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 following clinically significant adverse reactions are discussed elsewhere in the labeling: Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension [see Warnings and Precautions ( 5.1 )] Rebound Hypertension [see Warnings and Precautions ( 5.2 )] Sedation and Somnolence [see Warnings and Precautions ( 5.3 )] The most frequent adverse reactions are dry mouth, drowsiness, dizziness, constipation and sedation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trial 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.
Most adverse effects are mild and tend to diminish with continued therapy.
The most frequent (which appear to be dose-related) are dry mouth (40%), drowsiness (33%);
dizziness (16%);
constipation and sedation (10%, respectively).
The following less frequent adverse experiences have also been reported in patients receiving clonidine hydrochloride tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Body as a Whole: Fatigue, headache, pallor, malaise, weakness, and withdrawal syndrome.
Cardiovascular: Bradycardia, congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), orthostatic symptoms, palpitations, syncope, and tachycardia.
5 WARNINGS AND PRECAUTIONS Bradycardia, Cardiac Conduction Abnormalities, and Symptomatic Hypotension: Clonidine may cause bradycardia, conduction abnormalities, and hypotension.
Titrate slowly in patients with syncope, heart block, or vascular disease.
Monitor blood pressure and heart rate.
Avoid drugs affecting sinus or AV node function.
( 5.1 ) Rebound Hypertension: Abrupt discontinuation of JAVADIN may cause rebound hypertension, especially with high doses or beta-blocker use.
Like all medications, Javadin 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: