Loprox Side Effects

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.

Loprox Side Effects - 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.

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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