Catapres-TTS Side Effects

Please note - some side effects for Catapres-TTS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Catapres-TTS - for the Consumer

Catapres-TTS Patches

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 Catapres-TTS Patches:

Constipation, dizziness; drowsiness; dry mouth or throat; headache; lack of energy; mild skin irritation; tiredness; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Catapres-TTS Patches:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; chest pain; decrease in sexual desire or ability; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes (eg, agitation, anxiety, depression); rash, blisters, burning, or color change at the application site; severe or persistent headache or dizziness; skin irritation; swelling of the hands, ankles, or feet.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Catapres-TTS Side Effects - for the Professional

Catapres-TTS

Clinical trial experience with Catapres-TTS

Most systemic adverse effects during Catapres-TTS® (clonidine) transdermal therapeutic system therapy have been mild and have tended to diminish with continued therapy. In a 3-month multi-clinic trial of Catapres-TTS transdermal therapeutic system in 101 hypertensive patients, the systemic adverse reactions were, dry mouth (25 patients) and drowsiness (12), fatigue (6), headache (5), lethargy and sedation (3 each), insomnia, dizziness, impotence/sexual dysfunction, dry throat (2 each) and constipation, nausea, change in taste and nervousness (1 each).

In the above mentioned 3-month controlled clinical trial, as well as other uncontrolled clinical trials, the most frequent adverse reactions were dermatological and are described below.

In the 3-month trial, 51 of the 101 patients had localized skin reactions such as erythema (26 patients) and/or pruritus, particularly after using an adhesive cover throughout the 7-day dosage interval. Allergic contact sensitization to Catapres-TTS transdermal therapeutic system was observed in 5 patients. Other skin reactions were localized vesiculation (7 patients), hyperpigmentation (5), edema (3), excoriation (3), burning (3), papules (1), throbbing (1), blanching (1), and a generalized macular rash (1).

In additional clinical experience, contact dermatitis resulting in treatment discontinuation was observed in 128 of 673 patients (about 19 in 100) after a mean duration of treatment of 37 weeks. The incidence of contact dermatitis was about 34 in 100 among white women, about 18 in 100 in white men, about 14 in 100 in black women, and approximately 8 in 100 in black men. Analysis of skin reaction data showed that the risk of having to discontinue Catapres-TTS transdermal therapeutic system treatment because of contact dermatitis was greatest between treatment weeks 6 and 26, although sensitivity may develop either earlier or later in treatment.

In a large-scale clinical acceptability and safety study by 451 physicians in a total of 3539 patients, other allergic reactions were recorded for which a causal relationship to Catapres-TTS transdermal therapeutic system was not established: maculopapular rash (10 cases); urticaria (2 cases); and angioedema of the face (2 cases), which also affected the tongue in one of the patients.

Marketing Experience with Catapres-TTS

The following adverse reactions have been identified during post-approval use of Catapres-TTS transdermal therapeutic system. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Catapres-TTS transdermal therapeutic system.

Body as a Whole: Fever; malaise; weakness; pallor; and withdrawal syndrome.

Cardiovascular: Congestive heart failure; cerebrovascular accident; electrocardiographic abnormalities (i.e., bradycardia, sick sinus syndrome disturbances and arrhythmias); chest pain; orthostatic symptoms; syncope; increases in blood pressure; sinus bradycardia and atrioventricular (AV) block with and without the use of concomitant digitalis; Raynaud’s phenomenon; tachycardia; bradycardia; and palpitations.

Central and Peripheral Nervous System/Psychiatric: Delirium; mental depression; hallucinations (including visual and auditory); localized numbness; vivid dreams or nightmares; restlessness; anxiety; agitation; irritability; other behavioral changes; and drowsiness.

Dermatological: Angioneurotic edema; localized or generalized rash; hives; urticaria; contact dermatitis; pruritus; alopecia; and localized hypo or hyper pigmentation.

Gastrointestinal: Anorexia and vomiting.

Genitourinary: Difficult micturition; loss of libido; and decreased sexual activity.

Metabolic: Gynecomastia or breast enlargement and weight gain.

Musculoskeletal: Muscle or joint pain; and leg cramps.

Ophthalmological: Blurred vision; burning of the eyes and dryness of the eyes.

Adverse Events Associated with Oral CATAPRES Therapy: 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) 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 AV 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 urinary retention.

Hematologic: Thrombocytopenia.

Metabolic: Gynecomastia, transient elevation of blood glucose or serum creatine phosphokinase, and weight gain.

Musculoskeletal: Leg cramps and muscle or joint pain.

Oro-otolaryngeal: Dryness of the nasal mucosa.

Ophthalmological: Accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of the eyes.

Top

Side Effects by Body System - for Healthcare Professionals

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%), somnolence (19%), fatigue (13%), headache (19%), irritability (6%), insomnia (6%), nightmares (3%), body temperature increased (1%), abnormal sleep-related event (1%), and tremor (3%). 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 an 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, 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. There have also been reports of congestive heart failure, electrocardiographic abnormalities (i.e., sinus node arrest, junctional bradycardia, high degree AV block, and arrhythmias), 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.

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%), abdominal pain, anorexia, nausea, vomiting, diarrhea (1%), parotitis, pseudo-obstruction (including colonic pseudo-obstruction), and salivary gland pain. 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

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.

Dermatologic reactions have been reported in 10% to 38% of patients who use transdermal clonidine. These reactions include psoriasis exacerbations, local dermatitis and/or pigmentation, alopecia, angioneurotic edema, hives, pruritus, rash, and urticaria.

Psychiatric

Psychiatric side effects have included emotional disorder (5%), aggression (1%), tearfulness (3%) and 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 included leg cramps and muscle or joint pain. Moderately severe myalgia has been associated with the use of clonidine in patients treated for opioid withdrawal symptoms.

Immunologic

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

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.

Respiratory

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.

Respiratory system reactions have included nasal congestion (5%), asthma (1%), and nasopharyngitis (3%). A case of severe bronchospasm associated with clonidine has been reported in the pediatric literature.

Ocular

Ocular side effects have included accommodation disorder, blurred vision, burning of the eyes, decreased lacrimation, and dryness of the eyes.

Metabolic

Metabolic side effects have included thirst (3%) and throat pain (6%).

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.