Food and Drug Administration (FDA) Pregnancy Category Definitions8
| FDA Pregnancy Category | Definition |
|---|---|
| A | Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester (and there is no evidence of a risk in later trimesters), and the possibility of fetal harm seems to be remote. |
| B | Either animal reproductive studies have not demonstrated a fetal risk but there are no controlled studies of pregnant women, or animal reproductive studies have shown adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk during later trimesters). |
| C | Either studies in animals have revealed adverse effects on the fetus (teratogenic or embrocidal or other) and there are no controlled studies in women, or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. |
| D | There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (eg, if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
| X | Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. |