Imiquimod is a medicine sold in the U.S. under 3 brand and generic names, for basal cell carcinoma, condylomata acuminata and actinic keratosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Imiquimod (application ANDA205971). Other imiquimod products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use. (2.1) AK: Apply a thin layer once daily at bedtime to affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Apply up to 0.5 grams at each application. (2.2) EGW: Apply a thin layer once daily at bedtime until total clearance or up to 8 weeks. Apply up to 0.25 grams at each application. (2.3) 2.1 Important Dosage and Administration Instructions Imiquimod cream is for topical use only. Imiquimod cream is not for oral, ophthalmic, intra-anal or intravaginal use. Instruct patients on proper application technique. Wash hands before and after applying imiquimod cream. Prime the imiquimod cream pump bottle before first use by repeatedly depressing the actuator until the cream is dispensed. It is not necessary to repeat this priming process during treatment. If a imiquimod cream dose is missed, apply the next dose at the regularly scheduled time. Avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. Prescribe no more than 2 boxes (56 packets) or two 7.5 g bottle pumps of imiquimod cream for the entire treatment course for AK or EGW. Discard partially used packets and do not reuse. Discard pump bottles after completion of a full treatment course. 2.2 Dosage and Administration for Actinic Keratosis Use imiquimod…
The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1)] • Systemic Reactions [see Warnings and Precautions (5.2)] Most common adverse reactions (≥4%) are local skin reactions (erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, exudate,), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Actinic Keratosis The data described below reflect exposure to imiquimod cream or vehicle in 479 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [see Clinical Studies (14.1)]. Subjects applied up to two packets of imiquimod cream, 3.75%, or vehicle once daily, to the skin of the affected area (either entire face or…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Topical | Generic | $346 | View → | |
| 2 | Not yet rated | Prescription | Topical | Generic | $346 |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
None. None. ( 4 )
| 3 | Not yet rated | Prescription | Topical | Generic | $346 | View → |