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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is PARACETAMOL Used For?
| Indication | Reports |
|---|---|
| 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.