Pregnancy: There is a limited amount of data from the use of methylphenidate in pregnant women.
Cases of neonatal cardio-respiratory toxicity, specifically fetal tachycardia and respiratory distress have been reported in spontaneous case reports.
Studies in animals have only shown evidence of reproductive toxicity at maternally toxic doses (see Pharmacology: Toxicology: Preclinical safety data under Actions).
Methylphenidate is not recommended for use during pregnancy unless a clinical decision is made that postponing treatment may pose a greater risk to the pregnancy.
Breast-feeding: Methylphenidate has been found in the breast-milk of a woman treated with methylphenidate.
There is one case report of an infant who experienced an unspecified decrease in weight during the period of exposure but recovered and gained weight after the mother discontinued treatment with methylphenidate. A risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from methylphenidate therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: No human data on the effect of methylphenidate on fertility are available. In animal studies, no clinically relevant effects on fertility were observed.