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Nizoral (Ketoconazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

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.

Post-marketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. The following adverse drug reactions have been identified during post-marketing 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.



REPORTS OF SUSPECTED NIZORAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Nizoral. The information is not vetted and should not be considered as verified clinical evidence.

Possible Nizoral side effects / adverse reactions in 52 year old female

Reported by a pharmacist from China on 2011-10-17

Patient: 52 year old female

Reactions: Cholecystitis, Intentional Drug Misuse, Hepatitis, Gastritis

Adverse event resulted in: hospitalization

Suspect drug(s):
Nizoral
    Dosage: 26-jul, first box
    Administration route: Oral

Nizoral
    Dosage: 2 boxes in aug (year unspecified)
    Administration route: Oral
    Indication: Onychomycosis



Possible Nizoral side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from Korea, Republic of on 2011-11-21

Patient: 59 year old male

Reactions: Hypokinesia, Skin Exfoliation, Pyrexia, Rash

Suspect drug(s):
Nizoral



Possible Nizoral side effects / adverse reactions in 41 year old female

Reported by a consumer/non-health professional from United States on 2012-01-24

Patient: 41 year old female

Reactions: Cellulitis, Drug Ineffective

Suspect drug(s):
Armodafinil
    Indication: Product Used FOR Unknown Indication

Nizoral
    Indication: Product Used FOR Unknown Indication



See index of all Nizoral side effect reports >>

Drug label data at the top of this Page last updated: 2013-11-05

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