Tamsulosin Pregnancy and Breastfeeding Warnings

Tamsulosin is also known as: Flomax

Tamsulosin Pregnancy Warnings

Tamsulosin has been assigned to pregnancy category B by the FDA. Animal data have failed to reveal evidence of fetotoxicity, even after doses that yielded blood levels that were approximately 50 times the human therapeutic exposure. There are no approved indications for use of this drug in females.

Animal data have revealed significantly reduced fertility in males after doses that yielded blood levels that were approximately 50 times the human exposure with the maximum therapeutic dose. The mechanism is believed to be an adverse effect on the vaginal plug formation possibly due to changes of semen content or impairment of ejaculation. The effects on fertility were reversible within three days after a single dose and four to nine weeks after multiple dosing. Multiple doses up to 16 times the human exposure did not significantly alter male fertility in animals. Human data are not available. Animal data have revealed significantly reduced fertility in females after doses that yielded blood levels that were approximately 50 times the human exposure with the maximum therapeutic dose. The mechanism is believed to be related to impairment of fertilization. Multiple doses up to 16 times the human exposure did not significantly alter female fertility in animals. Human data are not available. There are no indications for this drug in females.

Tamsulosin Breastfeeding Warnings

There are no data on the excretion of tamsulosin in human milk. There are no indications for use of this drug in females.

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