USE OF TAMSULOSIN IN PREGNANCY
Date of issue: October 2022, Version: 3
Tamsulosin is an alpha 1A selective adrenoceptor-blocking drug used in the treatment of benign prostatic hypertrophy. While the drug is not licensed for use in women, it is used off-license in the treatment of renal calculi, renal colic, glomerulonephritis, and other disorders of the urinary tract.
The published data relating to gestational exposure to tamsulosin are limited to two small studies which collectively describe 94 exposed pregnancies, the majority of which were exposed in the second or third trimester. Due to the lack of safety data, it is not currently possible to provide an evidence-based risk assessment for exposure during the first trimester of pregnancy. Where such exposure has occurred, women should be strongly encouraged to attend their routine detailed fetal anomaly scan.
Exposure to tamsulosin in the second or third trimester of pregnancy has not been associated with miscarriage, stillbirth, preterm delivery, impaired fetal growth or neonatal complications. However, the data are absent or too limited to exclude such associations.
Other risk factors may be present in individual cases which may independently increase the risk of adverse pregnancy outcome. Clinicians are reminded of the importance of consideration of such factors when performing case-specific risk assessments.
UKTIS are currently collecting pregnancy outcome data for tamsulosin. If you have a pregnant patient who has been exposed to tamsulosin please telephone UKTIS on 0344 892 0909 or download a reporting form to inform us of this exposure.
This is a summary of the full UKTIS monograph for health care professionals and should not be used in isolation. The full UKTIS monograph and access to any hyperlinked related documents is available to NHS health care professionals who are logged in.
If you have a patient with exposure to a drug or chemical and require assistance in making a patient-specific risk assessment, please telephone UKTIS on 0344 892 0909 to discuss the case with a teratology specialist.
If you would like to report a pregnancy to UKTIS please click here to download our pregnancy reporting form. Please encourage all women to complete an online reporting form.