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Zyclara

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Zyclara

Zyclara

Zyclara Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Zyclara (imiquimod) Cream, 2.5% or 3.75% is used to treat actinic keratoses (AK) of the face or balding scalp. It is also used to treat external genital and perianal warts in people 12 years and older. It is an immune response modifier. Common side effects include headache, pain or itching at the treatment area, tiredness, nausea, or skin irritation.

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. Zyclara Cream may interact with other medications. Tell your doctor all prescription and over-the-counter medications and supplements you take. Zyclara Cream should only be used during pregnancy if prescribed. It is unknown if this medications passes into breast milk. Consult your doctor before breast-feeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zyclara in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty 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 is applied.

Stop using imiquimod topical and call your doctor at once if you have a serious side effect such as flu symptoms such as fever, chills, body aches, tired feeling, swollen glands.

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.

Less serious side effects may include:

  • mild skin irritation, itching, dryness, flaking, scabbing, crusting, redness, or hardening of the skin where the medicine was applied;
  • changes in the color of treated skin;
  • headache, dizziness, chest pain, back pain;
  • cold sores, fever blisters;
  • cold symptoms such as stuffy nose, sneezing, sore throat;
  • nausea, diarrhea, loss of appetite; or
  • vaginal itching or discharge.

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.

Read the entire detailed patient monograph for Zyclara (Imiquimod Cream) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zyclara FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 d%) 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%
*All Grades: 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

Gastro-Intestinal 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 Musculo-Skeletal 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

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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