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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\PHENYLEPHRINE: 430 Adverse Event Reports & Safety Profile

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430
Total FAERS Reports
35 (8.1%)
Deaths Reported
138
Hospitalizations
430
As Primary/Secondary Suspect
69
Life-Threatening
7
Disabilities

Active Ingredient: PHENYLEPHRINE\PHENYLEPHRINE HYDROCHLORIDE ·

First Report: 20070414 · Latest Report: 20190602

What Are the Most Common PHENYLEPHRINE\PHENYLEPHRINE Side Effects?

#1 Most Reported
Hypotension
44 reports (10.2%)
#2 Most Reported
Drug ineffective
43 reports (10.0%)
#3 Most Reported
Toxic anterior segment syndrome
28 reports (6.5%)

All PHENYLEPHRINE\PHENYLEPHRINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Hypotension 44 10.2% 12 14
Drug ineffective 43 10.0% 11 19
Bradycardia 28 6.5% 1 9
Toxic anterior segment syndrome 28 6.5% 0 0
Foetal exposure during pregnancy 23 5.4% 2 5
Exposure during pregnancy 21 4.9% 0 3
Maternal exposure during pregnancy 21 4.9% 0 7
Cardiac arrest 20 4.7% 15 5
Intentional overdose 20 4.7% 1 19
Seizure 19 4.4% 0 7
Tachycardia 19 4.4% 3 2
Hypertension 18 4.2% 4 1
Vomiting 17 4.0% 1 3
Depressed level of consciousness 14 3.3% 0 14
Arteriospasm coronary 13 3.0% 10 2
Drug interaction 13 3.0% 0 7
Hypertensive emergency 13 3.0% 0 13
Overdose 13 3.0% 2 9
Product preparation error 13 3.0% 0 0
Myocardial infarction 12 2.8% 9 5

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

Gender: 64.6% female, 35.4% male. Average age: 45.1 years. Most reports from: US. View detailed demographics →

Is PHENYLEPHRINE\PHENYLEPHRINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2007 10 0 0
2008 1 0 0
2009 4 0 0
2011 2 0 2
2012 1 0 0
2014 10 0 1
2015 18 1 9
2016 13 10 1
2017 7 0 0
2018 9 0 2
2019 1 0 0

View full timeline →

What Is PHENYLEPHRINE\PHENYLEPHRINE Used For?

IndicationReports
Product used for unknown indication 138
Hypotension 31
Priapism 11
Blood pressure decreased 10
Procedural hypotension 10
Cataract operation 9
Mydriasis 9
Prophylaxis 9
Foetal exposure during pregnancy 8
Blood pressure management 7

PHENYLEPHRINE\PHENYLEPHRINE vs Alternatives: Which Is Safer?

PHENYLEPHRINE\PHENYLEPHRINE vs PHENYLPROPANOLAMINE PHENYLEPHRINE\PHENYLEPHRINE vs PHENYTOIN PHENYLEPHRINE\PHENYLEPHRINE vs PHLEUM PRATENSE POLLEN PHENYLEPHRINE\PHENYLEPHRINE vs PHLOROGLUCINOL PHENYLEPHRINE\PHENYLEPHRINE vs PHLOROGLUCINOL\1,3,5-TRIMETHOXYBENZENE PHENYLEPHRINE\PHENYLEPHRINE vs PHOLCODINE PHENYLEPHRINE\PHENYLEPHRINE vs PHOSPHORUS PHENYLEPHRINE\PHENYLEPHRINE vs PHTHALYLSULFATHIAZOLE PHENYLEPHRINE\PHENYLEPHRINE vs PHYTONADIONE PHENYLEPHRINE\PHENYLEPHRINE vs PICATO

Official FDA Label for PHENYLEPHRINE\PHENYLEPHRINE

Official prescribing information from the FDA-approved drug label.