Tadalafil Pregnancy and Breastfeeding Warnings
Tadalafil Pregnancy Warnings
This drug is not indicated for use in women. Adcirca (R): UK: Use should be avoided. AU and US: This drug should be used only if clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B
No evidence of teratogenicity, embryotoxicity, or fetotoxicity was observed in pregnant rats or mice during organogenesis, at exposure up to 7 times maximum the recommended human dose (MRHD) of 40 mg/day. In a perinatal/postnatal developmental study in rats, postnatal pup survival decreased following maternal exposure to unbound tadalafil concentrations greater than 5 times the MRHD. Signs of maternal toxicity occurred at doses greater than 8 times the MRHD. Surviving offspring had normal development and reproductive performance. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Tadalafil Breastfeeding Warnings
This drug and/or its metabolites were excreted in the milk of lactating rats at concentrations up to 2.4-fold higher than the maximal maternal plasma concentration. A risk to the breastfed child cannot be excluded. There are no human data on the excretion of this drug into breast milk.
This drug is not indicated for use in women Adcirca (R): UK: Use should be avoided. AU and US: Caution is recommended. Excreted into human milk: Data not available Excreted into animal milk: Yes Comments: The effects in the nursing infant are unknown.
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