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Generic Name
Codeine and Phenyl toloxamine
Trade Name
Risk Category
  • Studies on animals show adverse effect and toxicity on fetus.
  • No adequate and well controlled studies done on pregnant women.
  • Drugs should be given only if the potential benefit outweighs the potential risk to the fetus.
FDA Pregnancy Risk Categories

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  • Antitussive.
  • Opioid analgesic.
  • Fetal Risk
    Fetal Risk
  • No well controlled data for Codeine, but suggested possible association with respiratory , genito-urinary malformations, Down's syndrome, umbilical and inguinal hernias, pyloric stenosis and hydrocephaly.
  • Opiates in general are suggested to produce cleft lip/palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of Codeine at term can cause neonatal withdrawal and respiratory depression.
  • No data for Phenyl toloxamine in pregnancy.
  • Breast Feeding
    Breast Feeding
  • Codeine is excreted into milk and safe in breast feeding.
  • No data for Phenyl toloxamine.
  • Other Trade Names
    The information on this Web site is not intended as a substitute for the advice and care of your doctor or other health-care provider. Always consult your doctor if you have any questions about exposures during pregnancy and lactation, and before you take any medications. Please read the Terms and Conditions before using this website.
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