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| {{DrugProjectFormSinglePage | | {{Details0|Diphenhydramine (oral)}} |
| |authorTag={{AJ}}
| | {{Details0|Diphenhydramine (Injection)}} |
| |OTC=Yes
| | {{Details0|Diphenhydramine (topical)}} |
| |genericName=Diphenhydramine hydrochloride
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| |aOrAn=a
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| |drugClass=Analgesic and antihistamine
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| |indicationType=treatment
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| |indication=temporarily relieves symptoms of the [[common cold]] like
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| [[Runny nose]], [[Sneezing]], [[Itchy]] watery [[eyes]], [[Itchy]] nose or [[throat]]
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| |adverseReactions=[[Xerostomia]], [[dizziness]], [[dyskinesia]], [[sedation]], [[somnolence]], dryness of [[nasal mucosa]], [[pharyngeal dryness]], thick sputum.
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| |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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| |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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| * Content
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| <!--Adult Indications and Dosage-->
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| <!--FDA-Labeled Indications and Dosage (Adult)-->
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| |fdaLIADAdult=* Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
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| :* [[Runny nose]]
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| :* [[Sneezing]]
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| :* [[Itchy]], watery [[eyes]]
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| :* [[Itchy]] nose or [[throat]]
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| * Temporarily relieves these symptoms of the [[common cold]]:
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| :* [[Runny nose]]
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| :* [[Sneezing]]
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| * Dosing Information
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| :* Take every 4 to 6 hours, not more than 6 doses in 24 hours
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| [[File:Diphenhydramine dosage table01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
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| |offLabelAdultGuideSupport=* [[Chemotherapy]]-induced [[nausea]] and [[vomiting]].
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| * [[Extrapyramidal]] [[disease]] - [[Medication]]-induced [[movement disorder]].
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| * [[Hyperemesis gravidarum]].
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| * [[Local anesthesia]]
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| |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine in adult patients.
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| <!--Pediatric Indications and Dosage-->
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| <!--FDA-Labeled Indications and Dosage (Pediatric)-->
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| |fdaLIADPed======Condition1=====
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| =====Condition2=====
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| There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
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| <!--Off-Label Use and Dosage (Pediatric)-->
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| <!--Guideline-Supported Use (Pediatric)-->
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| |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.
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| <!--Non–Guideline-Supported Use (Pediatric)-->
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| |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Diphenhydramine in pediatric patients.
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| <!--Contraindications-->
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| |contraindications=* Diphenhydramine is [[contraindicated]] in persons with known [[hypersensitivity]].
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| |warnings=* Do not use with any other product containing diphenhydramine, even one used on [[skin]]
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| * To make a child sleepy
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| * Ask a doctor before use if you have [[glaucoma]]
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| * Trouble [[urinating]] due to an enlarged [[prostate gland]]
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| * A breathing problem such as [[emphysema]] or [[chronic bronchitis]]
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| * Ask a doctor or [[pharmacist]] before use if you are taking [[sedatives]] or [[tranquilizers]]
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| When using this product
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| marked [[drowsiness]] may occur
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| avoid [[alcoholic]] drinks
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| excitability may occur, especially in children
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| [[alcohol]], [[sedatives]] and [[tranquilizers]] may increase [[drowsiness]]
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| be careful when driving a motor vehicle or operating machinery
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| If [[pregnant]] or [[breast-feeding]],
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| ask a health professional before use.
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| Keep out of reach of children.
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| In case of [[overdose]], get medical help or contact a [[Poison]] Control Center right away.
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| |clinicalTrials=====Digestive=====
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| * [[Xerostomia]]
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| =====Neurologic=====
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| * [[Sedation]]
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| * [[Dizziness]]
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| * [[Dyskinesia]]
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| * [[Somnolence]]
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| =====Respiratory=====
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| * Dryness of [[nasal mucosa]]
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| * [[Pharyngeal]] dryness
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| * Thick [[sputum]]
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| * [[Bronchial]] dryness
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| =====Miscellaneous=====
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| * [[Anaphylaxis]] reaction
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| <!--Postmarketing Experience-->
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| |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of Diphenhydramine in the drug label.
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| <!--Drug Interactions-->
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| |drugInteractions=There is limited information regarding <i>drug interactions</i> of Diphenhydramine in the drug label.
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| |FDAPregCat=B
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| |useInPregnancyFDA=* '''Pregnancy Category'''
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| |useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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| There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Diphenhydramine in women who are pregnant.
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| |useInLaborDelivery=There is no FDA guidance on use of Diphenhydramine during labor and delivery.
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| |useInNursing=There is no FDA guidance on the use of Diphenhydramine with respect to nursing mothers.
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| |useInPed=* Keep out of reach of children.
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| * In case of overdose, get medical help or contact a [[Poison]] Control Center right away.
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| |useInGeri=There is no FDA guidance on the use of Diphenhydramine with respect to geriatric patients.
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| |useInGender=There is no FDA guidance on the use of Diphenhydramine with respect to specific gender populations.
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| |useInRace=There is no FDA guidance on the use of Diphenhydramine with respect to specific racial populations.
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| |useInRenalImpair=There is no FDA guidance on the use of Diphenhydramine in patients with renal impairment.
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| |useInHepaticImpair=There is no FDA guidance on the use of Diphenhydramine in patients with hepatic impairment.
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| |useInReproPotential=There is no FDA guidance on the use of Diphenhydramine in women of reproductive potentials and males.
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| |useInImmunocomp=There is no FDA guidance one the use of Diphenhydramine in patients who are immunocompromised.
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| <!--Administration and Monitoring-->
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| |administration=* Intramuscular
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| * Intravenous
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| * Oral
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| |monitoring=There is limited information regarding <i>Monitoring</i> of Diphenhydramine in the drug label.
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| <!--IV Compatibility-->
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| |IVCompat=There is limited information regarding <i>IV Compatibility</i> of Diphenhydramine in the drug label.
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| <!--Overdosage-->
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| |overdose=There is limited information regarding <i>Chronic Overdose</i> of Diphenhydramine in the drug label.
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| <!--Pharmacology-->
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| <!--Drug box 2-->
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| |drugBox={{Drugbox2
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| | Verifiedfields = changed
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| | Watchedfields = changed
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| | verifiedrevid = 460791686
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| | IUPAC_name = 2-(diphenylmethoxy)-''N'',''N''-dimethylethanamine
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| | image = Diphenhydramine 2D skeletal.png
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| | width = 200 | |
| | image2 = Diphenhydramine ball-and-stick animation.gif
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| <!--Clinical data-->
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| | tradename = Benadryl, Unisom, Sominex, ZzzQuil,
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| | Drugs.com = {{drugs.com|monograph|diphenhydramine-hydrochloride}}
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| | MedlinePlus = a682539
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| | pregnancy_AU = A
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| | pregnancy_US = B
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| | legal_AU = S2
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| | legal_status = [[Over-the-counter drug|Over-the-counter]]
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| | routes_of_administration = Oral, parenteral ([[Intramuscular injection|IM]] and [[Intravenous therapy|IV]]), topical, suppository
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| | dependency_liability = Very low
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| <!--Pharmacokinetic data-->
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| | bioavailability = 40–60%<ref name="pmid2866055">{{cite journal | author = Paton DM, Webster DR | title = Clinical pharmacokinetics of H1-receptor antagonists (the antihistamines) | journal = Clin. Pharmacokinet. | volume = 10 | issue = 6 | pages = 477–97 | year = 1985 | pmid = 2866055 | doi = 10.2165/00003088-198510060-00002 }}</ref>
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| | protein_bound = 98–99%
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| | metabolism = Various [[cytochrome P450]] liver enzymes: [[CYP2D6]] (80%), [[CYP3A4|3A4]] (10%)<ref>{{cite web | author = | title = Showing Diphenhydramine (DB01075) | url = http://www.drugbank.ca/drugs/DB01075 | publisher = DrugBank | accessdate = 5 September 2009 }}</ref>
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| | elimination_half-life = 8 hours (children)<ref name="pmid2391399">{{cite journal | author = Simons KJ, Watson WT, Martin TJ, Chen XY, Simons FE | title = Diphenhydramine: pharmacokinetics and pharmacodynamics in elderly adults, young adults, and children | journal = J. Clin. Pharmacol. | volume = 30 | issue = 7 | pages = 665–71 |date=July 1990 | pmid = 2391399 | doi = 10.1002/j.1552-4604.1990.tb01871.x }}</ref><br />9 to 12 hours (adults)<ref name="pmid2391399" /><br />17 hours (elderly)<ref name="pmid2391399" />
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| | excretion = 94% through the urine, 6% through feces<ref name="pmid3962845">{{cite journal | author = Garnett WR | title = Diphenhydramine | journal = Am. Pharm. | volume = NS26 | issue = 2 | pages = 35–40 |date=February 1986 | pmid = 3962845 | doi = }}</ref>
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| <!--Identifiers-->
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| | CASNo_Ref = {{cascite|correct|CAS}}
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| | CAS_number_Ref = {{cascite|correct|??}}
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| | CAS_number = 58-73-1
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| | ATC_prefix = D04
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| | ATC_suffix = AA32
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| | ATC_supplemental = {{ATC|D04|AA33}}, {{ATC|R06|AA02}}
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| | PubChem = 3100
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| | IUPHAR_ligand = 1224
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| | DrugBank_Ref = {{drugbankcite|correct|drugbank}}
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| | DrugBank = DB01075
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| | ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
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| | ChemSpiderID = 2989
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| | UNII_Ref = {{fdacite|correct|FDA}}
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| | UNII = 8GTS82S83M
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| | KEGG_Ref = {{keggcite|changed|kegg}}
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| | KEGG = D00669
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| | ChEBI_Ref = {{ebicite|correct|EBI}}
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| | ChEBI = 4636
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| | ChEMBL_Ref = {{ebicite|correct|EBI}}
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| | ChEMBL = 657
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| <!--Chemical data-->
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| | C = 17 | H = 21 | N = 1 | O = 1
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| | molecular_weight = 255.355 g/mol
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| | smiles = O(CCN(C)C)C(c1ccccc1)c2ccccc2
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| | InChI = 1/C17H21NO/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16/h3-12,17H,13-14H2,1-2H3
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| | StdInChI_Ref = {{stdinchicite|correct|chemspider}}
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| | StdInChI = 1S/C17H21NO/c1-18(2)13-14-19-17(15-9-5-3-6-10-15)16-11-7-4-8-12-16/h3-12,17H,13-14H2,1-2H3
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| | StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
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| | StdInChIKey = ZZVUWRFHKOJYTH-UHFFFAOYSA-N
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| }}
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| |mechAction=* Diphenhydramine is an inverse agonist of the [[histamine]] [[H1 receptor]]. It is a member of the [[ethanolamine]] class of [[antihistaminergic]] agents. By reversing the effects of [[histamine]] on the [[capillaries]], it can reduce the intensity of [[allergic]] symptoms. It also crosses the [[blood–brain barrier]] and [[antagonizes]] the [[H1 receptors]] centrally. Its effects on central [[H1 receptors]] cause [[drowsiness]].
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| * Like many other first-generation [[antihistamines]], diphenhydramine is also a potent [[antimuscarinic]] (a [[competitive antagonist]] of [[muscarinic]] [[acetylcholine receptors]]) and, as such, at high doses can cause [[anticholinergic syndrome]].
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| <!--Structure-->
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| |structure=[[File:Diphenhydramine structure.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
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| <!--Pharmacodynamics-->
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| |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
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| <!--Pharmacokinetics-->
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| |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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| <!--Nonclinical Toxicology-->
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| |nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of Diphenhydramine in the drug label.
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| <!--Clinical Studies-->
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| |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of Diphenhydramine in the drug label.
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| <!--How Supplied-->
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| |howSupplied=
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| <!--Patient Counseling Information-->
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| |storage=store at 20°-25°C
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| |packLabel=[[File:Diphenhydramine drug lable01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
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| [[File:Diphenhydramine dosage table01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
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| |fdaPatientInfo=* Marked [[drowsiness]] may occur
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| * Avoid [[alcoholism|alcoholic]] drinks
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| * Excitability may occur, especially in children
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| * [[Alcohol]], [[sedatives]] and [[tranquilizers]] may increase [[drowsiness]]
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| * Be careful when driving a motor vehicle or operating machinery
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| |alcohol=* Avoid [[alcoholic]] drinks.
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| * [[Alcohol]], [[sedatives]] and [[tranquilizers]] may increase [[drowsiness]].
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| |brandNames=* Benadryl®
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| * Benylin Decongestant Cough®
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| * Diphenhist
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| * Diphenyl®
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| * Genahist®
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| * Geridryl®
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| * Nytol Quickcaps®
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| * Nytol Quickgels®
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| |lookAlike=* Benadryl® - benazepril®
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| * diphenhydrAMINE® - dimenhyDRINATE®
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| |drugShortage=
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| }} | |
| {{PillImage
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| |fileName=No image.jpg
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| }}
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| {{LabelImage}}
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| {{LabelImage}}
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| <!--Pill Image-->
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| <!--Label Display Image-->
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| <!--Category-->
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| [[Category:Drug]]
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