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Diphenhydramine
Advil, Aleve, Antitussive, Beldin, Belix, Benadryl, Benylin, Dibenil, Diphen, Hydramine, Silphen, Vicks (diphenhydramine) is a small molecule pharmaceutical. Diphenhydramine was first approved as Benadryl on 1982-01-01. It is used to treat allergic rhinitis perennial, anxiety disorders, motion sickness, nausea, and sleep initiation and maintenance disorders amongst others in the USA. The pharmaceutical is active against histamine H1 receptor. In addition, it is known to target histamine N-methyltransferase.
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Therapeutic Areas
Therapeutic Area
MeSH
respiratory tract diseasesD012140
otorhinolaryngologic diseasesD010038
nervous system diseasesD009422
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
mental disordersD001523
circulatory and respiratory physiological phenomenaD002943
Trade Name
FDA
EMA
Combinations
Advil, Aleve (generic drugs available since 1982-01-01, discontinued: Benylin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Diphenhydramine citrate
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021394 OTC2005-12-21
1 products, RLD, RS
Diphenhydramine hydrochloride
Tradename
Company
Number
Date
Products
BENADRYLMcNeil PharmaceuticalN-005845 DISCN1982-01-01
3 products
BENADRYLMcNeil PharmaceuticalN-006146 DISCN1982-01-01
2 products, RLD
BENADRYL PRESERVATIVE FREEMcNeil PharmaceuticalN-009486 DISCN1982-01-01
1 products, RLD
BENYLINPfizerN-006514 DISCN1982-01-01
1 products
Hide discontinued
Diphenhydramine hydrochloride
+
Ibuprofen
Tradename
Company
Number
Date
Products
ADVIL PMGSKN-021393 OTC2005-12-21
1 products, RLD, RS
Diphenhydramine hydrochloride
+
Naproxen sodium
Tradename
Company
Number
Date
Products
ALEVE PMBayerN-205352 OTC2014-01-17
1 products, RLD, RS
Diphenhydramine hydrochloride
+
Pseudoephedrine hydrochloride
Tradename
Company
Number
Date
Products
BENYLINPfizerN-019014 DISCN1985-06-11
1 products
Hide discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
advil dual action with acetaminophenNew Drug Application2023-04-13
bayer aleveNew Drug Application2023-03-20
benadryl allergy liqui-gelsOTC monograph final2023-05-17
severe cold, cold and fluOTC monograph final2023-06-20
vicks zzzquilOTC monograph final2023-06-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic rhinitis perennialEFO_1001417D012221J30.89
anxiety disordersEFO_0006788D001008F41.1
motion sickness—D009041T75.3
nauseaHP_0002018D009325R11.0
sleep initiation and maintenance disorders—D007319F51.01
sneezingHP_0025095D012912R06.7
urticariaEFO_0005531D014581L50
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
D: Dermatologicals
— D04: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04A: Antipruritics, incl. antihistamines, anesthetics, etc.
— D04AA: Antihistamines for topical use
— D04AA32: Diphenhydramine
— D04AA33: Diphenhydramine methylbromide
R: Respiratory system drugs
— R06: Antihistamines for systemic use
— R06A: Antihistamines for systemic use
— R06AA: Aminoalkyl ethers, systemic antihistamines
— R06AA02: Diphenhydramine
— R06AA52: Diphenhydramine, combinations
HCPCS
Code
Description
J1200
Injection, diphenhydramine hcl, up to 50 mg
Q0163
Diphenhydramine hydrochloride, 50 mg, oral, fda approved prescription anti-emetic, for use as a complete therapeutic substitute for an iv anti-emetic at time of chemotherapy treatment not to exceed a 48 hour dosage regimen
Clinical
Clinical Trials
1188 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PainD010146EFO_0003843R521621323019117
Healthy volunteers/patients—863148101
Postoperative painD010149G89.184918271572
Migraine disordersD008881EFO_0003821G43—31713942
OsteoarthritisD010003EFO_0002506M15-M1998164541
Patent ductus arteriosusD004374HP_0001643Q25.0291091239
Low back painD017116HP_0003419M54.5—8615229
Knee osteoarthritisD020370EFO_0004616M1751135528
Acute painD059787R523458121
FeverD005334HP_0001945R50.92—510320
Show 130 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80453—214
Breast neoplasmsD001943EFO_0003869C50133—39
ArthritisD001168EFO_0005856M05-M143—3—17
DepressionD003863F33.9—12—36
Treatment-resistant depressive disorderD061218131——4
SchizophreniaD012559EFO_0000692F20222——4
Type 2 diabetes mellitusD003924EFO_0001360E11—21—14
Rett syndromeD015518F84.2—21—14
Lupus nephritisD008181EFO_0005761—22——4
Systemic lupus erythematosusD008180EFO_0002690M32—23——4
Show 82 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple myelomaD009101C90.024———6
NeuralgiaD009437EFO_0009430—5——16
HyperalgesiaD00693012——25
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.032———4
Non-hodgkin lymphomaD008228C85.923———4
ContraceptionD003267—1——34
MalariaD008288EFO_0001068B5422———3
Spinal cord injuriesD013119EFO_100191912———3
Atopic dermatitisD003876EFO_0000274L2011——13
Soft tissue injuriesD017695—2——13
Show 84 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Therapeutic equivalencyD0138109————9
Drug interactionsD0043474———15
PharmacokineticsD0105994———15
Food-drug interactionsD0185652————2
Pure autonomic failureD0549701————1
Orthostatic hypotensionD007024I95.11————1
Graft vs host diseaseD006086D89.811————1
Mitochondrial diseasesD028361EFO_00005911————1
Hematologic neoplasmsD0193371————1
Hodgkin diseaseD006689C811————1
Show 24 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cystic fibrosisD003550EFO_0000390E84————33
HemorrhageD006470MP_0001914R58————22
Leg ulcerD007871————22
Long-term memoryD057567————11
Short-term memoryD008570EFO_0004335————11
Colonic neoplasmsD003110C18————11
HemostasisD006487————11
Urinary calculiD014545N20.9————11
Attention deficit disorder with hyperactivityD001289EFO_0003888F90————11
Pituitary dwarfismD004393EFO_1001109E23.0————11
Show 68 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDIPHENHYDRAMINE
INNdiphenhydramine
Description
Diphenhydramine is an ether that is the benzhydryl ether of 2-(dimethylamino)ethanol. It is a H1-receptor antagonist used as a antipruritic and antitussive drug. It has a role as a H1-receptor antagonist, an antiemetic, a sedative, an anti-allergic agent, a muscarinic antagonist, an antiparkinson drug, an antipruritic drug, a local anaesthetic, an antidyskinesia agent, an antitussive and a oneirogen. It is an ether and a tertiary amino compound.
Classification
Small molecule
Drug classfirst-generation antihistamine (ethanolamine), anticholinergic, hallucinogen (deliriant)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCOC(c1ccccc1)c1ccccc1
Identifiers
PDB2AOT
CAS-ID58-73-1
RxCUI3498
ChEMBL IDCHEMBL657
ChEBI ID4636
PubChem CID3100
DrugBankDB01075
UNII ID8GTS82S83M (ChemIDplus, GSRS)
Target
Agency Approved
HRH1
HRH1
Organism
Homo sapiens
Gene name
HRH1
Gene synonyms
NCBI Gene ID
3269
Protein name
histamine H1 receptor
Protein synonyms
histamine receptor, subclass H1
Uniprot ID
Q6P9E5
Mouse ortholog
Hrh1 (15465)
histamine H1 receptor (Q91XN3)
Alternate
HNMT
HNMT
Organism
Homo sapiens
Gene name
HNMT
Gene synonyms
NCBI Gene ID
3176
Protein name
histamine N-methyltransferase
Protein synonyms
Uniprot ID
P50135
Mouse ortholog
Hnmt (140483)
histamine N-methyltransferase (Q91VF2)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 3,111 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1,158 adverse events reported
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