Table 2: Pregnancy Risk Categories for Pharmacologic Agents.
US FDA category | Explanation |
Explanation | Controlled human studies indicate no apparent risk to the fetus. The possibility of risk to the fetus is remote. |
Category B | Animal studies do not indicate fetal risk. Well-controlled human studies have failed to demonstrate a risk |
Category C | Animal studies show an adverse effect on the fetus but there are no controlled studies in humans. The benefits from use of such drugs may be acceptable. |
Category D | Evidence of human risk, but in certain circumstances the use of such a drug may be acceptable in pregnant women despite its potential risk. |
Category X | Risk of use in pregnant women clearly outweighs possible benefits. |