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. Author manuscript; available in PMC: 2015 Feb 1.
Published in final edited form as: Arthritis Rheumatol. 2014 Feb;66(2):246–249. doi: 10.1002/art.38258

Table 1. US Food and Drug Administration pregnancy category of immunosuppressive drugs for systemic inflammatory diseases.

Description Non-biologic
immunosuppressive
Drugs
Biologic
immunosuppressive drugs
A Adequate and well-controlled human
studies fail to show a fetal risk
None None
B Animal studies fail to show a fetal risks
and there are no human studies
Sulfasalazine,
mesalamine A
Adalimumab, alefacept,
anakinra, certolizumab,
etanercept, golimumab,
infliximab, ustekinumab
C Animal studies show a fetal risk and
there are no adequate human studies
Cyclosporine, gold,
hydroxychloroquine b,
tacrolimus
Abatacept, natalizumab,
rituximab, tocilizumab
D There is evidence of fetal risk, but the
benefits may outweigh the risks
Azathioprine,
cyclophosphamide,
D-penicillamine,
mercaptopurine,
mycophenolate
X There is evidence of fetal risk and the
risks clearly outweigh any possible
benefits
Leflunomide,
Methotrexate
A

sacol is in category C,

b

not officially classified