PREGNANCY WARNINGS OF TRAMADOL

Tramadol has been shown to cause harm to the feotus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Tramadol while you are pregnant.

Pregnancy warning:

• Tramadol has been assigned to pregnancy category C by the FDA. 
• Animal studies have revealed evidence of embryotoxicity and fetotoxicity. There are no controlled data in human pregnancy. 
• Tramadol should only be given during pregnancy when benefit outweighs risk.
• Tramadol has been shown to cross the placental barrier, with an umbilical vein to maternal vein serum concentration ratio of 0.83.
• A case of tramadol withdrawal in a neonate has been reported following long-term analgesic treatment of the mother.
• At 35 hours of age, the infant showed signs of a severe withdrawal syndrome with high-pitched crying, trembling, and shortened sleeping hours.