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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.

CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE: 484 Adverse Event Reports & Safety Profile

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484
Total FAERS Reports
0
Deaths Reported
4
Hospitalizations
484
As Primary/Secondary Suspect

Active Ingredient: CHLORPHENIRAMINE MALEATE\IBUPROFEN\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 20140702 · Latest Report: 20250209

What Are the Most Common CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE Side Effects?

#1 Most Reported
Drug ineffective
149 reports (30.8%)
#2 Most Reported
Product use in unapproved indication
107 reports (22.1%)
#3 Most Reported
Drug effective for unapproved indication
96 reports (19.8%)

All CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug ineffective 149 30.8% 0 1
Product use in unapproved indication 107 22.1% 0 0
Drug effective for unapproved indication 96 19.8% 0 0
Somnolence 39 8.1% 0 0
Feeling abnormal 24 5.0% 0 0
Therapeutic product effect incomplete 18 3.7% 0 0
Therapeutic response unexpected 16 3.3% 0 0
Drug effect less than expected 13 2.7% 0 0
Dizziness 12 2.5% 0 0
Expired product administered 11 2.3% 0 0
Incorrect dose administered 11 2.3% 0 0
Drug effect incomplete 10 2.1% 0 1
Fatigue 10 2.1% 0 0
Condition aggravated 8 1.7% 0 0
Drug ineffective for unapproved indication 8 1.7% 0 0
Inappropriate schedule of product administration 8 1.7% 0 0
Intentional product use issue 8 1.7% 0 0
Malaise 7 1.5% 0 1
Pain 7 1.5% 0 0
Back pain 6 1.2% 0 0

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

Gender: 78.6% female, 21.4% male. Average age: 48.3 years. Most reports from: US. View detailed demographics →

Is CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 8 0 0
2015 15 0 0
2016 15 0 0
2017 9 0 0
2018 6 0 0
2019 9 0 1
2020 6 0 1
2021 5 0 0
2022 5 0 0
2023 2 0 0
2025 1 0 0

View full timeline →

What Is CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE Used For?

IndicationReports
Nasopharyngitis 64
Hypersensitivity 58
Product used for unknown indication 56
Headache 55
Nasal congestion 49
Rhinorrhoea 39
Pain 29
Paranasal sinus discomfort 20
Sneezing 17
Cough 14

CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs Alternatives: Which Is Safer?

CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHLORPHENIRAMINE\IBUPROFEN\PSEUDOEPHEDRINE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHLORPROMAZINE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHLORPROTHIXENE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHLORTHALIDONE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHLORZOXAZONE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHOLECALCIFEROL CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHOLECALCIFEROL\ERGOCALCIFEROL CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHOLESTYRAMINE CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHOLIC ACID CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE vs CHONDROITIN

Official FDA Label for CHLORPHENIRAMINE\IBUPROFEN\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.