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Ulesfia

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Ulesfia

Ulesfia Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ulesfia (benzyl alcohol) Lotion For topical use is a pediculicide used to treat head lice, tiny insects that live on and irritate your scalp. Common side effects include irritation, itching, redness, tingling, or numbness at the application site. Eye irritation may occur if the medication gets into the eyes.

Apply a sufficient dose of Ulesfia Lotion to dry hair to completely saturate the scalp and hair; leave on for 10 minutes, then thoroughly rinse off with water. Repeat treatment after 7 days. Ulesfia may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Ulesfia should be used only if prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Ulesfia (benzyl alcohol) Lotion For topical use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ulesfia in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

If the medicine gets in your eyes or on your skin, rinse with water. Call your doctor at once if you have severe stinging, itching, or irritation of the eyes or skin after rinsing.

Common side effects may include mild pain, itching, irritation, redness, or numbness of your scalp.

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.

Read the entire detailed patient monograph for Ulesfia (Benzyl Alcohol Lotion for Topical Use) »

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

SIDE EFFECTS: Irritation, itching, redness, tingling, or numbness at the application site may occur. Eye irritation may occur if the medication gets into the eyes (see also How to Use section). If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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) »

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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. Patient Discussions FAQs

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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