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.
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
- Erythema
Erythema
176 reports
- Fatigue
Fatigue
171 reports
- Pain
Pain
132 reports
- Nausea
Nausea
109 reports
- Influenza Like Illness
Influenza Like Illness
101 reports
- Application Site Erythema
Application Site Erythema
94 reports
- Headache
Headache
93 reports
- Pyrexia
Pyrexia
83 reports
- Pruritus
Pruritus
80 reports
- Diarrhoea
Diarrhoea
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) 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?
What pregnancy or breastfeeding source fields are listed for imiquimod?
Related Medications in Immune Response Modifier (Topical)
Other drugs grouped near imiquimod - same-class peers and common alternatives.
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azelaic acid
Finacea, Azelex
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benzoyl peroxide
Benzac, PanOxyl
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betamethasone
Diprosone, Luxiq
Betamethasone dipropionate cream is a strong steroid medicine used on the skin.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for imiquimod: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 2,179.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 2.98%.
- omalizumab Δ 0.01 pts · 79,748 reports · Anti-IgE Monoclonal Antibody 3.00%death share
- biotin Δ 0.07 pts · 29,879 reports · Vitamin B7 Supplement 3.05%death share
- conjugated estrogens Δ 0.10 pts · 57,675 reports · Conjugated Estrogen 3.08%death share
- tasimelteon Δ 0.10 pts · 5,762 reports · Melatonin Receptor Agonist 2.88%death share
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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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: January 31, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
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 from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
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