Prescription medication · Immune Response Modifier (Topical)
imiquimod
Also sold as Aldara. This medicine treats actinic keratosis (AK) on the face or scalp.
Data updated 2026-05-15
- 2,179
- FDA reportsRarely reported
- $23.01
- Generic price (NADAC)
imiquimod (Aldara) is a prescription Immune Response Modifier (Topical). This medicine treats actinic keratosis (AK) on the face or scalp.
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.
Verify with FDA → · CMS NADAC pricing →
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.
The sections below are summarized in plain English from imiquimod's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
This is a plain-language summary of imiquimod's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
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.
This is a plain-language summary of imiquimod's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, apply it when you remember. Then, continue with your regular schedule.
This is a plain-language summary of imiquimod's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at 39° to 77°F (4° to 25°C). Do not freeze.
Side Effects (from patient reports)
Based on 2,179 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for imiquimod, by number of reports
- Redness
Redness
176 reports
- Tiredness
Tiredness
171 reports
- Pain
Pain
132 reports
- Feeling sick to your stomach
Feeling sick to your stomach
109 reports
- Flu-like symptoms
Flu-like symptoms
101 reports
- Redness where the medicine was applied
Redness where the medicine was applied
94 reports
- Headache
Headache
93 reports
- Fever
Fever
83 reports
- Itching
Itching
80 reports
- Diarrhea
Diarrhea
72 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for imiquimod each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where imiquimod sits
imiquimod has more FDA adverse-event reports than 14% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is imiquimod; the line is the median (50th percentile).
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
Reports Mentioning Death
65
3.0% of reports — not proof of cause
Hospitalization Reports
302
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | ERYTHEMA | 176 |
| 3 | FATIGUE | 171 |
| 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 |
| 16 | APPLICATION SITE PAIN | 67 |
| 17 | DIZZINESS | 66 |
| 18 | ASTHENIA | 65 |
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?
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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 2,179 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.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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