Dantrolene Pregnancy and Breastfeeding Warnings
Brand names: Dantrium, Dantrium Intravenous, Revonto, Ryanodex
Medically reviewed by Drugs.com. Last updated on May 1, 2024.
Dantrolene Pregnancy Warnings
Benefit should outweigh risk
AU TGA pregnancy category: B2
US FDA pregnancy category: C
Studies in rabbits and rats dosed at 7 times the human oral dose revealed embryolethality and decreased pup survival in rabbits and rats, respectively. In a single uncontrolled study in pregnant women at term awaiting labor and delivery, a prophylactic oral dose of 100 mg per day was administered. This drug readily crossed the placenta, with maternal and fetal whole blood levels approximately equal at delivery; neonatal levels then fell approximately 50% per day for 2 days before declining sharply. No neonatal respiratory and neuromuscular side effects were observed. There are no controlled data in human pregnancy.
AU TGA pregnancy category B2: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Dantrolene Breastfeeding Warnings
Not recommended
Excreted into human milk: Yes
Comments: Due to the potential for serious adverse reactions including respiratory depression and muscle weakness in breastfed infants, this drug is not recommended while nursing.
There is a lack of information on the long-term use of this drug while breastfeeding. After short term use, the expected half-life of this drug in milk is 9.2 hours.
See also
References for pregnancy information
- (2001) "Product Information. Dantrium (dantrolene)." Procter and Gamble Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2001) "Product Information. Dantrium (dantrolene)." Procter and Gamble Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- 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.