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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\GUAIFENESIN\PHENYLEPHRINE: 340 Adverse Event Reports & Safety Profile

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340
Total FAERS Reports
15 (4.4%)
Deaths Reported
51
Hospitalizations
340
As Primary/Secondary Suspect
10
Life-Threatening
3
Disabilities

Active Ingredient: ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 2005 · Latest Report: 20250504

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

#1 Most Reported
Choking
46 reports (13.5%)
#2 Most Reported
Drug ineffective
35 reports (10.3%)
#3 Most Reported
Dizziness
28 reports (8.2%)

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

Side Effect Reports % of Total Deaths Hosp.
Choking 46 13.5% 0 0
Drug ineffective 35 10.3% 2 8
Dizziness 28 8.2% 0 2
Dyspnoea 25 7.4% 1 3
Foreign body in throat 20 5.9% 0 0
Nausea 20 5.9% 0 4
Loss of consciousness 19 5.6% 0 1
Vomiting 18 5.3% 0 7
Overdose 17 5.0% 1 6
Product use complaint 16 4.7% 0 0
Somnolence 16 4.7% 0 4
Urticaria 16 4.7% 0 1
Diarrhoea 15 4.4% 0 4
Hallucination 14 4.1% 0 0
Headache 14 4.1% 0 2
Abdominal pain upper 13 3.8% 0 5
Drug administration error 12 3.5% 0 1
Feeling abnormal 11 3.2% 0 2
Oropharyngeal pain 11 3.2% 0 0
Rash 11 3.2% 0 0

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

Gender: 68.0% female, 32.0% male. Average age: 48.8 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2005 2 0 1
2007 1 0 1
2009 1 0 0
2012 3 2 1
2013 4 0 3
2014 16 1 4
2015 39 1 7
2016 23 0 3
2017 26 2 5
2018 16 0 2
2019 21 1 5
2020 17 0 2
2021 10 0 0
2022 16 1 2
2023 14 0 1
2024 12 0 0
2025 5 0 0

View full timeline →

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

IndicationReports
Nasopharyngitis 115
Product used for unknown indication 101
Cough 41
Hypersensitivity 23
Influenza 23
Oropharyngeal pain 13
Nasal congestion 12
Respiratory tract congestion 8
Rhinorrhoea 7
Malaise 6

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

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

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

Official prescribing information from the FDA-approved drug label.