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Generic Name
Paracetamol (acetaminophen) and Codeine
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.
The risk category is B for paracetamol.
FDA Pregnancy Risk Categories

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  • analgesic.
  • Antitussive.
  • 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. For opiates in general possibly associated with cleft lip/palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of codeine at term can cause neonatal withdrawal and respiratory depression.
  • No adequate data for paracetamol but reported that maternal toxic doses can cause fetal liver toxicity,kidney abnormalities and intrauterine death suggested possible association with dislocation of the hip and clubfoot if used any time in pregnancy.
  • Breast Feeding
    Breast Feeding
  • Both drugs are excreted into milk and are safe in breast feeding. Reported single case of maculopapular rash in nursing infant exposed to paracetamol.
  • 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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