Pregnancy Categories

Question 1

Category A

Answer 1

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy

Question 2

Category B

Answer 2

Animal reproduction studies have failed to demonstrate a risk to the fetus, and there are no adequate and well-controlled studies in pregnant women

Question 3

Category C

Answer 3

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

Question 4

Category D

Answer 4

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

Question 5

Category X

Answer 5

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