Pregnancy Category X (ADEC)

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• Pregnancy Category A (ADEC)

  Drugs which have been taken by a large number of pregnant women and women of childbearing age without an increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed

• Pregnancy Category B1 (ADEC)

  Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed Studies in animals have not shown evidence of an increased...

• Pregnancy Category C (ADEC)

  Drugs which, owing to their pharmaceutical effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible

• Pregnancy Category B3 (ADEC)

  Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed Studies in animals have shown evidence of an increased...

• Pregnancy Category X (FDA)

  Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

• Pregnancy Category B2 (ADEC)

  Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed Studies in animals are inadequate or may be lacking, but...