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FDA pregnancy categories

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FDA pregnancy category A

Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters). This means that it is safe to use this medication.

FDA pregnancy category B

Animal studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women. This means that this medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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FDA pregnancy category C

Animal studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. This means that this medication harmful affect on fetus in not ruled out. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

FDA pregnancy category D

There is positive evidence of human fetal risk  based on studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. This means that there is a positive evidence of risk to unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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FDA pregnancy category X

Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk, and the
risks involved in use of the drug in pregnant women clearly outweigh potential benefits. This means that this medication is contraindicated in pregnancy. Tell your doctor if you are pregnant or plan to become pregnant during treatment.