Ulesfia
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Ulesfia
Ulesfia Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ulesfia Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Ulesfia (Benzyl Alcohol Lotion for Topical Use)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ulesfia FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 entire FDA prescribing information for Ulesfia (Benzyl Alcohol Lotion for Topical Use) »
Additional Ulesfia Information
Ulesfia - User Reviews
Ulesfia User Reviews
Now you can gain knowledge and insight about a drug treatment with Patient Discussions.
Here is a collection of user reviews for the medication Ulesfia sorted by most helpful.
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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