Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Imiquimod
Drug ID BADD_D01142
Description Imiquimod is an immune response modifier that acts as a toll-like receptor 7 agonist. Imiquimod is commonly used topically to treat warts on the skin of the genital and anal areas. Imiquimod does not cure warts, and new warts may appear during treatment. Imiquimod does not fight the viruses that cause warts directly, however, it does help to relieve and control wart production. Miquimod is also used to treat a skin condition of the face and scalp called actinic keratoses and certain types of skin cancer called superficial basal cell carcinoma.
Indications and Usage For the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults. Also indicated for the treatment of external genital and perianal warts/condyloma acuminata in individuals 12 years old and above.
Marketing Status approved; investigational
ATC Code D06BB10
DrugBank ID DB00724
KEGG ID D02500
MeSH ID D000077271
PubChem ID 57469
TTD Drug ID D06CTE
NDC Product Code 62350-0077; 68682-272; 72189-084; 0168-0432; 22365-121; 51672-4174; 99207-271; 66039-829; 71052-160; 64552-4008; 45802-368; 51552-1538; 62147-0087; 51672-4145; 63629-8818; 68462-536; 51927-0168; 72643-006; 0093-3133; 99207-260; 99207-270; 99207-276; 58175-0397; 62147-0072
UNII P1QW714R7M
Synonyms Imiquimod | 1-Isobutyl-1H-imidazo(4,5-c)quinolin-4-amine | S 26308 | S-26308 | R 837 | R-837 | R837 | Zyclara | Aldara
Chemical Information
Molecular Formula C14H16N4
CAS Registry Number 99011-02-6
SMILES CC(C)CN1C=NC2=C1C3=CC=CC=C3N=C2N
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 burn08.02.01.038; 12.07.01.038; 23.03.11.013---
Application site cellulitis08.02.01.043; 11.02.01.028; 12.07.01.043; 23.11.02.001---
Application site erosion08.02.01.021; 12.07.01.021; 23.07.03.0110.003029%-
Application site scab08.02.01.042; 12.07.01.042; 23.03.03.0500.001624%-
Treatment failure08.06.01.0170.002371%-
Oral herpes07.05.07.002; 11.05.02.005---
Adverse reaction08.06.01.0180.000439%-
Anorectal discomfort07.03.03.003---
Oropharyngeal pain07.05.05.004; 22.12.03.0160.001405%
Vulvovaginal pain21.08.02.009--
Neuropsychiatric syndrome17.02.10.014; 19.07.03.0090.000439%-
Application site haemorrhage08.02.01.040; 12.07.01.040; 24.07.01.0480.002458%-
Eye ulcer06.08.03.0180.000439%-
Multiple organ dysfunction syndrome08.01.03.0570.000439%
Burning sensation mucosal08.01.06.020; 17.02.06.031---
Malignant melanoma in situ16.03.01.004; 23.08.01.0040.000658%-
Lip erosion07.05.06.0110.000966%-
Genital erythema21.10.01.015; 23.03.06.0190.000439%-
Subacute cutaneous lupus erythematosus10.04.03.012; 15.06.02.012; 23.03.02.0200.001097%-
Skin plaque23.03.03.0440.003688%-
Chronic papillomatous dermatitis12.02.16.002; 23.01.04.0050.001405%-
Bacterial vulvovaginitis11.02.01.052; 21.14.02.013---
Chronic cutaneous lupus erythematosus10.04.03.013; 15.06.02.013; 23.03.02.0220.000658%-
Drug effective for unapproved indication08.06.01.037; 12.09.02.0010.000966%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.005707%-
Immune thrombocytopenia01.08.01.013; 10.02.01.083---
Therapeutic product effect incomplete08.06.01.0520.001932%-
Therapy non-responder08.06.01.0630.002502%-
Therapy partial responder08.06.01.0640.002502%-
Treatment noncompliance08.06.01.067; 12.09.02.0060.000439%-
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ADReCS-Target
Drug Name ADR Term Target
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