| Category A: | Controlled studies show no risk: adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus |
| Category B: | No evidence of risk in humans: either animal findings show risk, but human findings do not; or, if no adequate human studies have been performed, animal findings are negative |
| Category C: | Risk cannot be ruled out: human studies are lacking, and animal studies are either positive for fetal risk or lacking as well. However, potential benefits may outweigh risks |
| Category D: | Positive evidence of risk: investigational or postmarketing data show risk to the fetus. Nevertheless, potential benefits may outweigh risks |
| Category X: | Contraindicated in pregnancy: studies in animals or humans, or investigational or postmarketing reports, have shown fetal risk that clearly outweighs any possible benefit to the patient |