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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.

RESTASIS: 1,158 Adverse Event Reports & Safety Profile

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1,158
Total FAERS Reports
0
Deaths Reported
5
Hospitalizations
1,158
As Primary/Secondary Suspect
5
Disabilities

First Report: 2001 · Latest Report: 201410

What Are the Most Common RESTASIS Side Effects?

#1 Most Reported
Eye irritation
440 reports (38.0%)
#2 Most Reported
Drug ineffective
181 reports (15.6%)
#3 Most Reported
Eye pain
172 reports (14.9%)

All RESTASIS Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Eye irritation 440 38.0% 0 1
Drug ineffective 181 15.6% 0 0
Eye pain 172 14.9% 0 2
Vision blurred 161 13.9% 0 1
Ocular hyperaemia 137 11.8% 0 1
Lacrimation increased 99 8.6% 0 0
Foreign body sensation in eyes 92 7.9% 0 0
Eye pruritus 79 6.8% 0 0
Instillation site pain 73 6.3% 0 0
Dry eye 68 5.9% 0 0
Eye discharge 58 5.0% 0 1
Inappropriate schedule of drug administration 57 4.9% 0 0
Scleral hyperaemia 56 4.8% 0 0
Incorrect dose administered 40 3.5% 0 0
Headache 35 3.0% 0 0
Eye swelling 34 2.9% 0 0
Eyelid oedema 32 2.8% 0 0
Abnormal sensation in eye 30 2.6% 0 0
Wrong technique in drug usage process 26 2.3% 0 0
Erythema of eyelid 24 2.1% 0 0

Who Reports RESTASIS Side Effects? Age & Gender Data

Average age: 66.9 years. Most reports from: US. View detailed demographics →

Is RESTASIS Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2010 1 0 0
2011 6 0 0
2012 15 0 0
2013 101 0 2
2014 17 0 1

View full timeline →

What Is RESTASIS Used For?

IndicationReports
Dry eye 700
Product used for unknown indication 417
Sjogren's syndrome 8

RESTASIS vs Alternatives: Which Is Safer?

RESTASIS vs RETINOL RESTASIS vs REVATIO RESTASIS vs REVEFENACIN RESTASIS vs REVLIMID RESTASIS vs REVOLADE RESTASIS vs REVUMENIB RESTASIS vs REYATAZ RESTASIS vs REZAFUNGIN RESTASIS vs RIBASPHERE RESTASIS vs RIBAVIRIN

Official FDA Label for RESTASIS

Official prescribing information from the FDA-approved drug label.