Cardura XL Side Effects

Generic Name: doxazosin

Please note - some side effects for Cardura XL 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 Cardura XL - for the Consumer

Cardura XL Extended-Release Tablets

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 Cardura XL Extended-Release Tablets:

Dizziness; drowsiness; headache; heartburn; lightheadedness; stomach upset; weakness.

Seek medical attention right away if any of these SEVERE side effects occur when using Cardura XL Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fainting; fast or irregular heartbeat; painful or difficult urination; prolonged, painful erection; severe or prolonged dizziness or headache; shortness of breath; swelling of the hands, ankles, or feet; vision changes.

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.

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Cardura XL Side Effects - for the Professional

Cardura XL

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The incidence of adverse reactions was derived from two controlled efficacy and safety trials involving 1473 BPH patients. In Study 1, Cardura XL (n=317) was compared to doxazosin IR tablets (n=322) and to placebo (n=156). In Study 2, Cardura XL (n=350) was compared just to doxazosin IR tablets (n=330). In both of these studies, Cardura XL was initiated at a dose of 4 mg, which could be increased by the investigator to 8 mg after seven weeks if an adequate response was not seen [see Clinical Studies (14.1)]. Similarly, doxazosin IR was begun at a dose of 1 mg, which was increased in all patients to 2 mg after 1 week, followed by the option to increase to 4 mg after 4 weeks, and 8 mg after 7 weeks.

The most commonly reported adverse reactions leading to discontinuation in the Cardura XL group were: dizziness, dyspnea, asthenia, headache, hypotension, postural hypotension, and somnolence. The rates of discontinuation for adverse reactions were 6%, 7% and 3% in the Cardura XL, doxazosin IR, and placebo groups, respectively.

Table 1 lists the incidence rates of adverse reactions derived from all reported adverse events in the two controlled studies (Studies 1 and 2) combined, at a rate greater than placebo and in 1% or more of patients treated with Cardura XL.

TABLE 1 Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and Occurring in ≥1% of BPH Patients Treated with Cardura XL

Body System	Cardura XL (N = 666)	Doxazosin IR (N = 651)	Placebo (N = 156)
BODY AS A WHOLE
Abdominal Pain	1.8%	2.3%	0.6%
Asthenia	3.9%	6.9%	1.3%
Headache	6.0%	5.1%	4.5%
CARDIOVASCULAR
Hypotension	1.7%	1.8%	0.0%
Postural Hypotension	1.2%	2.2%	0.6%
DIGESTIVE
Dyspepsia	1.4%	1.2%	0.0%
Nausea	1.2%	2.3%	0.6%
MUSCULOSKELETAL
Myalgia	1.4%	0.5%	0.0%
NERVOUS
Dizziness	5.3%	9.1%	1.9%
Somnolence	1.5%	1.2%	0.0%
Vertigo	1.5%	4.1%	0.6%
RESPIRATORY
Dyspnea	1.2%	1.2%	0.0%
Respiratory Tract Infection	4.8%	4.5%	1.9%
UROGENITAL
Urinary Tract Infection	1.4%	0.8%	0.6%

Additional adverse events reported with Cardura XL, reported by less than 1% of patients, and those of clinical interest include: Cardiovascular System: angina pectoris, syncope, tachycardia, chest pain, palpitations; Digestive System: diarrhea; Musculoskeletal System: arthralgia; Nervous System: libido decreased; Urogenital System: impotence, dysuria.

In general, the adverse events reported in the open-label safety extension, in approximately 295 BPH patients treated for up to 37 weeks, were similar in type and frequency to the events described above in the controlled trials.

Postmarketing Experience

The following adverse events have been identified during post-approval use of doxazosin IR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Autonomic Nervous System: priapism; Cardiovascular System: cerebrovascular accidents, dizziness postural, myocardial infarction; Central and Peripheral Nervous System: hypoesthesia, paresthesia; Endocrine System: gynecomastia; Gastrointestinal System: vomiting; General Body System: fatigue, hot flushes, malaise; Heart Rate/Rhythm: bradycardia, cardiac arrhythmias; Hematopoietic: leukopenia, purpura, thrombocytopenia; Liver/Biliary System: abnormal liver function tests, hepatitis, hepatitis cholestatic, jaundice; Musculoskeletal System: muscle cramps, muscle weakness; Psychiatric: agitation, anorexia, nervousness; Respiratory System: bronchospasm aggravated; Skin Disorders: alopecia, urticaria, skin rash, pruritus; Special Senses: blurred vision, Intraoperative Floppy Iris Syndrome [see Warnings and Precautions (5.2)]; Urinary System: hematuria, micturition disorder, micturition frequency, nocturia, polyuria.

There have been rare reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug in this non-deformable sustained release formulation, although causal relationship to the drug is uncertain.

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Side Effects by Body System - for Healthcare Professionals

General

Doxazosin is generally well-tolerated. Side effects are usually mild to moderate in intensity and may resolve with continued therapy.

Cardiovascular

Like other alpha-blockers, doxazosin has been associated with significant decreases in total and LDL serum cholesterol and serum triglycerides. This beneficial effect on the lipid profile may be important in some patients with ischemic heart disease.

Data from ALLHAT (which led to the discontinuation of the doxazosin-treatment arm of the study) indicated that users of doxazosin had 25% more cardiovascular events and were twice as likely to be hospitalized for congestive heart failure compared to users of chlorthalidone. However, these two drugs were found to be similarly effective in preventing heart attacks and in reducing the risk of death from all causes.

Cardiovascular side effects are the most common. Dizziness has been reported in 3% to 14% of patients and is most likely to occur 2 to 6 hours after dosing. It may be minimized by administration of the drug at bedtime, particularly at the beginning of therapy. Rarely, syncope has been associated with doxazosin, and appears to be more likely in patients greater than 65 years old. Peripheral edema, palpitations, chest pain, and tachycardia have been reported in 7%, 4%, 3%, and 2% of patients, respectively.

Cerebrovascular accidents, postural dizziness, bradycardia, cardiac arrhythmias, and myocardial infarction have been reported in postmarketing studies.

Patients treated with doxazosin during the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) had a greater likelihood of developing congestive heart failure.

Ocular

Most reports were in patients treated with an alpha-1 blocker at the time IFIS occurred, but in some instances the alpha-1 blocker had been stopped prior to surgery. The manufacturer recommends that patients be questioned to determine whether or not they have taken alpha-1 blockers prior to being considered for cataract surgery. If it is determined that the patient has taken an alpha-1 blocker, the patient's ophthalmologist should be prepared for possible modifications to their surgical technique that may be necessary should IFIS be observed during the procedure.

Ocular side effects including Intraoperative Floppy Iris Syndrome (IFIS) have been observed in some patients undergoing phacoemulsification cataract surgery while being treated with alpha-1 blockers.

Blurred vision has been reported in postmarketing studies.

Nervous system

Anxiety, insomnia, and paresthesias have each been reported in 2% of patients. Dry mouth and flushing have been reported in less than 2% of patients.

Nervous system side effects have included dizziness in up to 17%, headache or fatigue/lethargy in 10% to 15%, and somnolence in 5% of patients. Hypoesthesia and paresthesia have been reported in postmarketing studies.

Respiratory

Respiratory system complaints of dyspnea and rhinitis have been reported in 3% to 4% of patients. Aggravated bronchospasm has been reported in postmarketing studies.

Gastrointestinal

Gastrointestinal side effects are unusual, and are mainly limited to nausea or diarrhea in 1% to 3% of patients.

Dyspepsia, general abdominal pain, flatulence, and constipation have each been reported in about 1% of patients.

Musculoskeletal

Musculoskeletal pain has been reported in 1% to 5% of patients. Muscle cramps and muscle weakness have been reported in postmarketing studies.

Genitourinary

Genitourinary complaints are rare. Approximately 3% of men have reported impotence and about 1% have reported urinary frequency. Hematuria, micturition disorder, micturition frequency, nocturia, polyuria, and gynecomastia have been reported in postmarketing studies. In addition, at lease one case of priapism associated with doxazosin use has been reported.

The Treatment of Mild Hypertension Study (TOMHS), a randomized, placebo-controlled, double-blind study has shown that there is a slightly and significantly higher incidence of sexual dysfunction (obtaining and maintaining erections) among male patients who were taking doxazosin for 48 months compared with placebo

Psychiatric

Psychiatric abnormalities including depression and anxiety have been reported in less than 2% of patients. Anorexia and nervousness have been reported in postmarketing studies. In addition, at least one case of psychosis associated with doxazosin use has been reported.

In a study of 23 hypertensive patients with renal insufficiency, a single case of a personality change has been associated with the use of doxazosin.

Hematologic

Hematologic abnormalities are extremely rare. Decreases in baseline white blood cell and neutrophil counts of 2.4% and 1.0%, respectively, have been reported from controlled clinical trials. Leukopenia, purpura, and thrombocytopenia have been reported in postmarketing studies.

The manufacturer has reported 4 possible doxazosin-related cases of neutropenia from a database of 2,400 patients. In cases where follow-up was available the white blood cell count and differential cell count returned to normal after drug discontinuation. No patients became symptomatic as a result of the low white blood cell or neutrophil counts.

Hypersensitivity

From a study of 1,548 patients, less than 2% reported a rash.

Hypersensitivity to doxazosin has been rarely reported.

Hepatic

Hepatic side effects including abnormal liver function tests, hepatitis, cholestatic hepatitis, and jaundice have been reported in postmarketing studies.

Dermatologic

Dermatologic side effects have included urticaria. Alopecia has been reported in postmarketing studies.

Other

Other side effects including fatigue, hot flashes, and malaise have been reported in postmarketing studies.

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