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 diseases | D012140 |
otorhinolaryngologic diseases | D010038 |
nervous system diseases | D009422 |
skin and connective tissue diseases | D017437 |
immune system diseases | D007154 |
signs and symptoms pathological conditions | D013568 |
mental disorders | D001523 |
circulatory and respiratory physiological phenomena | D002943 |
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
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Ibuprofen
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ADVIL PM | GSK | N-021394 OTC | 2005-12-21 | 1 products, RLD, RS |
Diphenhydramine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BENADRYL | McNeil Pharmaceutical | N-005845 DISCN | 1982-01-01 | 3 products |
BENADRYL | McNeil Pharmaceutical | N-006146 DISCN | 1982-01-01 | 2 products, RLD |
BENADRYL PRESERVATIVE FREE | McNeil Pharmaceutical | N-009486 DISCN | 1982-01-01 | 1 products, RLD |
BENYLIN | Pfizer | N-006514 DISCN | 1982-01-01 | 1 products |
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Diphenhydramine hydrochloride
+
Ibuprofen
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ADVIL PM | GSK | N-021393 OTC | 2005-12-21 | 1 products, RLD, RS |
Diphenhydramine hydrochloride
+
Naproxen sodium
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
ALEVE PM | Bayer | N-205352 OTC | 2014-01-17 | 1 products, RLD, RS |
Diphenhydramine hydrochloride
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Pseudoephedrine hydrochloride
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
BENYLIN | Pfizer | N-019014 DISCN | 1985-06-11 | 1 products |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
advil dual action with acetaminophen | New Drug Application | 2023-04-13 |
bayer aleve | New Drug Application | 2023-03-20 |
benadryl allergy liqui-gels | OTC monograph final | 2023-05-17 |
severe cold, cold and flu | OTC monograph final | 2023-06-20 |
vicks zzzquil | OTC monograph final | 2023-06-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
allergic rhinitis perennial | EFO_1001417 | D012221 | J30.89 |
anxiety disorders | EFO_0006788 | D001008 | F41.1 |
motion sickness | — | D009041 | T75.3 |
nausea | HP_0002018 | D009325 | R11.0 |
sleep initiation and maintenance disorders | — | D007319 | F51.01 |
sneezing | HP_0025095 | D012912 | R06.7 |
urticaria | EFO_0005531 | D014581 | L50 |
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
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 |
---|---|---|---|---|---|---|---|---|---|
Pain | D010146 | EFO_0003843 | R52 | 16 | 21 | 32 | 30 | 19 | 117 |
Healthy volunteers/patients | — | 86 | 3 | 1 | 4 | 8 | 101 | ||
Postoperative pain | D010149 | G89.18 | 4 | 9 | 18 | 27 | 15 | 72 | |
Migraine disorders | D008881 | EFO_0003821 | G43 | — | 3 | 17 | 13 | 9 | 42 |
Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 9 | 8 | 16 | 4 | 5 | 41 |
Patent ductus arteriosus | D004374 | HP_0001643 | Q25.0 | 2 | 9 | 10 | 9 | 12 | 39 |
Low back pain | D017116 | HP_0003419 | M54.5 | — | 8 | 6 | 15 | 2 | 29 |
Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 5 | 11 | 3 | 5 | 5 | 28 |
Acute pain | D059787 | R52 | 3 | 4 | 5 | 8 | 1 | 21 | |
Fever | D005334 | HP_0001945 | R50.9 | 2 | — | 5 | 10 | 3 | 20 |
Show 130 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 4 | 5 | 3 | — | 2 | 14 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 3 | 3 | — | 3 | 9 |
Arthritis | D001168 | EFO_0005856 | M05-M14 | 3 | — | 3 | — | 1 | 7 |
Depression | D003863 | F33.9 | — | 1 | 2 | — | 3 | 6 | |
Treatment-resistant depressive disorder | D061218 | 1 | 3 | 1 | — | — | 4 | ||
Schizophrenia | D012559 | EFO_0000692 | F20 | 2 | 2 | 2 | — | — | 4 |
Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | 1 | — | 1 | 4 |
Rett syndrome | D015518 | F84.2 | — | 2 | 1 | — | 1 | 4 | |
Lupus nephritis | D008181 | EFO_0005761 | — | 2 | 2 | — | — | 4 | |
Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 2 | 3 | — | — | 4 |
Show 82 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Multiple myeloma | D009101 | C90.0 | 2 | 4 | — | — | — | 6 | |
Neuralgia | D009437 | EFO_0009430 | — | 5 | — | — | 1 | 6 | |
Hyperalgesia | D006930 | 1 | 2 | — | — | 2 | 5 | ||
Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 3 | 2 | — | — | — | 4 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 2 | 3 | — | — | — | 4 | |
Contraception | D003267 | — | 1 | — | — | 3 | 4 | ||
Malaria | D008288 | EFO_0001068 | B54 | 2 | 2 | — | — | — | 3 |
Spinal cord injuries | D013119 | EFO_1001919 | 1 | 2 | — | — | — | 3 | |
Atopic dermatitis | D003876 | EFO_0000274 | L20 | 1 | 1 | — | — | 1 | 3 |
Soft tissue injuries | D017695 | — | 2 | — | — | 1 | 3 |
Show 84 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Therapeutic equivalency | D013810 | 9 | — | — | — | — | 9 | ||
Drug interactions | D004347 | 4 | — | — | — | 1 | 5 | ||
Pharmacokinetics | D010599 | 4 | — | — | — | 1 | 5 | ||
Food-drug interactions | D018565 | 2 | — | — | — | — | 2 | ||
Pure autonomic failure | D054970 | 1 | — | — | — | — | 1 | ||
Orthostatic hypotension | D007024 | I95.1 | 1 | — | — | — | — | 1 | |
Graft vs host disease | D006086 | D89.81 | 1 | — | — | — | — | 1 | |
Mitochondrial diseases | D028361 | EFO_0000591 | 1 | — | — | — | — | 1 | |
Hematologic neoplasms | D019337 | 1 | — | — | — | — | 1 | ||
Hodgkin disease | D006689 | C81 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 3 | 3 |
Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
Leg ulcer | D007871 | — | — | — | — | 2 | 2 | ||
Long-term memory | D057567 | — | — | — | — | 1 | 1 | ||
Short-term memory | D008570 | EFO_0004335 | — | — | — | — | 1 | 1 | |
Colonic neoplasms | D003110 | C18 | — | — | — | — | 1 | 1 | |
Hemostasis | D006487 | — | — | — | — | 1 | 1 | ||
Urinary calculi | D014545 | N20.9 | — | — | — | — | 1 | 1 | |
Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | — | — | — | 1 | 1 |
Pituitary dwarfism | D004393 | EFO_1001109 | E23.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DIPHENHYDRAMINE |
INN | diphenhydramine |
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 class | first-generation antihistamine (ethanolamine), anticholinergic, hallucinogen (deliriant) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CN(C)CCOC(c1ccccc1)c1ccccc1 |
Target
Variants
Clinical Variant
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 3,111 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,158 adverse events reported
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