IMIQUIMOD (imiquimod)

There are 0 contraindications.

There are 3 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Graft-versus-host disease
Skin photosensitivity
Sunburn

There are 2 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Autoimmune disease
Immunosuppression

There are 25 severe adverse reactions.

More Frequent	Less Frequent
Blistering skin Fungal infection Skin crusting Superficial skin ulcer	Severe erythema Squamous cell carcinoma Tinea cruris

Rare/Very Rare
Abnormal hepatic function tests Acute myocardial infarction Agitation Angioedema Arthralgia Bone marrow depression Depression Dyspnea Dysuria Flu-like symptoms Heart failure IgA vasculitis Insomnia Malignant lymphoma Proteinuria Syncope Thyroiditis Urinary retention

There are 27 less severe adverse reactions.

More Frequent	Less Frequent
Erythema Induration of skin Pruritus of skin Skin inflammation Skin rash Skin swelling Stinging of skin Treatment site sequelae Upper respiratory infection	Back pain Diarrhea Dry skin Edema Fatigue Fever Headache disorder Skin hypopigmentation Skin photosensitivity

Rare/Very Rare
Abdominal pain with cramps Alopecia Chills Dizziness Eczema Herpes simplex infection Sinusitis Vomiting Vulvar edema

There was no evidence of embryotoxicity or teratogenicity when oral imiquimod was used in rats and rabbits at dosages 98 times the maximum recommended human dose (MRHD) (based on area under the plasma concentration-time curve (AUC) comparisons) or when IV imiquimod was used in rabbits at dosages 407 times the MRHD (based on AUC) or 1.5 times the MRHD (based on body surface area). When oral imiquimod dosages 577 times the MRHD (based on AUC) were used in rats, maternal toxicity occurred and adverse fetal effects included increased resorptions, decreased fetal body weight, delayed skeletal ossification, bent limb bones, and exencephaly, protruding tongues, and low-set ears. There are no adequate and controlled studies using imiquimod in pregnant women, and the drug should be used during pregnancy only when clearly needed.

It is not known whether topically applied imiquimod is distributed into human milk. The drug should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.