FDA PREGNANCY 5 CATEGORIES

Question 1

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Answer 1

Category A.

Question 2

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy, and there is no evidence of risk in later trimesters.

Answer 2

Category A.

Question 3

Animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women,
or animal studies have shown an adverse effect, but adequate studies in pregnant women have not demonstrated a risk to the
fetus during the first trimester of pregnancy, and there is no
evidence of risk in later trimesters

Answer 3

CATEGORY B

Question 4

Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; the
benefits from the use of the drug in pregnant women may be
acceptable despite its potential risks, or there are no animal
reproduction studies and no adequate studies in humans.

Answer 4

CATEGORY C

Question 5

There is evidence of human fetal risk, but the
potential benefits from the use of the drug in pregnant women
may be acceptable despite its potential risks

Answer 5

CATEGORY D

Question 6

There is evidence of human fetal risk, but the
potential benefits from the use of the drug in pregnant women
may be acceptable despite its potential risks

Answer 6

CATEGORY D

Question 7

Studies in animals or humans demonstrate
fetal abnormalities or adverse reaction; reports indicate evidence
of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.

Answer 7

CATEGORY X

Question 8

Studies in animals or humans demonstrate
fetal abnormalities or adverse reaction; reports indicate evidence
of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.

Answer 8

CATEGORY X