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 Hepatotoxicity: Elevations of one or more hepatic function enzymes and bilirubin may occur during zileuton extended-release tablets therapy [see Warnings and Precautions ( 5 ) ].
The most commonly occurring adverse reactions (≥5%) with zileuton extended-release tablets are sinusitis, nausea, and pharyngolaryngeal pain.
Most common adverse reactions (≥5%) included: sinusitis, nausea, and pharyngolaryngeal pain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Short-Term Clinical Studies Experience The safety data described below reflect exposure to zileuton extended-release tablets in 199 patients for 12 weeks duration.
In a 12-week, randomized, double-blind, placebo-controlled trial in adults and adolescents 12 years of age and older with asthma, patients received zileuton extended-release tablets two 600 mg tablets (n=199) or placebo (n=198) twice daily by mouth.
Eighty-three percent of patients were white, 48% were male, and the mean age was 34 years.
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.
The most commonly reported adverse reactions (occurring at a frequency of ≥5%) in zileuton extended-release tablets -treated patients and at a frequency greater than placebo-treated patients are reflected in Table
Adverse Reactions with ≥5% Incidence in a 12-Week Placebo-Controlled Trial in Patients with Asthma.
Adverse Reaction Zileuton Extended-Release Tablets 600 mg 2 Tablets Twice Daily N=199 n (%) Placebo 2 Tablets Twice Daily N=198 n (%) Sinusitis 13 (6.5) 8 (4.0) Nausea 10 (5.0) 3 (1.5) Pharyngolaryngeal pain 10 (5.0) 8 (4.0) Less common adverse reactions occurring at a frequency ≥1% and more often in the zileuton extended-release tablets group than in the placebo group included gastrointestinal disorders (upper abdominal pain, diarrhea, dyspepsia, vomiting), rash, hypersensitivity, and hepatotoxicity.
5 WARNINGS AND PRECAUTIONS Hepatotoxicity: Elevations of one or more hepatic function enzymes and bilirubin may occur with zileuton extended-release tablets.
Assess hepatic function enzymes prior to initiation of zileuton extended-release tablets, monthly for the first 3 months, every 2 to 3 months for the remainder of the first year, and periodically thereafter.
Use zileuton extended-release tablets with caution in patients who consume substantial quantities of alcohol and/or have a history of liver disease.
( 5.1 ) Neuropsychiatric Events: Neuropsychiatric events, including sleep disorders and behavior changes, may occur with zileuton extended-release tablets.
Instruct patients to be alert for neuropsychiatric events.
Like all medications, Zileuton 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: