Key facts
What is Zyclara?
From the FDA label:ZYCLARA (imiquimod) cream, 2.5% or 3.75% is for topical administration. Each gram contains 25 mg or 37.5 mg of imiquimod, respectively, in a white to faintly yellow oil-in-water cream base consisting of benzyl alcohol, cetyl alcohol, glycerin, isostearic acid, methylparaben, polysorbate 60, propylparaben, purified water, sorbitan monostearate, stearyl alcohol, white petrolatum, and xanthan gum. Chemically, imiquimod is 1-(2-methylpropyl)-1 H -imidazol[4,5-c]quinolin-4-amine. Imiquimod has a molecular formula of C 14 H 16 N 4 and a molecular weight of 240.3. Its structural formula is: chem structure
How to use
For topical use only; not for oral, ophthalmic, intra-anal or intravaginal use. ( 2.1 ) • AK : Apply a thin layer once daily at bedtime to affected area (either entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period. Apply up to 0.5 grams at each application. ( 2.2 ) • EGW : Apply a thin layer once daily at bedtime until total clearance or up to 8 weeks. Apply up to 0.25 grams at each application. ( 2.3 ) 2.1 Important Dosage and Administration Instructions ZYCLARA is for topical use only. ZYCLARA is not for oral, ophthalmic, intra-anal or intravaginal use. Instruct patients on proper application technique. Wash hands before and after applying ZYCLARA. Prime the ZYCLARA pump bottle before first use by repeatedly depressing the actuator until the cream is dispensed. It is not necessary to repeat this priming process during treatment. If a ZYCLARA dose is missed, apply the next dose at the regularly scheduled time. Avoid contact with the eyes, lips, nostrils, or inside the anus and vagina. Prescribe no more than 2 boxes (56 packets) or two 7.5 g bottle pumps of ZYCLARA for the entire treatment course for AK or EGW. Discard partially used packets and do not reuse. Discard pump bottles after completion of a full treatment course. 2.2 Dosage and Administration for Actinic Keratosis Use ZYCLARA, 2.5% or 3.75% for the treatment of AK.…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1) ] • Systemic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥4%) are local skin reactions (erythema, scabbing/crusting, flaking/scaling/dryness, edema, erosion/ulceration, exudate), headache, application site pain, application site irritation, application site pruritus, fatigue, influenza-like illness, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience 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. Actinic Keratosis The data described below reflect exposure to ZYCLARA or vehicle in 479 subjects with AK enrolled in two double-blind, vehicle-controlled trials (Studies AK1 and AK2) [ Clinical Studies (14.1 )] . Subjects applied up to two packets of ZYCLARA, 3.75%, ZYCLARA, 2.5%, or vehicle once 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.…
Warnings
Important safety information
Local Skin Reactions : Intense local inflammatory reactions can occur (e.g., skin weeping, erosion). Dosage interruption may be required. Severe vulvar swelling may occur and lead to urinary retention; interrupt dosing or discontinue for severe vulvar swelling. ( 2.2 , 2.3 , 5.1 ) • Systemic Reactions : Flu-like signs and symptoms have occurred. Consider dosage interruption for systemic reactions. ( 5.2 ) • Ultraviolet Light Exposure Risks: Avoid or minimize exposure to sunlight and sunlamps. Wear protective clothing. ( 5.3 ) 5.1 Local Skin Reactions Local skin reactions including skin weeping or erosion have been reported with use of ZYCLARA and can occur after a few applications [ see Adverse Reactions (6) ]. Concomitant use of ZYCLARA and any other imiquimod products, in the same treatment area, may increase the risk for and severity of local skin reactions. ZYCLARA Cream has the potential to exacerbate inflammatory conditions of the skin, including chronic graft versus host disease. Severe local inflammatory reactions of the female external genitalia can lead to severe vulvar swelling and to urinary retention. Avoid sexual (genital, anal, oral) contact while ZYCLARA is on the skin. To reduce the risk of local skin reactions and manage local skin reactions that occur with ZYCLARA treatment: • Avoid concomitant use of ZYCLARA with any other imiquimod product in the same treatment area. • Avoid application of ZYCLARA to skin that is not intact (i.e., any area with an abrasion, cut, burn, rash, infection, or other condition that has altered skin integrity). • An interruption of dosing may be required for local skin reactions [ see Dosage and Administration (2.2 , 2.3 )]. Interrupt dosing or discontinue ZYCLARA for severe vulvar swelling [see Dosage and Administration (2.3 )]. • If severe local skin reactions occur, instruct patients to remove ZYCLARA by washing the treatment area with mild soap and water. 5.2 Systemic Reactions Flu-like signs and symptoms have been reported with use of ZYCLARA and may accompany, or even precede, local skin reactions [see Adverse Reactions (6) ] . Signs and symptoms may include fatigue, nausea, fever, myalgias, arthralgias, malaise and chills. Concomitant use of ZYCLARA and any other imiquimod products may increase the risk for and severity of systemic reactions. Lymphadenopathy occurred in 2% of subjects with AK treated with ZYCLARA, 3.75% and in 3% of subjects treated with ZYCLARA, 2.5% and in no patients in the vehicle arm [see Adverse Reactions (6.1 )]. This reaction resolved in all subjects by 4 weeks after completion of treatment. Consider an interruption of dosing if systemic reactions occur . 5.3 Ultraviolet Light Exposure Risks ZYCLARA may cause heightened sunburn susceptibility. Avoid or minimize exposure to sunlight (including sunlamps) during use of ZYCLARA. Instruct patients to use sunscreen and wear protective clothing (e.g., a hat). Advise patients not to use ZYCLARA until fully recovered from a sunburn. 5.4 Immune Cell Activation in Autoimmune Disease Imiquimod activates immune cells [see Clinical Pharmacology (12.2) ] . Carefully monitor patients with pre-existing autoimmune conditions who are using ZYCLARA.
Who should not take Zyclara
None. None. ( 4 )
Overdose — what happens if you take too much
Topical overdosing of ZYCLARA could result in an increased incidence of severe local skin reactions and may increase the risk for systemic reactions. Hypotension was reported in a clinical trial following multiple oral imiquimod doses of >200 mg (equivalent to ingestion of the imiquimod content of more than 21 packets or pump actuations of ZYCLARA, 3.75% or more than 32 pump actuations of ZYCLARA, 2.5%). The hypotension resolved following oral or intravenous fluid administration. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Storing Zyclara, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Store ZYCLARA pump bottles upright.”
May treat (source: NIH RxClass)
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Zyclara treat?
- Zyclara (Imiquimod) may be used to treat basal cell carcinoma, condylomata acuminata, actinic keratosis, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Zyclara cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $350.38 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Zyclara?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Zyclara. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Zyclara?
- Zyclara is marketed by Bausch. You can see Bausch's full profile, rating, and other products on pharmaranks.
- Is Zyclara a brand-name or generic drug?
- Zyclara is a brand-name product with the active ingredient Imiquimod. Lower-cost generic equivalents containing Imiquimod are available — ask your pharmacist.
- Is Zyclara available over the counter?
- No. Zyclara is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Zyclara come in?
- Zyclara is currently marketed as topical, per the FDA's National Drug Code Directory.
- Is Zyclara FDA-registered?
- Zyclara is on record with the U.S. FDA under application number NDA022483. You can verify this on its official FDA label.
- Is Zyclara safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Zyclara. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Zyclara?
- Zyclara's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: • Local Skin Reactions [see Warnings and Precautions (5.1) ] • Systemic Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥4%) are local skin reactions (erythema,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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