Dicyclomine Pregnancy and Breastfeeding Warnings
Brand names: Bemote, Bentyl, Bentyl Syrup, Byclomine, Di-Spaz, Dibent, Dicyclocot, Dilomine
Medically reviewed by Drugs.com. Last updated on Aug 4, 2023.
Dicyclomine Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category: B
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.
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 (1980) "Bilateral clinical anophthalmia: drugs as potential factors." South Med J, 73, p. 1404-7
- Morelock S, Hingson R, Kayne H, Dooling E, Zuckerman B, Day N, Alpert JJ, Flowerdew G (1982) "Bendectin and fetal development. A study of Boston City Hospital." Am J Obstet Gynecol, 142, p. 209-13
- Shapiro S, Heinonen OP, Siskind V, Kaufman DW, Monson RR, Slone D (1977) "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, p. 480-5
- Miklovich L, van den Berg BJ (1976) "An evaluation of the teratogenicity of certain antinauseant drugs." Am J Obstet Gynecol, 125, p. 244-8
- Wheatley D (1977) "Treatment of pregnancy sickness." Br J Obstet Gynaecol, 84, p. 444-7
- Harron DW, Griffiths K, Shanks RG (1980) "Debendox and congenital malformations in Northern Ireland." Br Med J, 281, p. 1379-81
- DonnaiD, Harris R (1978) "Unusual fetal malformations after antiemetics in early pregnancy." Br Med J, 1, p. 691-2
- Fleming DM, Knox JD, Crombie DL (1981) "Debendox in early pregnancy and fetal malformation." Br Med J (Clin Res Ed), 283, p. 99-101
- Williams J, Watkins-Jones R (1984) "Dicyclomine: worrying symptoms associated with its use in some small babies." Br Med J (Clin Res Ed), 288, p. 901
- Patterson DC (1977) "Congenital deformities associated with Benedectin." Can Med Assoc J, 116, p. 1348
- Cordero JF, Oakley GP Jr (1983) "Drug exposure during pregnancy: some epidemiologic considerations." Clin Obstet Gynecol, 26, p. 418-28
- Huff PS (1980) "Safety of drug therapy for nausea and vomiting of pregnancy." J Fam Pract, 11, p. 969-70
- Correy JF, Newman NM (1984) "Debendox withdrawn." Med J Aust, 140, p. 796-7
- Altman PM (1984) "Debendox withdrawn." Med J Aust, 140, p. 119
- Correy JF, Newman NM (1981) "Debendox and limb reduction deformities." Med J Aust, 1, p. 417-8
- Gibson GT, Colley DP, McMichael AJ, Hartshorne JM (1981) "Congenital anomalies in relation to the use of doxylamine/dicyclomine and other antenatal factors: an ongoing prospective study." Med J Aust, 1, p. 410-4
- Sheffield LJ, Batagol R (1985) "The creation of therapeutic orphans--or, what have we learnt from the Debendox fiasco?" Med J Aust, 143, p. 143-7
- Maling TJ (1984) "Debendox: a statement from the New Zealand Adverse Drug Reactions Committee." N Z Med J, 97, p. 203-4
- Harris R, Donnai D (1980) "Debendox and the media." Br Med J, 280, p. 480-1
- Mellor S (1978) "Fetal malformation after debendox treatment in early pregnancy." Br Med J, 1, p. 1055
- Smithells RW, Sheppard S (1978) "Fetal malformation after debendox treatment in early pregnancy." Br Med J, 1, p. 1055-6
- Dickson JH (1977) "Congenital deformities associated with bendectin." Can Med Assoc J, 117, p. 721-2
- Congenital Abnormalities Sub-Committee of the Australian Drug Evaluation Committtee (1980) "Debendox in pregnancy." Med J Aust, 1, p. 197
- Gordon I (1986) "Debendox." Med J Aust, 144, p. 51-2
- Mitchell AA (1986) "Debendox." Med J Aust, 144, p. 52
- (2002) "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
References for breastfeeding information
- Briggs GG, Freeman RK, Yaffe SJ.. (1998) "Drugs in Pregnancy and Lactation." Baltimore, MD: Williams & Wilkins
- (2002) "Product Information. Bentyl (dicyclomine)." Aventis Pharmaceuticals
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.