Uses
What the official label says Ketoconazole is used for
The FDA label for Ketoconazole states:
Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. …
Read the label's “Indications and usage” section (verbatim)
Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora.
Names & forms
Brand names, forms and strengths
Brand names (from RxNorm; not every brand is still sold): Extina, Ketodan, Kuric, T8 Keto Flush, Xolegel.
Generic name: ketoconazole · RxNorm ID (RxCUI): 6135
| Form | Strengths listed in RxNorm |
|---|---|
| Topical Cream | 10 MG/ML, 20 MG/ML |
| Topical Foam | 20 MG/ML |
| Topical Gel | 0.02 MG/MG |
| Topical Solution | 1 MG/ML |
Strengths are listed so you can recognise a product — not as dosing information. Only your prescriber can decide what is right for you.
Appearance
What Ketoconazole looks like
| Strength | Form | Colour | Shape | Size | Imprint | Score | Labeler |
|---|---|---|---|---|---|---|---|
| ketoconazole 20 mg per mL | shampoo | red“Red-orange” | — | — | — | — | ANI Pharmaceuticals, Inc. |
| ketoconazole 20 mg per g | cream | white“white to off white” | — | — | — | — | NORTHSTAR RX LLC |
From the product data in each manufacturer's label on DailyMed. Many companies make Ketoconazole, so your medicine may look different from any shown here. If a pill looks unfamiliar, ask your pharmacist before taking it.
Read the label's “How supplied” section (verbatim)
Ketoconazole Shampoo, 2% is a red-orange color liquid supplied in a 4-fluid ounce (120 mL) non-breakable plastic bottle (NDC 70954-662-10). Storage conditions: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. All trademarks are the property of their respective owners. Distributed by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 Issued: 07/2024 LB4643-01
Safety
Important warnings for Ketoconazole
Contraindications — who should not use it (verbatim)
Ketoconazole shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
Side effects — opening of the label's adverse reactions section
Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. In a double-blind, placebo-controlled trial in which patients with tinea versicolor were treated with either a single application of ketoconazole shampoo, 2% (n=106), a daily application for three consecutive days (n=107), or placebo (n=105), drug-related adverse events occurred in 5 (5%), 7 (7%) and 4 (4%) of patients, respectively. …
This is not a complete list of warnings or side effects. Read the full label and talk to your prescriber or pharmacist. To report a side effect to the FDA, use MedWatch.
Resources
If you were hurt at work
Whether a medicine is right for you is a decision for your prescriber. If you were injured on the job, these educational guides explain the next steps and who can help.
- Injured at work? →What to do after a workplace injury and how workers' comp generally works.
- Prescription home delivery →How mail-order pharmacies can deliver prescriptions to your door.
- Find help →Connect with workers' comp attorneys and doctors who take work-injury cases.
- Pharmacies near you →Search local pharmacies by ZIP code.