"The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.
Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSS"...
Penlac Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Penlac Nail Lacquer (ciclopirox) Topical Solution, 8% is used to treat fungal infections of the toenails and fingernails. It is a topical (for the skin) antifungal medication. This medication is available in generic form. Common side effects include redness/burning of treated skin or changes in shape/color of nail.
Penlac Nail Lacquer Topical Solution, 8%, should be applied once daily (preferably at bedtime or eight hours before washing) to all affected nails and over the entire nail plate with the applicator brush provided. The unattached, infected nail should be removed as frequently as monthly by a health care professional, and trimmed weekly by the patient, along with daily application of the medication. Penlac Nail Lacquer may interact with other topical products. Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with Penlac Nail Lacquer. Other drugs may interact with Penlac Nail Lacquer. Tell your doctor all prescription or over-the-counter medicines and supplements you use. During pregnancy, Penlac Nail Lacquer should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Our Penlac Nail Lacquer (ciclopirox) Topical Solution 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Penlac in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using ciclopirox and call your doctor at once if you have a serious side effect such as:
- unusual or severe itching, redness, burning, dryness, or irritation of treated skin; or
- discoloration or other changes in the nails.
Less serious side effects may include mild burning, itching, or redness.
Read the entire detailed patient monograph for Penlac (Ciclopirox Topical Solution)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Penlac Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: blistering/swelling/oozing at the application site.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Penlac (Ciclopirox Topical Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Penlac FDA Prescribing Information: Side Effects
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).
Read the entire FDA prescribing information for Penlac (Ciclopirox Topical Solution)
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