Effects on fertility: No human data on the effect of methylphenidate on fertility are available.
Women of child-bearing potential: Methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks (see Use in pregnancy as follows).
Use in pregnancy (Category D): The safety of methylphenidate for use during human pregnancy has not been established. Data from a cohort study of in total approximately 3,400 pregnancies exposed in the first trimester do not suggest an increased risk of overall birth defects. There was a small increased occurrence of cardiac malformations in women who receive methylphenidate during the first trimester of pregnancy, compared with non-exposed pregnancies. Methylphenidate should not be prescribed for pregnant women unless, in the opinion of the physician, the potential benefits outweigh the possible risks.
As a general rule no drugs should be taken during the first 3 months of pregnancy, and the benefits and risks of taking drugs should be carefully considered throughout the whole of the pregnancy.
Use in lactation: Case reports showed that methylphenidate was distributed into breast milk reaching a milk-to-plasma ratio of approximately 2.5. For safety reasons, mothers taking methylphenidate should refrain from breast-feeding their infants. A decision should be made by the prescriber whether the mother must abstain from breast-feeding or abstain from methylphenidate therapy, taking into account the benefit of breast-feeding to the child and the benefit of therapy to the mother.