SIDE EFFECTS
In controlled clinical trials, the most frequently reported
adverse reactions were those of local skin and application
site reactions; some patients also reported systemic reactions.
These reactions were usually mild to moderate in intensity;
however, severe reactions were reported with 3X/week application.
These reactions were more frequent and more intense with
daily application than with 3X/week application. Overall,
in the 3X/week application clinical studies, 1.2% (4/327)
of the patients discontinued due to local skin/application
site reactions.The incidence and severity of local skin
reactions during controlled clinical trials are shown
in the following table.
3X/WEEK APPLICATION Wart Site Reaction
as Assessed by Investigator
| |
MM/Moderate
|
Severe
|
|
Females
|
Males
|
Females
|
Males
|
|
5%
|
|
5%
|
|
5%
|
|
5%
|
|
|
Imiquimod
|
Vehicle
|
Imiquimod
|
Vehicle
|
Imiquimod
|
Vehicle
|
Imiquimod
|
Vehicle
|
| N=114 |
N=99 |
N=156 |
N=157 |
N=114 |
N=99 |
N=156 |
N=157 |
| Erythema |
61%
|
21%
|
54%
|
22%
|
4%
|
0%
|
4%
|
0%
|
| Erosion |
30%
|
8%
|
29%
|
6%
|
1%
|
0%
|
1%
|
0%
|
| Excoriation/
Flaking |
18%
|
8%
|
25%
|
8%
|
0%
|
0%
|
1%
|
0%
|
| Edema |
17%
|
5%
|
12%
|
1%
|
1%
|
0%
|
0%
|
0%
|
| Induration |
5%
|
2%
|
7%
|
2%
|
0%
|
0%
|
0%
|
0%
|
| Ulceration |
5%
|
1%
|
4%
|
1%
|
3%
|
0%
|
0%
|
0%
|
| Scabbing |
4%
|
0%
|
13%
|
3%
|
0%
|
0%
|
0%
|
0%
|
| Vesicles |
3%
|
0%
|
2%
|
0%
|
0%
|
0%
|
0%
|
0%
|
Remote site skin reactions were also reported
in female and male patients treated 3X/week with imiquimod
5% cream. The severe remote site skin reactions reported
for females were erythema (3%), ulceration (2%), and edema
(1%); and for males, erosion (2%), and erythema, edema,
induration, and excoriation/flaking (each 1%). Adverse
events judged to be probably or possibly related to Aldara
reported by more than 5% of patients are listed below;
also included are soreness, influenza-like symptoms and
myalgia.
3X/WEEK APPLICATlON
| |
Females
|
Males
|
|
5%
|
|
5%
|
|
|
Imiquimod
|
Vehicle
|
Imiquimod
|
Vehicle
|
|
N= 117
|
N= 103
|
N= 156
|
N= 158
|
| Application
Site Disorders: |
|
| Application
Site Reactions |
| Wart Site:
|
| Itching |
32%
|
20%
|
22%
|
10%
|
| Burning |
26%
|
12%
|
9%
|
5%
|
| Pain |
8%
|
2%
|
2%
|
1%
|
| Soreness
|
3%
|
0%
|
0%
|
1%
|
| Fungal
Infection* |
11%
|
3%
|
2%
|
1%
|
| Systemic
Reactions: |
|
|
|
|
| Headache
|
4%
|
3%
|
5%
|
2%
|
| Influenza-
like symptoms |
3%
|
2%
|
1%
|
0%
|
| Myalgia |
1%
|
0%
|
1%
|
1%
|
*Incidences reported without regard to causality
with Aldara.
Adverse events judged to be possibly or probably related
to Aldara and reported by more than 1% of patients include:
Application Site Disorders: Wart
Site Reactions (burning, hypopigmentation, irritation,
itching, pain, rash, sensitivity, soreness, stinging,
tenderness); Remote Site Reactions (bleeding,
burning, itching, pain, tenderness, tinea cruris); Body
as a Whole: fatigue, fever, influenza-like symptoms;
Central and Peripheral Nervous System Disorders:
headache; Gastro-intestinal System Disorders:
diarrhea; Musculo-Skeletal System Disorders:
myalgia.
DRUG INTERACTIONS
No information provided.
|
