Mirtazapine Pregnancy and Breastfeeding Warnings

Brand names: Remeron, Remeron SolTab

Medically reviewed by Drugs.com. Last updated on Dec 25, 2023.

Mirtazapine Pregnancy Warnings

Use is not recommended unless clearly needed.

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

Comments:
-Use of adequate methods of contraception should be encouraged.
-If used during or shortly before birth, monitor newborn for discontinuation effects.

Animal models have revealed evidence of post-implantation loss, post-natal mortality, and reduced pup survival at twenty times the maximum recommended human dose (MRHD); these effects were not seen at 3 times the MRHD. Limited human data did not indicate increased risk of developmental toxicity. Epidemiological data suggest that selective serotonin receptor inhibitors may increase the risk of persistent pulmonary hypertension in the newborn, and this risk has not been ruled out for this drug.

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.

See references

Mirtazapine Breastfeeding Warnings

Use is not recommended and 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: Yes

Comments: Breastfed infants should be monitored for behavioral side effects and adequate growth.

A small study reported that after maternal doses between 30 to 120 mg, nursing infants received approximately 1.5% of the weight-adjusted maternal dose. Animal models showed an increase in postnatal mortality when dams were given doses of 100 mg/kg/day; no adequate and well-controlled studies exist for humans, though limited human data suggest a low risk of adverse effects, especially in infants older than 2 months of age.

See references

Further information

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