imiquimod
Brand names: Aldara
Imiquimod cream helps your immune system fight certain skin problems. It is used on the skin to treat actinic keratosis, superficial basal cell carcinoma, and genital warts.
Drug Pricing (NADAC)
Generic Price
$23.01/unit
Generic Available
Yes (4 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats actinic keratosis (AK) on the face or scalp.
Common side effects
Redness, Flaking, scaling, or dryness, Scabbing or crusting
Key warnings
Imiquimod cream can cause intense skin reactions.
How It Works
Imiquimod cream helps your body's immune system fight the problem. It is not fully understood how it works. It stimulates the immune cells to release chemicals that attack the AK, sBCC, or warts.
How to Take It
This cream is only for use on the skin. Do not put it in your mouth, eyes, or vagina. Wash your hands before and after using the cream. Before applying, wash the treatment area with mild soap and water and let it dry for at least 10 minutes.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant. Animal studies suggest low risk, but there is limited human data. Talk to your doctor about the risks and benefits of using this medicine while breastfeeding.
Missed Dose
If you miss a dose, apply it when you remember. Then, continue with your regular schedule.
Storage
Store at 39° to 77°F (4° to 25°C). Do not freeze.
Side Effects (from patient reports)
Based on 1,454 FDA adverse event reports.
FDA Adverse Event Report Analysis
Detailed analysis of 2,179 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
2,179
Death-Related Reports
65
Hospitalization Reports
302
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | OFF LABEL USE | 257 |
| 2 | ERYTHEMA | 176 |
| 3 | FATIGUE | 171 |
| 4 | PRODUCT USE IN UNAPPROVED INDICATION | 164 |
| 5 | DRUG INEFFECTIVE | 157 |
| 6 | PAIN | 132 |
| 7 | NAUSEA | 109 |
| 8 | INFLUENZA LIKE ILLNESS | 101 |
| 9 | APPLICATION SITE ERYTHEMA | 94 |
| 10 | HEADACHE | 93 |
| 11 | PYREXIA | 83 |
| 12 | PRURITUS | 80 |
| 13 | DIARRHOEA | 72 |
| 14 | SCAB | 72 |
| 15 | MALAISE | 70 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Imiquimod cream can cause intense skin reactions. This may include weeping, erosion, or swelling. If you have severe vulvar swelling, stop using the cream. This medicine can also cause changes in skin color. Avoid sunlight or sunlamps while using this medicine. Use sunscreen and wear protective clothing.
Common Questions
Can I use this cream inside my mouth or vagina?
How often should I apply the cream for actinic keratosis?
What should I do if my skin gets very red and irritated?
Can I use a sunlamp while using this cream?
How long should I leave the cream on my skin?
Can I use more than one packet of cream at a time?
What if I get the cream in my eyes?
How long do I use this for genital warts?
Can I have sex while the cream is on my skin?
What do I do with leftover cream in the packet?
What are the common side effects of imiquimod?
What drug class is imiquimod?
Is imiquimod safe during pregnancy?
Related Medications in Immune Response Modifier (Topical)
Other drugs grouped near imiquimod — same-class peers and common alternatives.
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azelaic acid
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benzoyl peroxide
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
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What the FDA Data Shows for imiquimod
The FDA label for imiquimod (sold under brand names such as Aldara) classifies it as a prescription-only medication in the Immune Response Modifier (Topical) class. This medicine treats actinic keratosis (AK) on the face or scalp. Official labeling lists 10 commonly reported side effects, including Redness, Flaking, scaling, or dryness, Scabbing or crusting.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,454 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $23.01.
Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 31, 2025
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- FDA Orange Book — approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed — NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) — post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm — standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files — federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database — current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages