Tadalafil Pregnancy and Breastfeeding Warnings

Brand names: Adcirca, Alyq, Chewtadzy, Cialis, Tadliq

Medically reviewed by Drugs.com. Last updated on Dec 11, 2023.

Tadalafil Pregnancy Warnings

Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia (BPH): This drug is not indicated for use in women for such indications.
Pulmonary Arterial Hypertension (PAH): This drug should be used only if clearly needed.
-According to some authorities: Use should be avoided.

AU TGA pregnancy category: B1
US FDA pregnancy category (PAH): B
US FDA pregnancy category (ED and BPH): Not assigned.

US FDA Risk Summary (ED and BPH): No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have failed to reveal evidence of teratogenicity, embryotoxicity, or fetotoxicity when given to pregnant rats or mice during organogenesis, at exposure up to 11 times maximum the recommended human dose (MRHD) of 20 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Tadalafil Breastfeeding Warnings

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.

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.

See references

Further information

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