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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.

IBUPROFEN\PHENYLEPHRINE: 1,248 Adverse Event Reports & Safety Profile

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1,248
Total FAERS Reports
0
Deaths Reported
8
Hospitalizations
1,248
As Primary/Secondary Suspect
2
Disabilities

Active Ingredient: IBUPROFEN\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 2013 · Latest Report: 20240901

What Are the Most Common IBUPROFEN\PHENYLEPHRINE Side Effects?

#1 Most Reported
Drug ineffective
385 reports (30.8%)
#2 Most Reported
Product use in unapproved indication
296 reports (23.7%)
#3 Most Reported
Drug effective for unapproved indication
263 reports (21.1%)

All IBUPROFEN\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 385 30.9% 0 1
Product use in unapproved indication 296 23.7% 0 0
Drug effective for unapproved indication 263 21.1% 0 0
Drug effect incomplete 96 7.7% 0 0
Therapeutic product effect incomplete 72 5.8% 0 0
Drug ineffective for unapproved indication 57 4.6% 0 0
Therapeutic response unexpected 54 4.3% 0 0
Somnolence 48 3.9% 0 1
Pre-existing condition improved 45 3.6% 0 0
Feeling abnormal 29 2.3% 0 0
Product use issue 29 2.3% 0 0
Drug effect less than expected 25 2.0% 0 0
Condition aggravated 23 1.8% 0 0
Hypersensitivity 19 1.5% 0 1
Malaise 18 1.4% 0 0
Headache 16 1.3% 0 1
Dizziness 14 1.1% 0 1
Intentional product misuse 14 1.1% 0 0
Fatigue 13 1.0% 0 0
Insomnia 13 1.0% 0 1

Who Reports IBUPROFEN\PHENYLEPHRINE Side Effects? Age & Gender Data

Gender: 76.7% female, 23.3% male. Average age: 41.5 years. Most reports from: US. View detailed demographics →

Is IBUPROFEN\PHENYLEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 2 0 0
2014 6 0 0
2015 18 0 1
2016 8 0 0
2017 12 0 1
2018 10 0 1
2019 31 0 0
2020 32 0 1
2021 9 0 0
2022 12 0 0
2023 13 0 0
2024 5 0 0

View full timeline →

What Is IBUPROFEN\PHENYLEPHRINE Used For?

IndicationReports
Nasal congestion 190
Product used for unknown indication 148
Headache 141
Nasopharyngitis 123
Sinus congestion 122
Pain 111
Paranasal sinus discomfort 83
Sinusitis 80
Hypersensitivity 74
Sinus disorder 62

IBUPROFEN\PHENYLEPHRINE vs Alternatives: Which Is Safer?

IBUPROFEN\PHENYLEPHRINE vs IBUPROFEN\PSEUDOEPHEDRINE IBUPROFEN\PHENYLEPHRINE vs ICATIBANT IBUPROFEN\PHENYLEPHRINE vs ICHTHAMMOL\ZINC IBUPROFEN\PHENYLEPHRINE vs ICLUSIG IBUPROFEN\PHENYLEPHRINE vs ICODEXTRIN IBUPROFEN\PHENYLEPHRINE vs ICOSAPENT IBUPROFEN\PHENYLEPHRINE vs ICOSAPENT ETHYL IBUPROFEN\PHENYLEPHRINE vs IDARUBICIN IBUPROFEN\PHENYLEPHRINE vs IDARUCIZUMAB IBUPROFEN\PHENYLEPHRINE vs IDECABTAGENE VICLEUCEL

Official FDA Label for IBUPROFEN\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.