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Generic Name
Ergotamine tartrate and Caffeine
Trade Name
Drug Image
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).
  • Studies in animals and/or humans have demonstrated fetal abnormalities.
  • Fetal risk involved in use of drug, clearly outweighs potential benefit.
  • Contraindicated in women who are or may become pregnant. Don’t use.
FDA Pregnancy Risk Categories

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  • For treatment of migraine.
  • 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 oxytocic effect on the 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).
  • Breast Feeding
    Breast Feeding
  • Ergotamine and caffeine are excreted into milk. Usual amounts of caffeine are 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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