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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.

DIPHENHYDRAMINE\PHENYLEPHRINE: 73 Adverse Event Reports & Safety Profile

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73
Total FAERS Reports
5 (6.8%)
Deaths Reported
12
Hospitalizations
73
As Primary/Secondary Suspect
2
Life-Threatening
2
Disabilities

Active Ingredient: DIPHENHYDRAMINE HYDROCHLORIDE\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 2009 · Latest Report: 20250723

What Are the Most Common DIPHENHYDRAMINE\PHENYLEPHRINE Side Effects?

#1 Most Reported
Product use issue
7 reports (9.6%)
#2 Most Reported
Hallucination
7 reports (9.6%)
#3 Most Reported
Product use in unapproved indication
6 reports (8.2%)

All DIPHENHYDRAMINE\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hallucination 7 9.6% 0 0
Product use issue 7 9.6% 0 1
Pain 6 8.2% 0 2
Product use in unapproved indication 6 8.2% 0 0
Constipation 5 6.9% 0 2
Night sweats 5 6.9% 0 0
Off label use 5 6.9% 0 0
Urinary retention 5 6.9% 0 0
Vision blurred 5 6.9% 0 0

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

Gender: 63.9% female, 36.1% male. Average age: 37.5 years. Most reports from: US. View detailed demographics →

Is DIPHENHYDRAMINE\PHENYLEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2009 1 0 1
2012 3 2 1
2014 1 0 0
2015 11 0 1
2016 2 0 0
2017 2 0 1
2018 1 0 0
2019 3 0 1
2020 3 0 0
2021 3 0 0
2022 3 0 1
2025 2 0 1

View full timeline →

What Is DIPHENHYDRAMINE\PHENYLEPHRINE Used For?

IndicationReports
Product used for unknown indication 28
Cough 17
Nasal congestion 6
Nasopharyngitis 5

Official FDA Label for DIPHENHYDRAMINE\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.