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Naftin Cream

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Naftin Cream

Naftin Cream Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Naftin (naftifine hydrochloride) Cream is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. It is a topical (for the skin) antifungal medication. Common side effects include burning, stinging, irritation, redness, dry skin, or itching at application site.

Apply a thin layer of Naftin Cream, 2% dose once-daily to the affected areas plus a ½ inch margin of healthy surrounding skin for 2 weeks. Avoid using other topicals at the same time unless your doctor approves. Tell your doctor all medications and supplements you are taking. During pregnancy, Naftin Cream should be used only when prescribed. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Our Naftin (naftifine hydrochloride) 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.

Naftin Cream in Detail - Patient Information: Side Effects

Serious side effects of naftifine topical use are not expected. Stop using naftifine topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Naftin Cream (Naftifine Hcl) »

What is Prescribing information?

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

Naftin Cream FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 clinical practice.

During clinical trials, 760 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 421 subjects with interdigital tinea pedis and/or tinea cruris were treated with NAFTIN Cream.

In two randomized, vehicle-controlled trials (400 patients were treated with NAFTIN Cream). The population was 12 to 88 years old, primarily male (79%), 48% Caucasian, 36% Black or African American, 40% Hispanic or Latino and had either predominantly interdigital tinea pedis or tinea cruris. Most subjects received doses once-daily, topically, for 2 weeks to cover the affected skin areas plus a ½ inch margin of surrounding healthy skin. In the two vehicle-controlled trials, 17.5% of NAFTIN Cream treated subjects experienced an adverse reaction compared with 19.3% of vehicle subjects. The most common adverse reaction ( ≥ 1%) is pruritus. Most adverse reactions were mild in severity. The incidence of Adverse Reactions in the NAFTIN Cream treated population were not significantly different than the vehicle treated population.

In an open-label pediatric pharmacokinetics and safety trial, 22 pediatric subjects 13-17 years of age with interdigital tinea pedis and tinea cruris received NAFTIN Cream. The incidence of adverse reactions in the pediatric population was similar to that observed in the adult population.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of (naftifine hydrochloride): redness/irritation, inflammation, maceration, swelling, burning, blisters, serous drainage, crusting, headache, dizziness, leukopenia, agranulocytosis. 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.

Read the entire FDA prescribing information for Naftin Cream (Naftifine Hcl) »

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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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