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. This sheet talks about whether exposure to hydroxychloroquine may increase the risk for birth defects over that background risk. This information should not take the place of medical care and advice from your health care provider.

What is hydroxychloroquine?
Hydroxychloroquine is a medication used to treat autoimmune conditions including rheumatoid arthritis and lupus. For more information, please see the MotherToBaby fact sheet Lupus and Pregnancy at http://mothertobaby.org/fact-sheets/lupus-pregnancy/pdf/. Hydroxychloroquine can also be used to treat or prevent malaria. Malaria is a disease caused by a mosquito-borne parasite and is most common in Africa, parts of Asia, and South America. Malaria in pregnancy carries risks for mother and baby. If travel to a malaria risk area occurs during pregnancy, then hydroxychloroquine may be given to reduce the chance of getting malaria. Hydroxychloroquine is sold under several brand names, including Plaquenil®.

How long does hydroxychloroquine stay in the body? Should I stop taking it before I try to get pregnant?
Individuals break down medicines at different rates. About half of the medicine is expected to be gone from the body in about 50 days (called half-life). This means it would take over 8 months for all the hydroxychloroquine to be gone from a person’s body. Some women may choose to stop taking this medication before becoming pregnant; however, it’s important not to start or stop any medications before talking with a health care provider. Stopping the medicine during pregnancy will not stop fetal exposure but will likely stop controlling the pregnant mother’s symptoms.

It is important to think about the benefits of taking hydroxychloroquine and treating your condition during pregnancy versus the possible risks of continuing the medication.

Can taking hydroxychloroquine make it more difficult for me to become pregnant?
There are no reports of problems with fertility in individuals who take hydroxychloroquine. More studies are needed to know if taking hydroxychloroquine can make it more difficult to become pregnant.

Can taking hydroxychloroquine make it more likely for me to have a miscarriage?
Studies do not suggest an increased risk for miscarriage related directly to hydroxychloroquine. However, conditions such as lupus and malaria are thought to increase the risk of miscarriage.

Can taking hydroxychloroquine during my pregnancy cause birth defects?
Several studies have analyzed at total of over 400 pregnancies and have not found an increased risk for birth defects with hydroxychloroquine use for the treatment of rheumatic diseases. Other controlled studies have looked at chloroquine, which is the product into which hydroxychloroquine breaks down in the body. No increased risk for birth defects was found with the use of chloroquine during pregnancy.

Can taking hydroxychloroquine cause other problems for the baby?
Studies do not suggest that hydroxychloroquine directly increases the chance for premature delivery (delivery before 37 weeks of pregnancy). Lupus may increase the chance for premature delivery.

An uncommon side effect of this medicine is damage to the inner lining of the eye (called retinopathy). This has raised concern for vision problems in children whose mothers have taken hydroxychloroquine during pregnancy. However, most studies on young children whose mothers took hydroxychloroquine have not found an increase in eye problems.

Could taking hydroxychloroquine help prevent pregnancy complications?
Hydroxychloroquine may benefit pregnancies by reducing active disease of lupus. Hydroxychloroquine may also reduce the chance for a baby to be born with a specific heart conduction problem, called congenital heart block. More studies are needed to understand if hydroxychloroquine helps prevent pregnancy complications.

Can I take hydroxychloroquine while breastfeeding?
Small amounts of hydroxychloroquine have been found to enter breast milk. Small studies have reported no harmful effects in infants whose mothers’ breastfed while taking hydroxychloroquine. This includes no evidence of vision, hearing, or growth problems in young children who were followed up to about one year of age. Be sure to talk to your health care provider about all your choices for breastfeeding.

What if the father of the baby takes hydroxychloroquine?
There are no studies looking at possible risks to a pregnancy when the father takes hydroxychloroquine. 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 http://mothertobaby.org/fact-sheets/paternal-exposures-pregnancy/pdf/.

MotherToBaby is currently conducting a study looking at autoimmune diseases and the medications used to treat autoimmune diseases in pregnancy. If you are interested in taking part in this study, please call 1-877-311-8972.

Selected References:

  • Buchanan NMM et al. 1996. Hydroxychloroquine and lupus pregnancy: review of a series of 36 cases. Ann Rheum Dis 55(7):486-488.
  • Cimaz R et al. 2004. Electroretinograms of children born to mothers treated with hydroxychloroquine during pregnancy and breast-feeding: comment on the article by Costedoat-Chalumeau et al. Arthritis Rheum 50(9):3056-3057.
  • Clowse ME et al. 2006. Hydroxychloroquine in lupus pregnancy. Arthritis Rheum 54(11):3640-3647.
  • Costedoat-Chalumeau N et al. 2003.Safety of hydroxychloroquine in pregnant patients with connective tissue diseases: a study of one hundred thirty-three cases compared with a control group. Arthritis Rheum 48(11):3207-3211.
  • Diav-Citrin O et al. 2013. Pregnancy outcome following in utero exposure to hydroxychloroquine: a prospective comparative observational study. Reprod Toxicol 39:58-62.
  • Feldkamp M & Carey JC 1993. Clinical teratology counseling and consultation case report: low dose methotrexate exposure in the early weeks of pregnancy. Teratology 47(6):533-539.
  • Frassi M et al. 2004. Hydroxychloroquine in pregnant patients with rheumatic disease: a case control observation of 76 treated pregnancies. Lupus 13(9):755.
  • Ingster-Moati I and Albuisson E. 2010. Visual neurophysiological dysfunction in infants exposed to hydroxychloroquine in utero. Acta Paediatr. 99(1):4; author reply 4-5.