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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.

INGENOL MEBUTATE: 3,025 Adverse Event Reports & Safety Profile

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3,025
Total FAERS Reports
5 (0.2%)
Deaths Reported
58
Hospitalizations
3,025
As Primary/Secondary Suspect
19
Life-Threatening
36
Disabilities
Jan 23, 2012
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 202833 ·

Patent Expires: May 15, 2033 · First Report: 2012 · Latest Report: 20211103

What Are the Most Common INGENOL MEBUTATE Side Effects?

#1 Most Reported
Application site erythema
1,373 reports (45.4%)
#2 Most Reported
Application site pain
1,012 reports (33.5%)
#3 Most Reported
Application site vesicles
843 reports (27.9%)

All INGENOL MEBUTATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Application site erythema 1,373 45.4% 0 12
Application site pain 1,012 33.5% 0 13
Application site vesicles 843 27.9% 0 4
Application site exfoliation 586 19.4% 0 4
Drug administered at inappropriate site 500 16.5% 0 7
Application site swelling 489 16.2% 0 7
Application site scab 451 14.9% 0 5
Application site dryness 365 12.1% 0 0
Incorrect drug administration duration 339 11.2% 0 9
Application site pruritus 291 9.6% 0 2
Inappropriate schedule of drug administration 250 8.3% 0 3
Drug administration error 214 7.1% 0 3
Incorrect dose administered 214 7.1% 0 1
Eye swelling 198 6.6% 1 7
Application site discharge 188 6.2% 0 0
Application site reaction 160 5.3% 0 5
Application site erosion 123 4.1% 0 1
Drug ineffective 119 3.9% 0 0
Application site discolouration 115 3.8% 0 0
Headache 108 3.6% 1 4

Who Reports INGENOL MEBUTATE Side Effects? Age & Gender Data

Gender: 65.1% female, 34.9% male. Average age: 61.4 years. Most reports from: US. View detailed demographics →

Is INGENOL MEBUTATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 5 0 0
2013 49 0 5
2014 319 0 7
2015 488 2 12
2016 422 0 8
2017 191 0 7
2018 163 1 3
2019 151 0 3
2020 33 0 1
2021 3 0 0

View full timeline →

What Is INGENOL MEBUTATE Used For?

IndicationReports
Actinic keratosis 1,751
Product used for unknown indication 582
Precancerous skin lesion 416
Solar lentigo 77
Actinic cheilitis 43
Skin cancer 38
Squamous cell carcinoma 19
Basal cell carcinoma 18
Hyperkeratosis 16
Precancerous cells present 12

INGENOL MEBUTATE vs Alternatives: Which Is Safer?

INGENOL MEBUTATE vs INLYTA INGENOL MEBUTATE vs INOTERSEN INGENOL MEBUTATE vs INOTUZUMAB OZOGAMICIN INGENOL MEBUTATE vs INSULIN INGENOL MEBUTATE vs INSULIN ASPART INGENOL MEBUTATE vs INSULIN ASPART\INSULIN DEGLUDEC INGENOL MEBUTATE vs INSULIN BEEF INGENOL MEBUTATE vs INSULIN DEGLUDEC INGENOL MEBUTATE vs INSULIN DEGLUDEC\LIRAGLUTIDE INGENOL MEBUTATE vs INSULIN DETEMIR

Official FDA Label for INGENOL MEBUTATE

Official prescribing information from the FDA-approved drug label.