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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

ACETYLSALICYLIC ACID: 628 Adverse Event Reports & Safety Profile

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628
Total FAERS Reports
83 (13.2%)
Deaths Reported
259
Hospitalizations
628
As Primary/Secondary Suspect
49
Life-Threatening
11
Disabilities

First Report: 1975 · Latest Report: 20140609

What Are the Most Common ACETYLSALICYLIC ACID Side Effects?

#1 Most Reported
Angioedema
93 reports (14.8%)
#2 Most Reported
Gastrointestinal haemorrhage
32 reports (5.1%)
#3 Most Reported
Melaena
29 reports (4.6%)

All ACETYLSALICYLIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Angioedema 93 14.8% 0 7
Gastrointestinal haemorrhage 32 5.1% 7 21
Melaena 29 4.6% 2 28
Premature baby 25 4.0% 2 13
Anaemia 22 3.5% 1 18
Drug ineffective 22 3.5% 1 9
Exposure during pregnancy 21 3.3% 1 5
Toxicity to various agents 21 3.3% 17 10
Drug hypersensitivity 20 3.2% 0 2
Labelled drug-drug interaction medication error 20 3.2% 3 12
Low birth weight baby 19 3.0% 1 13
Maternal exposure during pregnancy 19 3.0% 1 5
Urticaria 19 3.0% 0 5
Completed suicide 18 2.9% 18 4
Epistaxis 18 2.9% 0 6
Dyspnoea 17 2.7% 0 5
Haemorrhage 17 2.7% 3 6
Vomiting 16 2.6% 4 9
Haematemesis 15 2.4% 0 15
Cerebral haemorrhage 14 2.2% 8 10

Who Reports ACETYLSALICYLIC ACID Side Effects? Age & Gender Data

Average age: 51.9 years. Most reports from: US. View detailed demographics →

Is ACETYLSALICYLIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 8 0 2
2004 3 0 0
2005 1 0 0
2006 2 0 1
2008 1 0 0
2009 14 1 11
2010 8 0 3
2011 6 3 5
2012 31 19 13
2013 86 6 47
2014 104 12 48

View full timeline →

What Is ACETYLSALICYLIC ACID Used For?

IndicationReports
Product used for unknown indication 58
Antiplatelet therapy 35
Prophylaxis 21
Anticoagulant therapy 13
Antiphospholipid syndrome 13
Coronary artery disease 13
Acute coronary syndrome 11
Cardiovascular event prophylaxis 9
Immune tolerance induction 9
Myocardial infarction 9

ACETYLSALICYLIC ACID vs Alternatives: Which Is Safer?

ACETYLSALICYLIC ACID vs ACITRETIN ACETYLSALICYLIC ACID vs ACLARUBICIN ACETYLSALICYLIC ACID vs ACLASTA ACETYLSALICYLIC ACID vs ACLIDINIUM ACETYLSALICYLIC ACID vs ACLIDINIUM\FORMOTEROL ACETYLSALICYLIC ACID vs ACORAMIDIS ACETYLSALICYLIC ACID vs ACTEMRA ACETYLSALICYLIC ACID vs ACTIQ ACETYLSALICYLIC ACID vs ACTIVATED CHARCOAL ACETYLSALICYLIC ACID vs ACTONEL

Official FDA Label for ACETYLSALICYLIC ACID

Official prescribing information from the FDA-approved drug label.