The prescribing information for propranolol hydrochloride tablets says there are no adequate and well-controlled studies in pregnant women, and that propranolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It also says propranolol is excreted in human milk. A general FDA consumer page on managing the benefits and risks of medicines says to tell your doctor, pharmacist or other health care professionals if you are or might become pregnant, or if you are nursing a baby.
What the label says about pregnancy
In its Pregnancy section, the label says there are no adequate and well-controlled studies in pregnant women. It also says intrauterine growth retardation, small placentas, and congenital abnormalities have been reported in neonates whose mothers received propranolol during pregnancy. The label's wording is "have been reported". In the passages cited here, that wording comes with no rate, no comparison group and no stated cause, and the passages do not say how many pregnancies were involved.
The label also states a condition for use. It says propranolol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
What the label says about childbirth and newborns
The label says neonates whose mothers received propranolol at parturition (the label's word for giving birth) have exhibited bradycardia, hypoglycemia, and/or respiratory depression. It adds that adequate facilities for monitoring such infants at birth should be available. Neonates are newborn infants. The passage cited here gives no number of infants and no dose.
What the label says about nursing mothers
In its Nursing Mothers section, the label says propranolol is excreted in human milk and caution should be exercised when propranolol is administered to a nursing woman. The passage cited here does not give an amount in milk, describe effects on a nursing infant, or say whether it refers to one dose or continued use.
What two FDA consumer pages say
Two FDA consumer pages address medicines and pregnancy in general. Neither is about propranolol. The page on managing the benefits and risks of medicines, in its tips for talking with your doctor, pharmacist or other health care professionals, says to tell them if you are or might become pregnant, or if you are nursing a baby. An FDA Office of Women's Health page on medicine and pregnancy says to ask your health care provider what medicines to take while pregnant or breastfeeding. It also says that before you get pregnant, you should make a plan with your health care provider to help you safely use your medicines.
The passages used here say who to talk to. They do not describe any pregnancy outcome. The label is prescribing information and the FDA pages are consumer information. None of them is a study, and this guide cites no study on pregnancy or breastfeeding.
What this does not tell you
These are statements from the label and two FDA consumer pages, reported here as written. The passages give no numbers, so they do not tell you the size of any risk. They also do not state a dose, a stage of pregnancy, a length of use or a group of people studied for any statement.
This guide does not say whether propranolol is or is not appropriate in pregnancy or while breastfeeding. The label's own condition is that potential benefit and potential risk are weighed, and a licensed provider decides that for an individual. This guide does not tell you to start, stop or change anything. The FDA consumer page says to tell your doctor, pharmacist or other health care professionals if you are or might become pregnant, or if you are nursing a baby.