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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\PHENYLEPHRINE: 377 Adverse Event Reports & Safety Profile

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377
Total FAERS Reports
13 (3.4%)
Deaths Reported
31
Hospitalizations
377
As Primary/Secondary Suspect
18
Life-Threatening
3
Disabilities

Active Ingredient: ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE SUCCINATE\PHENYLEPHRINE ·

First Report: 1990 · Latest Report: 20250902

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

#1 Most Reported
Choking
155 reports (41.1%)
#2 Most Reported
Foreign body in throat
98 reports (26.0%)
#3 Most Reported
Product use complaint
56 reports (14.9%)

All ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Choking 155 41.1% 0 1
Foreign body in throat 98 26.0% 0 0
Product use complaint 56 14.9% 0 0
Oropharyngeal pain 26 6.9% 0 2
Retching 25 6.6% 0 0
Dyspnoea 20 5.3% 0 2
Drug ineffective 18 4.8% 0 1
Vomiting 17 4.5% 0 6
Foreign body in respiratory tract 16 4.2% 0 0
Wrong technique in product usage process 15 4.0% 0 0
Dizziness 13 3.5% 0 3
Foreign body 11 2.9% 0 0
Somnolence 11 2.9% 0 3
Feeling abnormal 10 2.7% 0 0
Cough 9 2.4% 0 2
Diarrhoea 9 2.4% 0 3
Incorrect dose administered 9 2.4% 0 0
Product size issue 9 2.4% 0 0
Expired product administered 8 2.1% 1 0
Headache 8 2.1% 0 2

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

Gender: 70.2% female, 29.8% male. Average age: 59.2 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2011 1 0 0
2013 1 0 1
2014 21 1 3
2015 28 0 1
2016 11 0 2
2017 17 0 1
2018 20 0 4
2019 17 1 0
2020 19 1 2
2021 12 0 2
2022 21 0 0
2023 17 0 1
2024 18 0 0
2025 8 0 0

View full timeline →

What Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE Used For?

IndicationReports
Nasopharyngitis 186
Hypersensitivity 107
Product used for unknown indication 22
Allergic respiratory symptom 19
Influenza 12
Cough 11
Sinus congestion 8
Oropharyngeal pain 5
Pain 5

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

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

Official FDA Label for ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\DOXYLAMINE\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.