NATEGLINIDE (nateglinide)

There are 0 contraindications.

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Hypoglycemic disorder

There are 0 moderate contraindications.

There are 5 severe adverse reactions.

More Frequent	Less Frequent
None.	Hypoglycemic disorder

Rare/Very Rare
Abnormal hepatic function tests Cholestatic hepatitis Hypersensitivity drug reaction Jaundice

There are 12 less severe adverse reactions.

More Frequent	Less Frequent
Upper respiratory infection Weight gain	Arthritis Back pain Bronchitis Cough Diarrhea Dizziness Flu-like symptoms

Rare/Very Rare
Pruritus of skin Skin rash Urticaria

There is insufficient evidence with nateglinide in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproduction studies, there was no teratogenicity in rats and rabbits administered oral nateglinide during organogenesis at approximately 27 and 8 times the maximum recommended human dose, respectively, based on body surface area. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications.

Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related mortality. Nateglinide should be used during pregnancy only if the benefit justifies the potential risk to the fetus.

There is no information on the presence of nateglinide in human milk, the effects on the breast-fed infant, or the effects on milk production. Nateglinide is distributed into milk in rats. Because of the potential for hypoglycemia in nursing infants, nateglinide is not recommended for use while breastfeeding.

No substantial differences in safety and efficacy nor in the pharmacokinetics relative to younger adults, but increased sensitivity cannot be ruled out.