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Finacea (Azelaic Acid) - Side Effects and Adverse Reactions

 
 



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 1

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 (<1%)

Erythema/

irritation

6 (1%)7 (2%)2 (<1%)8 (2%)4 (1%)2 (1%)

Contact

dermatitis

2 (<1%)3 (1%)0 (0%)1 (<1%)0 (0%)0 (0%)
Edema 3 (1%)2 (<1%)0 (0%)3 (1%)0 (0%)0 (0%)
Acne3 (1%)1 (<1%)0 (0%)1 (<1%)0 (0%)0 (0%)

1 Subjects may have >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 ).

OVERDOSAGE

FINACEA Gel, 15%, is intended for cutaneous use only. If pronounced local irritation occurs, patients should be directed to discontinue use and appropriate therapy should be instituted (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



See index of all Finacea side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-31

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