Zyclara Side Effects Center

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Medical Editor: John P. Cunha, DO, FACOEP

What Is Zyclara?

Zyclara (imiquimod) Cream, 2.5% or 3.75% is an immune response modifier used to treat actinic keratoses (AK) of the face or balding scalp. Zyclara Cream is also used to treat external genital and perianal warts in people 12 years and older.

What Are Side Effects of Zyclara?

Common side effects of Zyclara Cream include:

headache,
treatment area skin reactions (irritation, pain, itching, dryness, flaking, scabbing, crusting, redness, hardening of skin, changes in color of treated skin),
tiredness,
nausea,
diarrhea,
loss of appetite,
headache,
dizziness,
chest pain,
back pain,
cold sores,
fever blisters,
cold symptoms (stuffy nose, sneezing, sore throat), or
vaginal itching or discharge.

Tell your doctor if you have a serious skin reaction to Zyclara Cream such as severe itching, burning, oozing, bleeding, or skin changes where the medicine is applied. Tell your doctor if you have a serious side effect of Zyclara Cream including flu symptoms such as fever, chills, body aches, tired feeling, or swollen glands.

ZYCLARA Cream may cause serious side effects, including:

Local Skin Reactions: Skin drainage (weeping) or breakdown of the outer layer of your skin (erosion). Swelling outside of the vagina (vulvar swelling) may happen in female patients. You should take special care if applying the cream at the opening of the vagina because local skin reactions on the delicate moist surfaces can cause pain or swelling, and may cause problems passing urine. Tell your healthcare provider if this happens.
Flu-like symptoms: Tell your healthcare provider if you have tiredness, nausea, vomiting, fever, chills, muscle pain, and joint pain.

Seek medical care or call 911 at once if you have the following serious side effects:

Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Zyclara

Zyclara Cream is applied once daily before bedtime to the skin of the affected area for two 2-week treatment cycles separated by a 2-week no-treatment period. It should be applied as a thin film to the entire treatment area and rubbed in until the cream is no longer visible. A dose of up to 0.5 grams (2 packets or 2 full actuations of the pump) may be applied at each application.

What Drugs, Substances, or Supplements Interact with Zyclara?

Zyclara Cream may interact with other medications. Tell your doctor all prescription and over-the-counter medications and supplements you take.

Zyclara During Pregnancy and Breastfeeding

Zyclara Cream should only be used during pregnancy if prescribed. It is unknown if this medications passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Zyclara (imiquimod) Cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Zyclara Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Wash off the medicine and call your doctor at once if you have a serious skin reaction such as severe itching, burning, oozing, bleeding, or skin changes where the medicine was applied.

When treating genital warts around the vagina, if you have severe swelling or urination problems, stop using imiquimod topical and call your doctor right away.

Call your doctor at once if you have:

flu-like symptoms such as fever, chills, nausea, tiredness, body aches, or swollen glands;
bleeding or swelling where you applied this medicine; or
symptoms of herpes zoster (shingles)--skin sores or blisters, itching, tingling, burning pain, rash on your face or torso.

Common side effects may include:

minor skin pain, irritation, itching, redness, dryness, flaking, scabbing, crusting, scaling, or swelling where the medicine was applied;
changes in the color of treated skin (may be permanent);
headache;
tiredness; or
nausea.

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Zyclara Professional Information

SIDE EFFECTS

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.

Clinical Trials Experience

Actinic Keratosis

The data described below reflect exposure to ZYCLARA Cream or vehicle in 479 subjects enrolled in two double-blind, vehicle-controlled trials. Subjects applied up to two packets of ZYCLARA Cream or vehicle daily to the skin of the affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period.

Table 1: Selected Adverse Reactions Occurring in ≥2% of ZYCLARA-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Studies (AK)

Adverse Reactions	ZYCLARA Cream, 3.75% (N=160)	ZYCLARA Cream, 2.5% (N=160)	Vehicle (N=159)
Headache	10 (6%)	3 (2%)	5 (3%)
Application site pruritus	7 (4%)	6 (4%)	1 (<1%)
Fatigue	7 (4%)	2 (1%)	0
Nausea	6 (4%)	1 (1%)	2 (1%)
Influenza-like illness	1 (<1%)	6 (4%)	0
Application site irritation	5 (3%)	4 (3%)	0
Pyrexia	5 (3%)	0	0
Anorexia	4 (3%)	0	0
Dizziness	4 (3%)	1 (<1%)	0
Herpes simplex	4 (3%)	0	1 (<1%)
Application site pain	5 (3%)	2 (1%)	0
Lymphadenopathy	3 (2%)	4 (3%)	0
Oral herpes	0	4 (3%)	0
Arthralgia	2 (1%)	4 (3%)	0
Cheilitis	0	3 (2%)	0
Diarrhea	3 (2%)	2 (1%)	0

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study. The incidence and severity of selected local skin reactions are shown in Table 2.

Table 2: Local Skin Reactions in the Treatment Area in ZYCLARA-Treated Subjects as Assessed by the Investigator (AK)

All Grades* (%) Severe (%)	ZYCLARA Cream, 3.75% (N=160)	ZYCLARA Cream, 2.5% (N=160)	Vehicle (N=159)
Erythema*	96%	96%	78%
Severe erythema	25%	14%	0%
Scabbing/Crusting*	93%	84%	45%
Severe scabbing/crusting	14%	9%	0%
Edema*	75%	63%	19%
Severe edema	6%	4%	0%
Erosion/Ulceration*	62%	52%	9%
Severe erosion/ulceration	11%	9%	0%
Exudate*	51%	39%	4%
Severe exudate	6%	1%	0%
Flaking/Scaling/Dryness*	91%	88%	77%
Severe flaking/scaling/dryness	8%	4%	1%
* Mild, moderate, or severe

Overall, in the clinical trials, 11% (17/160) of subjects in the ZYCLARA Cream, 3.75% arm, 7% (11/160) of subjects in the ZYCLARA Cream, 2.5% arm, and 0% in the vehicle cream arm required rest periods due to adverse local skin reactions.

Other adverse reactions observed in subjects treated with ZYCLARA Cream include: application site bleeding, application site swelling, chills, dermatitis, herpes zoster, insomnia, lethargy, myalgia, pancytopenia, pruritus, squamous cell carcinoma, and vomiting.

Clinical Trials Experience: External Genital Warts

In two double-blind, placebo-controlled studies, 602 subjects applied up to one packet of ZYCLARA Cream or vehicle daily for up to 8 weeks.

The most frequently reported adverse reactions were application site reactions and local skin reactions. Selected adverse reactions are listed in Table 3.

Table 3: Selected Adverse Reactions Occurring in ≥2% of ZYCLARA-Treated Subjects and at a Greater Frequency than with Vehicle in the Combined Trials (EGW)

Preferred Term	ZYCLARA Cream, 3.75% (N=400)	Vehicle Cream (N=202)
Application site pain	28 (7%)	1 (<1%)
Application site irritation	24 (6%)	2 (1%)
Application site pruritus	11 (3%)	2 (1%)
Vaginitis bacterial*	6 (3%)	2 (2%)
Headache	6 (2%)	1 (<1%)
* Percentage based on female population of 6/216 for ZYCLARA Cream 3.75% and 2/106 for vehicle cream

Local skin reactions were recorded as adverse reactions only if they extended beyond the treatment area, if they required any medical intervention, or they resulted in patient discontinuation from the study. The incidence and severity of selected local skin reactions are shown in Table 4.

Table 4: Selected Local Skin Reactions in the Treatment Area Assessed by the Investigator (EGW)

All Grades *(%) Severe (%)	ZYCLARA Cream, 3.75% (N=400)	Vehicle Cream (N=202)
Erythema*	70%	27%
Severe erythema	9%	<1%
Edema*	41%	8%
Severe edema	2%	0%
Erosion/ulceration*	36%	4%
Severe erosion/ulceration	11%	<1%
Exudate*	34%	2%
Severe exudate	2%	0%
* Mild, moderate, or severe

The frequency and severity of local skin reactions were similar in both genders, with the following exceptions: a) flaking/scaling occurred in 40% of men and in 26% of women and b) scabbing/crusting occurred in 34% of men and in 18% of women.

In the clinical trials, 32% (126/400) of subjects who used ZYCLARA Cream and 2% (4/202) of subjects who used vehicle cream discontinued treatment temporarily (required rest periods) due to adverse local skin reactions, and 1% (3/400) of subjects who used ZYCLARA Cream discontinued treatment permanently due to local skin/application site reactions.

Other adverse reactions reported in subjects treated with ZYCLARA Cream include: rash, back pain, application site rash, application site cellulitis, application site excoriation, application site bleeding, scrotal pain, scrotal erythema, scrotal ulcer, scrotal edema, sinusitis, nausea, pyrexia, and influenza-like symptoms.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of imiquimod. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Application Site Disorders: tingling at the application site

Body as a Whole: angioedema

Cardiovascular: capillary leak syndrome, cardiac failure, cardiomyopathy, pulmonary edema, arrhythmias (tachycardia, supraventricular tachycardia, atrial fibrillation, palpitations), chest pain, ischemia, myocardial infarction, syncope

Endocrine: thyroiditis

Gastrointestinal System Disorders: abdominal pain

Hematological: decreases in red cell, white cell and platelet counts (including idiopathic thrombocytopenic purpura), lymphoma

Hepatic: abnormal liver function

Infections and Infestations: herpes simplex

Musculoskeletal System Disorders: arthralgia

Neuropsychiatric: agitation, cerebrovascular accident, convulsions (including febrile convulsions), depression, insomnia, multiple sclerosis aggravation, paresis, suicide

Respiratory: dyspnea

Urinary System Disorders: proteinuria, urinary retention, dysuria

Skin and Appendages: exfoliative dermatitis, erythema multiforme,hyperpigmentation, hypertrophic scar, hypopigmentation

Vascular: Henoch-Schonlein purpura syndrome

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Zyclara (Imiquimod Cream)