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
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
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
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Acne23.02.01.0010.000966%Not Available
Actinic keratosis23.01.06.0010.000439%Not Available
Angioedema10.01.05.009;; Available
Anorectal disorder07.03.01.001--Not Available
Aphthous ulcer07.05.06.0020.001932%Not Available
Application site erythema23.03.06.005;; Available
Application site irritation12.07.01.003; Available
Application site oedema12.07.01.020; Available
Application site pain08.02.01.004; Available
Application site pruritus23.03.12.004;; Available
Application site rash23.03.13.008;; Available
Application site reaction12.07.01.006; Available
Application site ulcer23.07.03.010;; Available
Application site warmth08.02.01.029; Available
Arrhythmia02.03.02.0010.000439%Not Available
Asthenia08.01.01.0010.002283%Not Available
Atrial fibrillation02.03.03.0020.000878%
Atrophic vulvovaginitis21.02.01.003--Not Available
Autoimmune hepatitis09.01.07.019; Available
Back pain15.03.04.0050.001536%
Basal cell carcinoma16.03.02.001; Available
Blindness06.02.10.003; Available
Blister23.03.01.001; Available
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