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Diphenhydramine / ibuprofen Pregnancy and Breastfeeding Warnings

Diphenhydramine / ibuprofen is also known as: Advil PM, Ibuprofen PM, Motrin PM

Medically reviewed by Last updated on Oct 19, 2020.

Diphenhydramine / ibuprofen Pregnancy Warnings

Avoid use during last trimester of pregnancy
-Prior to 30 weeks gestation, use only if potential benefit justifies potential risk to the fetus

US FDA pregnancy category: Not formally assigned to a pregnancy category

Risk Summary: NSAID use during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus; data regarding the potential embryofetal risks of NSAID use in the first or second trimesters of pregnancy are inconclusive.

-Avoid ibuprofen use during third trimester of pregnancy as it may cause premature closure of the ductus arteriosus.
-Ibuprofen use is not recommended in women attempting to conceive as it may impair female fertility.

Ibuprofen use during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. In animal studies, administration of prostaglandin synthesis inhibitors such as ibuprofen, resulted in increased pre and post-implantation loss. There are no adequate and well-controlled studies of this combination drug in pregnant women.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Diphenhydramine / ibuprofen Breastfeeding Warnings

Larger diphenhydramine doses or more prolonged use may cause a decrease in milk supply, especially before lactation is well established. Use at bedtime (after the last feeding of the day) will minimize effects of the drug. For more than occasional use, nonsedating antihistamines are preferred. Ibuprofen is a preferred analgesic/anti-inflammatory agent in nursing mothers because of its low levels in breastmilk, short half-life, and safe use in infants in doses much higher than those excreted in breastmilk.

Caution is recommended

Excreted into human milk: Yes

Comments: Small, occasional doses of diphenhydramine are not expected to cause adverse effects in breastfed infants; ibuprofen is compatible with breastfeeding.

See references

References for pregnancy information

  1. Saxen I "Letter: Cleft palate and maternal diphenhydramine intake." Lancet 1 (1974): 407-8
  2. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  4. Zierler S, Purohit D "Prenatal antihistamine exposure and retrolental fibroplasia." Am J Epidemiol 123 (1986): 192-6
  5. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  6. Parkin DE "Probable Benadryl withdrawal manifestations in a newborn infant." J Pediatr 85 (1974): 580
  7. Leathem AM "Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy." Clin Pharm 5 (1986): 660-8
  8. Brost BC, Scardo JA, Newman RB "Diphenhydramine overdose during pregnancy: lessons from the past." Am J Obstet Gynecol 175 (1996): 1376-7
  9. Barry WS, Meinzinger MM, Howse CR "Ibuprofen overdose and exposure in Utero: results from a postmarketing voluntary reporting system." Am J Med 77 (1984): 35-9

References for breastfeeding information

  1. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  2. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Townsend RJ, Benedetti TJ, Erickson SH, Cengiz C, Gillespie Wr, Gschwend J, Albert KS "Excretion of ibuprofen into breast milk." Am J Obstet Gynecol 149 (1984): 184-6
  4. Ring ME, Corrigan JJ, Fenster PE "Effects of oral diltiazem on platelet function: alone and in combination with "low dose" aspirin." Thromb Res 44 (1986): 391-400
  5. Weibert RT, Townsend RJ, Kaiser DG, Naylor AJ "Lack of ibuprofen secretion into human milk." Clin Pharm 1 (1982): 457-8

Further information

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