Pregnancy Categories

Question 1

What is a category A pregnancy?

Answer 1

Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in 1st trimester (no evidence of risk in later trimesters)

Question 2

What is a category B pregnancy?

Answer 2

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

Question 3

What is a category C pregnancy?

Answer 3

Adverse effect on the fetus and no adequate & well-controlled studies in humans, but potential benefits may warrant use of drug in pregnant women despite potential risks.

Question 4

What is a category D pregnancy?

Answer 4

Positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in human, but potential benefits may warrant use of drug in pregnant women despite potential risk

Question 5

What is a category X pregnancy?

Answer 5

Teratogenic
Fetal abnormalities and/or positive evidence of human fetal risk based on adverse reaction date from investigational or marketing experience, & risk involved in use of drug in pregnant women clearly outweigh potential benefits