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Ulesfia

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Ulesfia

Ulesfia

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The rates of adverse reactions below were derived from two randomized, multi-center, vehicle-controlled clinical trials and one open-label study in subjects with head lice infestation.

Skin, scalp, and ocular irritation were monitored in the clinical trials. All subjects were queried about the presence of skin and scalp symptoms; the results are presented in Table 2.

Table 2: Monitored Adverse Reactions - Application Site Symptoms

Event Ulesfia Lotion Vehicle
Application site Irritation 2% (11/478) 1% (2/336)
Application site anesthesia & hypoesthesia 2% (10/478) 0% (0/336)
Pain 1% (5/478) 0% (1/336)

The subset of subjects who did not have pruritus, erythema, edema or pyoderma of skin and scalp, or ocular irritation prior to treatment were assessed for these signs and symptoms after treatment; the results are presented in Table 3.

Table 3: Monitored Adverse Reactions -Pruritus, Erythema, Pyoderma and Ocular Irritation with Onset After Treatment

Signs/Symptoms Ulesfia Lotion Vehicle
Pruritus 12% (14/116) 4% (3/67)
Erythema 10% (32/309) 9% (19/217)
Pyoderma 7% (22/308) 4% (10/230)
Ocular irritation 6% (26/428) 1% (3/313)

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: application site dryness, application site excoriation, paraesthesia, application site dermatitis, excoriation, thermal burn, dandruff, erythema, rash, and skin exfoliation.

Read the Ulesfia (benzyl alcohol lotion for topical use) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drug interaction studies were not conducted with Ulesfia (benzyl alcohol lotion for topical use) Lotion.

Last reviewed on RxList: 7/20/2010
This monograph has been modified to include the generic and brand name in many instances.

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Ulesfia - User Reviews

Ulesfia User Reviews

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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.


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