ADVERSE REACTIONS
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 hydrochloride USP), but in many cases patients were receiving concomitant medication and a causal relationship has not been established.
Body as a Whole
Weakness, about 10 in 100 patients; fatigue, about 4 in 100; headache and withdrawal syndrome each about 1 in 100. Also reported were pallor; a weakly positive Coombs’ test; increased sensitivity to alcohol; and fever.
Cardiovascular
Orthostatic symptoms, about 3 in 100 patients; palpitations and tachycardia, and bradycardia, each about 5 in 1000. Syncope, Raynaud’s phenomenon, congestive heart failure, and electrocardiographic abnormalities (i.e. sinus node arrest, junctional bradycardia, high degree AV block and arrhythmias) have been reported rarely. Rare cases of sinus bradycardia and atrioventricular block have been reported, both with and without the use of concomitant digitalis.
Central Nervous System
Nervousness and agitation, about 3 in 100 patients; mental depression, about 1 in 100 and insomnia, about 5 in 1000. Other behavioral changes, vivid dreams or nightmares, restlessness, anxiety, visual and auditory hallucinations and delirium have rarely been reported.
Dermatological
Rash, about 1 in 100 patients; pruritus, about 7 in 1000; hives, angioneurotic edema and urticaria, about 5 in 1000; alopecia, about 2 in 1000.
Gastrointestinal
Nausea and vomiting, about 5 in 100 patients; anorexia and malaise, each about 1 in 100; mild transient abnormalities in liver function tests, about 1 in 100; hepatitis, parotitis, constipation, pseuodo-obstruction, and abdominal pain, rarely.
Genitourinary
Decreased sexual activity, impotence and loss of libido, about 3 in 100 patients; nocturia, about 1 in 100; difficulty in micturition, about 2 in 1000; urinary retention, about 1 in 1000.
Hematologic
Thrombocytopenia, rarely.
Metabolic
Weight gain, about 1 in 100 patients; gynecomastia, about 1 in 1000; transient elevation of blood glucose or serum creatine phosphokinase, rarely.
Musculoskeletal
Muscle or joint pain, about 6 in 1000 and leg cramps, about 3 in 1000.
Oro-otolaryngeal
Dryness of the nasal mucosa was rarely reported.
Ophthalmological
Dryness of eyes, burning of the eyes and blurred vision were reported.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CATAPRES
Below is a sample of reports where side effects / adverse reactions may be related to Catapres. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Catapres side effects / adverse reactions in 41 year old male
Reported by a pharmacist from United States on 2007-02-13
Patient: 41 year old male
Reactions: Vomiting, Diarrhoea, Nausea, Hypertensive Crisis
Adverse event resulted in: hospitalization
Suspect drug(s):
Cellcept
Indication: Lupus Nephritis
Cellcept
Start date: 2007-02-03
Catapres
Indication: Hypertension
Possible Catapres side effects / adverse reactions in 40 year old female
Reported by a physician on 2007-02-20
Patient: 40 year old female weighing 58.0 kg (127.6 pounds)
Reactions: Hypotension, Headache
Adverse event resulted in: hospitalization
Suspect drug(s):
Catapres
Other drugs received by patient: Marcaine; Sufenta
Possible Catapres side effects / adverse reactions in 30 year old female
Reported by a physician from France on 2007-02-23
Patient: 30 year old female weighing 50.0 kg (110.0 pounds)
Reactions: Hypotension
Adverse event resulted in: hospitalization
Suspect drug(s):
Catapres
Other drugs received by patient: Marcaine; Sufenta
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