Rimantadine Pregnancy and Breastfeeding Warnings

Brand names: Flumadine

Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.

Rimantadine Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: C

Comments: The adamantanes (amantadine and rimantadine) are not recommended for use in the US at this time because of widespread antiviral resistance in circulating influenza A viruses.

This drug has been shown to cross the placenta in mice. In rats, it has been shown to be embryotoxic at doses 11 times the maximum recommended human dose (MRHD); a dose which also produces maternal toxicity. Administration to rats at doses 1.7, 3.4, and 6.8 times the MRHD revealed maternal toxicity during gestation at the 2 highest doses and at the highest dose, an increase in pup mortality during the first 2 to 4 days postpartum. 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.

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Rimantadine Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug

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

Comments: Breastfeeding is not recommended during use of this drug due to the potential for adverse effects in breastfed infants.

Two to 3 hours following administration of this drug to lactating rats, breast milk levels were approximately twice those observed in the serum. Adverse effects were noted in the offspring of rats treated with this drug during the nursing period.

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