Atomoxetine Pregnancy and Breastfeeding Warnings

Brand names: Strattera

Atomoxetine Pregnancy Warnings

Use is not recommended unless the benefit justifies the risk to the fetus.

AU TGA pregnancy category: B3
US FDA pregnancy category: C

Animal studies have revealed decreased number of live fetuses, increased early resorptions, decreased offspring weight, decreased offspring survival, and increased incidences of incomplete ossification of the vertebral arch in fetuses. However, animal data has not shown any effect on fertility or reproductive performance. There are no controlled data in human pregnancy.

AU TGA pregnancy category B3: 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 occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

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Atomoxetine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments: There is no published experience with this drug during breastfeeding; however, there have been reports of no serious adverse effects in 2 breastfed infants.

See references

Further information

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

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