wackytoposthere

Pregnancy Category C

Trazodone HCl has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat 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. There are no adequate and well-controlled studies in pregnant women. Trazodone HCl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Trazodone HCl and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. Caution should be exercised when trazodone HCl is administered to a nursing woman.

WARNINGS for males taking this drug:

TRAZODONE HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PRIAPISM. IN APPROXIMATELY 1/3 OF THE CASES REPORTED, SURGICAL INTERVENTION WAS REQUIRED AND, IN A PORTION OF THESE CASES, PERMANENT IMPAIRMENT OF ERECTILE FUNCTION OR IMPOTENCE RESULTED. MALE PATIENTS WITH PROLONGED OR INAPPROPRIATE ERECTIONS SHOULD IMMEDIATELY DISCONTINUE THE DRUG AND CONSULT THEIR PHYSICIAN.