Dexmethylphenidate Pregnancy and Breastfeeding Warnings

Brand names: Focalin, Focalin XR

Medically reviewed by Drugs.com. Last updated on Aug 15, 2025.

Dexmethylphenidate Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: Not assigned.

Risk summary: Based on the mechanism of action and its effects in pregnant patients and animals, this drug can cause fetal harm when administered to a pregnant woman; exposure during pregnancy may cause fetal malformations, decreased birth weight, premature delivery, and toxic effects in the newborn.

Comment:
-A pregnancy exposure registry is available.

Administration of this drug to rats and rabbits at doses up to 20 and 100 mg/kg/day, respectively, during organogenesis did not show teratogenicity; administration of racemic methylphenidate in doses up to 200 mg/kg/day has been shown to have teratogenic effects in rabbits. Delayed fetal skeletal ossification was observed at 20 mg/kg/day in rats. Administration throughout pregnancy and lactation to rats at doses estimated to be 5 times the maximum recommended human dose showed decreased postweaning weight gain in male offspring, but no other effects on postnatal development. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients with the National Pregnancy Registry for Attention Deficient Hyperactivity Disorder (ADHD) Medications at 1-866-961-2388 or by visiting www.womensmentalhealth.org/research/pregnancyregistry/adhd-medications/.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Dexmethylphenidate Breastfeeding Warnings

Caution is recommended

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Breastfed infants should be monitored for adverse reactions, such as agitation, insomnia, anorexia, and reduced weight gain.
-Long term neurodevelopmental effects on infants from CNS stimulant exposure are not known.

This drug is the more pharmacologically active d-enantiomer of racemic methylphenidate. No information is available on the clinical use of this drug during lactation, however, it has been estimated that a fully breastfed infant would receive a relative dose of 0.2% to 0.7% of the maternal weight adjusted dose.

See references

Further information

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