Duraclon Side Effects

Generic Name: clonidine

Please note - some side effects for Duraclon may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Duraclon - for the Consumer

Duraclon

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Duraclon:

Chest pain; confusion; constipation; drowsiness; dry mouth; flushing; general weakness; headache; nausea; ringing in the ears; sweating; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; decreased heartbeat; dizziness; fainting; fever; hallucinations; lightheadedness; painful burning on urination.

Duraclon Side Effects - for the Professional

Duraclon

Adverse reactions seen during continuous epidural clonidine infusion are dose-dependent and typical for a compound of this pharmacologic class. The adverse events most frequently reported in the pivotal controlled clinical trial of continuous epidural clonidine administration consisted of hypotension, postural hypotension, decreased heart rate, rebound hypertension, dry mouth, nausea, confusion, dizziness, somnolence, and fever. Hypotension is the adverse event that most frequently requires treatment. The hypotension is usually responsive to intravenous fluids and, if necessary, appropriate parenterally-administered pressor agents. Hypotension was observed more frequently in women and in lower weight patients, but no dose-related response was established.

Implantable epidural catheters are associated with a risk of catheter-related infections, including meningitis and/or epidural abscess. The risk depends on the clinical situation and the type of catheter used, but catheter related infections occur in 5%-20% of patients, depending on the kind of catheter used, catheter placement technique, quality of catheter care, and length of catheter placement.

The inadvertent intrathecal administration of clonidine has not been associated with a significantly increased risk of adverse events, but there are inadequate safety and efficacy data to support the use of intrathecal clonidine.

Epidural clonidine was compared to placebo in a two week double-blind study of 85 terminal cancer patients with intractable pain receiving epidural morphine. The following adverse events were reported in two or more patients and may be related to administration of either Duraclon or morphine.

An open label long-term extension of the above trial was performed. Thirty-two subjects received epidural clonidine and morphine for up to 94 weeks with a median dosing period of 10 weeks. The following adverse events (and percent incidence) were reported: hypotension/postural hypotension (47%); nausea (13%); anxiety/confusion (38%); somnolence (25%); urinary tract infection (22%); constipation, dyspnea, fever, infection (6% each); asthenia, hyperaesthesia, pain, skin ulcer, and vomiting (5% each). Eighteen percent of subjects discontinued this study as a result of catheter-related problems (infections, accidental dislodging, etc.), and one subject developed meningitis, possibly as a result of a catheter-related infection. In this study, rebound hypertension was not assessed, and ECG and laboratory data were not systematically sought.

The following adverse reactions have also been reported with the use of any dosage form of clonidine. In many cases patients were receiving concomitant medication and a causal relationship has not been established:

Body as a Whole: Weakness, 10%; fatigue, 4%; headache and withdrawal syndrome, each 1%. Also reported were pallor, a weakly positive Coomb's test, and increased sensitivity to alcohol.

Cardiovascular: Palpitations and tachycardia, and bradycardia, each 0.5%. Syncope, Raynaud's phenomenon, congestive heart failure, and electrocardiographic abnormalities (i.e., sinus node arrest, functional bradycardia, high degree AV block) 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, 3%; mental depression, 1%; insomnia, 0.5%. Cerebrovascular accidents, other behavioral changes, vivid dreams or nightmares, restlessness, and delirium have been reported rarely.

Dermatological: Rash, 1%; pruritus, 0.7%; hives, angioneurotic edema and urticaria, 0.5%; alopecia, 0.2%.

Gastrointestinal: Anorexia and malaise, each 1%; mild transient abnormalities in liver function tests, 1%; hepatitis, parotitis, ileus and pseudo obstruction, and abdominal pain, rarely.

Genitourinary: Decreased sexual activity, impotence, and libido, 3%; nocturia, about 1%; difficulty in micturition, about 0.2%; urinary retention, about 0.1%.

Hematologic: Thrombocytopenia, rarely.

Metabolic: Weight gain, 0.1%; gynecomastia, 1%; transient elevation of glucose or serum phosphatase, rarely.

Musculoskeletal: Muscle or joint pain, about 0.6%; leg cramps, 0.3%.

Oro-otolaryngeal: Dryness of the nasal mucosa was rarely reported.

Ophthalmological: Dryness of the eyes, burning of the eyes and blurred vision were rarely reported.

Side Effects by Body System

Other

The most common adverse side effects are related to the alpha-adrenergic blocking effects of clonidine. These side effects are dose-related, typically decrease over time, and mostly affect the nervous system, cardiovascular system, and the gastrointestinal system.

Nervous system

Nervous system side effects have included drowsiness (28%), dizziness (9%). Patients with decreased autoregulation of cerebral blood flow appear to be at increased risk for clonidine-induced cerebral hypoperfusion if blood pressure is lowered too much or too quickly. This may be important in some elderly patients. Confusion (13.2%) and hallucinations (5.3%) have been reported with epidural usage. Dose-dependent sedative effects, memory impairment, and reduced cognitive performance have been reported in subjects receiving intravenous clonidine.

A study of 13 patients who had pre- and post-clonidine cerebral blood flow (CBF) measured by nuclear scanning revealed that patients with a initially high pretreatment CBF tended to demonstrate decreased CBF after clonidine therapy.

Patients with traumatic spinal cord injury receiving clonidine may experience a delayed-onset of sedation regardless of the route of administration (i.e., intrathecal, intramuscular).

Cardiovascular

Cardiovascular side effects have included hypotension and sinus and atrioventricular arrhythmias. Postural hypotension occurs in 2% of patients. Rebound hypertension (which may be worse than pretreatment values) can present as irritability, tremors, headache, increased salivation, nausea, and palpitations. Rebound hypertension may be minimized by gradual reduction of dosage over two to four days.

Hypotension with epidural clonidine has been reported in 45% of 38 patients in one study. Hypotension occurred more commonly in the first four days, in women, in lower weight patients, and those receiving higher dosages.

Other cardiovascular side effects have included sinus bradycardia in approximately 0.3% of patients. A rare case of sinus arrest associated with clonidine has been reported. Patients with preexisting sinus node dysfunction, patients who have developed bradycardia while taking other sympatholytic agents, patients who are on another sympatholytic agent, and patients with renal dysfunction are at increased risk of clonidine-associated sinus bradycardia. Clonidine may cause hypertension in some patients with idiopathic orthostatic hypotension, particularly those with autonomic nervous system dysfunction.

A case of sinus arrest associated with clonidine has been reported. A 65-year-old man with diabetes, hypertension and unexplained syncope developed more frequent syncope and dizziness associated with documented episodes of sinus arrest during the first week of clonidine therapy. The patient had no hypoglycemia or orthostatic changes. The syncope and dizziness resolved upon discontinuation of clonidine; continuous electrocardiographic monitoring revealed a gradual and complete disappearance of sinus pauses. Junctional bradycardia and AV heart block have also been reported.

Ventricular tachycardia (VT) relatively refractory to lidocaine, but responsive to intravenous phentolamine, has been associated with clonidine withdrawal (case report). The authors believe that the VT was probably produced by humoral or neural stimulation of unregulated myocardial alpha-adrenergic receptors.

Transdermal clonidine has been implicated with hypertension in a quadriplegic patient with a C4 spinal lesion. The proposed mechanism is predominance of clonidine's peripheral alpha-1 adrenergic effects due to the patient's autonomic dysfunction, resulting in vasoconstriction and hypertension.

Sinus bradycardia or other supraventricular bradyarrhythmias are more likely in patients with underlying renal dysfunction.

In one case report, severe hypotension occurred during separation from cardiopulmonary bypass in a patient given intrathecal clonidine. The patient responded to volume expansion and use of vasoconstrictors.

Gastrointestinal

Gastrointestinal side effects have most commonly included dry mouth (30%) and constipation (15%). Nausea (13.2%) and vomiting (10.5%) have been reported with epidural clonidine.

Genitourinary

Genitourinary side effects have included impotence in male patients (24%), retrograde and delayed ejaculation, and an inability to achieve orgasm in female patients.

Dermatologic

Dermatologic reactions have been reported in 10% to 38% of patients who use transdermal clonidine. These reactions include psoriasis exacerbations and local dermatitis and/or pigmentation.

A 66-year-old woman with a history of psoriasis in remission developed erythematous, scaly plaques on the extensor surfaces of her forearms within three days after beginning clonidine therapy for control of flushing. The author of this case report suspected that clonidine may cause a fall in intracellular cAMP, leading to epidermal cell proliferation, and, in some cases, a psoriasiform eruption.

Psychiatric

Psychiatric side effects have included rare reports of depression, which has been the most common psychiatric reaction to clonidine. Rare cases of frank psychoses and delirium have been associated with clonidine withdrawal.

Endocrine

Endocrinologic side effects have been limited to rare cases of gynecomastia, hyperprolactinemia, or hyperglycemia.

A 68-year-old black man with hypertension, status post unilateral nephrectomy, was incidentally found to have 4+ proteinuria, 1+ glycosuria, new elevated blood glucose levels, and between 1.8 and 5.4 grams of protein per 24-hour urine collection within 6 weeks after starting clonidine. The signs and symptoms of diabetes and the nephrotic syndrome disappeared within five months after discontinuation of clonidine. Because of his solitary kidney, a renal biopsy was not performed.

Musculoskeletal

Musculoskeletal side effects have been rare. Moderately severe myalgia has been associated with the use of clonidine in patients treated for opioid withdrawal symptoms.

Immunologic

A 46-year-old woman developed forearm edema, mild thenar atrophy, and skin hypopigmentation within three months after beginning clonidine for perimenopausal flushing. Electromyelography was consistent with carpal tunnel syndrome. At surgical decompression, a skin biopsy revealed changes consistent with immune-complex disease. The patient's signs and symptoms abated after physical therapy and discontinuation of clonidine.

Immunologic side effects have rarely been reported and include one case of immune-complex disease.

Respiratory

Respiratory system reactions have been extremely rare. A case of severe bronchospasm associated with clonidine has been reported in the pediatric literature.

A 9-year-old boy with asthma developed a severe asthma attack after an oral clonidine stimulation test. He required hospitalization. The authors of this case report suspect that clonidine may have caused acute pulmonary artery vasoconstriction (directly), which could have decreased pulmonary blood flow, producing relative pulmonary hypoxemia, setting off an asthma attack.

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