"The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of dalbavancin 500 mg (Xydalba, Durata Therapeutics) for acute bacterial skin and skin structure infections (ABSSSI) in ad"...
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.
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
|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
|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 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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