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Generic Name
Paracetamol (acetaminophen), Codeine phosphate, Caffeine, Diphenhydramine hydrochloride and Phenyl ephrine hydrochloride
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, Caffeine and phenyl ephrine.
FDA Pregnancy Risk Categories

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  • decongestant.
  • Analgesic.
  • Antitussive.
  • Fetal Risk
    Fetal Risk
  • No adequate human data for paracetamol, reported that maternal toxic doses can cause fetal liver toxicity, kidney abnormalities and maternal blood, thus allow the fetus to grow">uterus">intrauterine death.
  • Suggested possible association with dislocation of the hip and clubfoot if used anytime in pregnancy.
  • Caffeine is teratogenic in animals at maternal toxic doses. No adequate human data, suggested association between high maternal caffeine intake and decreased fertility, increased abortion rate, low birth weight, growth retardation and preterm delivery.
  • maternal ingestion of more than 500 mg/day of caffeine may cause neonatal cardiac arrythmias as a feature of drug withdrawal and change in fetal behavior (frequent body movements, irregular heart rate and breathing activity).
  • No well – controlled data for codeine but suggested possible association with respiratory, genito – urinary malformations, down’s syndrome, umbilical area (center of abdomen)">umbilical and inguinal hernias, pyloric stenosis and hydrocephaly.
  • For opiates in general suggested to produce cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft lip/palate, heart, musculoskeletal, gastrointestinal malformations and inguinal hernias.
  • High doses of codeine at term can cause neonatal withdrawal and respiratory depression.
  • Phenylephrine is teratogenic in some animals, no well – controlled human data, but suggested possible association with eye, ear, digital defects and club foot during 1st trimester exposure and with musculoskeletal defects and umbilical area (center of abdomen)">umbilical hernia during exposure anytime during pregnancy.
  • It may cause uterine vessele spasm and potentiate the effects of oxytocic drugs on the maternal blood, thus allow the fetus to grow">uterus resulting in fetal hypoxia and bradycardia.
  • No fetal adverse effects for diphenhydramine in animals.
  • No well – controlled human data but suggested possible association with congenital defects in 1st trimester exposure including: genitourinary, eye, ear, cardiac defects, cleft palate is a split in roof of the mouth, due to failure of two sides to fuse during embryonic development. Could also be a cleft lip, which is a split in the lip">cleft palate hypospadias, inguinal hernia, polydactyly malformations of the diaphragm, and hypoplasia of cerebral hemisphere.
  • Chronic maternal ingestion of the drug can cause neonatal withdrawal.
  • Exposure during the last two weeks of pregnancy is associated with retrolental fibroplasia in premature infants.
  • It has oxytocic effect on the maternal blood, thus allow the fetus to grow">uterus.
  • Breast Feeding
    Breast Feeding
  • Diphenhydramine is excreted into milk. Contraindicated in breast feeding.
  • Paracetamol is safe, reported single case of maculopapular rash in exposed infant.
  • Usual amounts of caffeine are safe, heavy amounts may cause irritability and poor sleeping in nursing infants.
  • Codeine is safe.
  • No data for phenylephrine.
  • 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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