Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Diphenhydramine hydrochloride
Drug ID BADD_D00687
Description Diphenhydramine - perhaps known most commonly as its brand name formulation Benadryl - is a first-generation H1 receptor antihistamine that is used extensively for the treatment of seasonal allergies, insect bites and stings, and rashes [L5263, L5266, L5269, F3379]. However, it also has antiemetic, antitussive, hypnotic, and antiparkinson properties [L5269, F3352]. As histamine receptors exist both peripherally and in the central nervous system, diphenhydramine has been shown to cause sedation due to its competitive antagonism of histamine H1 receptors within the central nervous system [L5263, L5266, L5269, F3379, A174541]. While its use in allergy therapy can sometimes fall out of favor due to its sedative effect, diphenhydramine has been repurposed for use within many non-prescription over-the-counter sleep aids and cough-and-cold medications that have been marketed for "night time" use [L5263, L5281, L5287]. Diphenhydramine is also used in combination with [DB14132] as the anti-nausea drug [DB00985] where it is utilized primarily for its antagonism of H1 histamine receptors within the vestibular system [A1540]. Diphenhydramine has also been shown to be implicated in a number of neurotransmitter systems that affect behaviour including dopamine, norepinephrine, serotonin, acetylcholine, and opioid [A1539]. As a result, diphenhydramine is being investigated for its anxiolytic and anti-depressant properties.
Indications and Usage Diphenhydramine is a first-generation histamine H1 receptor antagonist (H1 antihistamine) that is widely available as a non-prescription, over-the-counter (OTC) medication. As an OTC medication, diphenhydramine is typically formulated as tablets and creams indicated for use in treating sneezing, runny nose, itchy/watery eyes, itching of nose or throat, insomnia, pruritis, urticaria, insect bites/stings, allergic rashes, and nausea [L5263, L5266, L5269, F3379, A174541]. Additionally, when the use of oral diphenhydramine is impractical, there are also prescription-only formulations such as diphenhydramine injection products that are effective in adults and pediatric patients (other than premature infants and neonates) for: i) the amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after acute allergic reaction symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated [F3352]; ii) the active treatment of motion sickness [F3352]; and iii) use in parkinsonism when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents [F3352].
Marketing Status approved; investigational
ATC Code D04AA32; R06AA02
DrugBank ID DB01075
KEGG ID D00669
MeSH ID D004155
PubChem ID 8980
TTD Drug ID D01FGR
NDC Product Code 76168-015; 76457-002; 79481-0036; 80267-431; 0904-5306; 12711-4367; 61474-4280; 11673-186; 11822-7530; 36800-909; 37000-500; 37808-012; 41163-290; 41163-613; 41250-659; 41250-893; 42961-218; 49580-0292; 51013-419; 51316-347; 53345-005; 55315-404; 55681-322; 55910-091; 55910-891; 61010-8300; 0363-0710; 63868-772; 63941-219; 63941-690; 63941-735; 64024-479; 0404-9851; 67751-156; 68016-823; 68210-1280; 68210-4131; 68788-7994; 70692-785; 71205-315; 71205-410; 72036-090; 72036-113; 72036-521; 76281-505; 80159-104; 80267-479; 51927-1079; 61474-4262; 62350-0047; 64728-070; 73056-018; 29485-6506; 30142-114; 0113-0479; 37000-501; 37808-690; 41250-479; 41250-738; 41520-996; 42571-169; 50580-534; 50804-236; 51013-181; 51316-779; 51824-056; 53345-002; 53943-090; 54738-116; 55315-092; 55319-353; 60760-332; 61919-079; 0363-0379; 0363-0753; 63187-167; 63187-771; 63323-664; 63629-1159; 0363-9835; 63868-970; 66715-5654; 67091-630; 67457-124; 68163-710; 68210-1002; 68210-6112; 69842-264; 70000-0207; 70000-0245; 70000-0492; 70000-0585; 70518-1082; 70518-2438; 72036-019; 73282-0012; 12294-9997; 38779-0282; 0924-0036; 61301-8010; 61474-4225; 68210-1250; 30142-651; 36800-413; 36800-910; 37808-019; 37808-104; 41226-160; 41520-778; 46122-699; 49580-0293; 50580-226; 50580-228; 51013-129; 51013-142; 52412-100; 53942-505; 53943-128; 55910-479; 56062-479; 58602-742; 0363-0293; 63941-860; 68016-789; 68016-795; 68071-2895; 68071-3465; 68094-018; 69339-151; 69968-0242; 71205-521; 72476-113; 54738-115; 55319-479; 55910-462; 58657-528; 59898-810; 0363-9895; 63941-413; 66715-5254; 66715-6743; 67091-114; 67751-166; 68071-2924; 68210-0210; 68210-2010; 68210-4127; 68210-4157; 68210-4195; 68391-200; 68788-7589; 71335-0435; 71872-7242; 79903-056; 79903-083; 59917-089; 30142-116; 30142-554; 30142-847; 36800-431; 41520-290; 50090-3867; 51013-104; 51013-179; 51316-710; 51316-835; 52584-376; 53345-022; 55910-431; 55910-618; 55910-959; 56062-462; 59779-893; 0363-7100; 0363-8989; 0363-9024; 66715-6943; 68210-4237; 68998-090; 69423-979; 69842-156; 70264-024; 70518-3410; 70692-783; 71205-259; 71872-7005; 72036-091; 72288-479; 72485-101; 82706-005; 83164-000; 10888-8148; 61281-6000; 61301-8014; 61474-4099; 61474-4263; 64728-023; 68166-001; 68210-0123; 68210-0124; 36800-436; 36800-937; 0121-0865; 37808-866; 41250-379; 42571-337; 46122-674; 50090-0878; 50580-843; 51013-138; 55910-702; 55910-863; 57344-091; 0363-7300; 63868-087; 63868-370; 66715-6843; 66715-9746; 67414-226; 68210-2020; 68210-4160; 68210-4179; 69256-293; 69423-965; 69721-005; 69842-299; 69842-392; 70000-0174; 70518-3685; 71872-7180; 72789-317; 82673-109; 90107-2410; 11014-0055; 49588-0002; 62207-789; 65498-232; 73056-020; 76420-294; 11673-690; 15579-828; 17714-135; 24385-379; 24385-479; 36800-379; 36800-654; 49035-600; 49348-045; 50486-616; 50580-370; 50580-535; 51662-1348; 51879-802; 53943-113; 56062-431; 59779-793; 60687-267; 0363-0092; 61919-174; 63629-1160; 63868-393; 63868-474; 63868-611; 63941-090; 66715-6803; 68016-501; 68163-730; 68998-091; 70000-0584; 70692-784; 71141-090; 71679-106; 0641-0376; 76045-102; 81522-109; 82501-1581; 61474-4033; 61474-4241; 62207-795; 62579-226; 17714-021; 24385-431; 29485-7963; 0113-0431; 36800-367; 0113-7479; 0121-0489; 37808-590; 41250-853; 42806-649; 50580-232; 51013-108; 51013-144; 51013-167; 52904-960; 53942-522; 53943-505; 54838-135; 0363-9023; 63868-492
UNII TC2D6JAD40
Synonyms Diphenhydramine | Benzhydramine | Diphenylhydramine | Diphenylhydramin | 2-Diphenylmethoxy-N,N-dimethylethylamine | Benhydramin | Benadryl | Benylin | Diphenhydramine Citrate | Citrate, Diphenhydramine | Diphenhydramine Citrate (1:1) | Diphenhydramine Hydrochloride | Hydrochloride, Diphenhydramine | Dormin | Allerdryl | Dimedrol
Chemical Information
Molecular Formula C17H21NO.ClH
CAS Registry Number 147-24-0
SMILES CN(C)CCOC(C1=CC=CC=C1)C2=CC=CC=C2.Cl
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nervousness19.06.02.003--Not Available
Neuritis17.09.03.001--Not Available
Palpitations02.11.04.012--
Paraesthesia23.03.03.094; 17.02.06.005--
Photosensitivity reaction23.03.09.003--
Pollakiuria20.02.02.007--
Restlessness19.11.02.002; 17.02.05.021--
Sedation17.02.04.005--Not Available
Seizure17.12.03.001--
Somnolence19.02.05.003; 17.02.04.006--
Tachycardia02.03.02.007--Not Available
Throat tightness22.12.03.031; 19.01.02.005--Not Available
Thrombocytopenia01.08.01.002--Not Available
Tinnitus17.04.07.004; 04.04.01.002--
Tremor17.01.06.002--
Urinary retention20.02.02.011--
Urticaria23.04.02.001; 10.01.06.001--
Vertigo04.04.01.003; 17.02.12.002--
Vision blurred17.17.01.010; 06.02.06.007--
Vomiting07.01.07.003--
Wheezing22.03.01.009--
Epigastric discomfort07.01.02.004--Not Available
Decreased appetite14.03.01.005; 08.01.09.028--
Urinary tract obstruction20.08.01.004--
Increased bronchial secretion22.12.01.002--Not Available
The 2th Page    First    Pre   2    Total 2 Pages