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 approved
ATC Code D06BX02
DrugBank ID DB05013
KEGG ID D09393
MeSH ID C486592
PubChem ID 6918670
TTD Drug ID D0E9KA
NDC Product Code 61200-037; 47848-047
UNII 7686S50JAH
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
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 reaction12.07.01.006; 08.02.01.006--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
Conjunctivitis11.01.06.012; 06.04.01.002--
Dermatitis23.03.04.002--Not Available
Drug ineffective08.06.01.006--Not Available
Erythema23.03.06.001--Not Available
Eye disorder06.08.03.001--Not Available
Eye pain06.08.03.002--
Eye swelling06.08.03.003--Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Flatulence07.01.04.002--
Headache17.14.01.001--
Infection11.01.08.002--Not Available
Instillation site pain12.07.01.008; 08.02.01.008--Not Available
Nasopharyngitis22.07.03.002; 11.01.13.002--Not Available
Nervous system disorder17.02.10.001--Not Available
Pain08.01.08.004--
Paraesthesia23.03.03.094; 17.02.06.005--
Periorbital oedema10.01.05.010; 06.08.03.017; 23.04.01.002--
Rash pustular23.03.10.003; 11.01.12.002--
Scab23.03.03.004--Not Available
Skin erosion23.07.03.002--Not Available
Skin exfoliation23.03.07.003--Not Available
Squamous cell carcinoma16.16.01.002--Not Available
Swelling08.01.03.015--Not Available
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