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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.

PARACETAMOL: 581 Adverse Event Reports & Safety Profile

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581
Total FAERS Reports
127 (21.9%)
Deaths Reported
288
Hospitalizations
581
As Primary/Secondary Suspect
66
Life-Threatening
6
Disabilities

First Report: 19821203 · Latest Report: 20140616

What Are the Most Common PARACETAMOL Side Effects?

#1 Most Reported
Toxicity to various agents
68 reports (11.7%)
#2 Most Reported
Overdose
58 reports (10.0%)
#3 Most Reported
Vomiting
42 reports (7.2%)

All PARACETAMOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 68 11.7% 35 32
Overdose 58 10.0% 5 48
Vomiting 42 7.2% 8 28
Renal failure acute 37 6.4% 1 31
Intentional overdose 32 5.5% 5 28
Drug interaction 31 5.3% 16 2
Acute hepatic failure 30 5.2% 5 28
Completed suicide 30 5.2% 29 1
Cardiac arrest 27 4.7% 17 13
Drug abuse 25 4.3% 10 9
Urticaria 25 4.3% 0 6
Abdominal pain 24 4.1% 5 17
Alanine aminotransferase increased 23 4.0% 1 18
Agitation 22 3.8% 0 14
Confusional state 22 3.8% 0 16
Nausea 22 3.8% 0 19
Dyspnoea 21 3.6% 4 7
Angioedema 20 3.4% 0 3
Hepatic failure 19 3.3% 10 9
Tachycardia 19 3.3% 0 17

Who Reports PARACETAMOL Side Effects? Age & Gender Data

Average age: 45.1 years. Most reports from: GB. View detailed demographics →

Is PARACETAMOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 2
2003 1 1 0
2007 8 1 2
2008 2 0 1
2009 2 1 0
2010 7 3 2
2011 5 0 3
2012 17 4 11
2013 140 18 99
2014 112 10 59

View full timeline →

What Is PARACETAMOL Used For?

IndicationReports
Product used for unknown indication 209
Pain 40
Pyrexia 29
Analgesic therapy 12
Back pain 9
Suicide attempt 9
Abdominal pain 7
Influenza like illness 6
Arthralgia 5
Influenza 5

PARACETAMOL vs Alternatives: Which Is Safer?

PARACETAMOL vs PARATHYROID HORMONE PARACETAMOL vs PARECOXIB PARACETAMOL vs PARICALCITOL PARACETAMOL vs PARITAPREVIR PARACETAMOL vs PAROXETINE PARACETAMOL vs PAROXETINE\PAROXETINE PARACETAMOL vs PAROXETINE\PAROXETINE ANHYDROUS PARACETAMOL vs PASIREOTIDE PARACETAMOL vs PASIREOTIDE DIASPARTATE PARACETAMOL vs PATIROMER

Official FDA Label for PARACETAMOL

Official prescribing information from the FDA-approved drug label.