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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.

ACETAMINOPHEN\OPIUM: 702 Adverse Event Reports & Safety Profile

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702
Total FAERS Reports
32 (4.6%)
Deaths Reported
477
Hospitalizations
702
As Primary/Secondary Suspect
87
Life-Threatening
11
Disabilities

First Report: 20080901 · Latest Report: 20250903

What Are the Most Common ACETAMINOPHEN\OPIUM Side Effects?

#1 Most Reported
Coma
87 reports (12.4%)
#2 Most Reported
Poisoning deliberate
80 reports (11.4%)
#3 Most Reported
Acute kidney injury
75 reports (10.7%)

All ACETAMINOPHEN\OPIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Coma 87 12.4% 5 76
Poisoning deliberate 80 11.4% 2 65
Acute kidney injury 75 10.7% 11 49
Somnolence 69 9.8% 6 53
Confusional state 45 6.4% 1 42
Drug use disorder 45 6.4% 0 19
Drug abuse 42 6.0% 1 21
Fall 41 5.8% 3 36
Hepatic cytolysis 35 5.0% 0 14
Vomiting 35 5.0% 0 26
Toxicity to various agents 34 4.8% 2 29
Hepatocellular injury 32 4.6% 0 26
Hypotension 29 4.1% 1 28
Condition aggravated 28 4.0% 0 26
Pancreatitis acute 28 4.0% 0 21
Bradypnoea 27 3.9% 0 27
Lactic acidosis 27 3.9% 0 16
Miosis 27 3.9% 0 22
Cholestasis 24 3.4% 0 10
Overdose 22 3.1% 2 18

Who Reports ACETAMINOPHEN\OPIUM Side Effects? Age & Gender Data

Gender: 69.1% female, 30.9% male. Average age: 55.9 years. Most reports from: FR. View detailed demographics →

Is ACETAMINOPHEN\OPIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 8 1 8
2013 1 0 0
2015 3 0 0
2016 12 0 11
2017 19 0 16
2018 91 8 79
2019 83 0 65
2020 74 2 57
2021 63 0 55
2022 106 9 56
2023 45 3 28
2024 91 2 48
2025 43 6 22

View full timeline →

What Is ACETAMINOPHEN\OPIUM Used For?

IndicationReports
Product used for unknown indication 233
Pain 156
Back pain 62
Intentional overdose 32
Sciatica 21
Toxicity to various agents 13
Poisoning deliberate 12
Analgesic intervention supportive therapy 11
Hiatus hernia 10
Migraine 10

ACETAMINOPHEN\OPIUM vs Alternatives: Which Is Safer?

ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\OXYCODONE ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\OXYCODONE\OXYCODONE ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\OXYCODONE\OXYCODONE TEREPHTHALATE ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\PROPOXYPHENE ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\PSEUDOEPHEDRINE ACETAMINOPHEN\OPIUM vs ACETAMINOPHEN\TRAMADOL ACETAMINOPHEN\OPIUM vs ACETAZOLAMIDE ACETAMINOPHEN\OPIUM vs ACETYLCYSTEINE ACETAMINOPHEN\OPIUM vs ACETYLLEUCINE ACETAMINOPHEN\OPIUM vs ACETYLLEUCINE, L-

Official FDA Label for ACETAMINOPHEN\OPIUM

Official prescribing information from the FDA-approved drug label.