Medical Editor: John P. Cunha, DO, FACOEP
Taclonex Topical Suspension (calcipotriene and betamethasone dipropionate) is a combination of a synthetic form of Vitamin D3 and a topical corticosteroid used to treat psoriasis vulgaris. Taclonex Topical Suspension is available in generic form. Common side effects of Taclonex Topical Suspension include:
- irritation of the skin
- red or scaly rash
- swollen hair follicles, or
- changes in the color of treated skin areas
Apply Taclonex Topical Suspension to affected areas once daily for up to 8 weeks. Do not exceed a maximum weekly dose of 100 g. Taclonex may interact with other steroid medicines, or other medicines to treat psoriasis. Tell your doctor all medications and supplements you use. During pregnancy, Taclonex should be used only if prescribed. It is unknown if this drug passes into breast milk when applied to the skin. Consult your doctor before breastfeeding.
Our Taclonex (calcipotriene and betamethasone dipropionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using betamethasone and calcipotriene and call your doctor at once if you have any of these serious side effects:
- severe skin irritation on treated areas;
- worsened symptoms or no improvement in psoriasis;
- pus, swelling, redness, increased itching, or other signs of skin infection;
- confusion, thirst, extreme tiredness, lost appetite, weight loss;
- adrenal insufficiency--nausea, vomiting, lost appetite, tiredness, trouble breathing, joint/muscle pain, feeling light-headed, fainting;
- Cushing syndrome--weight gain (especially in your face), thinning muscles in your arms or legs, easy bruising, thinning skin, acne, increased facial hair, darkened skin; or
- high blood sugar (hyperglycemia)--increased urination and thirst, nausea, vomiting.
Less serious side effects may include:
- burning or mild itching;
- red or scaly rash;
- swollen hair follicles; or
- changes in the color of treated skin areas.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Taclonex Scalp (Calcipotriene and Betamethasone Dipropionate Topical Suspension)
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
|Betamethasone dipropionate in vehicle
|Calcipotriene in vehicle
|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).
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 entire FDA prescribing information for Taclonex Scalp (Calcipotriene and Betamethasone Dipropionate Topical Suspension)
© Taclonex Scalp Patient Information is supplied by Cerner Multum, Inc. and Taclonex Scalp Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.