pms-Trazodone Use In Pregnancy & Lactation





Full Prescribing Info
Use In Pregnancy & Lactation
Pregnant Women: There are no adequate and well-controlled studies in pregnant women. In two studies using the rat, trazodone has been shown to cause increased fetal resorption and other adverse effects on the fetus when given at dose levels approximately 30 - 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 - 50 times the maximum human dose. pms-TRAZODONE should not be used in women of childbearing potential unless, in the opinion of the physician, the expected benefits justify the potential risk to the fetus.
Trazodone Hydrochloride Treatment during Pregnancy - Effects on Newborns: Postmarketing reports indicate that some neonates exposed to trazodone, SSRIs or other newer antidepressants late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. Most often, such complications begin immediately or soon (< 24 hours) after delivery. When treating a pregnant woman with pms-TRAZODONE during later stages of pregnancy, the physician should carefully consider the potential risks and benefits of treatment.
Nursing Women: Trazodone and its metabolites have been detected in the milk of lactating animals; it should not be administered to nursing mothers unless the potential benefits justify the possible risks to the child.
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