urgency, metrorrhagia, amenorrhea, polyuria, vaginal hemorrhage, breast enlargement, menorrhagia, urinary incontinence, abnormal ejaculation, hematuria, nocturia
Rare (less than 0.1%): Enlarged uterine fibroids, uterine hemorrhage, anorgasmia, oliguria
Postmarketing reports: Priapism[Ref]

Other

Very common (10% or more): Asthenia (11%)
Common (1% to 10%): Chills, fever, peripheral edema
Uncommon (0.1% to 1%): Malaise, face edema, hangover effect, hernia, increased lactic dehydrogenase, ear pain[Ref]

Endocrine

Postmarketing reports: Galactorrhea, gynecomastia (male), increased prolactin[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Postmarketing reports: Anaphylactic reactions, angioedema, Stevens-Johnson syndrome[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash
Uncommon (0.1% to 1%): Photosensitivity reaction, dry skin, acne, alopecia, urticaria, maculopapular rash, vesiculobullous rash, eczema[Ref]

Metabolic

Common (1% to 10%): Increased appetite, thirst
Uncommon (0.1% to 1%): Weight loss, gout, dehydration
Rare (less than 0.1%): Hypercholesteremia, hypoglycemia
Postmarketing reports: Hyponatremia[Ref]

Hematologic

Uncommon (0.1 to 1%): Ecchymosis, anemia, leukopenia, lymphadenopathy
Postmarketing reports: Thrombocytopenia[Ref]

Immunologic

Common (1% to 10%): Infection, flu syndrome
Rare (less than 0.1%): Cellulitis[Ref]

Musculoskeletal

Common (1% to 10%): Neck rigidity, arthralgia
Uncommon (0.1% to 1%): Arthritis, tenosynovitis, muscle stiffness, bursitis
Rare (less than 0.1%): Tendinous contracture
Postmarketing reports: Rhabdomyolysis ( in patients receiving the combination of nefazodone (the active ingredient contained in Serzone) and lovastatin or simvastatin)[Ref]

Respiratory

Common (1% to 10%): Pharyngitis, increased cough, dyspnea, bronchitis
Uncommon (0.1% to 1%): Asthma, pneumonia, laryngitis, voice alteration, epistaxis, hiccup
Rare (less than 0.1%): Hyperventilation, yawn[Ref]

Renal

Uncommon (0.1% to 1%): Kidney calculus[Ref]

References

1. "Product Information. Serzone (nefazodone)." Bristol-Myers Squibb, Princeton, NJ.

Some side effects of Serzone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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