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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
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 (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.