US FDA-assigned pregnancy categorie

US FDA-assigned pregnancy categories as used in the drug formulary.
Category A
Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and
there is no evidence of risk in later trimesters).
Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in
pregnant women.
Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in
humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or
studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Category X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on
adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women
clearly outweigh potential benefits.