Penlac Side Effects

Please note - some side effects for Penlac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Penlac - for the Consumer

Penlac Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Penlac Solution:

Change in shape of nail; discoloration; ingrown toenail; irritation; redness of the treated area.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; burning; increased redness; itching; oozing of the treated area; rash on the palms; swelling.

Penlac Side Effects - for the Professional

Penlac

In the vehicle-controlled clinical trials conducted in the US, 9% (30/327) of patients treated with Penlac ®NAIL LACQUER (ciclopirox) Topical Solution, 8%, and 7% (23/328) of patients treated with vehicle reported treatment-emergent adverse events (TEAE) considered by the investigator to be causally related to the test material.

The incidence of these adverse events, within each body system, was similar between the treatment groups except for Skin and Appendages: 8% (27/327) and 4% (14/328) of subjects in the ciclopirox and vehicle groups reported at least one adverse event, respectively. The most common were rash-related adverse events: periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, (5% [16/327]) than in patients treated with vehicle (1% [3/328]). Other TEAEs thought to be causally related included nail disorders such as shape change, irritation, ingrown toenail, and discoloration.

The incidence of nail disorders was similar between the treatment groups (2% [6/327] in the Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, group and 2% [7/328] in the vehicle group). Moreover, application site reactions and/or burning of the skin occurred in 1% of patients treated with Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, (3/327) and vehicle (4/328).

A 21-Day Cumulative Irritancy study was conducted under conditions of semi-occlusion. Mild reactions were seen in 46% of patients with the Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, 32% with the vehicle and 2% with the negative control, but all were reactions of mild transient erythema. There was no evidence of allergic contact sensitization for either the Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, or the vehicle base. In a separate study of the photosensitization potential of Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8% in a maximized test design that included the occluded application of sodium lauryl sulfate, no photoallergic reactions were noted. In four subjects localized allergic contact reactions were observed. In the vehicle-controlled studies, one patient treated with Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, discontinued treatment due to a rash, localized to the palm (causal relation to test material undetermined).

Use of Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, for 48 additional weeks was evaluated in an open-label extension study conducted in patients previously treated in the vehicle-controlled studies. Three percent (9/281) of subjects treated with Penlac® NAIL LACQUER (ciclopirox) Topical Solution, 8%, experienced at least one TEAE that the investigator thought was causally related to the test material. Mild rash in the form of periungual erythema (1% [2/281]) and nail disorders (1% [4/281]) were the most frequently reported. Four patients discontinued because of TEAEs. Two of the four had events considered to be related to test material: one patient's great toenail "broke away" and another had an elevated creatine phosphokinase level on Day 1 (after 48 weeks of treatment with vehicle in the previous vehicle-controlled study).

Side Effects by Body System

Nervous system

Nervous system side effects associated with the use of ciclopirox shampoo have included headache.

Cardiovascular

Cardiovascular side effects associated with ciclopirox shampoo have included ventricular tachycardia.

Dermatologic

Dermatologic side effects have included irritation, itching, erythema, and burning in 1% to 4% of treated patients. Seborrhea was the most common cause of early termination in subjects being treated with the shampoo. The shampoo has also been associated with rash and skin disorder. The topical nail solution has been associated with periungul erythema (1%) and proximal nail fold erythema, nail shape change, irritation, ingrown toenail, and nail discoloration.

Metabolic

Metabolic side effects associated with the topical nail solution have included 1 case of elevated creatine phosphokinase.

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