Nefazodone side effects

List of side effects
Associated with discontinuation of treatment Common in clinical trials Visual disturbances Laboratory changes ECG changes Post-introduction clinical experience

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%). Return to top

Common in clinical 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. Return to top

Visual disturbances
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. Return to top

Laboratory changes
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. Return to top

ECG changes
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. Return to top

Post-introduction 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. Return to top