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Nizoral Shampoo Side Effects

Generic Name: ketoconazole topical

Note: This page contains side effects data for the generic drug ketoconazole topical. It is possible that some of the dosage forms included below may not apply to the brand name Nizoral Shampoo.

For the Consumer

Applies to ketoconazole topical: topical cream, topical foam, topical gel/jelly, topical shampoo, topical solution

As well as its needed effects, ketoconazole topical (the active ingredient contained in Nizoral Shampoo) may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ketoconazole topical, check with your doctor immediately:

Less common—For cream, shampoo, foam, or gel
  • Itching, stinging, burning, or irritation not present before use of this medicine
Rare—For cream, foam, or gel
  • Acne
  • bleeding from sore in the mouth
  • blistering, crusting, irritation, itching, or reddening of the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • cracked, dry, or scaly skin
  • discoloration of the fingernails or toenails
  • dizziness
  • eye dryness, irritation, or swelling
  • red rash with watery, yellow-colored, or pus filled blisters with or without thick yellow to honey-colored crusts
  • skin dryness, pain, rash, redness, or swelling
  • sore in the mouth or on the gums
  • swelling of the face
Rare—For shampoo
  • Hair loss and irritation
Incidence not known—For gel
  • Pain
Incidence not known—For shampoo
  • Blistering, burning, crusting, dryness, or flaking of the skin
  • burning sensation of the skin
  • burning, itching, redness, skin rash, swelling, or soreness at the application site
  • discoloration of the hair
  • dry skin
  • fast heartbeat
  • fever
  • hives
  • hoarseness
  • irritation
  • itching, scaling, severe redness, or soreness of the skin
  • joint pain, stiffness, or swelling
  • rash
  • shortness of breath
  • swelling of the eyelids, face, lips, hands, or feet
  • thinning of the hair
  • tightness in the chest
  • troubled breathing or swallowing
  • wheezing

Minor Side Effects

Some ketoconazole topical side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common—For shampoo or gel
  • Dryness or oiliness of the hair and scalp
  • headache
Rare—For shampoo
  • Abnormal hair texture
  • mild dryness of the skin
  • scalp pustules

For Healthcare Professionals

Applies to ketoconazole topical: topical cream, topical foam, topical gel, topical kit, topical shampoo

Dermatologic

Cream:
-Common (1% to 10%): Skin burning sensation
-Uncommon (0.1% to 1%): Bullous eruption, contact dermatitis, rash, skin exfoliation, sticky skin
-Frequency not reported: Severe irritation, pruritus, stinging, urticaria

Foam:
-Frequency not reported: Reactions to a photoallergenicity study, contact sensitization

Gel:
-Frequency not reported: Impetigo, pyogenic granuloma, acne, nail discoloration

Shampoo:
-Uncommon (0.1% to 1%): Alopecia, dry skin, abnormal hair texture, rash, skin burning sensation, folliculitis
-Rare (0.01% to 0.1%): Acne, contact dermatitis, skin disorder, skin exfoliation
-Frequency not reported: Normal hair loss increased, irritation, scalp pustules, mild skin dryness, oiliness/dryness of hair and scalp, pruritus
-Postmarketing reports: Hair discoloration/hair color changes, itching, angioedema, urticaria, skin irritation[Ref]

Rare reports of contact dermatitis have been associated with the cream or 1 of its excipients (i.e., sodium sulfite or propylene glycol) during postmarketing experience.

Alopecia, dry skin, abnormal hair texture, rash, skin burning sensation, and contact dermatitis have also been reported during postmarketing experience with the shampoo.[Ref]

Local

Cream:
-Common (1% to 10%): Application site pruritus, application site erythema
-Uncommon (0.1% to 1%): Application site bleeding, application site discomfort, application site dryness, application site inflammation, application site irritation, application site paresthesia, application site reaction

Foam:
-Common (1% to 10%): Application site burning, application site reaction
-Frequency not reported: Application site reactions (dryness, erythema, irritation, paresthesia, pruritus, rash, warmth)

Gel:
-Common (1% to 10%): Application site burning
-Frequency not reported: Treatment-related application site reactions (dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, pustules)
-Postmarketing reports: Burning sensation, pain, skin irritation, erythema

Shampoo:
-Uncommon (0.1% to 1%): Application site erythema, application site irritation, application site pruritus, application site reaction
-Rare (0.01% to 0.1%): Application site hypersensitivity, application site pustules

Application site reactions have also been reported during postmarketing experience with the shampoo.

Hypersensitivity

Cream:
-Uncommon (0.1% to 1%): Hypersensitivity
-Frequency not reported: Painful allergic reaction

Shampoo:
-Rare (0.01% to 0.1%): Hypersensitivity
-Postmarketing reports: Hypersensitivity reactions (including anaphylaxis)[Ref]

Nervous system

Gel:
-Frequency not reported: Headache, dizziness, paresthesia

Shampoo:
-Rare (0.01% to 0.1%): Dysgeusia

Ocular

Gel:
-Frequency not reported: Eye irritation, eye swelling, keratoconjunctivitis sicca

Shampoo:
-Uncommon (0.1% to 1%): Increased lacrimation
-Rare (0.01% to 0.1%): Eye irritation

Other

Gel:
-Frequency not reported: Facial swelling

Shampoo:
-Frequency not reported: Removal of curl from permanently waved hair

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Nizoral (ketoconazole)." Janssen Pharmaceutica, Titusville, NJ.

It is possible that some side effects of Nizoral Shampoo may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

More about Nizoral Shampoo (ketoconazole topical)

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