Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Ingenol mebutate
Drug ID BADD_D01158
Description Ingenol mebutate was approved by the FDA in January 2012, and it is marketed under the name Picato®. Picato gel is indicated for the topical treatment of actinic keratosis. Before approval, ingenol mebutate was called PEP005 as an investigational drug. PEP005 is a selective small molecule activator of protein kinase C (PKC) extracted from the plant Euphorbia peplus, whose sap has been used as a traditional medicine for the treatment of skin conditions including warts and cancer. PEP005 also has potent anti-leukemic effects, inducing apoptosis in myeloid leukemia cell lines and primary AML cells at nanomolar concentrations.
Indications and Usage For the topical treatment of actinic keratosis.
Marketing Status Prescription
ATC Code D06BX02
DrugBank ID DB05013
KEGG ID D09393
MeSH ID C486592
PubChem ID 6918670
TTD Drug ID D0E9KA
NDC Product Code 61200-037; 50222-503; 47848-047
Synonyms 3-ingenyl angelate | ingenol 3-angelate | 3-ingenol angelate | PEP005 | PEP-005 | PEP 005 | picato | ingenol mebutate
Chemical Information
Molecular Formula C25H34O6
CAS Registry Number 75567-37-2
SMILES CC=C(C)C(=O)OC1C(=CC23C1(C(C(=CC(C2=O)C4C(C4(C)C)CC3C)CO)O)O)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Swelling face23.04.01.018; 10.01.05.0180.097988%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.068592%Not Available
Throat irritation22.02.05.013; 07.05.03.0040.019598%Not Available
Throat tightness22.02.05.015; 19.01.02.0050.019598%Not Available
Ulcer08.03.06.001--Not Available
Urticaria23.04.02.001; 10.01.06.0010.029397%
Vision blurred17.17.01.010; 06.02.06.0070.039195%
Visual acuity reduced17.17.01.011; 06.02.03.0010.019598%
Visual impairment06.02.06.0080.029397%Not Available
Vomiting07.01.07.003--
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.009--Not Available
Application site infection12.07.01.012; 11.01.08.012; 08.02.01.015--Not Available
Application site pustules11.01.12.014; 08.02.01.041; 23.03.10.004; 12.07.01.041--Not Available
Application site paraesthesia17.02.06.012; 12.07.01.026; 08.02.01.026--Not Available
Madarosis06.06.04.010; 23.02.02.0040.019598%Not Available
Eyelid margin crusting23.03.03.029; 06.04.04.005--Not Available
Eye oedema06.08.03.0130.019598%Not Available
Application site discharge08.02.01.039; 23.03.03.049; 12.07.01.039--Not Available
Application site swelling08.02.01.027; 12.07.01.027--Not Available
Hypoaesthesia oral17.02.06.021; 07.05.05.0030.029397%Not Available
Paraesthesia oral07.05.03.003; 17.02.06.0080.048994%Not Available
Staphylococcal infection11.02.05.0020.019598%Not Available
Infestation23.09.05.001; 11.09.01.001--Not Available
Inflammation08.01.05.0070.007669%Not Available
Disease progression08.01.03.0380.010225%
Application site exfoliation23.03.07.007; 12.07.01.022; 08.02.01.022--Not Available
Application site burn23.03.11.013; 12.07.01.038; 08.02.01.038--Not Available
Application site erosion23.07.03.011; 12.07.01.021; 08.02.01.021--Not Available
Application site scab12.07.01.042; 08.02.01.042; 23.03.03.050--Not Available
Oropharyngeal pain22.02.05.022; 07.05.05.0040.019598%
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