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Vaniqa

Last reviewed on RxList: 9/21/2020
Vaniqa Side Effects Center

Last reviewed on RxList 9/24/2018

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 breastfeeding.

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.

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Vaniqa Consumer Information

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

Stop using eflornithine and call your doctor at once if you have:

  • severe irritation of treated skin; or
  • redness or crusting around your hair follicles.

Common side effects may include:

  • temporary redness, rash, burning, stinging, itching, or tingling;
  • acne or red bumps on the skin;
  • skin dryness; or
  • headache.

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 Vaniqa (Eflornithine)

QUESTION

An average adult has about ________ square feet of skin. See Answer
Vaniqa Professional 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® were skin-related. The following table notes the percentage of adverse events associated with the use of VANIQA® 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
VANIQA®
(n=393)
Vehicle
(n=201)
VANIQA®
(n=1373)
Acne 21.3 21.4 10.8
Pseudofolliculitis Barbae 16.3 15.4 4.9
Stinging Skin 7.9 2.5 4.1
Headache 3.8 5.0 4.0
Burning Skin 4.3 2.0 3.5
Dry Skin 1.8 3.0 3.3
Pruritus (itching) 3.8 4.0 3.1
Erythema (redness) 1.3 0.0 2.5
Tingling Skin 3.6 1.5 2.2
Dyspepsia 2.5 2.0 1.9
Skin Irritation 1.0 1.0 1.8
Rash 2.8 0.0 1.5
Alopecia 1.5 2.5 1.3
Dizziness 1.5 1.5 1.3
Folliculitis 0.5 0.0 1.0
Hair Ingrown 0.3 2.0 0.9
Facial Edema 0.3 3.0 0.7
Anorexia 1.0 2.0 0.7
Nausea 0.5 1.0 0.7
Asthenia 0.0 1.0 0.3
Vertigo 0.3 1.0 0.1

Treatment-related skin adverse events that occurred in less than 1% of the subjects treated with VANIQA® 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®. Only 2% of subjects discontinued studies due to an adverse event related to use of VANIQA®.

Laboratory Test Abnormalities

No laboratory test abnormalities have been consistently found to be associated with VANIQA®. 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)

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© Vaniqa Patient Information is supplied by Cerner Multum, Inc. and Vaniqa Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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