Chemical formula: CHâ‚„Nâ‚‚O Molecular mass: 60.055 g/mol PubChem compound: 1176
Pregnancy category C.
Animal reproduction studies have not been conducted with 14C-urea breath test. It is also not known whether it can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. It should be given to a pregnant woman only if clearly needed.
There are no clinical data available concerning use in pregnancy.
There are no adequate experimental animal studies available concerning the effects on pregnancy, embryonic development, foetal development and/or post-natal development.
Caution must be exercised for use during pregnancy. However, indications of risks associated with topical applications of urea during pregnancy and while breast-feeding are not known.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 14C-urea breath test is administered to a nursing woman.
In breast-feeding women, the product should be removed from the breast area before breast-feeding.
No studies have been conducted with urea to evaluate its potential for carcinogenicity, impairment of fertility, or mutagenicity.
Urea has no or negligible influence on the ability to drive and use machines.
No adverse reactions were reported in clinical trials.
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