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Ingenol Side Effects

The most commonly reported side effects of ingenol include application site erythema, application site pain, and application site vesicles, based on 5,249 FDA adverse event reports from 2012 to 2023. 5.2% of reports found the drug to be ineffective.

Ingenol side effects

Percentages show how often each reaction appears relative to total reports for ingenol.

1
Application Site Erythema45.5%2,387
2
Application Site Pain32.5%1,708
3
Application Site Vesicles28.1%1,475
4
Drug Administered At Inappropriate Site20.6%1,081
5
Application Site Exfoliation19.1%1,001
6
Application Site Swelling15.9%832
7
Application Site Scab12.9%675
8
Incorrect Drug Administration Duration11.2%586
9
Application Site Dryness9.8%514
10
Application Site Pruritus9.7%507
11
Drug Administration Error8.8%460
12
Incorrect Dose Administered7.1%372
13
Inappropriate Schedule Of Drug Administration6.7%351
14
Drug Ineffective5.2%274
15
Eye Swelling5.1%269

These are voluntary reports and do not establish that ingenol caused these reactions.

Report severity

28.7%Serious1,505 reports
1.3%Hospitalizations70 reports
<0.1%Fatal5 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ingenol drug interactions

Other drugs that appear in adverse event reports alongside ingenol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Imiquimod0.2%9
2
Methotrexate0.2%9
3
Fluorouracil0.1%6
4
Levetiracetam0.1%6
5
Ramipril<0.1%5
6
Apremilast<0.1%4
7
Natalizumab<0.1%3
8
Vismodegib<0.1%3
9
Dexlansoprazole<0.1%3
10
Lansoprazole<0.1%3
11
Omeprazole<0.1%3
12
Prednisone<0.1%2
13
Simvastatin<0.1%2
14
Naproxen<0.1%2
15
Diclofenac<0.1%2

Taken alongside

1
Levothyroxine-sodium2.0%106
2
Aspirin1.7%89
3
Atorvastatin-calcium1.6%85
4
Omeprazole1.1%60
5
Lisinopril1.0%54
6
Ergocalciferol1.0%54
7
Simvastatin1.0%51
8
Hydrochlorothiazide0.9%49
9
Amlodipine0.8%43
10
Metformin0.8%41
11
Calcium0.8%41
12
Losartan-potassium0.8%40
13
Rosuvastatin0.8%40
14
Fish0.7%37
15
Acetaminophen0.7%37

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports ingenol side effects

63.4% of ingenol adverse event reports involve female patients and 35.1% involve male patients. The largest age group is adult at 67%. These figures reflect who reports side effects, not underlying risk.

Sex

Female63.4%
Male35.1%
Unknown1.5%

Age group

< 2<0.1%
2–11<0.1%
12–170.0%
18–6467.3%
65+32.6%

What is ingenol used for

Conditions and purposes for which patients were taking ingenol when the adverse event was reported.

Accidental Exposure To ProductAcneActinic CheilitisActinic KeratosisAngioedemaAngiokeratomaAnogenital WartsActinic KeratosisBasal Cell CarcinomaBowen^s DiseaseCarcinoma In SituDermatitis Papillaris CapillitiiDrug TherapyDrug Use For Unknown IndicationDry Skin

Showing 15 of 74 indications

Ingenol brand names and reporting trend

Ingenol is sold under the brand name Ingenol Mebutate.

Brand names

Ingenol Mebutate26

Quarterly reports (20122023)

2012201620202023

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking ingenol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.