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Fertility: No data on fertility are available.
Pregnancy: Reproduction studies performed in rats and rabbits at doses up to maternal toxicity have revealed no evidence of harm to the foetus due to isosorbide dinitrate. There are, however, no adequate and well-controlled studies in pregnant women.
Since animal studies are not always predictive of human response, isosorbide dinitrate should not be used during pregnancy or lactation unless considered essential by the physician and solely under the direction and continuous supervision of a physician.
Lactation: Available evidence is inconclusive or inadequate for determining infant risk when used during breastfeeding. There is data that nitrates are excreted in breast milk and may cause methaemoglobinemia in infants. The extent of excretion of isosorbide dinitrate and its metabolites in human breast milk has not been determined. Therefore, caution is appropriate when administering this agent to lactating women.
