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ACETYLSALICYLIC ACID

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Acetylsalicylic Acid Adverse Events Reported to the FDA Over Time

How are Acetylsalicylic Acid adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Acetylsalicylic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Acetylsalicylic Acid is flagged as the suspect drug causing the adverse event.

Most Common Acetylsalicylic Acid Adverse Events Reported to the FDA

What are the most common Acetylsalicylic Acid adverse events reported to the FDA?

Gastrointestinal Haemorrhage
204 (1.47%)
Completed Suicide
182 (1.31%)
Anaemia
164 (1.18%)
Angioedema
158 (1.14%)
Drug Interaction
141 (1.02%)
Renal Failure Acute
126 (.91%)
Hypotension
125 (.9%)
Dizziness
122 (.88%)
Vomiting
120 (.86%)
Nausea
119 (.86%)
Haemoglobin Decreased
106 (.76%)
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Haematemesis
100 (.72%)
Melaena
95 (.68%)
Drug Ineffective
94 (.68%)
Confusional State
87 (.63%)
Drug Toxicity
87 (.63%)
Somnolence
87 (.63%)
Asthenia
85 (.61%)
Haemorrhage
83 (.6%)
Overdose
83 (.6%)
Headache
82 (.59%)
Dyspnoea
81 (.58%)
Cerebrovascular Accident
80 (.58%)
Gastric Ulcer
79 (.57%)
Cerebral Haemorrhage
72 (.52%)
Cardiac Arrest
71 (.51%)
Diarrhoea
71 (.51%)
Malaise
70 (.5%)
Epistaxis
68 (.49%)
Pain
68 (.49%)
Drug Hypersensitivity
62 (.45%)
Myocardial Infarction
60 (.43%)
Abdominal Pain
58 (.42%)
Pneumonia
58 (.42%)
Pyrexia
58 (.42%)
Hypoglycaemia
57 (.41%)
Multiple Drug Overdose
57 (.41%)
Coma
56 (.4%)
Suicide Attempt
56 (.4%)
Therapeutic Agent Toxicity
56 (.4%)
Chest Pain
55 (.4%)
Hypertension
55 (.4%)
Death
54 (.39%)
Fatigue
54 (.39%)
Loss Of Consciousness
54 (.39%)
Intentional Overdose
52 (.37%)
Rash
52 (.37%)
Fall
51 (.37%)
Rectal Haemorrhage
51 (.37%)
Urinary Tract Infection
51 (.37%)
Convulsion
49 (.35%)
Haemoptysis
49 (.35%)
Syncope
49 (.35%)
Weight Decreased
49 (.35%)
Anxiety
48 (.35%)
Atrial Fibrillation
48 (.35%)
Hyperhidrosis
47 (.34%)
Thrombocytopenia
47 (.34%)
Renal Failure
46 (.33%)
General Physical Health Deteriorati...
45 (.32%)
Tremor
45 (.32%)
Drug Exposure During Pregnancy
44 (.32%)
Decreased Appetite
43 (.31%)
Haematoma
42 (.3%)
Blood Creatinine Increased
41 (.3%)
Condition Aggravated
41 (.3%)
Dehydration
41 (.3%)
Haematuria
41 (.3%)
Acute Myocardial Infarction
40 (.29%)
Contusion
40 (.29%)
Depression
40 (.29%)
Jaundice
40 (.29%)
Insomnia
39 (.28%)
Constipation
38 (.27%)
Gastritis Erosive
38 (.27%)
Stevens-johnson Syndrome
38 (.27%)
Upper Gastrointestinal Haemorrhage
38 (.27%)
Acute Respiratory Distress Syndrome
37 (.27%)
Agitation
37 (.27%)
Alanine Aminotransferase Increased
37 (.27%)
Gastritis
37 (.27%)
Haematochezia
37 (.27%)
Heart Rate Increased
37 (.27%)
Urticaria
37 (.27%)
Circulatory Collapse
36 (.26%)
Feeling Abnormal
36 (.26%)
Multi-organ Failure
36 (.26%)
International Normalised Ratio Incr...
35 (.25%)
Tachycardia
35 (.25%)
Blood Pressure Decreased
34 (.24%)
Blood Pressure Increased
34 (.24%)
Duodenal Ulcer
34 (.24%)
Myalgia
34 (.24%)
Pruritus
34 (.24%)
Renal Impairment
34 (.24%)
Oedema Peripheral
33 (.24%)
Rhabdomyolysis
33 (.24%)
Abdominal Pain Upper
32 (.23%)
Transient Ischaemic Attack
32 (.23%)
Cardiac Failure
31 (.22%)
Depressed Level Of Consciousness
31 (.22%)

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This graph shows the top adverse events submitted to the FDA for Acetylsalicylic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Acetylsalicylic Acid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Acetylsalicylic Acid

What are the most common Acetylsalicylic Acid adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Acetylsalicylic Acid, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Acetylsalicylic Acid is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Acetylsalicylic Acid According to Those Reporting Adverse Events

Why are people taking Acetylsalicylic Acid, according to those reporting adverse events to the FDA?

Drug Use For Unknown Indication
2452
Prophylaxis
692
Product Used For Unknown Indication
602
Cardiac Disorder
519
Anticoagulant Therapy
383
Coronary Artery Disease
375
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Thrombosis Prophylaxis
303
Cardiovascular Event Prophylaxis
299
Myocardial Infarction
196
Hypertension
192
Myocardial Ischaemia
149
Ischaemic Heart Disease Prophylaxis
144
Atrial Fibrillation
142
Antiplatelet Therapy
140
Pain
132
Headache
120
Cerebrovascular Accident
118
Ill-defined Disorder
115
Acute Coronary Syndrome
81
Angina Pectoris
79
Cardiovascular Disorder
69
Transient Ischaemic Attack
66
Acute Myocardial Infarction
55
Cerebrovascular Accident Prophylaxi...
47
Flushing
44
Migraine
42
Nasopharyngitis
40
Peripheral Arterial Occlusive Disea...
40
Cerebral Infarction
39
Stent Placement
38
Platelet Aggregation Inhibition
38
Essential Thrombocythaemia
33
Arthritis
32
Back Pain
31
Blood Disorder
31
Arteriosclerosis
29
Blood Cholesterol Increased
27
Coagulopathy
27
Arthralgia
26
Ischaemic Cardiomyopathy
25
Coronary Arterial Stent Insertion
25
Thrombosis
24
Diabetes Mellitus
24
Suicide Attempt
23
Cardiac Failure
21
Chest Pain
21
Premedication
20
Type 2 Diabetes Mellitus
17
Arrhythmia
16
Kawasakis Disease
15
Influenza
14

Acetylsalicylic Acid Case Reports

What Acetylsalicylic Acid safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Acetylsalicylic Acid. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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