Diphenhydramine Pregnancy and Breastfeeding Warnings
Diphenhydramine is also known as: Banophen, Benadryl, Benadryl Allergy, Benadryl Children's Allergy, Bydramine, Calm-Aid, DPH, Dicopanol, Diphedryl, Diphen, Diphenhist, Diphenyl, Dormin, Hydramine, Hydramine Cough Syrup, Nytol, Q-Dryl, Sleep, Sleep Tabs, Sleep-Eze-3, Sleep-ettes, Sominex, Tusstat, Unisom SleepGels, ZzzQuil
Diphenhydramine Pregnancy Warnings
A review of prenatal drug use in 3026 women with premature infants demonstrated an increased risk of retrolental fibroplasia with antihistamine use during the last two weeks of pregnancy. The dosage used or the particular antihistamine was not specified. The incidence of retrolental fibroplasia in premature infants exposed in utero to antihistamine during this time was 21% compared to 11% in premature infants not exposed. Diphenhydramine has been shown to have oxytocic effects in animal and human uteri. One case report of a pregnant woman who ingested a large amount of diphenhydramine in an attempted suicide developed strong, regular uterine contractions that were halted by the administration of intravenous magnesium.
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 only when benefit outweighs risk.
Diphenhydramine Breastfeeding Warnings
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.
References for pregnancy information
- Parkin DE "Probable Benadryl withdrawal manifestations in a newborn infant." J Pediatr 85 (1974): 580
- Zierler S, Purohit D "Prenatal antihistamine exposure and retrolental fibroplasia." Am J Epidemiol 123 (1986): 192-6
- Leathem AM "Safety and efficacy of antiemetics used to treat nausea and vomiting in pregnancy." Clin Pharm 5 (1986): 660-8
- Brost BC, Scardo JA, Newman RB "Diphenhydramine overdose during pregnancy: lessons from the past." Am J Obstet Gynecol 175 (1996): 1376-7
- Saxen I "Letter: Cleft palate and maternal diphenhydramine intake." Lancet 1 (1974): 407-8
- Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
References for breastfeeding information
- "Product Information. Benadryl (diphenhydramine)." Parke-Davis, Morris Plains, NJ.
Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.