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Extina Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Extina (ketoconazole foam, 2%) is used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin). It is a topical (for the skin) antifungal medication. This medication is available in generic form. Common side effects include burning or irritation at the application site.The recommended dose of Extina Foam is to apply to the affected area(s) twice daily for four weeks. Other drugs may interact with Extina. Tell your doctor all medications and supplements you use. During pregnancy, Extina should be used only when prescribed. It is unknown if this drug passes into breast milk when applied to the skin. Consult your doctor before breastfeeding. Our Extina (ketoconazole foam, 2%) 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.
Extina in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using ketoconazole topical and call your doctor if you have any of these serious side effects:
- severe itching, burning, or irritation where the medicine is applied;
- oily or dry scalp, mild hair loss;
- redness, pain, or oozing of treated skin areas; or
- eye redness, swelling, or irritation.
Less serious side effects include:
- mild skin itching or irritation;
- dry skin; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Extina (Ketoconazole Foam, 2%) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Extina 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.
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 Extina (Ketoconazole Foam, 2%)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Extina FDA Prescribing Information: Side Effects
Adverse Reactions in Clinical Trials
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 practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse reactions that appear to be related to drug use and for approximating rates. The safety data presented in Table 1 (below) reflect exposure to Extina (ketoconazole foam, 2%) Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied Extina (ketoconazole foam, 2%) Foam or vehicle foam twice daily for 4 weeks to affected areas on the face, scalp, and/or chest. Adverse reactions occurring in > 1% of subjects are presented in Table 1.
Table 1: Adverse Reactions Reported by > 1% Subjects in Clinical Trials
|Adverse Reactions||Extina (ketoconazole foam, 2%) Foam
N = 672
N = 497
|Subjects with an Adverse Reaction||188 (28%)||122 (25%)|
|Application site burning||67 (10%)||49 (10%)|
|Application site reaction||41 (6%)||24 (5%)|
Dermal Safety Studies
In a photoallergenicity study, 9 of 53 subjects (17%) had reactions during the challenge period at both the irradiated and non-irradiated sites treated with Extina (ketoconazole foam, 2%) Foam. Extina (ketoconazole foam, 2%) Foam may cause contact sensitization.
Read the entire FDA prescribing information for Extina (Ketoconazole Foam, 2%) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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