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Acetaminophen / diphenhydramine Pregnancy and Breastfeeding Warnings

Brand names: Acetadryl, Bayer Select Max Strength Night Time Pain, ConRx PM, Coricidin Night Time Cold Relief, Counteract PM Extra Strength, Excedrin PM, Genapap PM, Headache Formula PM, Headache Relief PM, Legatrin PM, Mapap PM, Midol PM, Night Time Pain, Non-Aspirin PM Extra Strength, Pain Relief PM Extra Strength, Pain Reliever PM, Percogesic Extra Strength, Percogesic Original Strength, Pharbetol PM, Sominex Pain Relief Formula, Tylenol PM, Tylenol Severe Allergy, Tylenol Sore Throat Nighttime, Unisom PM Pain, Wal-Nadol PM Extra Strength

Medically reviewed by Last updated on Sep 19, 2023.

Acetaminophen / diphenhydramine Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: Category A (acetaminophen/paracetamol)
AU TGA pregnancy category: Category A (diphenhydramine)
US FDA pregnancy category: Not assigned

Human use of acetaminophen (paracetamol) during pregnancy has not shown a clear association with birth defects, miscarriage, or adverse maternal or fetal outcomes; animal studies have demonstrated adverse events at clinically relevant doses. Acetaminophen is routinely used for short-term pain relief and fever in all stages of pregnancy and is believed to be safe in pregnancy when used intermittently for short durations.

Diphenhydramine studies in rats and rabbits have not revealed evidence of impaired fertility or fetal harm at doses up to 5 times the human dose. 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. There are no controlled data in human pregnancy.

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 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

Acetaminophen / diphenhydramine Breastfeeding Warnings

Use caution

Excreted into human milk: Yes

-Occasional doses of diphenhydramine are not expected to adversely affect breastfed infant; however, larger doses or more prolonged use may cause drowsiness in breastfed infant and/or decrease mother's milk supply.
-Acetaminophen (paracetamol) is considered compatible with breastfeeding.

Larger doses or prolonged use of diphenhydramine may decrease the mother's milk supply, especially before lactation is well established. Effects may be minimized with single bedtime doses after the last feeding of the day. Non-sedating antihistamines are generally preferred when an antihistamine is needed. Acetaminophen (paracetamol) is considered compatible with breastfeeding by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. (2005) "Product Information. Tylenol Extra Strength PM (acetaminophen-diphenhydramine)." Johnson and Johnson/Merck
  2. Cerner Multum, Inc. "Australian Product Information."
  3. (2019) "Product Information. DiphenhydrAMINE Hydrochloride (diphenhydramine)." West-Ward Pharmaceuticals Corporation (previously Roxane Laboratories Inc)

References for breastfeeding information

  1. Roberts RJ, Blumer JL, Gorman RL, et al. (1989) "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics, 84, p. 924-36
  2. (2002) "Product Information. Benadryl (diphenhydramine)." Parke-Davis
  3. Committee on Drugs, 1992 to 1993 (1994) "The transfer of drugs and other chemicals into human milk." Pediatrics, 93, p. 137-50
  4. (2005) "Product Information. Tylenol Extra Strength PM (acetaminophen-diphenhydramine)." Johnson and Johnson/Merck
  5. Cerner Multum, Inc. "Australian Product Information."
  6. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network.

Further information

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