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Acetaminophen / dextromethorphan / diphenhydramine Pregnancy and Breastfeeding Warnings

Acetaminophen / dextromethorphan / diphenhydramine is also known as: Diabetic Tussin Night Time Cold & Flu, Diabetic Tussin Night Time Formula

Acetaminophen / dextromethorphan / diphenhydramine Pregnancy Warnings

Acetaminophen/dextromethorphan/diphenhydramine has not been formally assigned to a pregnancy category by the FDA. Acetaminophen has not been formally assigned to pregnancy category by the FDA. It is routinely used for short-term pain relief and fever in all stages of pregnancy. Acetaminophen is believed to be safe in pregnancy when used intermittently for short durations. Acetaminophen should only be given during pregnancy when need has been clearly established. Dextromethorphan has been assigned to pregnancy category C by the FDA. A teratogenic effect has been demonstrated in chicken embryos. There are no controlled data in human pregnancy. Dextromethorphan is only recommended for use during pregnancy when benefit outweighs risk. Diphenhydramine has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal teratogenicity. The Collaborative Perinatal Project reported 595 first-trimester exposures and 2,948 exposures anytime during pregnancy. No relationship was found to large categories of malformations. Possible associations with individual malformation were found. One study reported a statistical relationship between diphenhydramine use in the first trimester and cleft palate. One case of withdrawal in an infant whose mother ingested 150 mg per day of diphenhydramine has been reported. This infant developed tremor on the fifth day of life which was treated with phenobarbital. Diphenhydramine is only recommended for use during pregnancy when benefit outweighs risk.

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Acetaminophen / dextromethorphan / diphenhydramine Breastfeeding Warnings

There are no data on the excretion of acetaminophen/dextromethorphan/diphenhydramine into human milk. Acetaminophen is excreted into human milk in small concentrations. One case of a rash has been reported in a nursing infant. Acetaminophen is considered compatible with breast-feeding by the American Academy of Pediatrics. There are no data on the excretion of dextromethorphan into human milk. Diphenhydramine is excreted into human milk. Diphenhydramine may also inhibit lactation. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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References for pregnancy information

  1. Byer AJ, Traylor TR, Semmer JR "Acetaminophen overdose in the third trimester of pregnancy." JAMA 247 (1982): 3114-5
  2. Roberts I, Robinson MJ, Mughal MZ, Ratcliffe JG, Prescott LF "Paracetamol metabolites in the neonate following maternal overdose." Br J Clin Pharmacol 18 (1984): 201-6
  3. Brost BC, Scardo JA, Newman RB "Diphenhydramine overdose during pregnancy: lessons from the past." Am J Obstet Gynecol 175 (1996): 1376-7
  4. Saxen I "Letter: Cleft palate and maternal diphenhydramine intake." Lancet 1 (1974): 407-8
  5. Rayburn W, Shukla U, Stetson P, Piehl E "Acetaminophen pharmacokinetics: comparison between pregnant and nonpregnant women." Am J Obstet Gynecol 155 (1986): 1353-6
  6. O'Brien WF, Krammer J, O'Leary TD, Mastrogiannis DS "The effect of acetaminophen on prostacyclin production in pregnant women." Am J Obstet Gynecol 168 (1993): 1164-9
  7. Debus O, Kurlemann G, Gehrmann J, Krasemann T "Dextromethorphan in pregnancy." Chest 120 (2001): 1038-40
  8. Andaloro VJ, Monaghan DT, Rosenquist TH "Dextromethorphan and other N-methyl-D-aspartate receptor antagonists are teratogenic in the avian embryo model." Pediatr Res 43 (1998): 1-7
  9. Galinsky RE, Levy G "Absorption and metabolism of acetaminophen shortly before parturition." Drug Intell Clin Pharm 18 (1984): 977-9
  10. Parkin DE "Probable Benadryl withdrawal manifestations in a newborn infant." J Pediatr 85 (1974): 580
  11. Miners JO, Robson RA, Birkett DJ "Paracetamol metabolism in pregnancy." Br J Clin Pharmacol 22 (1986): 359-62
  12. Einarson A, Lyszkiewicz D, Koren G "The safety of dextromethorphan in pregnancy - Results of a controlled study." Chest 119 (2001): 466-9
  13. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.
  14. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895
  15. Beaulac-Baillargeon L, Rocheleau S "Paracetamol pharmacokinetics during the first trimester of human pregnancy." Eur J Clin Pharmacol 46 (1994): 451-4
  16. Zierler S, Purohit D "Prenatal antihistamine exposure and retrolental fibroplasia." Am J Epidemiol 123 (1986): 192-6
  17. Leathem AM "Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy." Clin Pharm 5 (1986): 660-8
  18. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  19. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  20. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. Notarianni LJ, Oldham HG, Bennett PN "Passage of paracetamol into breast milk and its subsequent metabolism by the neonate." Br J Clin Pharmacol 24 (1987): 63-7
  2. 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 84 (1989): 924-36
  3. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  4. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  5. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  6. "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.
  7. Matheson I, Lunde PK, Notarianni L "Infant rash caused by paracetamol in breast milk." Pediatrics 76 (1985): 651-2
  8. "Product Information. Benylin DM (dextromethorphan)." Warner Lambert Laboratories, Morris Plains, NJ.

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