Catapres (Clonidine Hydrochloride) - Side Effects and Adverse Reactions

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.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO CATAPRES

Possible Catapres side effects / adverse reactions in 80 year old female

Reported by a individual with unspecified qualification from United States on 2009-04-03

Patient: 80 year old female

Reactions: Agitation, Confusional State, Thrombosis, Weight Decreased, Extrasystoles, Pain, Therapeutic Procedure, Fall, Weight Increased, Neuropathy Peripheral, Oedema Peripheral, Muscle Injury, DRY Mouth, Heart Rate Irregular, Pneumonia, Cataract, Cystitis, Paraesthesia, Diarrhoea, Dysphonia, Vision Blurred, Gait Disturbance, Hypertension, Influenza

Adverse event resulted in: hospitalization

Suspect drug(s):
ALL Other Therapeutic Products
    Indication: Blood Pressure
    Start date: 2008-07-31

Catapres
    Indication: Blood Pressure

Lyrica
    Dosage: 50 mg, 2x/day
    Start date: 2008-07-01
    End date: 2009-01-01

Neurontin
    Dosage: 300 mg, 2x/day
    Start date: 2007-08-30

Other drugs received by patient: Antihypertensives; Antidepressants

Possible Catapres side effects / adverse reactions in 66 year old female

Reported by a individual with unspecified qualification on 2009-04-09

Patient: 66 year old female

Reactions: Drug Interaction, Depressed Level of Consciousness

Suspect drug(s):
Catapres
    Indication: Agitation

Catapres
    Indication: Hypertension

Escitalopram
    Dosage: 5mg
    Indication: Depression

Possible Catapres side effects / adverse reactions in 80 year old female

Reported by a individual with unspecified qualification from United States on 2009-04-29

Patient: 80 year old female

Reactions: Agitation, Confusional State, Thrombosis, Weight Decreased, Extrasystoles, Pain, Therapeutic Procedure, Fall, Weight Increased, Neuropathy Peripheral, Oedema Peripheral, Muscle Injury, DRY Mouth, Heart Rate Irregular, Pneumonia, Cataract, Cystitis, Paraesthesia, Diarrhoea, Dysphonia, Vision Blurred, Gait Disturbance, Hypertension, Influenza

Adverse event resulted in: hospitalization

Suspect drug(s):
ALL Other Therapeutic Products
    Indication: Blood Pressure
    Start date: 2008-07-31

Catapres
    Indication: Blood Pressure

Lyrica
    Dosage: 50 mg, 2x/day
    Start date: 2008-07-01
    End date: 2009-01-01

Neurontin
    Dosage: 300 mg, 2x/day
    Start date: 2007-08-30

Other drugs received by patient: Antihypertensives; Antidepressants