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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.

GUAIFENESIN\PSEUDOEPHEDRINE: 914 Adverse Event Reports & Safety Profile

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914
Total FAERS Reports
14 (1.5%)
Deaths Reported
15
Hospitalizations
914
As Primary/Secondary Suspect
2
Life-Threatening
3
Disabilities

Active Ingredient: GUAIFENESIN\PSEUDOEPHEDRINE HYDROCHLORIDE ·

First Report: 19950101 · Latest Report: 20250331

What Are the Most Common GUAIFENESIN\PSEUDOEPHEDRINE Side Effects?

#1 Most Reported
Drug ineffective
134 reports (14.7%)
#2 Most Reported
Insomnia
128 reports (14.0%)
#3 Most Reported
Accidental overdose
74 reports (8.1%)

All GUAIFENESIN\PSEUDOEPHEDRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 134 14.7% 0 1
Insomnia 128 14.0% 0 2
Accidental overdose 74 8.1% 0 0
Dizziness 67 7.3% 0 2
Overdose 61 6.7% 1 4
Nausea 45 4.9% 0 4
Product use in unapproved indication 37 4.1% 0 1
Headache 36 3.9% 0 0
Incorrect drug administration duration 34 3.7% 0 1
No adverse event 30 3.3% 0 0
Expired product administered 28 3.1% 0 0
Drug hypersensitivity 27 3.0% 0 0
Feeling abnormal 27 3.0% 0 1
Underdose 26 2.8% 0 2
Heart rate increased 25 2.7% 0 4
Incorrect product administration duration 25 2.7% 0 0
Vomiting 25 2.7% 1 1
Wrong technique in product usage process 25 2.7% 0 0
Blood pressure increased 23 2.5% 0 2
Dysuria 23 2.5% 0 0

Who Reports GUAIFENESIN\PSEUDOEPHEDRINE Side Effects? Age & Gender Data

Gender: 62.8% female, 37.2% male. Average age: 59.7 years. Most reports from: US. View detailed demographics →

Is GUAIFENESIN\PSEUDOEPHEDRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 1 0 0
2013 4 2 1
2014 14 0 1
2015 44 0 0
2016 96 0 1
2017 125 0 1
2018 62 1 0
2019 63 0 3
2020 34 0 0
2021 9 0 0
2022 39 0 0
2023 26 0 1
2024 27 0 0
2025 14 0 0

View full timeline →

What Is GUAIFENESIN\PSEUDOEPHEDRINE Used For?

IndicationReports
Product used for unknown indication 494
Nasal congestion 76
Cough 65
Respiratory tract congestion 58
Nasopharyngitis 52
Sinus congestion 28
Productive cough 27
Sinusitis 21
Rhinorrhoea 17
Hypersensitivity 15

GUAIFENESIN\PSEUDOEPHEDRINE vs Alternatives: Which Is Safer?

GUAIFENESIN\PSEUDOEPHEDRINE vs GUANFACINE GUAIFENESIN\PSEUDOEPHEDRINE vs GUSELKUMAB GUAIFENESIN\PSEUDOEPHEDRINE vs HAIR KERATIN AMINO ACIDS GOLD COMPLEX GUAIFENESIN\PSEUDOEPHEDRINE vs HALDOL GUAIFENESIN\PSEUDOEPHEDRINE vs HALOBETASOL GUAIFENESIN\PSEUDOEPHEDRINE vs HALOPERIDOL GUAIFENESIN\PSEUDOEPHEDRINE vs HALOPERIDOL DECANOATE GUAIFENESIN\PSEUDOEPHEDRINE vs HECTOROL GUAIFENESIN\PSEUDOEPHEDRINE vs HEMIN GUAIFENESIN\PSEUDOEPHEDRINE vs HEPARIN

Official FDA Label for GUAIFENESIN\PSEUDOEPHEDRINE

Official prescribing information from the FDA-approved drug label.