Extina
- Generic Name: ketoconazole foam, 2%
- Brand Name: Extina
Extina (Ketoconazole Foam, 2%) side effects drug center
Extina Side Effects Center
What Is Extina?
Extina (ketoconazole foam, 2%) is a topical (for the skin) antifungal medication used to treat fungal infections of the skin such as athlete's foot, jock itch, ringworm, and seborrhea (dry, flaking skin). Extina is available in generic form.
What Are Side Effects of Extina?
Common side effects of Extina include:
- burning or irritation at the application site,
- skin itching,
- dry skin, or
- headache
Dosage for Extina
The recommended dose of Extina Foam is to apply to the affected area(s) twice daily for four weeks.
What Drugs, Substances, or Supplements Interact with Extina?
Other drugs may interact with Extina. Tell your doctor all medications and supplements you use.
Extina During Pregnancy and Breastfeeding
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.
Additional Information
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.
Extina Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- burning, stinging, or severe irritation after using this medicine;
- redness, pain, or oozing of treated skin; or
- shortness of breath.
Common side effects may include:
- thinning hair;
- changes in the color or texture of your hair;
- dry skin; or
- mild itching.
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.
Read the entire detailed patient monograph for Extina (Ketoconazole Foam, 2%)
Extina Professional 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® Foam in 672 subjects, 12 years and older with seborrheic dermatitis. Subjects applied EXTINA® 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® Foam N = 672 n (%) |
Vehicle Foam N = 497 n (%) |
| Subjects with an Adverse Reaction | 188 (28%) | 122 (25%) |
| Application site burning | 67 (10%) | 49 (10%) |
| Application site reaction | 41 (6%) | 24 (5%) |
Application site reactions that were reported in < 1% of subjects were dryness, erythema, irritation, paresthesia, pruritus, rash and warmth.
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® Foam. EXTINA® Foam may cause contact sensitization.
Read the entire FDA prescribing information for Extina (Ketoconazole Foam, 2%)
&Copy; Extina Patient Information is supplied by Cerner Multum, Inc. and Extina Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.