Finasteride / tadalafil Pregnancy and Breastfeeding Warnings

Brand names: Entadfi

Medically reviewed by Drugs.com. Last updated on Nov 29, 2022.

Finasteride / tadalafil Pregnancy Warnings

Use is contraindicated in pregnancy and not indicated for use in females.

US FDA pregnancy category: Not assigned

Risk summary:
Administration of finasteride to a pregnant female can result in abnormal development of external genitalia in a male fetus.

Comment:
-Pregnant women or women expecting a potential pregnancy, should not handle crushed or open capsules of this product to avoid fetal exposure to finasteride.
-Finasteride is present in semen and therefore may pose a risk to the fetus. Male patients should be instructed to wear a condom during intercourse with women of childbearing potential or discontinue finasteride. The drug should be discontinued in patients wishing to conceive a child.

Finasteride: Animal studies in rats revealed the potential of this drug to cause abnormal development of external genitalia in a male fetus if administered to a pregnant female. Oral administration of finasteride to pregnant rats during the period of major organogenesis showed an increase in hypospadias [at maternal doses approximately 0.1 to 86 times the maximum recommended human dose (MRHD)], decreased prostatic and seminal vesicular weights, delayed preputial separation, transient nipple development, and decreased anogenital distance in male offspring at maternal doses approximately 0.003 times the MRHD. There are no controlled data in human pregnancy.

Tadalafil: Animal reproduction studies failed to show adverse developmental effects following oral administration of this drug to pregnant rats or mice during organogenesis at doses up to 44 times the MRHD of 5 mg/day. There are no controlled data in human pregnancy.

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 decision and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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Finasteride / tadalafil Breastfeeding Warnings

This product is not indicated for use in female patients.

Excreted into human milk: Unknown (Finasteride), Data not available (Tadalafil)
Excreted into animal milk: Unknown (Finasteride), Yes (Tadalafil)

Comment: The effects in the nursing infant are unknown.

See references

Further information

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