Loprox Side Effects

Generic name: ciclopirox topical

Please note - some side effects for Loprox 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 Loprox - for the consumer

Loprox Cream

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 Loprox Cream:

Burning; itching at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; oozing; swelling.

Loprox Gel

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 Loprox Gel:

Burning sensation at the application site; itching; skin inflammation.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; oozing; swelling.

Loprox Shampoo

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 Loprox Shampoo:

Itching; headache; rash; skin disorder.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fast heartbeat.

Loprox Suspension

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 Loprox Suspension:

Burning; itching at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; oozing; swelling.

For the professional

Loprox

In 626 patients treated with Loprox Shampoo twice weekly in the two pivotal clinical studies, the most frequent adverse events were increased itching in 1% of patients, and application site reactions, such as burning, erythema, and itching, also in 1% of patients. Other adverse events occurred in individual patients only.

Adverse events that led to early study medication termination in clinical trials occurred in 1.5% (26/1738) of patients treated with Loprox Shampoo and 2.0% (12/661) of patients treated with shampoo vehicle. The most common adverse events leading to termination of study medication in either group was seborrhea. In the Loprox Shampoo group, other adverse events included rash, pruritus, headache, ventricular tachycardia, and skin disorder. In the shampoo vehicle group, other adverse events included skin disorder and rash.

Loprox Cream

In all controlled clinical studies with 514 patients using Loprox® Cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.

Loprox Gel

In clinical trials, 140 (39%) of 359 subjects treated with Loprox® Gel reported adverse experiences, irrespective of relationship to test materials, which resulted in 8 subjects discontinuing treatment. The most frequent experience reported was skin burning sensation upon application, which occurred in approximately 34% of seborrheic dermatitis patients and 7% of tinea pedis patients. Adverse experiences occurring between 1% to 5% were contact dermatitis and pruritus. Other reactions that occurred in less than 1% included dry skin, acne, rash, alopecia, pain upon application, eye pain, and facial edema.

Loprox Topical Suspension

In the controlled clinical trial with 89 patients using Loprox® Topical Suspension and 89 patients using the vehicle, the incidence of adverse reactions was low. Those considered possibly related to treatment or occurring in more than one patient were pruritus, which occurred in two patients using ciclopirox topical suspension and one patient using the suspension vehicle, and burning, which occurred in one patient using ciclopirox topical suspension.

By body system

Nervous system side effects

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

Cardiovascular side effects

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

Dermatologic side effects

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 side effects

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

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