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  1. Pregnancy Exposure Registries

Pregnancy Exposure Registry Information for Health Professionals

From the FDA Office of Women's Health

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Image of pregnant woman and HCP consultation

 Find a Pregnancy Exposure Registry

Help your patients enroll in pregnancy exposure registry research studies

Help your patients voluntarily enroll in a pregnancy exposure registry study. The information collected supplements the safety information for prescription medicines and vaccines used during pregnancy and may be used to update medicine and vaccine labeling. The information collected will be retained in a secure manner and when shared with researchers and FDA the identity of your patient will remain private.

  1. Check the list of pregnancy exposure registries. The list includes the website and/or phone number for you to contact each registry study.
  2. Encourage your patients to voluntarily enroll. Pregnancy exposure registry studies collect information on pregnancy outcomes in those who are pregnant and who are taking or have taken a certain medicine or received a certain vaccine while pregnant. Some pregnancy exposure registries also collect information from those who are pregnant and have not taken a certain medicine or received a certain vaccine.
  3. Get medication guides and pregnancy resources to share with your patients. FDA’s Office of Women’s Health (OWH) also offers free publications and information about pregnancy. 

FDA-funded pregnancy research

FDA funds research to learn more about the safety of medicines and vaccines used during pregnancy to expand our knowledge about medicine and vaccine use during pregnancy. Read about OWH-supported research on pregnancy and reproductive health. 

Pregnancy labeling

The format and content of prescription medicine and vaccine labeling for information about use during pregnancy changed in 2015. In the Pregnancy subsection, the pregnancy letter category has been removed from all prescription medicine and vaccine labeling. For medicines and vaccines approved on or after June 30, 2001, the pregnancy letter categories have been replaced with a Risk Summary that provides a detailed summary of the risks and benefits of using a medicine or vaccine during pregnancy. The “Nursing Mothers” subsection has been renamed “Lactation.”

There is now a subsection called “Females and Males of Reproductive Potential” that provides information on pregnancy testing and contraception recommendations and information about a medicine’s effects on fertility, when this information is appropriate. 

Learn more about the Pregnancy and Lactation Labeling Rule. 

Other medicine information

  • Drugs@FDA – Product labels and other information on FDA-approved drugs (medicines).
  • FDA Label Search – Medicine labels and other drug-specific information on this website represent the most recent drug listing information companies have submitted to FDA
  • Drug-Specific Information - Index of information on some FDA-approved drugs (medicines).
  • Vaccines, Blood, and Biologics – Information including a list of vaccines licensed for use in the United States.
  • Daily Med - National Library of Medicine website where you can find information from the drug (medicine) labels for over 20,000 drugs.
 
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