Aspirin

Aggrenox, Axotal, Azdone, Codoxy, Darvon, Darvon W/ Asa, Durlaza, Equagesic, Excedrin, Fiorinal, Invagesic, Lanorinal, Micrainin, Norgesic, Percodan, Percodan-demi, Pravigard, Q-gesic, Robaxisal, Roxiprin, Soma, Synalgos-dc, Talwin, Vazalore, Vicoprin, W/ Asa, Yosprala (aspirin) is a small molecule pharmaceutical. Aspirin was first approved as Codeine, aspirin, apap formula no. 4 on 1982-01-01. It is used to treat fever, gout, inflammation, osteoarthritis, and pain amongst others in the USA. The pharmaceutical is active against prostaglandin G/H synthase 2 and prostaglandin G/H synthase 1. In addition, it is known to target acid-sensing ion channel 3, transient receptor potential cation channel subfamily V member 3, and N-formyl peptide receptor 2.

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Therapeutic Areas

Therapeutic Area	MeSH
infections	D007239
musculoskeletal diseases	D009140
hereditary congenital and neonatal diseases and abnormalities	D009358
skin and connective tissue diseases	D017437
nutritional and metabolic diseases	D009750
immune system diseases	D007154
signs and symptoms pathological conditions	D013568
psychological phenomena	D011579
musculoskeletal and neural physiological phenomena	D055687

Trade Name

FDA

EMA

Durlaza, Vazalore (discontinued: 8-hour bayer, Measurin)

Combinations

Excedrin, Percodan (generic drugs available since 1985-10-11, discontinued: , Aggrenox, Axotal, Azdone, Codoxy, Darvon, Darvon w/ asa, Darvon-n w/ asa, Equagesic, Fiorinal, Invagesic, Lanorinal, Micrainin, Norgesic, Percodan, Percodan-demi, Pravigard, Q-gesic, Robaxisal, Roxiprin, Soma, Synalgos-dc, Talwin, Vicoprin, Yosprala)

Drug Products

FDA

EMA

New Drug Application (NDA)

Abbreviated New Drug Application (ANDA)

Acetaminophen

Aspirin

Caffeine

Tradename	Company	Number	Date	Products
EXCEDRIN (MIGRAINE)	GSK	N-020802 OTC	1998-01-14	1 products, RLD, RS

Aspirin

Tradename	Company	Number	Date	Products
DURLAZA	Espero BioPharma	N-200671 RX	2015-09-04	1 products, RLD, RS
VAZALORE	PLx Pharma	N-203697 OTC	2013-01-14	2 products, RLD, RS

Show 3 discontinued

Aspirin

Butalbital

Caffeine

Tradename	Company	Number	Date	Products
FIORINAL	Allergan	N-017534 DISCN	1986-04-16	2 products, RLD

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Aspirin

Butalbital

Caffeine

Codeine phosphate

Tradename	Company	Number	Date	Products
FIORINAL W/CODEINE	Allergan	N-019429 DISCN	1990-10-26	1 products, RLD

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Aspirin

Caffeine

Dihydrocodeine bitartrate

Tradename	Company	Number	Date	Products
SYNALGOS-DC	Sun Pharmaceutical Industries	N-011483 DISCN	1983-09-06	1 products, RLD

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Aspirin

Caffeine

Orphenadrine citrate

Tradename	Company	Number	Date	Products
NORGESIC	Bausch Health Companies	N-013416 DISCN	1982-10-27	1 products, RLD
NORGESIC FORTE	Bausch Health Companies	N-013416 DISCN	1982-10-27	1 products, RLD

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Aspirin

Caffeine

Propoxyphene hydrochloride

Tradename	Company	Number	Date	Products
DARVON COMPOUND	Xanodyne Pharmaceuticals	N-010996 DISCN	1983-03-08	1 products
DARVON COMPOUND-65	Xanodyne Pharmaceuticals	N-010996 DISCN	1983-03-08	1 products

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Aspirin

Carisoprodol

Tradename	Company	Number	Date	Products
SOMA COMPOUND	Meda AB	N-012365 DISCN	1983-07-11	1 products

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Aspirin

Carisoprodol

Codeine phosphate

Tradename	Company	Number	Date	Products
SOMA COMPOUND W/ CODEINE	Meda AB	N-012366 DISCN	1983-07-11	1 products

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Aspirin

Dipyridamole

Tradename	Company	Number	Date	Products
AGGRENOX	Boehringer Ingelheim	N-020884 DISCN	1999-11-22	1 products, RLD

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Aspirin

Meprobamate

Tradename	Company	Number	Date	Products
EQUAGESIC	Sun Pharmaceutical Industries	N-011702 DISCN	1983-12-29	1 products

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Aspirin

Methocarbamol

Tradename	Company	Number	Date	Products
ROBAXISAL	A.H. Robins Company	N-012281 DISCN	1982-01-01	1 products, RLD

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Aspirin

Omeprazole

Tradename	Company	Number	Date	Products
YOSPRALA	Genus Lifesciences	N-205103 DISCN	2016-09-14	2 products, RLD

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Aspirin

Oxycodone hydrochloride

Tradename	Company	Number	Date	Products
PERCODAN	Endo	N-007337 RX	2005-08-05	1 products, RLD, RS

Aspirin

Oxycodone hydrochloride

Oxycodone terephthalate

Tradename	Company	Number	Date	Products
PERCODAN-DEMI	Endo	N-007337 DISCN	1982-01-01	1 products
PERCODAN	Endo	N-007337 DISCN	1982-01-01	1 products

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Aspirin

Pentazocine hydrochloride

Tradename	Company	Number	Date	Products
TALWIN COMPOUND	Sanofi	N-016891 DISCN	1982-01-01	1 products, RLD

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Aspirin

Pravastatin sodium

Tradename	Company	Number	Date	Products
PRAVIGARD PAC (COPACKAGED)	Bristol Myers Squibb	N-021387 DISCN	2003-06-24	6 products

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Aspirin

Propoxyphene hydrochloride

Tradename	Company	Number	Date	Products
DARVON W/ ASA	Xanodyne Pharmaceuticals	N-010996 DISCN	1982-01-01	1 products

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Aspirin

Propoxyphene napsylate

Tradename	Company	Number	Date	Products
DARVON-N W/ ASA	AAIPharma	N-016829 DISCN	1982-01-01	1 products
DARVON-N W/ ASA	AAIPharma	N-016863 DISCN	1982-01-01	1 products

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Labels

FDA

EMA

Brand Name	Status	Last Update
aggrenox	New Drug Application	2016-08-06
carisoprodol	ANDA	2023-05-31
darvon-n	New Drug Application	2009-10-27
durlaza	New Drug Application	2015-09-25
low dose aspirin	OTC monograph final	2023-06-20
norgesic	ANDA	2022-05-17
orphengesic forte	ANDA	2021-04-28
vazalore	New Drug Application	2023-01-05
yosprala	New Drug Application	2021-08-31

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
fever	HP_0001945	D005334	R50.9
gout	EFO_0004274	D006073	M10
inflammation	MP_0001845	D007249	—
osteoarthritis	EFO_0002506	D010003	M15-M19
pain	EFO_0003843	D010146	R52
rheumatic fever	EFO_1001160	D012213	I00-I02
rheumatoid arthritis	EFO_0000685	D001172	M06.9

Agency Specific

FDA

EMA

No data

Patent Expiration

Patent	Expires	Flag	FDA Information
Aspirin / Omeprazole, Yosprala, Genus Lifesciences
9539214	2033-03-13		U-1902, U-1902
9987231	2033-01-02		U-2324, U-2324
6926907	2023-02-28	DP	U-1902, U-1902
8206741	2023-02-28	DP	U-1902, U-1902
Aspirin, Vazalore, Plx Pharma
9216150	2032-09-29	DP
9226892	2032-09-29		U-1731, U-1732, U-1733

ATC Codes

A: Alimentary tract and metabolism drugs

— A01: Stomatological preparations

— A01A: Stomatological preparations

— A01AD: Other agents for local oral treatment in atc

— A01AD05: Acetylsalicylic acid

B: Blood and blood forming organ drugs

— B01: Antithrombotic agents

— B01A: Antithrombotic agents

— B01AC: Platelet aggregation inhibitors excl. heparin

— B01AC06: Acetylsalicylic acid

— B01AC56: Acetylsalicylic acid, combinations with proton pump inhibitors

C: Cardiovascular system drugs

— C07: Beta-adrenergic blocking agents

— C07F: Beta blocking agents, other combinations

— C07FX: Beta blocking agents, other combinations

— C07FX02: Sotalol and acetylsalicylic acid

— C07FX03: Metoprolol and acetylsalicylic acid

— C07FX04: Bisoprolol and acetylsalicylic acid

— C10: Lipid modifying agents

— C10B: Lipid modifying agents, combinations

— C10BX: Lipid modifying agents in combination with other drugs

— C10BX01: Simvastatin and acetylsalicylic acid

— C10BX02: Pravastatin and acetylsalicylic acid

— C10BX04: Simvastatin, acetylsalicylic acid and ramipril

— C10BX05: Rosuvastatin and acetylsalicylic acid

— C10BX06: Atorvastatin, acetylsalicylic acid and ramipril

— C10BX08: Atorvastatin and acetylsalicylic acid

— C10BX12: Atorvastatin, acetylsalicylic acid and perindopril

M: Musculo-skeletal system drugs

— M01: Antiinflammatory and antirheumatic products

— M01B: Antiinflammatory/antirheumatic agents in combination

— M01BA: Antiinflammatory/antirheumatic agents in combination with corticosteroids

— M01BA03: Acetylsalicylic acid and corticosteroids

N: Nervous system drugs

— N02: Analgesics

— N02A: Opioid analgesics

— N02AJ: Opioids in combination with non-opioid analgesics

— N02AJ02: Dihydrocodeine and acetylsalicylic acid

— N02AJ07: Codeine and acetylsalicylic acid

— N02AJ18: Oxycodone and acetylsalicylic acid

— N02B: Other analgesics and antipyretics in atc

— N02BA: Salicylic acid and derivatives, analgesics and antipyretics

— N02BA01: Acetylsalicylic acid

— N02BA51: Acetylsalicylic acid, combinations excl. psycholeptics

— N02BA71: Acetylsalicylic acid, combinations with psycholeptics

HCPCS

Code	Description
G2128	Documentation of medical reason(s) for not on a daily aspirin or other antiplatelet (e.g. history of gastrointestinal bleed, intra-cranial bleed, blood disorders, idiopathic thrombocytopenic purpura (itp), gastric bypass or documentation of active anticoagulant use during the measurement period)
G8598	Aspirin or another antiplatelet therapy used
G8599	Aspirin or another antiplatelet therapy not used, reason not given
G9277	Documentation that the patient is on daily aspirin or anti-platelet or has documentation of a valid contraindication or exception to aspirin/anti-platelet; contraindications/exceptions include anti-coagulant use, allergy to aspirin or anti-platelets, history of gastrointestinal bleed and bleeding disorder; additionally, the following exceptions documented by the physician as a reason for not taking daily aspirin or anti-platelet are acceptable (use of non-steroidal anti-inflammatory agents, documented risk for drug interaction, uncontrolled hypertension defined as >180 systolic or >110 diastolic or gastroesophageal reflux)
G9278	Documentation that the patient is not on daily aspirin or anti-platelet regimen
G9793	Patient is currently on a daily aspirin or other antiplatelet
G9794	Documentation of medical reason(s) for not on a daily aspirin or other antiplatelet (e.g., history of gastrointestinal bleed, intra-cranial bleed, idiopathic thrombocytopenic purpura (itp), gastric bypass or documentation of active anticoagulant use during the measurement period)
G9795	Patient is not currently on a daily aspirin or other antiplatelet
M1055	Aspirin or another antiplatelet therapy used
M1056	Prescribed anticoagulant medication during the performance period, history of gi bleeding, history of intracranial bleeding, bleeding disorder and specific provider documented reasons: allergy to aspirin or anti-platelets, use of non-steroidal anti-inflammatory agents, drug-drug interaction, uncontrolled hypertension > 180/110 mmhg or gastroesophageal reflux disease

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Clinical

Clinical Trials

1069 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Coronary artery disease	D003324		I25.1	4	4	13	60	23	104
Stroke	D020521	EFO_0000712	I63.9	2	9	25	22	12	64
Healthy volunteers/patients	—			38	4	1	4	9	56
Cardiovascular diseases	D002318	EFO_0000319	I98	7	8	11	13	11	48
Ischemic stroke	D000083242			6	13	17	10	8	45
Acute coronary syndrome	D054058	EFO_0005672		4	2	6	24	5	41
Pre-eclampsia	D011225	EFO_0000668	O14	3	6	10	12	10	39
Myocardial infarction	D009203	EFO_0000612	I21	—	2	10	11	7	29
Atrial fibrillation	D001281	EFO_0000275	I48.0	—	2	6	14	4	26
Coronary disease	D003327			—	1	8	13	4	25

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Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Colorectal neoplasms	D015179			2	9	10	—	7	25
Breast neoplasms	D001943	EFO_0003869	C50	2	7	3	—	1	12
Covid-19	D000086382		U07.1	1	2	5	—	1	9
Inflammation	D007249			3	5	1	—	—	8
Colonic neoplasms	D003110		C18	—	2	3	—	2	7
Non-small-cell lung carcinoma	D002289			1	1	2	—	3	6
Respiratory distress syndrome	D012128	EFO_1000637	J80	—	3	2	—	1	5
Chronic obstructive pulmonary disease	D029424	EFO_0000341	J44.9	—	4	1	—	—	5
Cerebrovascular disorders	D002561	EFO_0003763	I60-I69	—	2	1	—	2	5
Polycythemia vera	D011087		D45	—	3	1	—	—	4

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Hiv infections	D015658	EFO_0000764	B20	—	5	—	—	—	5
Hypercholesterolemia	D006937	HP_0003124		1	2	—	—	2	5
Hiv	D006678		O98.7	—	3	—	—	1	4
Tobacco use disorder	D014029		F17	1	3	—	—	—	4
Bipolar disorder	D001714	EFO_0000289	F30.9	—	4	—	—	—	4
Cognitive dysfunction	D060825		G31.84	—	1	—	—	2	3
Melanoma	D008545			—	2	—	—	—	2
Lung neoplasms	D008175		C34.90	—	2	—	—	—	2
Diet therapy	D004035			1	1	—	—	—	2
Head and neck neoplasms	D006258			1	1	—	—	—	2

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Therapeutic equivalency	D013810			3	—	—	—	—	3
Antiphospholipid syndrome	D016736	EFO_0002689	D68.61	1	—	—	—	2	3
Fallopian tube neoplasms	D005185			2	—	—	—	—	2
Drug interactions	D004347			2	—	—	—	—	2
Pharmacokinetics	D010599			2	—	—	—	—	2
Plasma cell neoplasms	D054219			1	—	—	—	—	1
Adenomyosis	D062788	EFO_1001757	N80.0	1	—	—	—	—	1
Aging	D000375	GO_0007568	R41.81	1	—	—	—	—	1
Postpartum period	D049590			1	—	—	—	—	1
Typhoid fever	D014435	EFO_0006789	A01.0	1	—	—	—	—	1

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Endotoxemia	D019446			—	—	—	—	2	2
Drug resistance	D004351		Z16.30	—	—	—	—	2	2
Asymptomatic diseases	D058070			—	—	—	—	2	2
Pregnancy rate	D018873			—	—	—	—	2	2
Heart valve prosthesis	D006350	EFO_0003906		—	—	—	—	1	1
Coronary occlusion	D054059		I21	—	—	—	—	1	1
May-thurner syndrome	D062108			—	—	—	—	1	1
Cerebral amyloid angiopathy	D016657	EFO_0006790	I68.0	—	—	—	—	1	1
Drug-related side effects and adverse reactions	D064420		T88.7	—	—	—	—	1	1
Disease-free survival	D018572	EFO_0000409		—	—	—	—	1	1

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Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	ASPIRIN
INN	carisoprodol
Description	Acetylsalicylic acid is a member of the class of benzoic acids that is salicylic acid in which the hydrogen that is attached to the phenolic hydroxy group has been replaced by an acetoxy group. A non-steroidal anti-inflammatory drug with cyclooxygenase inhibitor activity. It has a role as a non-steroidal anti-inflammatory drug, a non-narcotic analgesic, a platelet aggregation inhibitor, an antipyretic, a cyclooxygenase 2 inhibitor, a cyclooxygenase 1 inhibitor, a prostaglandin antagonist, a teratogenic agent, an anticoagulant, a plant activator, an EC 1.1.1.188 (prostaglandin-F synthase) inhibitor, a drug allergen and a geroprotector. It is a member of benzoic acids, a member of salicylates and a member of phenyl acetates. It is functionally related to a salicylic acid. It is a conjugate acid of an acetylsalicylate.
Classification	Small molecule
Drug class	—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	CC(=O)Oc1ccccc1C(=O)O

Identifiers

PDB	4NSB
CAS-ID	50-78-2
RxCUI	1191
ChEMBL ID	CHEMBL25
ChEBI ID	15365
PubChem CID	2244
DrugBank	DB00945
UNII ID	21925K482H (ChemIDplus, GSRS)

Target

Agency Approved

PTGS2

PTGS1

Organism

Homo sapiens

Gene name

PTGS2

Gene synonyms

COX2

NCBI Gene ID

5743

Protein name

prostaglandin G/H synthase 2

Protein synonyms

COX-2, cyclooxygenase 2, cyclooxygenase 2b, Cyclooxygenase-2, PGH synthase 2, PGHS-2, PHS II, Prostaglandin H2 synthase 2, Prostaglandin-endoperoxide synthase 2, prostaglandin-endoperoxide synthase 2 (prostaglandin G/H synthase and cyclooxygenase)

Uniprot ID

Q16876

Mouse ortholog

Ptgs2 (19225)

prostaglandin G/H synthase 2 (Q543K3)

Alternate

ASIC3

TRPV3

FPR2

Organism

Homo sapiens

Gene name

ASIC3

Gene synonyms

ACCN3, SLNAC1, TNAC1

NCBI Gene ID

9311

Protein name

acid-sensing ion channel 3

Protein synonyms

acid sensing (proton gated) ion channel 3, Amiloride-sensitive cation channel 3, amiloride-sensitive cation channel 3, testis, hTNaC1, modulatory subunit of ASIC2a, Neuronal amiloride-sensitive cation channel 3, proton-gated cation channel subunit, Testis sodium channel 1

Uniprot ID

Q9UHC4

Mouse ortholog

Asic3 (171209)

acid-sensing ion channel 3 (Q6X1Y6)

Variants

Clinical Variant

No data

Financial

Vazalore - PLx Pharma

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Trends

PubMed Central

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Safety

Black-box Warning

Black-box warning for: Darvon-n

Adverse Events

Top Adverse Reactions

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9,274 adverse events reported

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