July 27, 2016
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Taclonex Scalp

"Subtle signs of joint involvement detectable using magnetic resonance imaging (MRI) of the hand helped identify a subset of patients with psoriasis who were at high risk of developing psoriatic arthritis (PsA), researchers report in an article pu"...

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Taclonex Scalp




Side Effects
Interactions

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directed compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Conducted In Subjects 18 Years And Older With Scalp Psoriasis

The rates of adverse reactions given below were derived from randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult 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® Topical Suspension and at a rate higher than in subjects treated with vehicle are presented in Table 1:

Table 1: Number and Percentage with Adverse Reactions in Scalp Psoriasis Trials (Events Reported by ≥ 1% of Subjects and for Which a Relationship is Possible)

  Taclonex® 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%)

Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: acne, exacerbation of psoriasis, eye irritation, and pustular rash.

In a 52-week trial, adverse reactions that were reported by > 1% of subjects treated with Taclonex® Topical Suspension were pruritus (3.6%), psoriasis (2.4%), erythema (2.1%), skin irritation (1.4%), and folliculitis (1.2%).

Clinical Trials Conducted In Subjects 18 Years And Older With Psoriasis On The Body

In randomized, multicenter, prospective vehicle- and/or active controlled clinical trials in adult subjects with plaque psoriasis on non-scalp areas, subjects applied study product once daily for 8 weeks. A total of 824 subjects were treated with Taclonex® Topical Suspension and the median weekly dose was 22.6 g. There were no adverse reactions that occurred in ≥ 1% of subjects treated with Taclonex® Topical Suspension and at a rate higher than in subjects treated with vehicle.

Other less common adverse reactions ( < 1% but > 0.1%) were, in decreasing order of incidence: rash and folliculitis.

Clinical Trials Conducted In Subjects 12 To 17 Years With Scalp Psoriasis

In two uncontrolled prospective clinical trials, a total of 109 subjects aged 12-17 years with plaque psoriasis of the scalp were treated with Taclonex® Topical Suspension once daily for up to 8 weeks. The median weekly dose was 40 g. Adverse reactions included acne, acneiform dermatitis and application site pruritus (0.9% each).

Postmarketing Experience

Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing reports for local adverse reactions to topical corticosteroids may also include: atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.

Read the Taclonex Scalp (calcipotriene and betamethasone dipropionate topical suspension) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No information provided.

Read the Taclonex Scalp Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 7/6/2016

Side Effects
Interactions

Taclonex Scalp - User Reviews

Taclonex Scalp User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Taclonex Scalp sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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