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)
Actinic keratosis23.01.06.0010.019598%Not Available
Alopecia23.02.02.001--
Angioedema23.04.01.001; 10.01.05.0090.048994%Not Available
Anosmia22.04.03.006; 17.04.04.0010.019598%
Anxiety19.06.02.002--
Application site erythema23.03.06.005; 12.07.01.001; 08.02.01.001--Not Available
Application site irritation12.07.01.003; 08.02.01.003--Not Available
Application site pain12.07.01.004; 08.02.01.004--Not Available
Application site pruritus23.03.12.004; 12.07.01.005; 08.02.01.005--Not Available
Application site ulcer23.07.03.010; 12.07.01.007; 08.02.01.007--Not Available
Application site warmth12.07.01.029; 08.02.01.029--Not Available
Asthenia08.01.01.001--Not Available
Basal cell carcinoma23.08.02.001; 16.03.02.0010.068592%Not Available
Blindness17.17.01.003; 06.02.02.0010.019598%Not Available
Blister12.01.06.002; 23.03.01.0010.078391%Not Available
Bowen's disease16.03.02.004; 23.08.02.0040.029397%Not Available
Cellulitis23.09.01.001; 11.02.01.0010.019598%Not Available
Chills15.05.03.016; 08.01.09.0010.019598%
Conjunctivitis11.01.06.012; 06.04.01.002--
Dermatitis23.03.04.0020.019598%Not Available
Dermatitis bullous23.03.01.0020.019598%
Dermatitis contact10.01.01.003; 23.03.04.004; 12.03.01.0400.078391%Not Available
Diarrhoea07.02.01.001--
Diplopia17.17.01.005; 06.02.06.0020.019598%Not Available
Dizziness17.02.05.003; 02.01.02.004; 24.06.02.0070.068592%
Dry mouth07.06.01.0020.019598%
Dysgeusia17.02.07.003; 07.14.03.0010.029397%
Dysphagia07.01.06.0030.039195%
Dyspnoea22.02.01.004; 02.01.03.0020.078391%
Erythema23.03.06.0010.146983%Not Available
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