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)
Eye disorder06.08.03.001--Not Available
Eye irritation06.04.05.0030.195977%Not Available
Eye pain06.08.03.0020.107787%
Eye swelling06.08.03.0030.342960%Not Available
Eyelid oedema23.04.01.003; 10.01.05.001; 06.04.04.0040.127385%Not Available
Face oedema23.04.01.004; 08.01.07.003; 10.01.05.0020.048994%
Facial paralysis17.04.03.0080.019598%Not Available
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Gait disturbance17.02.05.016; 08.01.02.0020.019598%
Headache17.14.01.0010.166580%
Herpes zoster23.09.03.002; 11.05.02.0030.088190%
Hyperkeratosis23.01.01.0010.019598%
Hypersensitivity10.01.03.0030.166580%
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.0230.019598%Not Available
Impetigo23.09.01.006; 11.01.12.0060.019598%Not Available
Infection11.01.08.002--Not Available
Influenza like illness08.01.03.0100.058793%
Insomnia19.02.01.002; 17.15.03.0020.068592%
Instillation site pain08.02.01.008; 12.07.01.008--Not Available
Keratoacanthoma23.08.02.007; 16.03.02.0070.019598%Not Available
Lacrimation increased06.08.02.0040.039195%
Lip oedema23.04.01.006; 10.01.05.004; 07.05.04.0040.019598%Not Available
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.068592%Not Available
Local swelling08.01.03.0130.019598%Not Available
Loss of consciousness17.02.04.0040.019598%Not Available
Malaise08.01.01.003--
Malignant melanoma16.03.01.001; 23.08.01.0010.019598%Not Available
Mouth ulceration07.05.06.0040.039195%Not Available
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