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Does Cardura (doxazosin) cause side effects?
Cardura (doxazosin) is an alpha-1 adrenergic blocker used to treat high blood pressure (hypertension) and symptoms of benign prostatic hyperplasia (BPH, a noncancerous enlargement of the prostate gland).
Cardura prevents norepinephrine that is released by nerves from binding to alpha-1 receptors on smooth muscle surrounding blood vessels and in the prostate and bladder. By blocking the effect of norepinephrine, Cardura relaxes the smooth muscle.
Relaxation of the smooth muscle surrounding blood vessels causes them to enlarge (dilate) and thereby reduces blood pressure. Relaxation of smooth muscle in the prostate and bladder improves the flow of urine and reduces the pain and discomfort characteristic of BPH.
Common side effects of Cardura include
- shortness of breath,
- abdominal pain,
- fluid retention (edema) and
- low blood pressure.
Cardura causes significant reduction in blood pressure after administration of the first dose. This reduction in blood pressure may be associated with dizziness and fainting, especially when rising from a sitting position.
Serious side effects of Cardura include
- priapism (painful, prolonged penile erection),
- a reduction in white blood cells, and
- intraoperative floppy iris syndrome (IFIS) during cataract surgery.
What are the important side effects of Cardura (doxazosin)?
Common side effects of doxazosin include:
- shortness of breath,
- abdominal pain,
- edema (fluid accumulation) and
- low blood pressure.
Doxazosin causes significant reduction in blood pressure after administration of the first dose (first dose effect). This reduction in blood pressure may be associated with dizziness and fainting, especially when rising from a sitting position. To avoid this, patients should rise slowly from a sitting position, start treatment with the 1 mg dose, and then doses should be adjusted upwards slowly.
Priapism (painful, prolonged penile erection) and a reduction in white blood cells have been associated with doxazosin.
Doxazosin can cause intraoperative floppy iris syndrome (IFIS) during cataract surgery. Patients should inform their eye surgeon that they are taking doxazosin.
Cardura (doxazosin) side effects list for healthcare professionals
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 practice.
Benign Prostatic Hyperplasia (BPH)
The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 2) are based on combined data from seven placebo-controlled trials involving once-daily administration of Cardura in doses of 1 to 16 mg in hypertensives and 0.5 to 8 mg in normotensives. Adverse reactions occurring more than 1% more frequently in BPH patients treated with Cardura vs placebo are summarized in Table 1.
Table 1: Adverse Reactions Occurring more than 1% More
Frequently in BPH Patients Treated with Cardura Versus Placebo
|NERVOUS SYSTEM DISORDERS|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS|
Other adverse reactions occurring less than 1% more frequently in BPH patients treated with Cardura vs placebo but plausibly related to Cardura include: palpitations.
Cardura has been administered to approximately 4000 hypertensive patients in clinical trials, of whom 1679 were included in the hypertension clinical development program. In placebo-controlled studies, adverse events occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group.
Adverse reactions occurring more than 1% more frequently in hypertensive patients treated with Cardura vs placebo are summarized in Table 1. . Postural effects and edema appeared to be dose-related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once-daily administration of doxazosin at doses ranging from 1 to 16 mg.
Table 2: Adverse Reactions
Occurring more than 1% More Frequently in Hypertensive Patients Treated with
Cardura versus Placebo
|NERVOUS SYSTEM DISORDERS|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS|
|RENAL AND URINARY DISORDERS|
|REPRODUCTIVE SYSTEM AND BREAST DISORDERS GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS|
|Fatigue / Malaise||12%||6%|
Other adverse reactions occurring less than 1% more frequently in hypertensive patients treated with Cardura vs placebo but plausibly related to Cardura use include
Cardura has been associated with decreases in white blood cell counts
Laboratory Changes Observed In Clinical Studies
Leukopenia/Neutropenia: Decreases in mean white blood cell (WBC) and mean neutrophil count were observed in controlled clinical trials of hypertensive patients receiving Cardura. In cases where follow-up was available, WBC and neutrophil counts returned to normal after discontinuation of Cardura. No patients became symptomatic as a result of the low WBC or neutrophil counts.
The following adverse reactions have been identified during post-approval use of Cardura. 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.
In post-marketing experience, the following additional adverse reactions have been reported:
- Blood and Lymphatic System Disorders: leukopenia, thrombocytopenia;
- Immune System Disorders: allergic reaction;
- Nervous System Disorders: hypoesthesia;
- Eye Disorders: Intraoperative Floppy Iris Syndrome;
- Cardiac Disorders: bradycardia;
- Respiratory, Thoracic and Mediastinal Disorders: bronchospasm aggravated;
- Gastrointestinal Disorders: vomiting;
- Hepatobiliary Disorders: cholestasis, hepatitis cholestatic;
- Skin and Subcutaneous Tissue Disorders: urticaria;
- Musculoskeletal and Connective Tissue Disorders: muscle cramps, muscle weakness;
- Renal and Urinary Disorders: hematuria, micturition disorder, micturition frequency, nocturia;
- Reproductive System and Breast Disorders: gynecomastia, priapism.
What drugs interact with Cardura (doxazosin)?
CYP 3A Inhibitors
- In vitro studies suggest that doxazosin is a substrate of CYP 3A4. Strong CYP3A inhibitors may increase exposure to doxazosin.
- Monitor blood pressure and for symptoms of hypotension when Cardura is used concomitantly with strong CYP3A inhibitors.
Phosphodiesterase-5 (PDE-5) inhibitors
Cardura (doxazosin) is an alpha-1 adrenergic blocker used to treat high blood pressure (hypertension) and symptoms of benign prostatic hyperplasia (BPH, a noncancerous enlargement of the prostate gland). Common side effects of Cardura include dizziness, fatigue, headache, shortness of breath, diarrhea, abdominal pain, fluid retention (edema) and low blood pressure. Cardura causes significant reduction in blood pressure after administration of the first dose. There are no adequate studies of Cardura in nursing mothers. Consult your doctor before breastfeeding.
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Related Disease Conditions
High Blood Pressure (Hypertension)
High blood pressure (hypertension) is a disease in which pressure within the arteries of the body is elevated. About 75 million people in the US have hypertension (1 in 3 adults), and only half of them are able to manage it. Many people do not know that they have high blood pressure because it often has no has no warning signs or symptoms. Systolic and diastolic are the two readings in which blood pressure is measured. The American College of Cardiology released new guidelines for high blood pressure in 2017. The guidelines now state that blood normal blood pressure is 120/80 mmHg. If either one of those numbers is higher, you have high blood pressure. The American Academy of Cardiology defines high blood pressure slightly differently. The AAC considers 130/80 mm Hg. or greater (either number) stage 1 hypertension. Stage 2 hypertension is considered 140/90 mm Hg. or greater. If you have high blood pressure you are at risk of developing life threatening diseases like stroke and heart attack.REFERENCE: CDC. High Blood Pressure. Updated: Nov 13, 2017.
Prostatitis vs. BPH (Enlarged Prostate): What Is the Difference?
Prostatitis and BPH (benign prostatic hyperplasia, enlarged prostate gland) are both conditions of the prostate gland. There are four types of prostatitis that can be caused by infections (usually bacterial) or other health conditions or problems, acute bacterial prostatitis (type I), chronic bacterial prostatitis (type II), chronic prostatitis and chronic pelvic pain syndrome (type III), and asymptomatic inflammatory prostatitis (type IV). BPH is inflammation of the prostate gland, and most men have the condition by age 50. Doctor's don't know what causes this inflammation, but they theorize that it may be related to hormones. Both of these conditions can cause similar symptoms like low back pain, pain during urination, or difficulty or the inability to urinate. However, prostatitis has many more symptoms and signs than BPH, and they based on the type of prostatitis. Examples include low back pain and/or abdominal pain, painful urination, fever, chills, feeling tired, recurrent urinary tract infections (UTIs), painful urination intermittently, intermittent obstruction urinary tract symptoms (frequent, painful, or incomplete urination), pelvic pain and/or discomfort, pain with ejaculation, and erectile dysfunction (ED). If you think you have either of these conditions contact your doctor or other health care professional. Bacterial prostatitis can be cured with antibiotics; however, there is no cure for BPH.
Does an Enlarged Prostate Affect a Man Sexually?
An enlarged prostate can cause sexual problems in men. Sexual problems, such as erectile dysfunction or ejaculation problems, may occur in men with noncancerous enlargement of the prostate (benign prostatic hyperplasia or BPH).
High Blood Pressure Treatment (Natural Home Remedies, Diet, Medications)
High blood pressure (hypertension) means high pressure (tension) in the arteries. Treatment for high blood pressure include lifestyle modifications (alcohol, smoking, coffee, salt, diet, exercise), drugs and medications such as ACE inhibitors, angiotensin receptor blockers, beta blockers, diuretics, calcium channel blockers (CCBs), alpha blockers, clonidine, minoxidil, and Exforge.
Enlarged Prostate (BPH, Benign Prostatic Hyperplasia)
Benign prostatic hyperplasia (BPH or enlarged prostate) is very common in men over 50 years of age. Half of all men over the age of 50 develop symptoms of BPH, but few need medical treatment. This noncancerous enlargement of the prostate can impede urine flow, slow the flow of urine, create the urge to urinate frequently and cause other symptoms like complete blockage of urine and urinary tract infections. More serious symptoms are urinary tract infections (UTIs) and complete blockage of the urethra, which may be a medical emergency. BPH is not cancer. Not all men with the condition need treatment, and usually is closely monitored if no symptoms are present. Treatment measures usually are reserved for men with significant symptoms, and can include medications, surgery, microwave therapy, and laser procedures. Men can prevent prostate problems by having regular medical checkups that include a prostate exam.
High Blood Pressure Symptoms
Most people with high blood pressure have no signs or symptoms, even if blood pressure readings reach dangerously high levels. In some patients, symptoms may include fatigue, headaches, dizziness, confusion, sweating, chest pain and vision problems.
What Is High Blood Pressure (Hypertension)?
High blood pressure or hypertension is when the blood pressure readings consistently range from 140 or higher for systolic or 90 or higher for diastolic. Blood pressure readings above 180/120 mmHg are dangerously high and require immediate medical attention.
Treatment & Diagnosis
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Medications & Supplements
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.