Tramadol (Ultram) is an FDA pregnancy category C drug, which means that animal reproduction studies have shown risks to a developing fetus but there no adequate studies done in humans to determine risk to a developing baby.
In animal studies, tramadol was toxic to the fetuses of pregnant mice, rats, and rabbits when given at very high doses to the mothers. The doses given were 2 to 15 times the human dose (on a pound-for-pound basis). At these doses, tramadol was toxic to the mothers, and the fetuses had low birth weights, bone problems, and developmental delays after being born. For these reasons, doctors recommend tramadol not be given during pregnancy unless the risks to the mother (from uncontrolled pain) clearly outweigh the risks to the developing baby.
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