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CATAPRES (CLONIDINE HCL) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS

Most adverse effects are mild and tend to diminish with continued therapy. The most frequent (which appear to be dose-related) are dry mouth, occurring in about 40 of 100 patients; drowsiness, about 33 in 100; dizziness, about 16 in 100; constipation and sedation, each about 10 in 100.

The following less frequent adverse experiences have also been reported in patients receiving Catapres (Clonidine HCl) tablets, but in many cases patients were receiving concomitant medication and a causal relationship has not been established.

Body as a Whole: fatigue, headache, fever, pallor, weakness, withdrawal syndrome. Also reported were a weakly positive Coombs' test and increased sensitivity to alcohol.

Cardiovascular: congestive heart failure, bradycardia, electrocardiographic abnormalities (i.e.,sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias), palpitations, orthostatic symptoms, Raynaud's phenomenon, syncope, tachycardia. Cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.

Central Nervous System: anxiety, agitation, delirium, hallucinations (including visual and auditory), delusional perception, insomnia, nervousness, mental depression, other behavioral changes, restlessness, paresthesia, sleep disorder, vivid dreams or nightmares.

Dermatological: alopecia, hives, angioneurotic edema, pruritus, rash, urticaria.

Gastrointestinal: anorexia, abdominal pain, constipation, malaise, hepatitis, mild transient abnormalities in liver function tests, parotitis, nausea, vomiting, pseudo-obstruction (including colonic pseudo-obstruction), salivary gland pain.

Genitourinary: difficulty in micturition, decreased sexual activity, erectile dysfunction, loss of libido, nocturia, urinary retention.

Hematologic: thrombocytopenia.

Metabolic: gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, weight gain.

Musculoskeletal: leg cramps and muscle or joint pain.

Oro-otolaryngeal: dryness of the nasal mucosa.

Ophthalmological: blurred vision, accommodation disorder, burning of the eyes, decreased lacrimation, dryness of eyes.

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