FDA Pregnancy Categories for Drugs

Question 1

Category A-

Answer 1

controlled studies with humans have not demonstrated a risk of the drug to
the fetus.

Question 2

Category B

Answer 2

controlled studies with animals have not demonstrated a risk of the drug to
the animal fetus. Fetal risks in humans not identified

Question 3

Category C

Answer 3

animal studies have found adverse effects of the drug on the fetus and there
are no controlled studies with humans, or no animal or human studies are available; drug
is used only if benefit justifies the potential risk

Question 4

Category D

Answer 4

there is evidence of risk to the fetus in humans; drug may be used in life threatening
situations or to treat a serious disease.

Question 5

Category X

Answer 5

animal and/or human studies have shown harm to the fetus from the drug that
outweighs any potential benefit; drug is contraindicated in pregnancy.