Taclonex

Taclonex

Taclonex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Taclonex (calcipotriene and betamethasone dipropionate) Ointment is a combination drug used to treat psoriasis vulgaris. Calcipotriene is a form of vitamin D, and betamethasone is a topical (for the skin) corticosteroid. Common side effects include itching, burning, redness, or irritation of the skin.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Taclonex in Detail - Patient Information: Side Effects

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 (Calcipotriene and Betamethasone Dipropionate) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Taclonex FDA Prescribing Information: Side Effects
(Adverse Reactions)

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to Taclonex® (calcipotriene and betamethasone dipropionate) Ointment in 2448 patients, including 1992 exposed for 4 weeks, and 289 exposed for 8 weeks. In the trials that included assessment of the effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on calcium metabolism, such testing was done after 4 weeks of treatment. The effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on calcium metabolism following treatment durations of longer than 4 weeks are not known (See PRECAUTIONS). The effects of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment on the HPA axis following treatment durations of longer than 4 weeks have not been adequately studied. Taclonex® (calcipotriene and betamethasone dipropionate) 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 patients 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® (calcipotriene and betamethasone dipropionate) Ointment group, 33.0% in the calcipotriene group, 28.3% in the betamethasone group, and 33.4% in the vehicle group.

  Taclonex® (calcipotriene and betamethasone dipropionate)
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 20 (0.8) 19 (0.6) 12 (1.0) 3 (0.6)
tract infection 15 (0.6) 54 (1.7) 3 (0.3) 5 (1.1)
Erythema Application site 13 (0.5) 24 (0.8) 10 (0.9) 6 (1.3)
pruritus 11 (0.4) 60 (1.9) 8 (0.7) 5 (1.1)
Skin irritation 7 (0.3) 12 (0.4) 3 (0.3) 5 (1.1)
Pain Burning sensation 6 (0.2) 30 (0.9) 3 (0.3) 6 (1.3)

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

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

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

  Taclonex® (calcipotriene and betamethasone dipropionate)
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® (calcipotriene and betamethasone dipropionate) 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 study, patients (N=207) with at least moderate disease severity were given Taclonex® (calcipotriene and betamethasone dipropionate) 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® (calcipotriene and betamethasone dipropionate) 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 patients: 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 a serious flare-up of psoriasis was reported.

Development of pustular psoriasis has been reported as an adverse reaction during and following use of Taclonex® (calcipotriene and betamethasone dipropionate) Ointment.

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

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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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