Taclonex Topical Suspension Side Effects
Please note - some side effects for Taclonex Topical Suspension may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Taclonex Topical Suspension Side Effects - for the Professional
Taclonex Topical Suspension
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Clinical Studies Experience
The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active-controlled clinical studies in subjects with scalp psoriasis. Subjects applied study product once daily for 8 weeks, and the median weekly
dose was 12.6 g.
Adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex Scalp® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:
|
Number and Percentage of Patients with Adverse Reactions in Scalp Psoriasis Studies (Events Reported by ≥ 1% of Subjects and for Which a Relationship is Possible) |
||||
| Taclonex Scalp® Topical Suspension N=1,953 |
Betamethasone dipropionate in vehicle N=1,214 |
Calcipotriene in vehicle N=979 |
Vehicle N=173 |
|
| Event | # of subjects (%) | |||
| Folliculitis | 16 (1%) | 12 (1%) | 5 (1%) | 0 (0%) |
| Burning sensation of skin | 13 (1%) | 10 (1%) | 29 (3%) | 0 (0.0%) |
Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.
In a 52-week study, adverse reactions that were reported by greater than 1% of subjects treated with Taclonex Scalp® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%). The effects of Taclonex Scalp® Topical Suspension on calcium metabolism and the HPA axis were not investigated in the 52-week study.
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