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Generic Name
Ergotamine, Caffeine, Butalbital and Total Alkaloids of belladonna C
Trade Name
Cafergot PB
Drug Image
Cafergot PB
Risk Category
  • Positive evidence of human fetal risk exists.
  • Potential benefits may warrant use of the drug in pregnant women despite potential risks (e.g. life threatening situations or serious illness).
The risk category is B for Caffeine.
The risk category is C for Butalbital.
The risk category is C for Belladona.
The risk category will be D for Butalbital (only if used in high doses at term or for prolonged periods).
The risk category is D for Ergotamine.
FDA Pregnancy Risk Categories

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  • Used for treatment of migraine sedative.
  • Fetal Risk
    Fetal Risk
  • Caffeine is teratogenic in animals at maternal toxic doses.
  • Suggested association between high caffeine intake with decreased fertility, increased abortion rate, low birth weight, growth retardation and preterm delivery. maternal caffeine intake of more than 500mg/day may be associated with neonatal cardiac arrythmias as a feature of caffeine withdrawal and change in fetal behavior (frequent body movement irregular FHR baseline and breathing activity).
  • Ergotamine is not teratogenic in animals but fetotoxic at high doses.
  • The drug has traction">oxytocic effect on the tract that is specialized to allow the embryo to get nourished from the maternal blood, thus allow the fetus to grow">uterus causing tetanic contractions leading to fetal hypoxia and death.
  • Suggested possible association between 1st trimester exposure and congenital defects involving neural tube - neuronal crest development (hydrocephalus, sacral agenesis, digital and muscle hypoplasia).
  • High doses or chronic use of the drug is associated with fetal vascular injuries related to vasospasm resulting in intestinal atresia, arrest of cerebral and spinal cord development (microcephaly, hypotonia of limbs, paraplegia and arthrogryposis multiplex).
  • Limited data for butalbital, no association with congenital anomalies has been reported when used in the 1st trimester but may cause neonatal withdrawal if used in the last trimester of the pregnancy.
  • Belladona is anticholinergic agent.
  • No adequate data but reported association with congenital anomalies especially respiratory tract, eye, ear defects and hypospadias when used in 1st trimester.
  • Breast Feeding
    Breast Feeding
  • No data for butalbital in breast feeding.
  • Belladonna considered safe.
  • Ergotamine and caffeine are excreted into milk usual amounts of caffeine is safe, heavy amounts may cause irritability and poor sleeping in the nursing infant.
  • Ergotamine is contraindicated as it causes vomiting, diarrhea and convulsions in nursing infants.
  • 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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