Uridine Pregnancy and Breastfeeding Warnings

Brand names: Vistogard, Xuriden

Medically reviewed by Drugs.com. Last updated on Jun 14, 2024.

Uridine Pregnancy Warnings

Safety has not been established during pregnancy

US FDA pregnancy category: Not Assigned

Risk Summary: There are insufficient data available to inform a drug-associated risk of birth defects and miscarriage; animal studies with doses estimated to be one-half the maximum recommended human dose (MRHD) have not shown teratogenicity or adverse effects on embryo-fetal development.

Animal studies in pregnant rats have not revealed evidence of teratogenicity or fetal harm, and there was no effect on maternal body weight or overall health when this drug was administered at one-half the MRHD during the period of organogenesis. 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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Uridine Breastfeeding Warnings

Safety has not been established during lactation; Benefit should outweigh risk.

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

Comments: The effects in the nursing infant and on milk production are unknown.

See references

Further information

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