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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.

PHENYLEPHRINE\TROPICAMIDE: 89 Adverse Event Reports & Safety Profile

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89
Total FAERS Reports
1 (1.1%)
Deaths Reported
20
Hospitalizations
89
As Primary/Secondary Suspect
1
Life-Threatening
6
Disabilities

Active Ingredient: PHENYLEPHRINE HYDROCHLORIDE\TROPICAMIDE ·

First Report: 1998 · Latest Report: 20250405

What Are the Most Common PHENYLEPHRINE\TROPICAMIDE Side Effects?

#1 Most Reported
Toxic anterior segment syndrome
29 reports (32.6%)
#2 Most Reported
Aqueous fibrin
19 reports (21.3%)
#3 Most Reported
Conjunctivitis
18 reports (20.2%)

All PHENYLEPHRINE\TROPICAMIDE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxic anterior segment syndrome 29 32.6% 0 0
Aqueous fibrin 19 21.4% 0 0
Conjunctivitis 18 20.2% 0 0
Inflammation 17 19.1% 1 1
Congenital anomaly 15 16.9% 0 0
Foetal exposure during pregnancy 12 13.5% 0 0
Endophthalmitis 11 12.4% 0 7
Hypopyon 10 11.2% 0 0
Vitritis 10 11.2% 0 0
Maternal exposure during pregnancy 5 5.6% 0 0

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

Gender: 69.8% female, 30.2% male. Average age: 66.5 years. Most reports from: BE. View detailed demographics →

Is PHENYLEPHRINE\TROPICAMIDE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2013 3 0 3
2014 1 0 0
2015 3 0 0
2017 4 0 4
2018 2 0 0
2019 1 0 0
2020 5 0 2
2021 1 0 0
2022 34 0 5
2023 7 0 2
2024 1 0 0
2025 1 0 0

View full timeline →

What Is PHENYLEPHRINE\TROPICAMIDE Used For?

IndicationReports
Preoperative care 28
Product used for unknown indication 22
Foetal exposure during pregnancy 9
Cataract operation 6
Pupil dilation procedure 6
Mydriasis 5

Official FDA Label for PHENYLEPHRINE\TROPICAMIDE

Official prescribing information from the FDA-approved drug label.