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Taclonex

Last reviewed on RxList: 1/7/2019
Taclonex Side Effects Center

Last reviewed on RxList 01/07/2019

Taclonex (calcipotriene and betamethasone dipropionate) Ointment is a combination of a form of vitamin D and a topical (for the skin) corticosteroid used to treat psoriasis vulgaris. Common side effects of Taclonex include skin itching, burning, redness, or irritation, scaly rash, swollen hair follicles, or changes in the color of treated skin areas.

Apply an adequate layer of Taclonex Ointment to the affected area(s) once daily for up to 4 weeks. Rub in gently and completely. The maximum weekly dose should not exceed 100 g. Taclonex may interact with other steroid medicines, or other medicines to treat psoriasis. Tell your doctor all medications and supplements you use. Taclonex should be used only when prescribed during pregnancy. It is unknown if this drug passes into breast milk. 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.

SLIDESHOW

Types of Psoriasis: Medical Pictures and Treatments See Slideshow
Taclonex Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Topical steroid medicine can be absorbed through the skin, which may cause steroid side effects throughout the body. Tell your doctor if you have:

  • weight gain (especially in your face or your upper back and torso);
  • slow wound healing, thinning skin, increased body hair;
  • irregular menstrual periods, changes in sexual function; or
  • muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Children can absorb larger amounts of this medicine through the skin and may be more likely to have side effects.

Stop using the medicine and call your doctor at once if you have:

  • severe burning or irritation where the medicine was applied;
  • redness or crusting around your hair follicles;
  • pus, swelling, redness, increased itching, or other signs of skin infection;
  • high levels of calcium in your blood--constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling; or
  • signs of low adrenal gland hormones--worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting, loss of appetite, diarrhea, and weight loss.

Common side effects may include:

  • skin dryness, itching, burning, or irritation;
  • mild rash; or
  • changes in skin color.

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.

Read the entire detailed patient monograph for Taclonex (Calcipotriene and Betamethasone Dipropionate)

QUESTION

Psoriasis causes the top layer of skin cells to become inflamed and grow too quickly and flake off. See Answer
Taclonex Professional Information

SIDE EFFECTS

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 Trials Experience

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

The data described below reflect exposure to Taclonex® Ointment in 2448 subjects with plaque psoriasis, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. Taclonex® Ointment was studied primarily in placebo- and active-controlled trials (N = 1176, and N = 1272, respectively). The population was 15-97 years old, 61% males and 39% females, mostly white (97%) and had a baseline disease severity ranging from mild to very severe. Most subjects received once daily application, and the median weekly dose was 24.5 g.

The percentage of subjects reporting at least one adverse event was 27.1% in the Taclonex® Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.

Table 1: Adverse Events Reported by ≥1% of Subjects by Preferred Term

  Taclonex® Ointment
N = 2448
Calcipotriene
N = 3197
Betamethasone dipropionate
N = 1164
Vehicle
N = 470
Any Adverse Event 663 (27.1) 1055 (33.0) 329 (28.3) 157 (33.4)
Preferred Term # of subjects (%)
Pruritus 75 (3.1) 183 (5.7) 38 (3.3) 43 (9.1)
Headache 69 (2.8) 75 (2.3) 44 (3.8) 12 (2.6)
Nasopharyngitis 56 (2.3) 77 (2.4) 34 (2.9) 9 (1.9)
Psoriasis 30 (1.2) 47 (1.5) 14 (1.2) 5 (1.1)
Rash scaly 30 (1.2) 40 (1.3) 0 (0.0) 1 (0.2)
Influenza 23 (0.9) 34 (1.1) 14 (1.2) 6 (1.3)
Upper respiratory tract infection 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6)
Erythema 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1)
Application site pruritus 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
Skin irritation 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1)
Pain 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1)
Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3)

A lesional/perilesional adverse event was generally defined as an adverse event located ≤ 2 cm from the lesional border.

Table 2: Lesional/Perilesional Adverse Events Reported by ≥1% of Subjects

  Taclonex®
Ointment
N = 2448
Calcipotriene
N = 3197
Betamethasone
dipropionate
N = 1164
Vehicle
N = 470
Any Adverse Event 213 (8.7) 419 (13.1) 85 (7.3) 76
(16.2)
Preferred Term # of subjects (%)
Pruritus 69 (2.8) 170 (5.3) 31 (2.7) 41 (8.7)
Rash scaly 29 (1.2) 38 (1.2) 0 (0.0) 0 (0.0)
Application site
pruritus
12 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
Erythema 9 (0.4) 36 (1.1) 2 (0.2) 4 (0.9)
Skin irritation 9 (0.4) 51 (1.6) 8 (0.7) 5 (1.1)
Burning sensation 6 (0.2) 25 (0.8) 3 (0.3) 5 (1.1)

For subjects who reported lesional/perilesional adverse events, the median time to onset was 7 days for Taclonex® Ointment, 7 days for calcipotriene, 5 days for betamethasone dipropionate, and 3 days for vehicle.

Other less common reactions (less than 1% but more than 0.1%) were, in decreasing order of incidence, folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia and skin hyperpigmentation were reported infrequently (0.1%).

In a separate trial, subjects (N = 207) with at least moderate disease severity were given Taclonex® Ointment intermittently on an "as needed" basis for up to 52 weeks. The median use was 15.4 g per week. The effects of Taclonex® Ointment on calcium metabolism were not studied and the effects on the HPA axis were not adequately studied. The following adverse reactions were reported by 1% or more of the subjects: pruritus (7.2%), psoriasis (3.4%), skin atrophy (1.9%), folliculitis (1.4%), burning sensation (1.4%), skin depigmentation (1.4%), ecchymosis (1.0%), erythema (1.0%) and hand dermatitis (1.0%). One case of serious flare-up of psoriasis was reported.

Postmarketing Experience

The following adverse reactions associated with the use of Taclonex® Ointment have been identified post-approval: pustular psoriasis and rebound effect.

Because these 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: striae, dryness, acneiform eruptions, perioral dermatitis, secondary infection and miliaria.

Read the entire FDA prescribing information for Taclonex (Calcipotriene and Betamethasone Dipropionate)

Related Resources for Taclonex

© Taclonex Patient Information is supplied by Cerner Multum, Inc. and Taclonex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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