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8 Clinical Experience in Adults
General Tolerability and Treatment Discontinuations
Tacrolimus ointment is well
tolerated, with its adverse
events occuring primarily
at the application site
Overall, the tolerability of tacrolimus ointment is excellent, with very few patients
discontinuing treatment. Pooled data from two large vehicle-controlled trials
showed that most of the adverse events reported in both the vehicle and tacrolimus
ointment groups occurred at the site of application [29]. The number of non-application-site events judged to be related to treatment was low and not dissimilar to those
seen with vehicle. Most importantly, few adverse events resulted in discontinuation – in fact, more patients using vehicle discontinued due to adverse events. The
low discontinuation rate seen with tacrolimus ointment is likely to be a reflection
of the clinical effectiveness of the treatment and underlines the good tolerability of
the product. Taken together, these findings demonstrate that tacrolimus ointment is
well tolerated, with its adverse events occurring primarily at the application site.
Local Adverse Events
Local, application-site adverse events are the most frequently encountered type of
side effect associated with topical tacrolimus. The most common such events occurring in the two U.S. vehicle-controlled studies are summarised in Table 8.3. The most
frequent adverse events recorded in all clinical studies of tacrolimus ointment have
been a burning sensation, pruritus and erythema at the site of application. All of
these events are generally mild in nature and transient. However, it is worth noting
that the incidence of treatment-related pruritus and skin burning is relatively high
Table 8.3. Vehicle-controlled studies with tacrolimus: incidence (%) of local adverse events (adapted
from [13])
Adverse Event
Treatment group
P value
Vehicle
(n=212)
0.03%
tacrolimus
ointment
(n=210)
0.1%
tacrolimus
ointment
(n=209)
0.03%
tacrolimus
ointment
vs. vehicle
0.1%
tacrolimus
ointment
vs. vehicle
Skin burning
25.8
45.6
57.7
<0.001
<0.001
Pruritus
36.5
46.1
46.1
NS
NS
Skin erythema
19.8
24.8
27.9
NS
NS
Skin infection
10.6
12.4
4.7
NS
NS
Skin tingling
2.4
3.4
7.6
NS
0.015
Alcohol intolerance
0.0
3.4
6.9
0.013
<0.001
Hyperaesthesia
0.5
3.0
6.5
0.052
0.001
Folliculitis
0.5
6.2
4.3
0.002
0.016
NS not significant.
148