Elocon (Mometasone Furoate Topical) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 clinical practice.

In controlled clinical trials involving 319 subjects, the incidence of adverse reactions associated with the use of ELOCON Cream was 1.6%. Reported reactions included burning, pruritus, and skin atrophy. Reports of rosacea associated with the use of ELOCON Cream have also been received. In controlled clinical trials (n=74) involving pediatric subjects 2 to 12 years of age, the incidence of adverse experiences associated with the use of ELOCON Cream was approximately 7%. Reported reactions included stinging, pruritus, and furunculosis.

The following adverse reactions were reported to be possibly or probably related to treatment with ELOCON Cream during clinical trials in 4% of 182 pediatric subjects 6 months to 2 years of age: decreased glucocorticoid levels, 2; paresthesia, 2; folliculitis, 1; moniliasis, 1; bacterial infection, 1; skin depigmentation, 1. The following signs of skin atrophy were also observed among 97 subjects treated with ELOCON Cream in a clinical trial: shininess, 4; telangiectasia, 1; loss of elasticity, 4; loss of normal skin markings, 4; thinness, 1; and bruising, 1.

The following additional local adverse reactions have been reported with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, striae, and miliaria.

REPORTS OF SUSPECTED ELOCON SIDE EFFECTS / ADVERSE REACTIONS

Possible Elocon side effects / adverse reactions in 67 year old female

Reported by a pharmacist from Croatia (Local Name: Hrvatska) on 2011-12-16

Patient: 67 year old female weighing 73.0 kg (160.6 pounds)

Reactions: Pruritus Generalised, Ocular Hyperaemia, Eye Swelling, Erythema

Suspect drug(s):
Elocon

Other drugs received by patient: Levothyroxine Sodium

Possible Elocon side effects / adverse reactions in 72 year old male

Reported by a pharmacist from United Kingdom on 2012-03-28

Patient: 72 year old male

Reactions: Loss of Consciousness

Suspect drug(s):
Betnovate
    Dosage: unk
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Urea (Urea /00481901/)
    Dosage: unk
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-01-01
    End date: 2012-01-01

Harvix (Hepatitis A Vaccine)
    Dosage: 1 df, qd, unk
    Indication: Prophylaxis
    Start date: 2011-01-01
    End date: 2012-01-01

Aqueous Cream (Phenoxyethanol)
    Dosage: unk
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Elocon
    Dosage: unk
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Revaxis (Revaxis 01525501/)
    Dosage: 1 df, qd, unk
    Indication: Prophylaxis

Influenza Virus (Influenza Virus)
    Dosage: 1 df, qd, unk
    Indication: Prophylaxis

Menthol (Menthol /00482701/)
    Dosage: unk
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Possible Elocon side effects / adverse reactions in 73 year old male

Reported by a pharmacist from United Kingdom on 2012-03-30

Patient: 73 year old male weighing 72.7 kg (159.9 pounds)

Reactions: Loss of Consciousness

Suspect drug(s):
Urea (Urea /00481901/)
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Elocon
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Havrix
    Dosage: 1 df;qd
    Indication: Prophylaxis

Influenza Virus (Influenza Vaccine)
    Dosage: 1 df;qd
    Indication: Prophylaxis

Betamethasone
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Aqueous Cream (Phenoxyethanol)
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Menthol (Menthol /00482701/)
    Indication: DRY Skin
    Start date: 2011-01-01
    End date: 2012-01-01

Revaxis (Revaxis /01525501/)
    Dosage: 1 df;qd
    Indication: Prophylaxis