Mometasoneside effects

Most common adverse reactions are burning, pruritus, skin atrophy, tingling/stinging and furunculosis. To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc., at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are discussed in more detail in other sections of the labeling:

Endocrine System Adverse Reactions

Ophthalmic Adverse Reactions

Allergic Contact Dermatitis

Concomitant Skin infections

6.1 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 clinical practice. In controlled clinical trials the incidence of adverse reactions associated with the use of mometasone furoate ointment was 4.8%. Reported reactions included burning, pruritus, skin atrophy, tingling/stinging, and furunculosis. Cases of rosacea associated with the use of mometasone furoate ointment have been reported.

6.2 Postmarketing

Experience The following adverse reactions have been identified during postapproval use of topical corticosteroids. Because adverse 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.

Endocrine Disorders: Cushing’s syndrome, linear growth retardation, and delayed weight gain.

Local Adverse Reactions: irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, striae, and miliaria.

Nervous System Disorders: intracranial hypertension.

Ophthalmic Adverse Reactions: blurred vision, cataracts, glaucoma, and increased intraocular pressure.