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 SUSPECTED CATAPRES SIDE EFFECTS / ADVERSE REACTIONS

Possible Catapres side effects / adverse reactions in 9 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-04

Patient: 9 year old male weighing 46.2 kg (101.6 pounds)

Reactions: Nausea, Chest Pain, Dizziness, Feeling of Body Temperature Change, Headache, Hyperhidrosis, Abdominal Pain Upper

Suspect drug(s):
Catapres

Possible Catapres side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 72 year old female weighing 58.0 kg (127.7 pounds)

Reactions: Weight Decreased, Tongue DRY, Anxiety, Burn Oesophageal, Tongue Disorder, Hair Texture Abnormal, Gastrointestinal Disorder, DRY Mouth, Drug Dependence, Decreased Appetite

Adverse event resulted in: disablity

Suspect drug(s):
Norvasc
    Dosage: (7.5 mg, 1 d), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01

Lisinopril
    Indication: Hypertension

Plavix
    Indication: Anticoagulant Therapy

Zantac
    Dosage: (600 mg, 1 d),
    Indication: Burn Oesophageal

Zantac
    Dosage: (600 mg, 1 d),
    Indication: Gastrooesophageal Reflux Disease

Catapres
    Dosage: (1 wk), transdermal
    Indication: Hypertension
    Start date: 2010-01-01

Metoprolol Tartrate
    Dosage: 40 mg (20 mg, 2 in 1 d), oral
    Administration route: Oral
    Start date: 2010-01-01

Xanax
    Dosage: 1 and 1/4 mg tablets ( by splitting 1mg) (1 d), oral 3/4 tablet (1 d), oral
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-06-08

Celexa
    Dosage: (120 mg), (10 mg),
    Indication: Anxiety

Benicar
    Dosage: (40 mg, 1 d),
    Indication: Hypertension
    Start date: 2010-01-01

Possible Catapres side effects / adverse reactions in 72 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-31

Patient: 72 year old female weighing 58.1 kg (127.8 pounds)

Reactions: Blood Pressure Increased, Weight Decreased, Tongue DRY, Anxiety, Burn Oesophageal, OFF Label USE, Hair Texture Abnormal, DRY Mouth, Gastrointestinal Disorder, Drug Dependence, Decreased Appetite

Adverse event resulted in: disablity

Suspect drug(s):
Zantac
    Dosage: 600 mg (600 mg, 1 in 1 d)
    Indication: Burn Oesophageal

Lisinopril
    Indication: Hypertension

Celexa
    Dosage: (10 mg)
    Indication: Drug Dependence

Benicar
    Dosage: 40 mg (40 mg, 1 in 1 d)
    Indication: Hypertension
    Start date: 2010-01-01

Xanax
    Dosage: 1.25 mg (1.25 mg, 1 in 1 d), oral 0.75 mg (0.75 mg, 1 in 1 d), oral
    Administration route: Oral
    Indication: Anxiety
    Start date: 2010-06-08

Metoprolol Tartrate
    Dosage: 40 mg (20 mg, 2 in 1 d)
    Indication: Hypertension
    Start date: 2010-01-01

Celexa
    Dosage: (120 mg)
    Indication: Drug Dependence

Norvasc
    Dosage: 7.5 mg (bid (5mg in morning + 2.5mg in evening)), oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01

Plavix
    Indication: Thrombosis

Catapres
    Dosage: (1 in 1 wk)
    Indication: Hypertension
    Start date: 2010-01-01