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Naftin Gel

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Naftin Gel

Naftin Gel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Naftin (naftifine) Gel, 1% 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.

A sufficient quantity of Naftin Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application. Naftin Gel may interact with other skin medications. 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 Gel 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) Gel 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 Gel 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 Gel (Naftifine) »

What is Prescribing information?

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

Naftin Gel 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.

In two randomized, vehicle-controlled trials, 1143 subjects were treated with NAFTIN Gel versus 571 subjects treated with the vehicle. The trial subjects were 12 to 92 years old, were primarily male (76%), and were 59% Caucasian, 38% Black or African American, and 23% Hispanic or Latino. Subjects received doses once daily, topically, for 2 weeks to cover the affected skin areas plus a ½-inch margin of surrounding healthy skin. The most common adverse reactions were application site reactions which occurred at the rate of 2% in NAFTIN Gel arm versus 1% in vehicle arm. Most adverse reactions were mild in severity.

In an open-label pediatric pharmacokinetics and safety trial 22 pediatric subjects 12-17 years of age with interdigital tinea pedis received NAFTIN Gel. The incidence of adverse reactions in the pediatric population was similar to that observed in adult population. Cumulative irritancy testing revealed the potential for NAFTIN Gel to cause irritation. There was no evidence that NAFTIN Gel causes contact sensitization, phototoxicity, or photoallergenicity in healthy skin.

Postmarketing Experience

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. The following adverse reactions have been identified during post-approval use of naftifine hydrochloride: blisters, burning sensation, crusting, dryness, erythema/redness, inflammation, irritation, maceration, pain, pruritus [mild]/itching, rash and swelling.

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

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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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