Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Acetylsalicylic acid
Drug ID BADD_D00033
Description Also known as _Aspirin_, acetylsalicylic acid (ASA) is a commonly used drug for the treatment of pain and fever due to various causes. Acetylsalicylic acid has both anti-inflammatory and antipyretic effects. This drug also inhibits platelet aggregation and is used in the prevention of blood clots stroke, and myocardial infarction (MI) [FDA label]. Interestingly, the results of various studies have demonstrated that long-term use of acetylsalicylic acid may decrease the risk of various cancers, including colorectal, esophageal, breast, lung, prostate, liver and skin cancer [A177325]. Aspirin is classified as a _non-selective cyclooxygenase (COX) inhibitor_ [A32682, A177268] and is available in many doses and forms, including chewable tablets, suppositories, extended release formulations, and others [L5968]. Acetylsalicylic acid is a very common cause of accidental poisoning in young children. It should be kept out of reach from young children, toddlers, and infants [FDA label].
Indications and Usage **Pain, fever, and inflammation** Acetylsalicylic acid (ASA), in the regular tablet form (immediate-release), is indicated to relieve pain, fever, and inflammation associated with many conditions, including the flu, the common cold, neck and back pain, dysmenorrhea, headache, tooth pain, sprains, fractures, myositis, neuralgia, synovitis, arthritis, bursitis, burns, and various injuries. It is also used for symptomatic pain relief after surgical and dental procedures [FDA label]. The _extra strength_ formulation of acetylsalicylic acid is also indicated for the management migraine pain with photophobia (sensitivity to light) and phonophobia (sensitivity to sound)[FDA label]. **Other indications** ASA is also indicated for various other purposes, due to its ability to inhibit platelet aggregation. These include: Reducing the risk of cardiovascular death in suspected cases of myocardial infarction (MI) [FDA label]. Reducing the risk of a first non-fatal myocardial infarction in patients, and for reducing the risk of morbidity and mortality in cases of unstable angina and in those who have had a prior myocardial infarction [FDA label]. For reducing the risk of transient ischemic attacks (TIA) and to prevent atherothrombotic cerebral infarction (in conjunction with other treatments) [FDA label]. For the prevention of thromboembolism after hip replacement surgery [FDA label]. For decreasing platelet to platelet adhesion following carotid endarterectomy, aiding in the prevention of transient ischemic attacks (TIA) [FDA label]. Used for patients undergoing hemodialysis with a silicone rubber arteriovenous cannula inserted to prevent thrombosis at the insertion site [FDA Label]. **Important note regarding use of the extended-release formulation [F4405]** In the setting of acute myocardial infarction, or before percutaneous interventions, the extended-release form of acetylsalicylic acid should not be used. Use immediate-release formulations in scenarios requiring rapid onset of action [Label, F4405]. The extended-release form is taken to decrease the incidence of mortality and myocardial infarction (MI) for individuals diagnosed with chronic coronary artery disease (CAD), including patients with previous myocardial infarction (MI) or unstable angina or with chronic stable angina. Additionally, the extended-release form is used to decrease the risk of death and recurrent episodes of stroke in patients with a history of stroke or TIA [F4405].
Marketing Status approved; vet_approved
ATC Code A01AD05; B01AC06; N02BA01
DrugBank ID DB00945
KEGG ID D00109
MeSH ID D001241
PubChem ID 2244
TTD Drug ID D0GY5Z
NDC Product Code 73678-160; 80363-001
UNII R16CO5Y76E
Synonyms Aspirin | Acetylsalicylic Acid | Acid, Acetylsalicylic | 2-(Acetyloxy)benzoic Acid | Acylpyrin | Aloxiprimum | Colfarit | Dispril | Easprin | Ecotrin | Endosprin | Magnecyl | Micristin | Polopirin | Polopiryna | Solprin | Solupsan | Zorprin | Acetysal
Chemical Information
Molecular Formula C9H8O4
CAS Registry Number 50-78-2
SMILES CC(=O)OC1=CC=CC=C1C(=O)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.0010.000055%
Abdominal pain07.01.05.0020.000358%
Abdominal pain upper07.01.05.0030.000214%
Abdominal tenderness07.01.05.0040.000022%Not Available
Abortion18.01.01.0010.000022%Not Available
Abortion spontaneous18.01.04.0010.000077%Not Available
Acidosis14.01.03.002--
Acute hepatic failure09.01.03.0010.000044%Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000210%Not Available
Acute respiratory distress syndrome24.03.02.034; 10.02.01.067; 22.01.03.0010.000033%
Acute respiratory failure22.02.06.001; 14.01.04.0040.000044%Not Available
Adrenal insufficiency05.01.02.001; 14.11.01.004--
Agitation19.06.02.001; 17.02.05.012--
Agranulocytosis01.02.03.0010.000022%Not Available
Anaemia01.03.02.0010.000745%
Anaphylactic reaction10.01.07.001; 24.06.03.0060.000354%
Anaphylactic shock24.06.02.004; 10.01.07.0020.000033%Not Available
Angina pectoris24.04.04.002; 02.02.02.0020.000088%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.0090.000564%Not Available
Arrhythmia02.03.02.0010.000082%Not Available
Arteriosclerosis24.04.02.0010.000022%Not Available
Arteriospasm coronary12.02.01.031; 24.04.04.005; 02.02.02.0050.000022%Not Available
Arthralgia15.01.02.001--
Asthenia08.01.01.0010.000336%Not Available
Asthma22.03.01.002; 10.01.03.0100.000336%Not Available
Atrial fibrillation02.03.03.0020.000111%
Atrioventricular block02.03.01.0020.000022%Not Available
Atrioventricular block complete02.03.01.0030.000022%
Benign prostatic hyperplasia21.04.02.0010.000044%Not Available
Blindness06.02.10.003; 17.17.01.0030.000033%Not Available
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ADReCS-Target
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