ADVERSE REACTIONS
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 directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials with CLOBEX Shampoo, 0.05%, the following adverse reactions have been reported: headache, burning/stinging, pruritus, edema, folliculitis, acne, dry skin, irritant dermatitis, alopecia, urticaria, skin atrophy and telangiectasia.
Table 1 summarizes selected adverse reactions that occurred in at least 1% of subjects in the Phase 2 and 3 studies for scalp psoriasis.
Table 1: Summary of Selected Adverse Reactions ≥1% by Body System
| Body System |
CLOBEX Shampoo, 0.05%
N=558
|
Vehicle Shampoo, 0.05%
N=127
|
| Skin and Appendages |
49 (8.8%) |
28 (22.0%) |
| Discomfort Skin |
26 (4.7%) |
16 (12.6%) |
| Pruritus |
3 (0.5%) |
9 (7.1%) |
| Body As A Whole |
33 (5.9%) |
12 (9.4%) |
| Headache |
10 (1.8%) |
1 (0.8%) |
Systemic absorption of topical corticosteroids has produced reversible HPA axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Postmarketing Experience
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. The following adverse reactions have been identified during post-approval use of CLOBEX Shampoo, 0.05%.
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Endocrine disorders: Cushing’s syndrome, Adrenal suppression
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Eye: Eye pain, Vision blurred, Eye irritation
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CNS: Dizziness
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GI: Nausea
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Skin: Erythema, Skin exfoliation, Rash, Skin irritation, Hair color changes, Allergic contact dermatitis, Pain of skin, Skin tightness
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Other: Psoriasis (aggravation)
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REPORTS OF SUSPECTED CLOBEX SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Clobex. The information is not vetted and should not be considered as verified clinical evidence.
Possible Clobex side effects / adverse reactions in 72 year old female
Reported by a consumer/non-health professional from United States on 2011-12-19
Patient: 72 year old female
Reactions: Swelling Face, Pruritus, Malaise, Eye Swelling, Blister, Stevens-Johnson Syndrome
Suspect drug(s):
Clobex
Other drugs received by patient: Travatan; Quinapril; Tricor
Possible Clobex side effects / adverse reactions in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-01-03
Patient: 58 year old female weighing 81.6 kg (179.6 pounds)
Reactions: Skin Exfoliation, DRY Skin
Suspect drug(s):
Clobex
Possible Clobex side effects / adverse reactions in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-04-26
Patient: 72 year old female
Reactions: Pruritus, Haemorrhage, Skin Discolouration, Scab, Skin Hypertrophy, Stevens-Johnson Syndrome, Blister
Suspect drug(s):
Clobex
Other drugs received by patient: Travatan; Tricor; Quinapril
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