Skip to main content

Clindamycin Pregnancy and Breastfeeding Warnings

Brand names: Cleocin, Cleocin HCl, Cleocin Pediatric, Cleocin Phosphate, Cleocin Phosphate ADD-Vantage

Clindamycin Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity. In clinical trials with pregnant women, systemic administration of clindamycin during the second and third trimesters was not associated with an increased frequency of congenital abnormalities. There are no controlled data in pregnant women during the first trimester of pregnancy.

The results of a study have suggested that early second trimester treatment of bacterial vaginosis and abnormal vaginal flora with oral clindamycin may reduce the incidence of preterm delivery and late miscarriage (n=485).

AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.

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.

Use during the first trimester is not recommended unless clearly needed.

AU TGA pregnancy category: A
US FDA pregnancy category: B

Comments: Clindamycin solution for injection contains benzyl alcohol as a preservative, which can cross the placenta and is associated with the potentially fatal "gasping syndrome" in pediatric patients.

See references

Clindamycin Breastfeeding Warnings

Use is not recommended; an alternate drug may be preferred

Excreted into human milk: Yes

Comments: Infants should be monitored for side effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash), or rarely, blood in the stool.

A report of bloody stools in a 5-day-old breastfed infant may have been caused by the concurrent maternal administration of IV clindamycin and gentamicin. Symptoms resolved 24 hours after breastfeeding was stopped and no further difficulties reported when breastfeeding was resumed on day 6 of age, after the maternal antibiotics were stopped.

Concentrations in breast milk after oral administration of clindamycin 150 mg orally three times a day after at least 1 week of therapy have been reported at 1.2 mg/L (average, 6 hours after dosing) and at 0.3 to 1.2 mg/L between one and 6 hours after a single 150 mg dose.

Peak concentrations in breast milk after oral dosing of 300 mg every six hours have been reported at 1.3 mg/L after 3.5 hours and 1.8 mg/L after 2 hours. Peak concentrations in breast milk after IV administration of clindamycin 600 mg IV every six hours have been reported at 2.65 mg/L after 3.5 hours and 3.1 mg/L after 30 minutes.

See references

References for pregnancy information

  1. Product Information. Cleocin (clindamycin). Pharmacia and Upjohn. 2002;PROD.
  2. Ugwumadu A, Manyonda I, Reid F, Hay P. Effect of early oral clindamycin on late miscarriage and preterm delivery in asymptomatic women with abnormal vaginal flora and bacterial vaginosis: a randomised controlled trial. Lancet. 2003;361:983-8.
  3. Cerner Multum, Inc. UK Summary of Product Characteristics.
  4. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Smith JA, Morgan JR, Rachlis AR, Papsin FR. Clindamycin in human breast milk. Can Med Assoc J. 1975;112:806.
  2. Steen B, Rane A. Clindamycin passage into human milk. Br J Clin Pharmacol. 1982;13:661-4.
  3. Roberts RJ, Blumer JL, Gorman RL, et al. American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk. Pediatrics. 1989;84:924-36.
  4. Matsuda S. Transfer of antibiotics into maternal milk. Biol Res Pregnancy Perinatol. 1984;5:57-60.
  5. Mann CF. Clindamycin and breast-feeding. Pediatrics. 1980;66:1030-1.
  6. Product Information. Cleocin (clindamycin). Pharmacia and Upjohn. 2002;PROD.
  7. Cerner Multum, Inc. Australian Product Information.
  8. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  9. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization. Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. 2014.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.