ADVERSE REACTIONS
Overall, treatment related adverse events, including burning,
stinging/ tingling, dryness/tightness/scaling, itching, and
erythema/irritation/redness, were 19.4% (24/124) for FINACEA Gel, 15%, and 7.1%
(9/127) for the active comparator gel at 15 weeks.
In two vehicle controlled, and one active controlled U.S. clinical studies,
treatment safety was monitored in 788 patients who used twice daily FINACEA Gel,
15%, for 12 weeks (N=333) or for 15 weeks (N=124), or the gel vehicle (N=331)
for 12 weeks
Table 3. Cutaneous Adverse Events Occurring in ≥1% of Subjects in the
Rosacea Trials by Treatment Group and Maximum Intensity *
|
FINACEA® Gel, 15%
N=457 (100%)
|
Vehicle
N=331 (100%) |
|
Mild
n=99
(22%) |
Moderate
n=61
(13%) |
Severe
n=27
(6%) |
Mild
n=46
(14%) |
Moderate
n=30
(9%) |
Severe
n=5
(2%)
|
|
Burning/
stinging/
tingling |
71 (16%) |
42 (9%) |
17 (4%) |
8 (2%) |
6 (2%) |
2 (1%) |
| Pruritus |
29 (6%) |
18 (4%) |
5 (1%) |
9 (3%) |
6 (2%) |
0 (0%) |
|
Scaling/dry
skin/xerosis |
21 (5%) |
10 (2%) |
5 (1%) |
31 (9%) |
14 (4%) |
1 (less than 1%) |
|
Erythema/
irritation |
6 (1%) |
7 (2%) |
2 (less than 1%) |
8 (2%) |
4 (1%) |
2 (1%) |
|
Contact
dermatitis |
2 (less than 1%) |
3 (1%) |
0 (0%) |
1 (less than 1%) |
0 (0%) |
0 (0%) |
| Edema |
3 (1%) |
2 (less than 1%) |
0 (0%) |
3 (1%) |
0 (0%) |
0 (0%) |
| Acne |
3 (1%) |
1 (less than 1%) |
0 (0%) |
1 (less than 1%) |
0 (0%) |
0 (0%) |
* Subjects may have greater than 1 cutaneous adverse event; thus, the sum of the
frequencies of preferred terms may exceed the number of subjects with at least 1
cutaneous adverse event.
FINACEA Gel, 15%, and its vehicle caused irritant reactions at the
application site in human dermal safety studies. FINACEA Gel, 15%, caused
significantly more irritation than its vehicle in a cumulative irritation study.
Some improvement in irritation was demonstrated over the course of the clinical
studies, but this improvement might be attributed to subject dropouts. No
phototoxicity or photoallergenicity were reported in human dermal safety
studies.
In patients using azelaic acid formulations, the following additional adverse
experiences have been reported rarely: worsening of asthma, vitiligo
depigmentation, small depigmented spots, hypertrichosis, reddening (signs of
keratosis pilaris), and exacerbation of recurrent herpes labialis.
Post-marketing safety-Skin: facial burning and irritation; Eyes:
iridocyclitis on accidental exposure with FINACEA Gel, 15%, to the eye (see
PRECAUTIONS
).
|
REPORTS OF SUSPECTED FINACEA SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Finacea. The information is not vetted and should not be considered as verified clinical evidence.
Possible Finacea side effects / adverse reactions in 58 year old female
Reported by a consumer/non-health professional from United States on 2011-12-14
Patient: 58 year old female
Reactions: Vomiting, Nausea
Suspect drug(s):
Finacea
Other drugs received by patient: Lyrica; Zestril; Metformin HCL; Metronidazole; Aczone; Oracea; Oracea; Topamax
Possible Finacea side effects / adverse reactions in 29 year old female
Reported by a pharmacist from United States on 2011-12-15
Patient: 29 year old female
Reactions: Burning Sensation, Urticaria, Oedema
Suspect drug(s):
Finacea
Possible Finacea side effects / adverse reactions in 52 year old female
Reported by a consumer/non-health professional from United States on 2011-12-15
Patient: 52 year old female
Reactions: Rosacea
Suspect drug(s):
Finacea
|
