THIS MEDICATION MAY CAUSE HARM TO YOUR BABY:
Buspirone should not be taken during pregnancy unless clearly indicated. There have been limited human studies that have looked at the safety of buspirone during pregnancy, but animal studies indicate that taking buspirone during pregnancy is not harmful to the developing baby. It is important to weigh the risks versus benefits before using this medication while breastfeeding.
What is buspirone?
Buspirone is an anti-anxiety medication available as a generic only. The brand name of buspirone (Buspar™) was discontinued in the United States. Buspirone is available as oral tablets and is taken as divided doses 2 to 3 three times a day. It is available by prescription from your doctor. 
What is buspirone used to treat?
Buspirone is used to manage generalized anxiety disorder in adults. Anxiety can be common in pregnant women, but can be associated with negative effects on the baby and mother. Women with generalized anxiety disorder can experience varying severity levels. Anxiety can cause tension, high heart rate, fear, rumination, irritability, and over awareness leading to distraction among other symptoms.
Pregnant women and breastfeeding mothers can experience anxiety. You can read about anxiety and its impact on pregnancy here.
How does buspirone work?
Buspirone works by binding to and activating serotonin and dopamine receptors in the brain. This helps to balance the brain chemistry and reduce symptoms of anxiety.
If I am taking buspirone, can it harm my baby?
There are limited human studies or case reports that have looked at the safety of this medication in pregnancy. Animal studies show that taking buspirone during pregnancy has a low risk of causing harm to your baby. It is recommended to only use this medication during pregnancy if clearly needed.
Evidence from animal studies with buspirone:
When buspirone was given to rats and rabbits at doses 30 times the recommended human dose, no birth defects were observed in the offspring. High doses of buspirone caused decreased maternal activity and lower newborn weight.
Evidence for the risks of buspirone in human babies:
It is unknown if buspirone crosses the human placenta. A study of 42 infants in Michigan born between 1985 and 1992 and who were exposed to buspirone during the first trimester reported only one birth defect. A 1998 report describes a woman who gave birth to a healthy baby after using buspirone and other medications during her 42 week pregnancy. A 1998 questionnaire survey of postpartum women who took 1 of 34 new medications during their pregnancy found buspirone was used during the first trimester in 16 total pregnancies. Of these 16 pregnancies, there were 12 healthy infants, 1 miscarriage, 2 elective abortions, and 1 infant with cystic fibrosis.
Bottom line: Buspirone should not be taken during pregnancy unless the medication is clearly indicated. There have been limited human studies that have looked at the safety of buspirone during pregnancy, but available studies have found no increased risk of birth defects with first trimester exposure to this medication. Further study is required to understand the safety of this medication in pregnant women.
If I am taking buspirone and become pregnant, what should I do?
If you are taking buspirone and become pregnant, you should contact your doctor immediately. Your doctor will determine if your medication is medically necessary, or if it should be discontinued until after the birth of your baby.
If I am taking buspirone, can I safely breastfeed my baby?
Buspirone is expected to pass into breast milk. Buspirone can increase milk production. A case report of a nursing infant exposed to buspirone over 3 weeks detailed the development of seizures in the nursing infant. A neurologic exam was normal in the infant at 1 year and no cause for the seizures was determined. Due to the potential for neurologic side effects, the maternal use of buspirone while breastfeeding should be avoided for prolonged periods of time or avoided altogether. The manufacturer recommends not breastfeeding while taking this medication. The American Academy of Pediatrics classifies similar medications as of concern with unknown long-term effects in infants. The manufacturer of this medication recommends weighing the risks versus benefits before using it while breastfeeding.
Bottom line: Buspirone is expected to pass into breast milk. Nursing infants exposed to this medication should be monitored for seizure-like activity. Due to the potential for neurologic side effects, the maternal use of buspirone while breastfeeding should be avoided for prolonged periods of time or avoided altogether.
If I am taking buspirone, will it be more difficult to get pregnant?
Rats and rabbits who received doses of buspirone 30 times the recommended human dose did not experience reduced fertility. There are reports of men who used this medication and experienced decreased ejaculation, lower libido, and inability to ejaculate or orgasm.
If I am taking buspirone, what should I know?
Buspirone should not be taken during pregnancy unless clearly indicated. Available human studies have found no increased risk of birth defects with first trimester exposure to this medication. Further study is required to understand the safety of this medication in pregnant women.
Buspirone is expected to pass into breast milk. Due to the potential for neurologic side effects, the maternal use of buspirone while breastfeeding should be avoided for prolonged periods of time or avoided altogether.
If I am taking any medication, what should I know?
This report provides a summary of available information about the use of buspirone during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.
You may find Pregistry's expert report about anxiety here, reports about other mental health disorders and reports about the individual medications used to treat mental health disorders here. Additional information can also be found in the resources below.
For more information about buspirone during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:
U.S. Food and Drug Administration: Buspar Prescribing Information