"Today, the U.S. Food and Drug Administration issued a proposed order that, if finalized, would reclassify sunlamp products and require labeling to include a recommendation designed to warn young people not to use these devices.
Vaniqa Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Vaniqa (eflornithine hydrochloride) Cream is used to reduce unwanted facial hair in women. It blocks a certain enzyme needed for hair growth in the skin. This effect slows hair growth and may also make the hair finer and lighter. It does not remove hair or cause the hair to fall out. Common side effects include burning, stinging, tingling, and redness of the skin.
Apply a thin layer dose of Vaniqa Cream, 13.9% to affected areas of the face and adjacent involved areas under the chin and rub in thoroughly. Do not wash treated area for at least 4 hours. Use twice daily at least 8 hours apart or as directed by a physician. Vaniqa may interact with other topical (for the skin) preparations. Tell your doctor all medications and supplements you use. During pregnancy, Vaniqa should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Our Vaniqa (eflornithine hydrochloride) 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.
Vaniqa in Detail - Patient Information: Side Effects
Eflornithine topical may cause temporary redness, rash, burning, stinging, or tingling, especially if it is applied to broken or irritated skin. If irritation develops, reduce the application of eflornithine topical to once a day. If irritation continues, stop using eflornithine topical and contact your doctor.
Hair bumps (folliculitis) may also occur. If these continue, contact your doctor.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Vaniqa (Eflornithine) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Vaniqa 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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: acne, "hair bumps" (folliculitis).
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 Vaniqa (Eflornithine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Vaniqa FDA Prescribing Information: Side Effects
Adverse events reported for most body systems occurred at similar frequencies in VANIQA (eflornithine hydrochloride) Cream, 13.9% and vehicle control groups. The most frequent adverse events related to treatment with VANIQA (eflornithine) were skin-related. The following table notes the percentage of adverse events associated with the use of VANIQA (eflornithine) or its vehicle that occurred at greater than 1% in both the vehicle controlled studies and the open-label safety studies up to 1 year of continuous use.
|Adverse Event Term||Vehicle-Controlled Studies||Vehicle- Controlled and Open-Label Studies|
Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with VANIQA (eflornithine) are: bleeding skin, cheilitis, contact dermatitis, swelling of lips, herpes simplex, numbness and rosacea.
Adverse events were primarily mild in intensity and generally resolved without medical treatment or discontinuation of VANIQA (eflornithine) . Only 2% of subjects discontinued studies due to an adverse event related to use of VANIQA (eflornithine) .
Laboratory Test Abnormalities
No laboratory test abnormalities have been consistently found to be associated with VANIQA (eflornithine) . In an open-label study, some patients showed an increase in their transaminases; however, the clinical significance of these findings is not known.
Read the entire FDA prescribing information for Vaniqa (Eflornithine) »
Additional Vaniqa Information
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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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