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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.

PROTOPIC: 155 Adverse Event Reports & Safety Profile

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155
Total FAERS Reports
2 (1.3%)
Deaths Reported
4
Hospitalizations
155
As Primary/Secondary Suspect
4
Life-Threatening
3
Disabilities

First Report: 2003 · Latest Report: 20140617

What Are the Most Common PROTOPIC Side Effects?

#1 Most Reported
Off label use
83 reports (53.5%)
#2 Most Reported
Pruritus
14 reports (9.0%)
#3 Most Reported
Drug ineffective
9 reports (5.8%)

All PROTOPIC Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 83 53.6% 1 3
Pruritus 14 9.0% 0 0
Burning sensation 9 5.8% 0 0
Drug ineffective 9 5.8% 0 0
Hypersensitivity 7 4.5% 0 0
Application site pain 6 3.9% 0 0
Condition aggravated 6 3.9% 0 0
Drug prescribing error 6 3.9% 0 1
Skin burning sensation 6 3.9% 0 0
Acne 5 3.2% 0 0
Rash 5 3.2% 0 0

Who Reports PROTOPIC Side Effects? Age & Gender Data

Average age: 41.9 years. Most reports from: US. View detailed demographics →

Is PROTOPIC Getting Safer? Reports by Year

YearReportsDeathsHosp.
2003 2 0 0
2009 2 0 0
2010 1 0 1
2011 1 0 0
2012 2 0 0
2013 24 0 0
2014 14 1 2

View full timeline →

What Is PROTOPIC Used For?

IndicationReports
Product used for unknown indication 34
Eczema 26
Vitiligo 17
Dermatitis atopic 10
Psoriasis 8
Lichen planus 5
Rash 5

PROTOPIC vs Alternatives: Which Is Safer?

PROTOPIC vs PROVENGE PROTOPIC vs PROVENTIL PROTOPIC vs PROVERA PROTOPIC vs PROZAC PROTOPIC vs PRUCALOPRIDE PROTOPIC vs PSEUDOEPHEDRINE PROTOPIC vs PSEUDOEPHEDRINE\TRIPROLIDINE PROTOPIC vs PSYLLIUM HUSK PROTOPIC vs PULMICORT FLEXHALER PROTOPIC vs PYRAZINAMIDE

Official FDA Label for PROTOPIC

Official prescribing information from the FDA-approved drug label.