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    HomeMedication GuideDiphenhydramine safety
    First-generation antihistamine

    Diphenhydramine: What to Know Before You Take It

    Also known as Benadryl

    A patient-focused safety profile with information from public regulatory sources.

    Reviewed by the OmniRx Health clinical team•Last reviewed Jul 4, 2026

    In plain language

    What Diphenhydramine is used for

    Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

    Read before you decide

    Risks and precautions

    Risks and warnings

    Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis

    Medication review

    Diphenhydramine drug interactions

    Check this against your full medication list in the Interaction Checker

    FDA safety data

    Most-reported side effects

    Based on 195,250 FAERS reports. Reports do not prove the drug caused the effect.

    off label use 18,865fatigue 17,722nausea 16,264headache 15,547drug ineffective 14,926pain 13,890dyspnoea 12,039pruritus 10,825arthralgia 10,162diarrhoea 9,989infusion related reaction 9,960rash 9,855
    Explore full FDA safety data

    Regulatory record

    FDA recalls (4)

    Class IITerminated · Apr 13, 2022

    cGMP deviations: Temperature abuse

    Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office

    Class IITerminated · Mar 15, 2021

    CGMP Deviations: Intermittent exposure to temperature excursion during storage.

    Recalling firm: Cardinal Health Inc.

    Class IITerminated · Jul 10, 2019

    Microbial contamination of non-sterile product

    Recalling firm: LNK International, Inc.

    Class IIITerminated · Feb 26, 2014

    Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate.

    Recalling firm: Pfizer Us Pharmaceutical Group

    Common questions

    Patient questions

    What is Diphenhydramine prescribed for?

    Uses temporarily relieves these symptoms due to hay fever or other respiratory allergies: ■ sneezing ■ itching of the nose or throat ■ runny nose ■ itchy watery eyes ■temporarily relieves these symptoms due to the common cold: ■ sneezing ■ runny nose

    What are the key warnings and safety precautions for Diphenhydramine?

    Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy Ask a doctor before use if the child has ■ glaucoma ■ a breathing problem such as chronic bronchitis

    Does Diphenhydramine interact with other medications or foods?

    Diphenhydramine has 1 documented drug interaction(s) and 0 food interaction(s) in clinical databases. Always provide your complete medication list to your clinician.

    This information is educational — not medical advice.

    This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.

    Have medication questions?

    A licensed OmniRx provider can review your health history and medication list. Availability and treatment options are determined individually.