Serzone Side Effects
Serzone Information
Serzone Side Effects
Associated with Discontinuation of Treatment
Approximately 16% of the 3496 patients who received Serzone (nefazodone) in worldwide premarketing clinical trials discontinued treatment due to an adverse Serzone side effects. The more common (≥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 Serzone (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
Commonly Observed Adverse Events in Controlled Clinical Trials: The most commonly observed adverse events associated with the use of Serzone (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),were:
- somnolence
- dry mouth
- nausea
- dizziness
- constipation
- asthenia
- lightheadedness
- blurred vision
- confusion
- abnormal vision
Postintroduction Clinical Experience
Postmarketing experience with Serzone has shown an adverse experience (side effects) profile similar to that seen during the premarketing evaluation of nefazodone. Voluntary reports of adverse events temporally associated with Serzone have been received since market introduction that are not listed above and for which a causal relationship has not been established. These Serzone side effects 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 (see WARNINGS)
- priapism
- prolactin increased
- rhabdomyolysis involving patients receiving the combination of Serzone and lovastatin or simvastatin
- serotonin syndrome
- Stevens-Johnson syndrome
- thrombocytopenia
Serzone Information
