Ciclopirox (Penlac) Adverse Reactions
- contact dermatitis
- erythema
- nail discoloration
- pruritus
- rash (unspecified)
- skin irritation
Ciclopirox (Penlac) Adverse Reactions
The incidence of adverse reactions in patients using ciclopirox 1% lotion or cream (e.g., Loprox®) is low. Adverse reactions which were considered possibly related to treatment in clinical trials include: pruritus, burning or worsening of the underlying clinical signs and symptoms. Other potential reactions to the cream or lotion included skin irritation or erythema. In patients treated with ciclopirox shampoo, the most frequent adverse events were increased itching (pruritus) in 1% of patients, and application site reactions, such as burning, erythema, and pruritus, also in 1% of patients. Other adverse events occurred in individual patients only. Early shampoo discontinuation occurred in 1.5% of patients treated with ciclopirox shampoo and 2% of patients treated with the shampoo vehicle alone. The most common adverse event leading to termination of study medication in either group was seborrhea (worsening of the underlying condition). In the ciclopirox shampoo group, other adverse events included rash (unspecified), pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash (unspecified).
In controlled clinical trials, 9% (30 of 327) of patients treated with Penlac™ Nail Lacquer Topical Solution and 7% (23 of 328) of patients treated with the control vehicle reported adverse events considered by the investigator to be related to the treatment. There was a higher percentage of patients who experience adverse events related to the skin and appendages in the Penlac™ group (8% versus 4% for the vehicle group). The most common adverse events were rash-related. Periungual erythema and erythema of the proximal nail fold were reported more frequently in patients treated with Penlac™ (5% versus 1% for the vehicle group). Other adverse events thought to be causally related to the treatment included nail disorders such as shape change, irritation, ingrown toenail, and nail discoloration. The incidence of nail disorders was similar between the treatment groups (2% in the Penlac™ group and 2% in the vehicle group). Application site reactions and/or burning of the skin occurred in 1% of patients treated with Penlac™ and 1% treated with the vehicle. Ciclopirox nail solution was associated with similar adverse events when evaluated for 48 additional weeks in an open-label extension study. A 21-day cumulative study of treatment irritancy was conducted for ciclopirox nail solution under conditions of semi-occlusion. Transient, mild erythema reactions were seen in 46% of patients with the Penlac™, 32% with the vehicle and 2% with the negative control. There was no evidence of allergic contact sensitization for either the ciclopirox or the vehicle base. In the vehicle-controlled studies, one patient treated with ciclopirox discontinued treatment due to a rash (unspecified), localized to the palm (causality not determined). In a separate study by the manufacturer, the photosensitization potential of Penlac™ was evaluated; no photoallergic/photosensitivity reactions were noted. In four subjects, localized allergic contact reactions (contact dermatitis) were observed.
[ Last revised: 2/9/2005 2:00:00 PM ]
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