Dicyclomine Pregnancy and Breastfeeding Warnings
Medically reviewed by Drugs.com. Last updated on Jul 8, 2021.
Dicyclomine is also known as: Bemote, Bentyl, Bentyl Syrup, Byclomine, Di-Spaz, Dibent, Dicyclocot, Dilomine
Dicyclomine Pregnancy Warnings
Animal studies in rats and rabbits have revealed no evidence of harm to the fetus with this drug. Adequate and well-controlled studies have not been conducted in pregnant women.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
Dicyclomine Breastfeeding Warnings
Use should be avoided.
Excreted into human milk: Yes
Excreted into animal milk: Data not available
Comments: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
A single case has been reported of a breast-fed 12 day old infant who developed apnea whose mother was receiving dicyclomine. A causal relationship between dicyclomine and apnea could not be confirmed. Similar adverse reactions have occurred with direct administration of dicyclomine to infants.
See also
References for pregnancy information
- Golden SM, Perman KI "Bilateral clinical anophthalmia: drugs as potential factors." South Med J 73 (1980): 1404-7
- Morelock S, Hingson R, Kayne H, Dooling E, Zuckerman B, Day N, Alpert JJ, Flowerdew G "Bendectin and fetal development. A study of Boston City Hospital." Am J Obstet Gynecol 142 (1982): 209-13
- Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D "Antenatal exposure to doxylamine succinate and dicyclomine hydrochloride (Benedectin) in relation to congenital malformations, perinatal mortality rate, birth weight, and intelligence quotient score." Am J Obstet Gynecol 128 (1977): 480-5
- Miklovich L, van den Berg BJ "An evaluation of the teratogenicity of certain antinauseant drugs." Am J Obstet Gynecol 125 (1976): 244-8
- Wheatley D "Treatment of pregnancy sickness." Br J Obstet Gynaecol 84 (1977): 444-7
- Harron DW, Griffiths K, Shanks RG "Debendox and congenital malformations in Northern Ireland." Br Med J 281 (1980): 1379-81
- DonnaiD, Harris R "Unusual fetal malformations after antiemetics in early pregnancy." Br Med J 1 (1978): 691-2
- Fleming DM, Knox JD, Crombie DL "Debendox in early pregnancy and fetal malformation." Br Med J (Clin Res Ed) 283 (1981): 99-101
- Williams J, Watkins-Jones R "Dicyclomine: worrying symptoms associated with its use in some small babies." Br Med J (Clin Res Ed) 288 (1984): 901
- Patterson DC "Congenital deformities associated with Benedectin." Can Med Assoc J 116 (1977): 1348
- Cordero JF, Oakley GP Jr "Drug exposure during pregnancy: some epidemiologic considerations." Clin Obstet Gynecol 26 (1983): 418-28
- Huff PS "Safety of drug therapy for nausea and vomiting of pregnancy." J Fam Pract 11 (1980): 969-70
- Correy JF, Newman NM "Debendox withdrawn." Med J Aust 140 (1984): 796-7
- Altman PM "Debendox withdrawn." Med J Aust 140 (1984): 119
- Correy JF, Newman NM "Debendox and limb reduction deformities." Med J Aust 1 (1981): 417-8
- Gibson GT, Colley DP, McMichael AJ, Hartshorne JM "Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study." Med J Aust 1 (1981): 410-4
- Sheffield LJ, Batagol R "The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?" Med J Aust 143 (1985): 143-7
- Maling TJ "Debendox: a statement from the New Zealand Adverse Drug Reactions Committee." N Z Med J 97 (1984): 203-4
- Harris R, Donnai D "Debendox and the media." Br Med J 280 (1980): 480-1
- Mellor S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055
- Smithells RW, Sheppard S "Fetal malformation after debendox treatment in early pregnancy." Br Med J 1 (1978): 1055-6
- Dickson JH "Congenital deformities associated with bendectin." Can Med Assoc J 117 (1977): 721-2
- Congenital Abnormalities Sub-Committee of the Australian Drug Evaluation Committtee "Debendox in pregnancy." Med J Aust 1 (1980): 197
- Gordon I "Debendox." Med J Aust 144 (1986): 51-2
- Mitchell AA "Debendox." Med J Aust 144 (1986): 52
- "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals (2002):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References for breastfeeding information
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins (1998):
- "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals (2002):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.