Skip to content
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\PHENYLEPHRINE: 183 Adverse Event Reports & Safety Profile

Boost Your Natural Energy & Metabolism

Mitolyn — 6 exotic plants to unlock your body's fat-burning power. 90-day guarantee.

Try Mitolyn Now
183
Total FAERS Reports
23 (12.6%)
Deaths Reported
34
Hospitalizations
183
As Primary/Secondary Suspect
11
Life-Threatening
3
Disabilities

Active Ingredient: ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 20050909 · Latest Report: 20250101

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

#1 Most Reported
Choking
30 reports (16.4%)
#2 Most Reported
Foreign body in throat
19 reports (10.4%)
#3 Most Reported
Drug ineffective
19 reports (10.4%)

All ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Choking 30 16.4% 0 0
Drug ineffective 19 10.4% 0 4
Foreign body in throat 19 10.4% 0 0
Dyspnoea 13 7.1% 0 4
Vomiting 13 7.1% 0 2
Toxicity to various agents 12 6.6% 11 8
Dizziness 11 6.0% 0 4
Product use complaint 9 4.9% 0 0
Nausea 8 4.4% 0 0
Loss of consciousness 7 3.8% 0 2
Anxiety 6 3.3% 0 2
Asthenia 6 3.3% 0 3
Cough 6 3.3% 0 2
Drug administration error 6 3.3% 0 0
Exposure to toxic agent 6 3.3% 6 0
Hypersensitivity 6 3.3% 0 3
Malaise 6 3.3% 0 2
Abdominal pain upper 5 2.7% 0 4
Expired product administered 5 2.7% 0 0
Feeling abnormal 5 2.7% 0 1

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

Gender: 58.8% female, 41.2% male. Average age: 51.6 years. Most reports from: US. View detailed demographics →

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

YearReportsDeathsHosp.
2005 1 0 0
2007 1 0 1
2010 1 0 1
2011 1 0 0
2012 3 1 1
2014 4 0 1
2015 11 0 2
2016 14 0 3
2017 8 0 2
2018 13 0 2
2019 9 0 2
2020 6 1 1
2021 8 3 2
2022 6 2 1
2023 10 1 2
2024 6 0 0
2025 1 0 0

View full timeline →

What Is ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE Used For?

IndicationReports
Nasopharyngitis 68
Product used for unknown indication 46
Hypersensitivity 22
Cough 16
Influenza 13
Nasal congestion 8
Allergic respiratory symptom 6

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

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

Official FDA Label for ACETAMINOPHEN\DEXTROMETHORPHAN HYDROBROMIDE\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.