Vaniqa side effects, 2000 (unpublished clinical report)


Vaniqa FDA data, 2000

Title: FDA submission

Authors: Manufacturer

Journal:

PMID:

Affiliated institution: Bristol-Meyers Squibb/Gillette

Cited in: Prescription insert at www.vaniqa.com

Adverse events reported for most body systems occurred at similar frequencies in VANIQA 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. 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:

Adverse Event VANIQA Vehicle VANIQA
  (n=393) (n=201) (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