This sheet talks about exposure to baclofen in pregnancy and while breastfeeding. This information should not take the place of medical care and advice from your healthcare provider.
What is baclofen?

Baclofen is a medication.  that helps muscles connected to the skeleton relax (a muscle relaxant).  Baclofen is used to treat muscle spasms or rigid muscles caused by conditions like multiple sclerosis, cerebral palsy, and spinal cord or brain injuries. Baclofen can also be used to treat certain cases of hiccups. It can be taken by mouth or given through anintrathecal pump (a device that brings the medication directly to the spinal cord). Baclofen can also be applied to the skin as cream (topically). Sometimes it is combined with other prescription medications that are applied to skin to treat pain.  Some brand names for baclofen are Lioresal® and Gablofen®. Topically applied baclofen is sold by the name EnorvaRX-Baclofen®.

I take baclofen. Can it make it harder for me to get pregnant?

Studies have not been done to see if baclofen could make it harder for a woman to get pregnant.

I just found out I am pregnant. Should I stop taking baclofen?

Talk with your healthcare provider before making any changes to this medication. It is important to consider all the risks and benefits of taking a medication. Suddenly stopping baclofen can cause serious withdrawal symptoms including seizures, hallucinations, general agitation, and personality changes.

Does taking baclofen increase the chance for miscarriage? 

Miscarriage can happen in any pregnancy. Studies on women have not been done to see if baclofen increases the chance of miscarriage.

Does taking baclofen in the first trimester increase the chance of birth defects?

In every pregnancy, a woman starts out with a 3-5% chance of having a baby with a birth defect. This is called her background risk.

Experimental studies in animals raised concern that baclofen could increase the chance for birth defects.  But, the animals were given doses of baclofen that were much higher than what a person would take.

There are several case reports of women who took baclofen throughout pregnancy and birth defects were not reported in their babies.

Could taking baclofen in the second or third trimester cause other pregnancy complications?

Withdrawal symptoms have been reported in babies whose mother’s took baclofen by mouth throughout pregnancy. Withdrawal symptom may include seizures, tremors, rigidity, drowsiness, wide pupils, dry mouth, and problems feeding. Short-term treatment with baclofen in newborns whose mothers used baclofen up to delivery has been used to manage or prevent withdrawal symptoms.

No withdrawal symptoms have been reported in babies whose mothers were treated with baclofen by intrathecal pump.

Does taking baclofen in pregnancy cause long-term problems in behavior or learning for the baby?

Studies on long-term development of children whose mothers took baclofen during pregnancy have not been done.

Can I breastfeed while taking baclofen?

There’s very little information about baclofen use and breastfeeding. One study found that very low amounts of baclofen enter the breastmilk when the mother took baclofen by mouth. When baclofen is taken via intrathecal pump, another study found even less enters the breastmilk. No harmful effects in nursing infants have been reported.

If your baby is born prematurely (born before 37 weeks of pregnancy), talk with your healthcare provider about the risks and benefits of breastfeeding while using baclofen. If you suspect that the baby has any symptoms that could be related to your baclofen use, such as drowsiness, contact the child’s health care provider.

If a man takes baclofen could it affect his fertility (ability to get partner pregnant) or increase the chance of birth defects?

There are no studies looking at the fertility of men who take baclofen. In general, exposures that fathers have are unlikely to increase risks to a pregnancy. For more information, please see the MotherToBaby fact sheet Paternal Exposures and Pregnancy at https://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

Selected References:

  • Briggs, GG and Freeman RK. 2016. Drugs in Pregnancy and Lactation, Tenth Edition; Wolters Kluwer. 122-3.
  • Freeman, EH and Delaney, RM. 2016. Neonatal Baclofen Withdrawal: A Case Report of an Infant Presenting with Severe Feeding Difficulties.J Pediatr Nurs. May-Jun: 31(3):346-9.
  • Hale TW and Rowe HE. 2015. Medications and Mother’s Milk 2017. Springer Publishing Co. 93-4.
  • Hara T, Nakajima M, Sugano H, Karagiozov K, Hirose E, Goto K, Arai H. 2018. Pregnancy and breastfeeding during intrathecal baclofen therapy – A case study and review. NMC Case Rep J. Jun 25;5(3):65-8.
  • Hyser, CL and Drake, ME. 1984. Status Epilepticus after Baclofen Withdrawal. J Natl Med Assoc. May;76(5):533, 537-8.
  • Moran LR, Almeida PG, Worden S, Huttner KM. 2004. Intrauterine Baclofen Exposure: A Multidisciplinary Approach. Pediatrics; 114(2): e267-8.
  • Morton CM, Rosenow J, Wong C, Kirschner KL. 2009. Intrathecal baclofen administration during pregnancy: a case series and focused clinical review. PM R. Nov;1(11):1025-9.
  • Ratnayaka BD, Dhaliwal H, Watkin S. 2001. Drug points: Neonatal convulsions after withdrawal of baclofen. BMJ. Jul 14;323(7304):85.