Diphenhydramine injection

FDA label, Micro Labs Limited, intravenous, effective 2025-08-23. Full label on DailyMed

Other products: Diphenhydramine

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Preparation and administration

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DOSAGE AND ADMINISTRATION THIS PRODUCT IS FOR INTRAVENOUS OR INTRAMUSCULAR ADMINISTRATION ONLY. Diphenhydramine hydrochloride injection, is indicated when the oral form is impractical. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  • Diphenhydramine injection
Label text (1 paragraph)

Drug Interactions Diphenhydramine hydrochloride has additive effects with alcohol and other CNS depressants (hypnotics, sedatives, tranquilizers, etc.) MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

Contraindications

Use in Neonates or Premature Infants This drug should not be used in neonates or premature infants. Use in Nursing Mothers Because of the higher risk of antihistamines for infants generally, and for neonates and prematures in particular, antihistamine therapy is contraindicated in nursing mothers. Use as a Local Anesthetic Because of the risk of local necrosis, this drug should not be used as a local anesthetic. Antihistamines are also contraindicated in the following conditions: Hypersensitivity to diphenhydramine hydrochloride and other antihistamines of similar chemical structure.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

E

Likelihood score E: Unlikely to be a cause of clinically apparent liver injury.

Diphenhydramine is a first generation antihistamine that is used for symptoms of allergic rhinitis and the common cold. It is also commonly used as a mild sleeping aid. Diphenhydramine has not been linked to instances of clinically apparent acute liver injury.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Diphenhydramine (NIDDK, public domain)Chapter updated Jan 16, 2017

Pregnancy and lactation

Pregnancy

Pregnancy Reproduction studies have been performed in rats and rabbits at doses up to 5 times the human dose and have revealed no evidence of impaired fertility or harm to the fetus due to diphenhydramine hydrochloride. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Breastfeeding (LactMed)

Small (25 mg or less), occasional doses of diphenhydramine would not be expected to cause any adverse effects in breastfed infants. Larger doses or more prolonged use may cause effects in the infant or decrease the milk supply, particularly in combination with a sympathomimetic such as pseudoephedrine or before lactation is well established. Single bedtime doses after the last feeding of the day may be adequate for many women and will minimize any effects of the drug. The nonsedating antihistamines are preferred alternatives.

Alternatives LactMed suggests considering:
Source: LactMed: Diphenhydramine (NICHD, public domain)Revised Sep 15, 2025

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