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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\BELLADONNA LEAF\CAFFEINE\OPIUM: 420 Adverse Event Reports & Safety Profile

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420
Total FAERS Reports
46 (11.0%)
Deaths Reported
273
Hospitalizations
420
As Primary/Secondary Suspect
47
Life-Threatening
15
Disabilities

First Report: 2000 · Latest Report: 20250512

What Are the Most Common ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM Side Effects?

#1 Most Reported
Somnolence
51 reports (12.1%)
#2 Most Reported
Poisoning deliberate
40 reports (9.5%)
#3 Most Reported
Acute kidney injury
33 reports (7.9%)

All ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Somnolence 51 12.1% 7 40
Poisoning deliberate 40 9.5% 4 23
Acute kidney injury 33 7.9% 4 21
Hypotension 32 7.6% 0 24
Coma 30 7.1% 0 17
Fall 30 7.1% 0 30
Rhabdomyolysis 25 6.0% 0 25
Pneumonia aspiration 24 5.7% 7 14
Anaemia 22 5.2% 10 12
Nausea 22 5.2% 0 19
Drug use disorder 20 4.8% 0 8
Intentional overdose 20 4.8% 0 14
Vomiting 20 4.8% 0 18
Cholestasis 18 4.3% 0 13
Pancreatitis acute 18 4.3% 0 18
Miosis 17 4.1% 0 16
Confusional state 16 3.8% 1 15
Malaise 16 3.8% 0 11
Respiratory distress 16 3.8% 11 7
Eosinophilia 15 3.6% 0 14

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

Gender: 64.6% female, 35.4% male. Average age: 60.2 years. Most reports from: FR. View detailed demographics →

Is ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 1
2006 3 0 3
2012 2 0 2
2013 4 4 4
2014 5 0 0
2015 8 0 6
2017 30 3 21
2018 79 13 60
2019 91 0 66
2020 40 6 26
2021 30 0 25
2022 35 9 20
2023 37 6 15
2024 15 3 4
2025 10 0 3

View full timeline →

What Is ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM Used For?

IndicationReports
Pain 156
Product used for unknown indication 109
Back pain 19
Toxicity to various agents 14
Intentional overdose 13
Arthralgia 12
Migraine 9
Poisoning deliberate 9
Procedural pain 7
Gait disturbance 6

ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs Alternatives: Which Is Safer?

ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\BUTALBITAL ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\BUTALBITAL\CAFFEINE\CODEINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE\CODEINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE\DIHYDROCODEINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE\OPIUM ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE\PROPYPHENAZONE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CAFFEINE\PYRILAMINE ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM vs ACETAMINOPHEN\CHLORPHENIRAMINE

Official FDA Label for ACETAMINOPHEN\BELLADONNA LEAF\CAFFEINE\OPIUM

Official prescribing information from the FDA-approved drug label.