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Dexmethylphenidate Pregnancy and Breastfeeding Warnings

Dexmethylphenidate is also known as: Focalin, Focalin XR

Medically reviewed on Jul 10, 2017

Dexmethylphenidate Pregnancy Warnings

Benefit should outweigh risk.

US FDA pregnancy category: C

Comments: Use of adequate methods of contraception should be encouraged.

Animal studies have failed to reveal evidence of teratogenicity; however, delayed fetal skeletal ossification, decreased postweaning weight gain in male offspring, and increased drug plasma levels were observed at the highest doses tested. Racemic methylphenidate has been shown to have teratogenic effects in animals when given in doses of 200 mg/kg/day throughout organogenesis. Animal studies did not reveal any evidence of fertility impairment at doses of up to 160 mg/kg/day. There are no controlled data in human pregnancy.

US FDA pregnancy category C: Animal reproduction 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.

See references

Dexmethylphenidate Breastfeeding Warnings

-Based on 4 published case reports, milk concentration of racemic methylphenidate range from undetectable to 15.4 ng/mL at maternal doses of 35 to 80 mg/day. The calculated infant daily dose for an exclusively breastfed infant would be about 0.4 to 2.9 mcg/kg/day (0.2% to 0.7% of the maternal weight adjusted dose).

-There is limited data about the effects of methylphenidate in milk on the neurological development of the infant. In a study of 8 infants whose mothers were taking either dextroamphetamine or methylphenidate, 7 of the infants had no drug-related adverse reactions and were developing normally for their ages which averaged 4.4 months.

-Methylphenidate reduces serum prolactin, but the effect of methylphenidate on milk production is unknown. Large dosages of methylphenidate might interfere with milk production, especially in women whose lactation is not well established.

Caution is recommended.

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

See references

References for pregnancy information

  1. "Product Information. Focalin (dexmethylphenidate)." Mikart Inc, Atlanta, GA.

References for breastfeeding information

  1. "Product Information. Focalin (dexmethylphenidate)." Mikart Inc, Atlanta, GA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.