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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.

ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE: 63 Adverse Event Reports & Safety Profile

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63
Total FAERS Reports
0
Deaths Reported
31
Hospitalizations
63
As Primary/Secondary Suspect
5
Life-Threatening
2
Disabilities

Active Ingredient: ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 20110730 · Latest Report: 20221013

What Are the Most Common ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Side Effects?

#1 Most Reported
Vomiting
10 reports (15.9%)
#2 Most Reported
Product prescribing error
10 reports (15.9%)
#3 Most Reported
Intentional overdose
10 reports (15.9%)

All ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug interaction 10 15.9% 0 10
General physical health deterioration 10 15.9% 0 10
Intentional overdose 10 15.9% 0 10
Product prescribing error 10 15.9% 0 10
Vomiting 10 15.9% 0 6
Suicide attempt 9 14.3% 0 9
Nausea 8 12.7% 0 0
Balance disorder 7 11.1% 0 6
Hypotension 7 11.1% 0 7
Abdominal pain upper 6 9.5% 0 1
Blood calcium decreased 6 9.5% 0 6
Cognitive disorder 6 9.5% 0 6
Constipation 6 9.5% 0 6
Creatinine renal clearance decreased 6 9.5% 0 6
Depressed level of consciousness 6 9.5% 0 6
Diarrhoea 6 9.5% 0 0
Fall 6 9.5% 0 6
Malaise 6 9.5% 0 0
Mobility decreased 6 9.5% 0 6
Orthostatic hypotension 6 9.5% 0 6

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

Gender: 93.8% female, 6.3% male. Average age: 50.3 years. Most reports from: GB. View detailed demographics →

Is ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 1
2014 2 0 1
2015 12 0 10
2016 9 0 1
2017 5 0 1
2018 6 0 0
2019 5 0 0
2020 2 0 0
2021 8 0 8
2022 2 0 2

View full timeline →

What Is ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE Used For?

IndicationReports
Product used for unknown indication 24
Nasopharyngitis 16
Pain 5

Official FDA Label for ACETAMINOPHEN\CAFFEINE\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.