Naftin Cream

Last updated on RxList: 5/8/2018
Naftin Cream Side Effects Center

Last reviewed on RxList 5/8/2018

Naftin (naftifine hydrochloride) Cream is a topical (for the skin) antifungal medication used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. Common side effects of Naftin Cream include:

  • application site reactions (burning, stinging, irritation, redness, dry skin, itching, inflammation, softening and breakdown of skin, blisters, serous drainage, or crusting),
  • headache, and
  • dizziness.

Apply a thin layer dose of Naftin Cream, 2% 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 to avoid interactions. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plant to become pregnant before using Naftin Cream; it is unknown if it would affect a fetus. It is unknown if Naftin Cream passes into breast milk. Consult your doctor before breastfeeding.

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.

SLIDESHOW

Rosacea, Acne, Shingles, Covid-19 Rashes: Common Adult Skin Diseases See Slideshow
Naftin Cream Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe skin irritation after applying this medicine.

Common side effects may include dryness or irritation of treated skin.

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 Naftin Cream (Naftifine Hcl)

QUESTION

Ringworm is caused by a fungus. See Answer
Naftin Cream Professional Information

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, 903 subjects were exposed to naftifine 1% and 2% cream formulations. A total of 564 subjects with interdigital tinea pedis, tinea cruris, or tinea corporis 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 was not significantly different than in the vehicle treated population.

In a third randomized, vehicle-controlled trial, 116 pediatric subjects with tinea corporis were treated with NAFTIN Cream. The population was aged ≥2 to <18 years (mean age of 9 years), predominantly male (61%), 47% White, 51% Black or African American, 92% Hispanic or Latino, and infected with tinea corporis. NAFTIN Cream was topically applied once daily for 2 weeks to all affected body surface areas with tinea corporis plus a ½ inch margin of healthy skin surrounding the affected lesions. The incidence of adverse reactions in the NAFTIN Cream treated population was not significantly different than in the vehicle treated population.

In two open-label pediatric pharmacokinetics and safety trials, 49 pediatric subjects 2 to <18 years of age with interdigital tinea pedis, tinea cruris, and tinea corporis 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)

© Naftin Cream Patient Information is supplied by Cerner Multum, Inc. and Naftin Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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