OpenClaim

Imiquimod Side Effects

The most commonly reported side effects of imiquimod include off label use, fatigue, and erythema, based on 3,480 FDA adverse event reports from 2004 to 2025. 5.2% of reports found the drug to be ineffective.

Imiquimod side effects

Percentages show how often each reaction appears relative to total reports for imiquimod.

1
Off Label Use9.2%321
2
Fatigue6.3%219
3
Erythema5.5%193
4
Product Use In Unapproved Indication5.5%192
5
Drug Ineffective5.2%181
6
Pain5.0%174
7
Nausea4.0%140
8
Application Site Erythema3.4%118
9
Influenza Like Illness3.4%118
10
Headache3.4%117
11
Pruritus3.0%103
12
Pyrexia2.9%100
13
Diarrhoea2.8%98
14
Application Site Pain2.7%93
15
Malaise2.4%85

These are voluntary reports and do not establish that imiquimod caused these reactions.

Report severity

62.0%Serious2,157 reports
18.9%Hospitalizations657 reports
3.4%Fatal119 reports

Seriousness is determined by the reporter, not by OpenClaim.

Imiquimod drug interactions

Other drugs that appear in adverse event reports alongside imiquimod. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Tenofovir2.0%68
2
Prednisone1.7%60
3
Emtricitabine1.4%47
4
Lenalidomide1.3%46
5
Acyclovir1.2%43
6
Tacrolimus1.2%41
7
Dupilumab1.1%40
8
Mycophenolate1.1%38
9
Fluorouracil1.1%37
10
Methotrexate1.0%36
11
Vismodegib0.9%32
12
Cetirizine-hydrochloride0.9%32
13
Mepolizumab0.9%32
14
Ethinyl-estradiol0.9%30
15
Tiotropium-bromide0.9%30

Taken alongside

1
Aspirin7.7%267
2
Acetaminophen7.6%264
3
Ergocalciferol7.1%246
4
Omeprazole6.1%213
5
Levothyroxine-sodium6.1%211
6
Prednisone5.9%204
7
Atorvastatin-calcium5.8%201
8
Albuterol5.2%181
9
Metoprolol4.8%166
10
Furosemide4.6%161
11
Pantoprazole-sodium4.6%159
12
Amlodipine4.5%156
13
Lisinopril4.4%154
14
Gabapentin4.3%151
15
Acyclovir4.2%145

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports imiquimod side effects

42.6% of imiquimod adverse event reports involve female patients and 40.5% involve male patients. The largest age group is adult at 49%. These figures reflect who reports side effects, not underlying risk.

Sex

Female42.6%
Male40.5%
Unknown16.8%

Age group

< 20.4%
2–112.5%
12–171.3%
18–6449.1%
65+46.8%

What is imiquimod used for

Conditions and purposes for which patients were taking imiquimod when the adverse event was reported.

AcneActinic CheilitisActinic KeratosisAnal CancerAnal PolypAnaplastic Large-cell LymphomaAnogenital DysplasiaAnogenital WartsAnorectal DisorderAnorectal Human Papilloma Virus InfectionAphthous StomatitisAcral Lentiginous MelanomaActinic CheilitisActinic KeratosisAdverse Event

Showing 15 of 302 indications

Imiquimod brand names and reporting trend

Imiquimod is sold under the brand name Zyclara.

Brand names

Zyclara2,394

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking imiquimod with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.