Table 3.

Disease-modifying antirheumatic drugs

Agent	FDA pregnancy category	Adverse effects in human pregnancy	Summary risk assessment
Methotrexate	X	Pattern of malformation, including apparent dose-related abnormalities of growth, craniofacies, limb development, and neurodevelopment	Based on available data, contraindicated in human pregnancy; unknown magnitude of risk
Sulfasalazine	B	Possible increased risk for malformations suggested in two studies; other studies negative	Based on limited data, a substantial teratogenic risk is unlikely
Leflunomide	X	No documented increased risk for structural defects in humans	Based on minimal data in human pregnancy, teratogenic risk is undetermined
Hydroxychloroquine	C	No documented increased risks for malformations; theoretical concerns for retinal toxicity and ototoxicity, but no reported cases	Although data are insufficient, a substantial teratogenic risk is unlikely
Azathioprine	D	No documented increased risk for structural defects; growth and gestational age effects may be related to transplant status	Although data are limited, a substantial risk for structural malformations is unlikely
Cyclosporine	C	No documented increased risk for structural defects; growth and gestational age effects may be related to transplant status	Based on limited data, risk for structural malformations is unlikely
Chlorambucil	D	Case reports only – two with unilateral renal agenesis	Based on insufficient data, teratogenic risk is undetermined
Cyclophosphamide	D	Pattern of malformation including increased risk for abnormalities of growth, craniofacies, limb development, and neurodevelopment	Based on available data, contraindicated in human pregnancy; unknown magnitude of risk