Fluocinoloneside effects

The following serious adverse reactions are discussed in more detail in other sections of the labeling:

Endocrine System Adverse Reactions

Local Adverse Reactions

Ophthalmic Adverse Reactions The most commonly reported adverse reactions (≥ 1%) were headache (3%), URI (2%), cough (2%), eczematous otitis (1%). To report SUSPECTED ADVERSE REACTIONS, contact Hill Dermaceuticals, Inc. at 1-800-344-5707 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Studies 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 trials that enrolled 154 subjects (adults and pediatric subjects 2 years and older) with chronic eczematous external otitis who were treated with five drops per ear of DERMOTIC OIL twice daily for a maximum 14 days of treatment, the following adverse reactions were reported: Table 1: Adverse Reactions in ≥ 1% of DERMOTIC OIL-Treated Adult and Pediatric Subjects 2 Years of Age and Older with Chronic Eczematous External Otitis, N=154 Adverse Reaction n (%) Headache 4 URI 3 Cough 3 Eczematous otitis 2

6.2 Postmarketing

Experience The following adverse reactions have been identified during post-approval use of products containing topical corticosteroids. Because postmarketing 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: HPA axis suppression and Cushing’s syndrome Eye Disorders: glaucoma and cataracts Nervous System Disorders: intracranial hypertension including bulging fontanelles, headaches, and bilateral papilledema