Pregnancy outcome following in utero exposure to hydroxychloroquine: a prospective comparative observational study

Reprod Toxicol. 2013 Aug:39:58-62. doi: 10.1016/j.reprotox.2013.04.005. Epub 2013 Apr 17.


Objective: To evaluate pregnancy safety of hydroxychloroquine (HCQ) for rheumatologic diseases.

Design: Prospective comparative observational study done at the Israeli teratology information service between 1998 and 2006.

Results: 114 HCQ-exposed pregnancies (98.2% in the first trimester, T1) were followed-up and compared with 455 pregnancies of women counseled for non-teratogenic exposure. The difference in the rate of congenital anomalies was not statistically significant [7/97 (7.2%) vs. 15/440 (3.4%), p=0.094]. The analysis was repeated among those exposed in T1 excluding genetic or cytogenetic anomalies or congenital infections [5/95 (5.3%) vs. 14/440 (3.2%), p=0.355]. There were no cases of neonatal lupus erythematosus. The gestational age at delivery was earlier, rate of preterm delivery higher, and birth weight lower, in the HCQ group.

Conclusion: The present study suggests that HCQ treatment in pregnancy is not a major human teratogen. The earlier gestational age and lower birth weight might be associated with maternal disease.

Publication types

  • Observational Study

MeSH terms

  • Abnormalities, Drug-Induced / epidemiology*
  • Adult
  • Antirheumatic Agents / therapeutic use*
  • Arthritis, Rheumatoid / drug therapy*
  • Birth Weight
  • Crohn Disease / drug therapy
  • Female
  • Gestational Age
  • Humans
  • Hydroxychloroquine / therapeutic use*
  • Infant, Newborn
  • Israel / epidemiology
  • Lupus Erythematosus, Systemic / drug therapy*
  • Male
  • Pregnancy
  • Pregnancy Outcome / epidemiology*
  • Prospective Studies


  • Antirheumatic Agents
  • Hydroxychloroquine