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Zyclara Side Effects

Generic Name: imiquimod topical

Note: This document contains side effect information about imiquimod topical. Some of the dosage forms listed on this page may not apply to the brand name Zyclara.

In Summary

Common side effects of Zyclara include: dermal ulcer, application site reaction, burning sensation, desquamation, edema, excoriation, exfoliation of skin, pruritus, skin erosion, and erythema. Other side effects include: back pain, headache, and pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to imiquimod topical: topical cream, topical kit

Along with its needed effects, imiquimod topical (the active ingredient contained in Zyclara) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking imiquimod topical:

More Common

  • Blisters on the skin
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • itching in the genital or other skin areas
  • loss of voice
  • open sores or scabs on the skin
  • pain or tenderness around the eyes and cheekbones
  • redness of the skin (severe)
  • scaling
  • shortness of breath or troubled breathing
  • skin rash
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tightness of the chest or wheezing
  • unusual tiredness or weakness

Less Common

  • Abdominal or stomach pain
  • ankle, knee, or great toe joint pain
  • bladder pain
  • bloody or cloudy urine
  • blurred vision
  • chest pain
  • cold flu-like symptoms
  • difficult, burning, or painful urination
  • dizziness
  • fainting
  • fast or irregular heartbeat
  • frequent urge to urinate
  • hoarseness
  • joint stiffness or swelling
  • lower back or side pain
  • lump in the abdomen or stomach
  • nervousness
  • persistent non-healing sore
  • pink growth on the skin
  • pounding in the ears
  • reddish patch or irritated area
  • severe headache
  • shiny bump on the skin
  • slow or fast heartbeat
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • white, yellow or waxy scar-like area

Incidence Not Known

  • Blue lips and fingernails
  • convulsions
  • coughing that sometimes produces a pink frothy sputum
  • dilated neck veins
  • extreme fatigue
  • fast, irregular, or pounding heartbeat
  • headache
  • irregular breathing
  • nausea or vomiting
  • pain in the shoulders, arms, jaw, or neck
  • slurred speech
  • sudden and severe inability to speak
  • suicide
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • temporary blindness
  • weakness in the arm or leg on one side of the body
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking imiquimod topical:

Symptoms of Overdose

  • Confusion
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

Some side effects of imiquimod topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Burning or stinging of the skin (mild)
  • flaking of the skin
  • mild headache
  • pain, soreness, or tenderness of the skin (mild)
  • rash
  • redness of the skin (mild)
  • swelling at place of application

Less Common

For Healthcare Professionals

Applies to imiquimod topical: topical cream

General

The most frequently reported side effects are local skin reactions (e.g., erythema, edema, weeping/exudate, flaking/scaling/dryness, scabbing/crusting, and erosion/ulceration), headache, application site reactions, influenza-like illness, fatigue, nausea, and fever.[Ref]

Local

Very common (10% or more): Induration (78%), application site reaction (up to 33%), application site application site vesicles (up to 29%), pruritus/itching (up to 26.4%), application site burning (up to 16.1%), application site erythema, application site scabbing, application site exfoliation, application site dryness, application site edema, application site ulcer, application site discharge, application site pain

Common (1% to 10%): Application site irritation, application site swelling, application site rash, application site bleeding, application site papules, application site paresthesia, application site stinging sensation, application site tenderness

Uncommon (0.1% to 1%): Application site dermatitis, application site hyperesthesia, application site inflammation, application site scar, application site skin breakdown, application site warmth[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (up to 15%)

Common (1% to 10%): Sinusitis

Uncommon (0.1% to 1%): Nasal congestion, pharyngolaryngeal pain, rhinitis, pharyngitis[Ref]

Immunologic

Rare (less than 0.1%): Autoimmune condition exacerbated[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness

Uncommon (0.1% to 1%): Lethargy, paresthesia, migraine, somnolence[Ref]

Other

Very common (10% or more): Edema (up to 71%)

Common (1% to 10%): Fatigue, pyrexia, herpes simplex, pain, chest pain, influenza-like illness, infection, pustule, viral infection

Uncommon (0.1% to 1%): Face edema, asthenia, chills, discomfort, inflammation, bacterial infection, fungal infection, tinnitus, rigors, malaise[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, diarrhea, chelitis, vomiting

Uncommon (0.1% to 1%): Dry mouth, abdominal pain, rectal disorder, rectal tenesmus[Ref]

Oncologic

Common (1% to 10%): Carcinoma squamous[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy

Frequency not reported: Hemoglobin decreased, white blood cell count decreased, neutrophil count decreased, platelet count decreased[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation

Uncommon (0.1% to 1%): Flushing[Ref]

Dermatologic

Very common (10% or more): Excoriation/flaking/scaling/dryness (up to 87%), erythema (up to 69%), scab/crusting (up to 64%), erosion/ulceration (up to 54%), skin exfoliation, skin edema, skin ulcer, skin hypopigmentation

Common (1% to 10%): Dermatitis

Uncommon (0.1% to 1%): Pruritus, folliculitis, rash erythematous, eczema, rash, sweating increased, urticaria, actinic keratosis

Frequency not reported: Skin infection, alopecia, erythema multiforme, Stevens-Johnson syndrome, skin hyperpigmentation, cutaneous lupus erythematosus[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, arthralgia, back pain

Uncommon (0.1% to 1%): Pain in extremity[Ref]

Genitourinary

Uncommon (0.1% to 1%): Genital candidiasis, vaginitis, vulvitis, dysuria, male genital pain, penile disorder, dyspareunia, erectile dysfunction, uterovaginal prolapse, vaginal pain, vaginitis atrophic, vulval disorder[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Uncommon (0.1% to 1%): Depression, irritability[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctival irritation, eyelid edema[Ref]

Metabolic

Common (1% to 10%): Anorexia, blood glucose increased[Ref]

Hepatic

Frequency not reported: Hepatic enzyme increased[Ref]

Endocrine

Postmarketing reports: Thyroiditis[Ref]

References

1. "Product Information. Aldara (imiquimod topical)." 3M Pharmaceuticals, St. Paul, MN.

2. "Product Information. Zyclara (imiquimod topical)." Medicis Pharmaceutical Corporation, Scottsdale, AZ.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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