Nefazodone Disease Interactions

Nefazodone has alpha-1 adrenergic blocking activity and may cause significant decreases in blood pressure, including orthostatic hypotension, in approximately 5% of patients. Therapy with nefazodone should be administered cautiously in patients with preexisting hypotension or conditions that could be exacerbated by hypotension, such as a history of myocardial infarction, angina, or ischemic stroke. Patients with dehydration (e.g., due to severe diarrhea or vomiting) may be predisposed to hypotension and should also be managed carefully during therapy with nefazodone. Blood pressure should be monitored at regular intervals, particularly during dosage escalation or whenever dosage has been altered, and patients should be advised not to rise abruptly from a sitting or recumbent position.

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In general, treatment with nefazodone should not be initiated in patients with active liver disease or elevated baseline serum transaminase levels. Cases of hepatic failure resulting in death or liver transplant, at an estimated rate of 1 per 250,000 to 300,000 patient-years of nefazodone treatment in the U.S. (approximately 3 to 4 times the background rate), have been reported during postmarketing use. The time to liver injury for the reported cases typically ranged from 2 weeks to 6 months of use. Dark urine and nonspecific prodromal symptoms (e.g., nausea, anorexia, malaise, gastrointestinal complaints) were reported in some, but not all, cases prior to the onset of jaundice. There is no evidence that preexisting liver disease increases the likelihood of developing liver failure. However, baseline abnormalities can delay the recognition or confound the diagnosis of a drug-induced hepatotoxic effect, thus use of nefazodone is discouraged in this population. In patients who do receive nefazodone therapy, routine liver function testing should be considered to permit early detection of hepatic injury. Nefazodone therapy should be promptly discontinued if clinical signs or symptoms suggestive of liver injury occur, or if serum transaminase levels exceed 3 times the upper limit of normal. Therapy should be permanently discontinued in patients with presumed or confirmed drug-induced hepatotoxicity. In addition, the use of nefazodone is contraindicated in patients who were withdrawn from nefazodone because of evidence of liver injury.

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Some antidepressants exert mydriatic activity that can induce increased intraocular pressure and result in angle-closure (narrow-angle) glaucoma in a patient with anatomically narrow angles who does not have a patent iridectomy. Prior to initiating therapy with these agents, patients should be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible. The use of these drugs in patients with untreated anatomically narrow angles should be avoided.

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All antidepressants may occasionally cause mania or hypomania, particularly in patients with bipolar disorder. Therapy with antidepressants should be administered cautiously in patients with a history of mania/hypomania.

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The use of most antidepressants is associated with a risk of seizures. There have been only rare reports of convulsions, including grand mal seizures, following the administration of nefazodone or trazodone. Although a causal relationship has not been established, therapy with these agents should be administered cautiously in patients with a history of seizures.

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Adults, young adults and children patients with depression and other psychiatric disorders may experience worsening of their symptoms and may have the emergence of suicidal thoughts and behavior. Patients should be monitored appropriately and observed closely for worsening of their symptoms, suicidality or changes in their behavior, especially during the first few months of treatment, and at times of dose changes. Discontinuing the medication should be considered if symptoms are persistently worse, or abrupt in onset. Phenylpiperazine antidepressants are not approved for use in pediatric patients.

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