Diphenhydramine - PharmaKB

Diphenhydramine

Advil, Aleve, Benylin, Diphenhydramine, Diphenhydramine / (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.

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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)

Abbreviated New Drug Application (ANDA)

Diphenhydramine citrate

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

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
24 / 7 life extra strength pain reliever pm	OTC monograph not final	2023-07-19
24/7 life allergy relief	OTC monograph final	2023-07-19
acetadryl	OTC monograph not final	2013-11-12
acetaflu nighttime	OTC monograph final	2020-03-26
acetaflu nighttime effervescent	OTC monograph final	2020-03-26
acetamax pm	OTC monograph not final	2020-08-31
acetaminophen	OTC monograph not final	2023-02-27
acetaminophen 500mg diphenhydramine hcl 25mg	OTC monograph not final	2020-11-16
acetaminophen and diphenhydramine hcl	C200263	2023-12-18
acetaminophen and diphenhydramine hydrochloride	C200263	2023-12-05

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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

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

2349 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	34	40	49	45	41	204
Healthy volunteers/patients	—	—	—	130	3	1	8	13	154
Postoperative pain	D010149	—	G89.18	10	17	22	60	40	145
Osteoarthritis	D010003	EFO_0002506	M15-M19	9	13	24	9	8	61
Migraine disorders	D008881	EFO_0003821	G43	3	5	21	17	10	54
Opioid-related disorders	D009293	EFO_0005611	F11	10	12	11	6	15	51
Low back pain	D017116	HP_0003419	M54.5	—	10	15	17	10	50
Patent ductus arteriosus	D004374	HP_0001643	Q25.0	2	13	12	9	17	49
Knee osteoarthritis	D020370	EFO_0004616	M17	5	15	5	8	9	41
Acute pain	D059787	—	R52	8	5	7	11	8	39

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Breast neoplasms	D001943	EFO_0003869	C50	5	9	3	—	8	22
Multiple myeloma	D009101	—	C90.0	4	7	3	—	1	15
Non-hodgkin lymphoma	D008228	—	C85.9	3	10	1	—	1	13
Leukemia	D007938	—	C95	2	5	1	—	3	11
Lymphoma	D008223	—	C85.9	2	4	2	—	1	9
Cocaine-related disorders	D019970	—	F14	4	4	1	—	—	8
Myelodysplastic syndromes	D009190	—	D46	1	6	1	—	1	8
Colorectal neoplasms	D015179	—	—	2	5	1	—	1	7
Non-small-cell lung carcinoma	D002289	—	—	3	2	2	—	—	7
Plasma cell neoplasms	D054219	—	—	2	2	1	—	1	6

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Precursor cell lymphoblastic leukemia-lymphoma	D054198	—	C91.0	4	5	—	—	1	9
Myeloid leukemia acute	D015470	—	C92.0	4	4	—	—	—	7
Graft vs host disease	D006086	—	D89.81	2	4	—	—	—	5
Hepatitis b	D006509	—	—	1	4	—	—	—	5
B-cell chronic lymphocytic leukemia	D015451	—	C91.1	2	4	—	—	—	5
Foot and mouth disease hand	D006232	EFO_0007294	B08.4	—	1	—	—	4	5
Contraception	D003267	—	—	—	1	—	—	4	5
Melanoma	D008545	—	—	3	2	—	—	—	4
Chronic disease	D002908	—	—	1	3	—	—	1	4
Cognitive dysfunction	D060825	HP_0001268	G31.84	—	1	—	—	3	4

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Drug interactions	D004347	—	—	10	—	—	—	3	13
Therapeutic equivalency	D013810	—	—	10	—	—	—	—	10
Pharmacokinetics	D010599	—	—	4	—	—	—	1	5
Pneumonia	D011014	EFO_0003106	—	1	—	—	—	2	3
Hypersensitivity	D006967	HP_0012393	T78.40	2	—	—	—	1	3
Systemic scleroderma	D012595	EFO_0000717	M34	1	—	—	—	1	2
Food-drug interactions	D018565	—	—	2	—	—	—	—	2
Alcohol-related disorders	D019973	—	F10	1	—	—	—	1	2
Gallstones	D042882	EFO_0004210	—	1	—	—	—	1	2
Abdominal aortic aneurysm	D017544	EFO_0004214	—	1	—	—	—	1	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pelvic pain	D017699	—	—	—	—	—	—	5	5
Trismus	D014313	—	—	—	—	—	—	3	3
Cystic fibrosis	D003550	EFO_0000390	E84	—	—	—	—	3	3
Post-traumatic stress disorders	D013313	EFO_0001358	F43.1	—	—	—	—	2	2
Prolapse	D011391	—	—	—	—	—	—	2	2
Anaphylaxis	D000707	—	T78.2	—	—	—	—	2	2
Lacerations	D022125	—	—	—	—	—	—	2	2
Laparoscopic cholecystectomy	D017081	—	—	—	—	—	—	2	2
Sarcopenia	D055948	EFO_1000653	M62.84	—	—	—	—	2	2
Osteoporosis	D010024	HP_0000939	M81.0	—	—	—	—	2	2

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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

Identifiers

PDB	—
CAS-ID	58-73-1
RxCUI	—
ChEMBL ID	CHEMBL657
ChEBI ID	4636
PubChem CID	3100
DrugBank	DB01075
UNII ID	8GTS82S83M (ChemIDplus, GSRS)

Target

Agency Approved

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

No data

Variants

No data

Financial

Revenue by drug

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Estimated US medical usage

Diphenhydramine

Acetaminophen

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Diphenhydramine

Acetaminophen

Phenylephrine

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Diphenhydramine

Phenylephrine

Brompheniramine

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Diphenhydramine

Carbetapentane

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Diphenhydramine

Carbetapentane

Phenylephrine

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Diphenhydramine

Phenylephrine

Codeine

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Diphenhydramine

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Diphenhydramine

Phenylephrine

Hydrocodone

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Diphenhydramine

Lidocaine

Nystatin

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Diphenhydramine

Phenylephrine

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Trends

PubMed Central

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Additional graphs summarizing 17,148 documents

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Safety

Black-box Warning

Black-box warning for: Direct rx, Theraflu expressmax daytime nighttime value pack

Adverse Events

Top Adverse Reactions

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116,355 adverse events reported

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