Rimantadine Pregnancy and Breastfeeding Warnings

Brand names: Flumadine

Medically reviewed by Drugs.com. Last updated on Jul 31, 2025.

Rimantadine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of embryotoxicity (increased fetal resorption). They have also revealed maternal ataxia, tremors, convulsions, and significantly reduced weight gain. One study showed maternal toxicity during gestation where pup mortality was increased during the first 2 to 4 days postpartum as well as decreased fertility. There are no controlled data in human pregnancy.

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.

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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.

See references

Further information

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