Dihydroergotamine Pregnancy and Breastfeeding Warnings
Brand names: Atzumi, Brekiya, D.H.E. 45, Migranal, Trudhesa
Medically reviewed by Drugs.com. Last updated on Jul 25, 2025.
Dihydroergotamine Pregnancy Warnings
Use is contraindicated.
AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned
Risk summary: Based on the mechanism of action and published literature, this drug may cause preterm labor when used during pregnancy. No data are available on the use of this drug in pregnant women to inform a drug-related risk.
Comment:
-This drug should be discontinued immediately if a pregnancy occurs; if used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazards to the fetus.
Animal studies have revealed evidence of developmental toxicity including decreased fetal body weights and/or skeletal ossification, delayed skeletal ossification, and impaired reproductive function (decreased mating indices) in the offspring. These development effects occurred at doses below those producing maternal toxicity. As this drug induces uterine contractions, it may cause premature parturition or hypertonic labor. There are no controlled data in human pregnancy.
AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
Dihydroergotamine Breastfeeding Warnings
Use is contraindicated
Excreted into human milk: Unknown (probably)
Comment:
-This drug should not be used while breastfeeding due to the potential for serious adverse events in nursing infants.
Specific data documenting the concentration of this drug in human breast milk is lacking, but since ergot drugs are known to be excreted in human milk, it is likely this drug is present in breast milk. Potential adverse events in nursing infants may include vomiting, diarrhea, weak pulse, and unstable blood pressure. Ergot drugs are known to inhibit prolactin.
See also
References for pregnancy information
- (2002) "Product Information. D.H.E. 45 (dihydroergotamine)." Sandoz Pharmaceuticals Corporation
- (2001) "Product Information. Migranal (dihydroergotamine nasal)." Novartis Pharmaceuticals
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2002) "Product Information. D.H.E. 45 (dihydroergotamine)." Sandoz Pharmaceuticals Corporation
- (2001) "Product Information. Migranal (dihydroergotamine nasal)." Novartis Pharmaceuticals
- Cerner Multum, Inc. "Australian Product Information."
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.