In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk. This sheet talks about whether exposure to finasteride may increase the risk for birth defects above that background risk. This information should not take the place of medical care and advice from your health care provider.

What is finasteride?

Finasteride is a medication used for the treatment and prevention of male pattern baldness (hair loss in men). It blocks a chemical in the body called 5-alpha-reductase. Finasteride has also been approved for treatment of benign prostatic hyperplasia (BPH), which is noncancerous enlargement of the prostate gland. Finasteride is not approved at this time for use in women. Finasteride is marketed under the brand names Propecia® and Proscar®.

Is there an increased risk for birth defects if I take finasteride during pregnancy?

Finasteride is not approved for use in women, but has been used “off-label” among women. Pregnant monkeys who were given large doses of finasteride by mouth had male offspring with abnormalities of the sex organs. Pregnant rats given finasteride had increased risk of preterm birth and impaired cognitive functioning in the newborns. To date there are no reports of adverse pregnancy outcomes in women exposed to finasteride. However, because of the possible risk of genital defects in male babies, women should not take this medication during pregnancy.

My partner is taking finasteride but is wondering if he should stop before I become pregnant. Is this necessary, and if so, how long does it stay in the body?

Your partner should discuss the benefits of taking the medication and any possible harmful effects from not taking it with his health care provider before deciding to stop treatment. There is no known reason for him to stop taking this medication while planning a family. If he does decide to stop using finasteride, it takes an average of two days for almost all of the drug to be gone from the body after the last dose.

If my partner decides to continue taking finasteride, will it be more difficult for me to become pregnant?

There is no evidence that if your partner is taking this medication it will make it harder for you to become pregnant. Some small differences have been seen in the semen of males taking finasteride, such as low sperm counts. For most men, their sperm levels returned to their normal levels when they stopped taking the medication. There are no reports linking this medication to infertility in humans or the inability to become pregnant.

Is there an increased risk for birth defects if the baby’s father is taking finasteride when I become pregnant?

A study in rats did not show an increased risk for birth defects after the male rats were given finasteride. At this time, there are no studies in humans. It is not likely that a man taking finasteride at the time of conception would have an increased risk of fathering a baby with a birth defect. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures and Pregnancy at http://mothertobaby.wpengine.com/fact-sheets/paternal-exposures-pregnancy/pdf/.

Should my partner stop taking finasteride while I am pregnant?

No. There was a theoretical concern for birth defects of a male baby’s sex organs if the couple had intercourse during the time in pregnancy when the sex organs are developing (8 to 15 weeks of gestation). The amount of the drug found in semen is so small it is not felt to be enough to cause a problem.

If my partner stops using finasteride, will there be side effects?

Finasteride must be used daily for three months, on average, before results can be seen. Continued use is recommended to sustain this benefit. There is no lasting benefit if treatment is stopped, and there will be a reversal of any benefits within twelve months of stopping treatment.

If I touch or handle finasteride tablets during pregnancy, does the baby have an increased risk for birth defects?

No. Women are told not to handle finasteride tablets that are crushed or broken during pregnancy as a precaution. However, it is highly unlikely that enough of the medication would get through the skin during the course of normal handling to be a problem.

Is it a problem if my husband uses finasteride while I am breastfeeding?

No. Having sexual intercourse with your partner while he is taking finasteride will not result in high enough amounts of the medication entering your body to affect your breast milk. Be sure to talk to your health care provider about all your choices for breastfeeding.

References:

  • Amory JK, et al. 2007. The effect of 5- alpha-reductase inhibition with dutasteride and finasteride on semen parameters and serum hormones in healthy men. J Clin Endocrinol Metab 92:1659-1665.
  • Carlin JR, et al. 1992. Disposition and pharmacokinetics of (14C)finasteride after oral administration in humans. Drug Metab Dispos Biol Fate Chem; 20:148-55.
  • Cather JC, et al. 1999. Finasteride – An update and review. Cutis 64:167-172.
  • Laborde, E. and R. E. Brannigan. 2010. “Effect of 1-mg dose of finasteride on spermatogenesis and pregnancy.” J Androl 31(2): e1-2.
  • Overstreet JW, et al. 1999. Chronic treatment with finasteride daily does not affect spermatogenesis or semen production in young men. J Urol 162:1295-1300.
  • Paris JJ, et al. 2011. Inhibition of 5 alpha reductase activity in late pregnancy decreases gestational length and fecundity and impairs object memory and central progestogen milieu of juvenile rat offspring. J Neuroendocrinol. 23(11): 1079-90.
  • Pole, M. and G. Koren. 2001. “Finasteride. Does it affect spermatogenesis and pregnancy?” Can Fam Physician 47: 2469-2470.
  • Propecia prescribing information. 2007. Accessible from http://www.propecia.com/finasteride/propecia/consumer/product_information/pi/index.jsp.
  • Ricci G, et al. 2012. Finasteride and fertility: case report and review of the literature. J Drugs Dermatol; 11(12):1511-3. Rittmaster, RS, 1994. Drug Therapy: Finasteride. New Engl J Med 330:120-125.
  • Salvarci A, Istanbulluoglu O. 2013. Secondary infertility due to use of low-dose finasteride. Int Urol Nephrol; 45(1):83-5.
  • Samplaski MK, et al. 2013. Finasteride use in the male infertility population: effects on semen and hormone parameters. Fertility and Sterility; 100:1528-1529.
  • Wise LD, et al. 1991. Reversible decreases of fertility in male Sprague-Dawley rats treated orally with finasteride, a 5-alpha-reductase inhibitor. Reprod Toxicol 5:353-362.