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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\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE: 467 Adverse Event Reports & Safety Profile

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467
Total FAERS Reports
111 (23.8%)
Deaths Reported
144
Hospitalizations
467
As Primary/Secondary Suspect
39
Life-Threatening
10
Disabilities

Active Ingredient: ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE SUCCINATE ·

First Report: 1990 · Latest Report: 20250826

What Are the Most Common ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE Side Effects?

#1 Most Reported
Toxicity to various agents
75 reports (16.1%)
#2 Most Reported
Completed suicide
44 reports (9.4%)
#3 Most Reported
Intentional overdose
38 reports (8.1%)

All ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 75 16.1% 40 55
Completed suicide 44 9.4% 44 16
Intentional overdose 38 8.1% 3 33
Loss of consciousness 34 7.3% 0 24
Drug ineffective 33 7.1% 1 5
Vomiting 31 6.6% 0 11
Overdose 29 6.2% 2 14
Nasopharyngitis 27 5.8% 0 4
Dizziness 25 5.4% 0 4
Dyspnoea 22 4.7% 0 3
Sinus tachycardia 22 4.7% 0 22
Death 21 4.5% 21 7
Feeling abnormal 21 4.5% 0 0
Cough 20 4.3% 0 2
Insomnia 19 4.1% 0 3
Lactic acidosis 19 4.1% 0 19
Somnolence 19 4.1% 0 6
Nausea 18 3.9% 0 5
Suicide attempt 18 3.9% 0 15
Blood glucose increased 17 3.6% 0 14

Who Reports ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE Side Effects? Age & Gender Data

Gender: 64.5% female, 35.5% male. Average age: 44.9 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 3 2 2
2005 1 0 0
2007 2 1 0
2008 2 0 1
2009 1 0 0
2010 4 0 1
2011 4 1 2
2012 6 0 6
2013 8 5 0
2014 20 2 3
2015 29 1 5
2016 20 4 9
2017 28 7 10
2018 11 6 3
2019 11 0 0
2020 9 0 2
2021 12 2 6
2022 26 3 3
2023 13 4 4
2024 8 0 2
2025 6 0 2

View full timeline →

What Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE Used For?

IndicationReports
Product used for unknown indication 198
Nasopharyngitis 52
Cough 20
Influenza 13
Pyrexia 7
Insomnia 6
Oropharyngeal pain 6
Suicide attempt 6
Sleep disorder therapy 5
Upper respiratory tract infection 5

ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs Alternatives: Which Is Safer?

ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN\PHENYLEPHRINE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\DIHYDROCODEINE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\DIPHENHYDRAMINE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\HYDROCODONE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN/HYDROCODONE ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\IBUPROFEN ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\METHOCARBAMOL ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE vs ACETAMINOPHEN\OPIUM

Official FDA Label for ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE

Official prescribing information from the FDA-approved drug label.