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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: 114 Adverse Event Reports & Safety Profile

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114
Total FAERS Reports
6 (5.3%)
Deaths Reported
18
Hospitalizations
114
As Primary/Secondary Suspect

First Report: 19740101 · Latest Report: 20250804

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

#1 Most Reported
Drug ineffective
24 reports (21.1%)
#2 Most Reported
Product use in unapproved indication
17 reports (14.9%)
#3 Most Reported
Recalled product administered
15 reports (13.2%)

All ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 24 21.1% 0 7
Product use in unapproved indication 17 14.9% 0 0
Recalled product administered 15 13.2% 0 3
Nausea 14 12.3% 0 8
Therapeutic product effect incomplete 11 9.7% 0 7
Dyspepsia 10 8.8% 0 7
Drug effective for unapproved indication 9 7.9% 0 0
Headache 9 7.9% 0 7
Malaise 9 7.9% 0 7
Abdominal pain 8 7.0% 0 8
Constipation 8 7.0% 0 8
Erythema 8 7.0% 0 8
Haematochezia 8 7.0% 0 7
Pain 8 7.0% 0 7
Paraesthesia oral 8 7.0% 0 7
Pyrexia 8 7.0% 0 8
Anaemia 7 6.1% 0 7
Chronic sinusitis 7 6.1% 0 7
Colitis 7 6.1% 0 7
Female genital tract fistula 7 6.1% 0 7

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

Gender: 71.2% female, 28.8% male. Average age: 53.5 years. Most reports from: US. View detailed demographics →

Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 1 0
2020 2 0 0
2021 1 0 0
2022 3 1 0
2023 6 1 0
2024 8 0 2
2025 3 0 0

View full timeline →

What Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE Used For?

IndicationReports
Product used for unknown indication 54
Nasopharyngitis 19
Cough 12
Influenza 8
Oropharyngeal pain 7
Pain 6

ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE vs Alternatives: Which Is Safer?

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

Official FDA Label for ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE

Official prescribing information from the FDA-approved drug label.