Taclonex Side Effects

Please note - some side effects for Taclonex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Taclonex - for the Consumer

Taclonex Ointment

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Taclonex Ointment:

Dry skin; headache; itching; mild burning at the application site; throat irritation.

Seek medical attention right away if any of these SEVERE side effects occur when using Taclonex Ointment:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; burning, cracking, irritation, redness, or peeling skin not present before you began using Taclonex Ointment; excessive hair growth; inflamed hair follicles; inflammation around the mouth; muscle weakness; thinning, softening, or discoloration of the skin; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Taclonex Scalp Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Taclonex Scalp Suspension:

Mild burning, itching, pain, or redness at the application site.

Seek medical attention right away if any of these SEVERE side effects occur when using Taclonex Scalp Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne-like rash; confusion; eye irritation; increased thirst or urination; inflamed hair pores; muscle weakness; persistent headache; severe burning, cracking, irritation, redness, or peeling skin not present before you began using Taclonex Scalp Suspension; severe or persistent dizziness, drowsiness, or weakness; severe or persistent vomiting; thinning, softening, or discoloration of the skin; unusual or easy bruising; unusual weight gain, especially in the face.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Taclonex Side Effects - for the Professional

Taclonex

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 Study Experience

The data described below reflect exposure to Taclonex® Ointment in 2448 subjects, 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 (%)
Pruritis	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 (%)
Pruritis	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 study, 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.

Post-marketing 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.

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Side Effects by Body System - for Healthcare Professionals

Dermatologic

Dermatologic side effects reported in clinical trials have included pruritus (3.1%), psoriasis (1.2%), scaly rash (1.2%), erythema (0.6%), skin irritation (0.4%), pain (0.3%), and burning sensation (0.2%). Other, less common reactions (less than 1%) include folliculitis, rash papular, rash pustular, and skin hypopigmentation. Skin atrophy, telangiectasia, and skin hyperpigmentation were reported infrequently.

Respiratory

Respiratory side effects reported in clinical trials have included nasopharyngitis (2.3%), influenza (0.9%), and upper respiratory tract infection (0.8%).

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