Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most commonly reported adverse reactions (≥1%) were headache, application site burning, nasopharyngitis, and nasal congestion.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical trials, a total of 443 adult subjects with atopic dermatitis or plaque-type psoriasis were treated once daily or twice daily with fluocinonide cream, 0.1% for 2 weeks.
The most commonly observed adverse reactions in these clinical trials were as follows: Table 1: Most Commonly Observed Adverse Reactions (≥1%) in Adult Clinical Trials Safety in patients 12 to 17 years of age was similar to that observed in adults.
Table 1 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of fluocinonide cream, 0.1%: Administration Site Conditions : discoloration, erythema, irritation, pruritus, swelling, pain and condition aggravated.
Immune System Disorders: hypersensitivity.
Nervous System Disorders : headache and dizziness.
Skin and Subcutaneous Tissue Disorders : acne, dry skin, rash, skin exfoliation and skin tightness.
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.
Warnings For external use only Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns When using this product ■ do not get into eyes Stop use and ask a doctor if ■ condition worsens ■ symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Like all medications, Fluopar can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: