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.

BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE: 77 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
77
Total FAERS Reports
10 (13.0%)
Deaths Reported
39
Hospitalizations
77
As Primary/Secondary Suspect
1
Life-Threatening
3
Disabilities

Active Ingredient: BROMPHENIRAMINE MALEATE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 20140514 · Latest Report: 20250225

What Are the Most Common BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Headache
8 reports (10.4%)
#2 Most Reported
Vomiting
7 reports (9.1%)
#3 Most Reported
Nausea
7 reports (9.1%)

All BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Headache 8 10.4% 0 3
Nausea 7 9.1% 0 3
Vomiting 7 9.1% 1 4
Dyspnoea 6 7.8% 0 3
Tachycardia 6 7.8% 1 5
Death 5 6.5% 5 0
Insomnia 5 6.5% 0 3
Somnolence 5 6.5% 0 2

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

Gender: 53.8% female, 46.2% male. Average age: 41.2 years. Most reports from: US. View detailed demographics →

Is BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 1 0 1
2015 3 0 0
2016 3 0 1
2017 5 0 0
2018 3 3 0
2019 2 0 0
2020 1 0 0
2021 1 0 0
2022 2 0 1
2023 2 0 1
2024 4 0 1
2025 1 0 0

View full timeline →

What Is BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE Used For?

IndicationReports
Product used for unknown indication 25
Cough 12

Official FDA Label for BROMPHENIRAMINE\DEXTROMETHORPHAN HYDROBROMIDE\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.