Ciclopiroxside effects
ciclopirox 10 MG/ML Medicated Shampoo
Adverse reactions
The most frequently reported adverse reactions are pruritus, burning, and erythema. To report SUSPECTED ADVERSE REACTIONS, contact Padagis at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical
Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In 626 subjects treated with ciclopirox shampoo, 1% twice weekly in the two pivotal clinical trials, the most frequent adverse events were increased itching in 1% of subjects, and application site reactions, such as burning, erythema, and itching, also in 1% of subjects.
6.2 Post Marketing
Experience The following adverse reactions have been identified during post approval use of Ciclopirox Shampoo, 1%: hair discoloration and abnormal hair texture, alopecia, irritation and rash. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 1, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Warnings
5.1 Local Effects
If a reaction suggesting sensitivity or irritation occurs with the use of ciclopirox shampoo, treatment should be discontinued and appropriate therapy instituted. Contact of cicloplrox shampoo with the eyes should be avoided. If contact occurs, rinse thoroughly with water. In patients with lighter hair color, hair discoloration has been reported.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 1, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Contraindications
None. None
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective March 1, 2023. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
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