Nefazodone Side Effects

Brand Names: Serzone

Please note - some side effects for Nefazodone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Nefazodone - for the consumer

Nefazodone

All medicines may cause side effects, but many people have no, or minor side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nefazodone:

Abnormal dreams; abnormal skin sensations; changes in taste; chills; confusion; constipation; decreased concentration; decreased sex drive; diarrhea; dizziness; drowsiness; dry mouth; fever; frequent urination; headache; incoordination; increased appetite; increased cough; indigestion; lightheadedness; memory loss; mental confusion; ringing in the ears; sleeplessness; sore throat; swelling of the hands and feet; tremor; urinary retention; urinary tract infection; vaginal infection; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; blurred vision; dark urine; extreme fatigue; fainting; general body discomfort; hostility; impulsive feelings; irregular heartbeat; irritability; loss of appetite; mental or mood changes; nausea; painful, prolonged erections; seizures; severe restlessness; stomach pain; thoughts of hurting yourself; upset stomach; vomiting; worsening of depression; yellowing of skin/eyes.

For the professional

Nefazodone

Associated with Discontinuation of Treatment

Approximately 16% of the 3496 patients who received Nefazodone in worldwide premarketing clinical trials discontinued treatment due to an adverse experience. The more common (³ 1%) events in clinical trials associated with discontinuation and considered to be drug related (i.e., those events associated with dropout at a rate approximately twice or greater for Nefazodone compared to placebo) included: nausea (3.5%), dizziness (1.9%), insomnia (1.5%), asthenia (1.3%), and agitation (1.2%).

Incidence in Controlled Trials

The most commonly observed adverse events associated with the use of Nefazodone (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (i.e., significantly higher incidence for Nefazodone compared to placebo, p ≤ 0.05), derived from the table below, were: somnolence, dry mouth, nausea, dizziness, constipation, asthenia, lightheadedness, blurred vision, confusion, and abnormal vision.

The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among Nefazodone-treated patients who participated in short-term (6 to 8 week) placebo-controlled trials in which patients were dosed with Nefazodone to ranges of 300 to 600 mg/day. This table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using standard COSTART-based Dictionary terminology.

The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.

The table that follows enumerates adverse events that were more frequent in the Nefazodone dose range of 300 to 600 mg/day than in the Nefazodone dose range of up to 300 mg/day. This table shows only those adverse events for which there was a statistically significant difference (p ≤ 0.05) in incidence between the Nefazodone dose ranges as well as a difference between the high dose range and placebo.

In controlled clinical trials, blurred vision occurred in 9% of Nefazodone-treated patients compared to 3% of placebo-treated patients. In these same trials abnormal vision, including scotomata and visual trails, occurred in 7% of Nefazodone-treated patients compared to 1% of placebo-treated. Dose-dependency was observed for these events in these trials, with none of the scotomata and visual trails at doses below 300 mg/day. However, scotomata and visual trails observed at doses below 300 mg/day have been reported in postmarketing experience with Nefazodone.

In a pooled analysis of placebo-controlled premarketing studies, there were no differences between Nefazodone and placebo groups in the proportions of patients meeting criteria for potentially important increases or decreases in body weight (a change of ≥ 7%).

Of the serum chemistry, serum hematology, and urinalysis parameters monitored during placebo-controlled premarketing studies with Nefazodone, a pooled analysis revealed a statistical trend between Nefazodone and placebo for hematocrit, i.e., 2.8% of Nefazodone patients met criteria for a potentially important decrease in hematocrit (≤ 37% male or ≤ 32% female) compared to 1.5% of placebo patients (0.05 < p ≤ 0.10). Decreases in hematocrit, presumably dilutional, have been reported with many other drugs that block alpha1-adrenergic receptors. There was no apparent clinical significance of the observed changes in the few patients meeting these criteria.

Of the ECG parameters monitored during placebo-controlled premarketing studies with Nefazodone, a pooled analysis revealed a statistically significant difference between Nefazodone and placebo for sinus bradycardia, i.e., 1.5% of Nefazodone patients met criteria for a potentially important decrease in heart rate (≤ 50 bpm and a decrease of ≥ 15 bpm) compared to 0.4% of placebo patients (p < 0.05). There was no obvious clinical significance of the observed changes in the few patients meeting these criteria.

Other Events Observed During the Premarketing Evaluation of Nefazodone

During its premarketing assessment, multiple doses of Nefazodone were administered to 3496 patients in clinical studies, including more than 250 patients treated for at least one year. The conditions and duration of exposure to Nefazodone varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient and outpatient studies, fixed-dose and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.

In the tabulations that follow, reported adverse events were classified using standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 3496 patients exposed to multiple doses of Nefazodone who experienced an event of the type cited on at least one occasion while receiving Nefazodone. All reported events are included except those already listed in the Treatment-Emergent Adverse Experience Incidence table, those events listed in other safety-related sections of this insert, those adverse experiences subsumed under COSTART terms that are either overly general or excessively specific so as to be uninformative, those events for which a drug cause was very remote, and those events which were not serious and occurred in fewer than two patients.

It is important to emphasize that, although the events reported occurred during treatment with Nefazodone, they were not necessarily caused by it.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on one or more occasions in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.

Body as a whole – Infrequent: allergic reaction, malaise, photosensitivity reaction, face edema, hangover effect, abdomen enlarged, hernia, pelvic pain, and halitosis. Rare: cellulitis.

Cardiovascular system – Infrequent: tachycardia, hypertension, syncope, ventricular extrasystoles, and angina pectoris. Rare: AV block, congestive heart failure, hemorrhage, pallor, and varicose vein.

Dermatological system – Infrequent: dry skin, acne, alopecia, urticaria, maculopapular rash, vesiculobullous rash, and eczema.

Gastrointestinal system – Frequent: gastroenteritis. Infrequent: eructation, periodontal abscess, abnormal liver function tests, gingivitis, colitis, gastritis, mouth ulceration, stomatitis, esophagitis, peptic ulcer, and rectal hemorrhage. Rare: glossitis, hepatitis, dysphagia, gastrointestinal hemorrhage, oral moniliasis, and ulcerative colitis.

Hemic and lymphatic system – Infrequent: ecchymosis, anemia, leukopenia, and lymphadenopathy.

Metabolic and nutritional system – Infrequent: weight loss, gout, dehydration, lactic dehydrogenase increased, SGOT increased, and SGPT increased. Rare: hypercholesteremia and hypoglycemia.

Musculoskeletal system – Infrequent: arthritis, tenosynovitis, muscle stiffness, and bursitis. Rare: tendinous contracture.

Nervous system – Infrequent: vertigo, twitching, depersonalization, hallucinations, suicide attempt, apathy, euphoria, hostility, suicidal thoughts, abnormal gait, thinking abnormal, attention decreased, derealization, neuralgia, paranoid reaction, dysarthria, increased libido, suicide, and myoclonus. Rare: hyperkinesia, increased salivation, cerebrovascular accident, hyperesthesia, hypotonia, ptosis, and neuroleptic malignant syndrome.

Respiratory system – Frequent: dyspnea and bronchitis. Infrequent: asthma, pneumonia, laryngitis, voice alteration, epistaxis, hiccup. Rare: hyperventilation and yawn.

Special senses – Frequent: eye pain. Infrequent: dry eye, ear pain, abnormality of accommodation, diplopia, conjunctivitis, mydriasis, keratoconjunctivitis, hyperacusis, and photophobia. Rare: deafness, glaucoma, night blindness, and taste loss.

Urogenital system – Frequent: impotencea1. Infrequent: cystitis, urinary urgency, metrorrhagiaa1, amenorrheaa1, polyuria, vaginal hemorrhagea1, breast enlargementa1, menorrhagiaa1, urinary incontinence, abnormal ejaculationa1, hematuria, nocturia, and kidney calculus. Rare: uterine fibroids enlargeda1, uterine hemorrhagea1, anorgasmia, and oliguria.

1

a Adjusted for gender.

Postintroduction Clinical Experience

Postmarketing experience with Nefazodone has shown an adverse experience profile similar to that seen during the premarketing evaluation of Nefazodone. Voluntary reports of adverse events temporally associated with Nefazodone have been received since market introduction that are not listed above and for which a causal relationship has not been established. These include:

Anaphylactic reactions; angioedema; convulsions (including grand mal seizures); galactorrhea; gynecomastia (male); hyponatremia; liver necrosis and liver failure, in some cases leading to liver transplantation and/or death; priapism; prolactin increased; rhabdomyolysis involving patients receiving the combination of Nefazodone and lovastatin or simvastatin; serotonin syndrome; and Stevens-Johnson syndrome; and thrombocytopenia.

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