November 30, 2015
Recommended Topic Related To:

Nizoral Shampoo

"The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.

Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) cau"...

Nizoral Shampoo

Side Effects


In 11 double-blind trials in 264 patients using ketoconazole 2% shampoo 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 NIZORAL® (ketoconazole) 2% Shampoo (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. The only events that occurred in more than one patient in any one of the three treatment groups were pruritus, application site reaction, and dry skin; none of these events occurred in more than 3% of the patients in any one of the three groups.

In worldwide experience with NIZORAL® (ketoconazole) Shampoo there have been reports of hair discoloration and abnormal hair texture, itching, skin burning sensation, contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

Read the Nizoral Shampoo (ketoconazole 2%) Side Effects Center for a complete guide to possible side effects


No information provided.

Read the Nizoral Shampoo Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/14/2012

Side Effects

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.

Women's Health

Find out what women really need.