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 tablets, but in many cases
patients were receiving concomitant medication and a causal relationship has
not been established.
Body as a Whole: Fatigue, fever, headache, pallor,
weakness, and withdrawal syndrome. Also reported were a weakly positive Coombs'
test and increased sensitivity to alcohol.
Cardiovascular: Bradycardia, congestive heart
failure, electrocardiographic abnormalities (i.e., sinus node arrest,
junctional bradycardia, high degree AV block and arrhythmias), orthostatic
symptoms, palpitations, Raynaud's phenomenon, syncope, and tachycardia. Cases of
sinus bradycardia and atrioventricular block have been reported, both with and
without the use of concomitant digitalis.
Central Nervous System: Agitation, anxiety,
delirium, delusional perception, hallucinations (including visual and
auditory), insomnia, mental depression, nervousness, other behavioral changes,
paresthesia, restlessness, sleep disorder, and vivid dreams or nightmares.
Dermatological: Alopecia, angioneurotic edema,
hives, pruritus, rash, and urticaria.
Gastrointestinal: Abdominal pain, anorexia,
constipation, hepatitis, malaise, mild transient abnormalities in liver
function tests, nausea, parotitis, pseudo-obstruction (including colonic pseudo-obstruction),
salivary gland pain, and vomiting.
Genitourinary: Decreased sexual activity,
difficulty in micturition, erectile dysfunction, loss of libido, nocturia, and
Metabolic: Gynecomastia, transient elevation of
blood glucose or serum creatine phosphokinase, and weight gain.
Musculoskeletal: Leg cramps and muscle or joint
Oro-otolaryngeal: Dryness of the nasal mucosa.
Ophthalmological: Accommodation disorder, blurred
vision, burning of the eyes, decreased lacrimation, and dryness of eyes.