Ketoconazole Shampoo 2% Antifungal Shampoo, Medicated 4 oz

Ketoconazole shampoo (e.g. Nizoral) is an antifungal topical shampoo used to treat fungal/yeast-related scalp and skin conditions. Its primary uses are for scalp dandruff (seborrheic dermatitis) and for pityriasis (tinea) versicolor on the body. For example, medical sources note that ketoconazole shampoo “treats fungal infections… such as seborrheic dermatitis (dandruff), dandruff, and tinea versicolor”. The FDA‐approved 2% ketoconazole shampoo is specifically indicated for tinea (pityriasis) versicolor (a Malassezia yeast infection on the trunk/neck). In practice, ketoconazole (often 1% OTC or 2% by prescription) is widely used for seborrheic scalp dermatitis because it reduces the Malassezia yeast that cause flaking and itching.

Other uses include fungal scalp infections. Ketoconazole shampoo can help clear scalp ringworm (tinea capitis) or reduce fungal colonization in stubborn scalp psoriasis (since Malassezia often overgrows in psoriatic plaques). Some clinicians also use it as adjunct for hair loss/alopecia (its anti-fungal and mild anti-inflammatory effects may benefit scalp health), though this is secondary. Overall, ketoconazole shampoo’s uses center on killing skin yeasts and fungi: reducing dandruff (seborrhea) and treating yeast infections of the scalp/skin

Uses and Applications

Ketoconazole 2% Shampoo is indicated for the treatment and management of:

• Dandruff (Seborrheic Dermatitis): Controls scaling, itching, and flaking of the scalp.
• Tinea Versicolor: Treats fungal skin discoloration, uneven pigmentation, and scaling caused by Malassezia species.
• Scalp & Skin Fungal Infections: Fights ringworm (tinea capitis, corporis, cruris), and other fungal pathogens where applicable.
• Preventing Relapse: Maintains a healthy, flake-free scalp and prevents recurrence of fungal overgrowth.

Ketoconazole Shampoo Side Effects

Common side effects: Ketoconazole shampoo is generally well tolerated, but the most frequent complaints involve scalp or hair changes. Many users experience skin irritation at the application site (e.g. redness, itching, or stinging). The shampoo can also alter the feel or appearance of hair: it may cause dryness or oiliness of hair and scalp, changes in hair texture, or temporary hair discoloration. In some cases (usually mild) people notice “pimple-like” bumps on the treated skin or slight irritation (burning or warmth) while shampooing. These symptoms typically resolve after stopping use. Rarely, the shampoo can cause hair to lose its style (for instance, permed hair may relax), and very occasionally users report increased hair shedding (alopecia), though this is uncommon.

Less common effects: In a few cases, people have reported dandruff-like shedding worsening before improving (known as “dandruff rebound”), dry skin, or scalp tightness. Discomfort from shampoo run-off (into the eyes) can cause transient redness or eye irritation. The OTC concentration (1%) is more gentle; prescription-strength (2%) may have higher rates of mild irritation.

Allergic reactions: Serious allergic reactions to ketoconazole shampoo are very rare. Nevertheless, one should stop using it if severe symptoms occur. Seek immediate medical care if any of the following develop after use: hives, swelling of the face, lips, or tongue, difficulty breathing, severe itching, rash, or dizziness. Anaphylaxis (deathly allergic shock) is extremely unlikely but possible; signs would include wheezing, tight chest, trouble swallowing, or sudden drop in blood pressure.

In summary, the side effects of ketoconazole shampoo are mainly local scalp effects: mild irritation, itching, oily or dry hair/scalp, and (rarely) bleaching or texture changes of the hair. These are usually not severe and often improve after you finish treatment. Severe systemic effects are extremely rare since very little is absorbed. If you experience severe itching, rash, or any signs of allergy (swelling, trouble breathing), you should discontinue use and consult a doctor

Side Effects

Common (generally mild, temporary):

• Mild scalp itching or irritation
• Dryness or oiliness of hair/scalp
• Abnormal hair texture
• Localized redness or burning
• Rarely, hair discoloration or abnormal hair loss

Serious (very rare, seek medical help):

• Allergic reaction: rash, swelling, severe itch
• Severe skin irritation or contact dermatitis
• Blistering, open sores
• Eye irritation (if contact occurs)
• Swelling of face/lips/throat (very rare)

Warnings

• Allergy warning: Do not use if allergic to ketoconazole or any ingredient in the shampoo.
• External use only: Not for ingestion or internal use.
• Pregnancy/Breastfeeding: Use only as directed by a healthcare provider.
• Children: Safety and efficacy in children under 12 not established unless prescribed.
• Contact lenses: Remove before shampooing scalp to avoid accidental contact.
• Avoid frequent/prolonged use without clear medical guidance—reduces risk of resistance or unnecessary irritation.

Brand Names

• Nizoral® (Rx 2%)
• Extina® (foam)
• Ketozole®
• Xolegel® (gel)
• Generic Ketoconazole 2% Shampoo (Rx, including Viona Pharmaceuticals)

How to Use

For external use only. Use exactly as prescribed or as directed by your healthcare provider.

• For Dandruff/Seborrheic Dermatitis:

  • Wet hair and scalp thoroughly.
  • Apply a small amount (approx. 1-2 teaspoons) to affected areas.
  • Massage gently into scalp and hair, working into a rich lather.
  • Leave on for 5 minutes.
  • Rinse thoroughly with water.
  • Use twice weekly for 2-4 weeks. To prevent relapse, use once every 1-2 weeks as maintenance.

• For Tinea Versicolor:

  • Apply to damp skin on affected areas.
  • Leave on for 5 minutes.
  • Rinse well.
  • Repeat daily for up to 5 days, or as directed by physician.

• Missed a dose: Skip and continue with next application; do not apply extra.

• Avoid contact with eyes, mouth, or inside the nose. If accidental exposure occurs, rinse well with water.

Ketoconazole Shampoo 2% is an antifungal shampoo used to treat certain scalp and skin conditions like dandruff (seborrheic dermatitis), tinea versicolor, and pityriasis capitis (fungal dandruff).

Dosage Guidelines

For Scalp Conditions (Dandruff, Seborrheic Dermatitis):

• Adults and children over 12 years:
  • Apply the shampoo to the affected area(s) of the scalp or skin.
  • Leave on for 3 to 5 minutes before rinsing thoroughly.
  • Use twice weekly (with at least 3 days between applications) for 2 to 4 weeks.
  • After the condition is controlled, use once every 1–2 weeks as needed to prevent recurrence.

For Tinea (Pityriasis) Versicolor (on the body):

• Apply to affected area(s) and a wide margin of surrounding skin.
• Leave on for 5 minutes, then rinse thoroughly.
• Use once daily for up to 5 days.

Children under 12:

• Consult a healthcare provider for appropriate dosing and safety.

Drug Interactions

Ketoconazole shampoo is topical and has minimal systemic absorption, but care should be taken when used concurrently with other scalp or skin medications:

• Topical corticosteroids: May enhance local absorption.
• Topical retinoids or other medicated shampoos: Increased risk of scalp irritation.
• Consult your doctor before combining ketoconazole shampoo with other prescription or over-the-counter topical treatments.
• Oral medications: No known significant interactions with topical ketoconazole; oral ketoconazole has different interaction profile.

Specifications

• Active Ingredient: Ketoconazole 2% (20 mg/mL)
• Form: Medicated shampoo
• Size: 4 fl oz (118 mL) bottle
• Manufacturer: Viona Pharmaceuticals Inc.
• NDC: 7257-80156-12
• UPC: 372578156121
• Prescription Required: Yes (for 2% strength)
• Appearance: Red/orange viscous liquid
• Scent: Characteristic, mild medicinal fragrance
• FDA Approved: Yes