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Cardura

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Cardura

Cardura Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Cardura (doxazosin) is a medication belonging to the drug class alpha-1 adrenergic blockers. Cardura is available as a generic drug. Cardura is prescribed for treating high blood pressure, and symptoms associated with 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, edema (fluid accumulation), and low blood pressure.

Cardura dosage ranges from 1-16 mg daily depending on the indication. Drug interactions include vardenafil (Levitra) or tadalafil (Cialis). Cardura causes significant reduction in blood pressure after taking the first dose and this may cause dizziness and fainting, particularly when rising from a sitting position. Cardura has not been sufficiently studied in pregnant women and nursing mothers.

Our Cardura Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cardura in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • fast or pounding heartbeats, fluttering in your chest;
  • trouble breathing;
  • swelling in your hands, ankles, or feet; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • tired feeling, drowsiness;
  • headache;
  • nausea; or
  • runny nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cardura (Doxazosin Mesylate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Cardura Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, drowsiness, unusual tiredness, or weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, shortness of breath, weakness, swelling of hands/feet, yellowing eyes/skin, dark urine, easy bleeding/bruising, fever, persistent sore throat.

Get medical help right away if you have any very serious side effects, including: vision changes, chest pain, jaw/left arm pain, weakness on one side of the body, slurred speech, confusion.

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Cardura (Doxazosin Mesylate)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cardura FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 3) are based on combined data from seven placebo-controlled trials involving once-daily administration of CARDURA in doses of 1-16 mg in hypertensives and 0.5-8 mg in normotensives. The adverse events when the incidence in the CARDURA group was at least 1% are summarized in Table 3. No significant difference in the incidence of adverse events compared to placebo was seen except for dizziness, fatigue, hypotension, edema, and dyspnea. Dizziness and dyspnea appeared to be dose-related.

TABLE 3 : ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES BENIGN PROSTATIC HYPERPLASIA

Body System (N=665) (N=300)
BODY AS A WHOLE
  Back Pain 1.80% 2.00%
  Chest Pain 1.20% 0.70%
  Fatigue 8.0%* 1.70%
  Headache 9.90% 9.00%
  Influenza-like Symptoms 1.10% 1.00%
  Pain 2.00% 1.00%
CARDIOVASCULAR SYSTEM
  Hypotension 1.7%* 0.00%
  Palpitation 1.20% 0.30%
DIGESTIVE SYSTEM
  Abdominal Pain 2.40% 2.00%
  Diarrhea 2.30% 2.00%
  Dyspepsia 1.70% 1.70%
  Nausea 1.50% 0.70%
METABOLIC AND NUTRITIONAL DISORDERS
  Edema 2.7%* 0.70%
NERVOUS SYSTEM
  Dizziness† 15.6%* 9.00%
  Mouth Dry 1.40% 0.30%
  Somnolence 3.00% 1.00%
RESPIRATORY SYSTEM
  Dyspnea 2.6%* 0.30%
  Respiratory Disorder 1.10% 0.70%
SPECIAL SENSES
  Vision Abnormal 1.40% 0.70%
UROGENITAL SYSTEM
  Impotence 1.10% 1.00%
  Urinary Tract Infection 1.40% 2.30%
SKIN & APPENDAGES
  Sweating Increased 1.10% 1.00%
PSYCHIATRIC DISORDERS
  Anxiety 1.10% 0.30%
  Insomnia 1.20% 0.30%
*p ≤ 0.05 for treatment differences
†Includes vertigo

In these placebo-controlled studies of 665 CARDURA patients treated for a mean of 85 days, additional adverse reactions have been reported. These are less than 1% and not distinguishable from those that occurred in the placebo group. Adverse reactions with an incidence of less than 1% but of clinical interest are (CARDURA vs. placebo): Cardiovascular System: angina pectoris (0.6% vs. 0.7%), postural hypotension (0.3% vs. 0.3%), syncope (0.5% vs. 0.0%), tachycardia (0.9% vs. 0.0%); Urogenital System: dysuria (0.5% vs. 1.3%); and Psychiatric Disorders: libido decreased (0.8% vs. 0.3%). The safety profile in patients treated for up to three years was similar to that in the placebo-controlled studies.

The majority of adverse experiences with CARDURA were mild.

Hypertension

CARDURA has been administered to approximately 4000 hypertensive patients, of whom 1679 were included in the hypertension clinical development program. In that program, minor adverse effects were frequent, but led to discontinuation of treatment in only 7% of patients. In placebo-controlled studies, adverse effects 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. The major reasons for discontinuation were postural effects (2%), edema, malaise/fatigue, and some heart rate disturbance, each about 0.7%.

In controlled hypertension clinical trials directly comparing CARDURA to placebo, there was no significant difference in the incidence of side effects, except for dizziness (including postural), weight gain, somnolence, and fatigue/malaise. 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 1-16 mg. Table 4 summarizes those adverse experiences (possibly/probably related) reported for patients in these hypertension studies where the prevalence rate in the doxazosin group was at least 0.5% or where the reaction is of particular interest.

TABLE 4 : ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES

  HYPERTENSION DOXAZOSIN
(N=339)
PLACEBO
(N=336)
CARDIOVASCULAR SYSTEM
  Dizziness 19% 9%
  Vertigo 2% 1%
  Postural Hypotension 0.30% 0%
  Edema 4% 3%
  Palpitation 2% 3%
  Arrhythmia 1% 0%
  Hypotension 1% 0%
  Tachycardia 0.30% 1%
  Peripheral Ischemia 0.30% 0%
SKIN & APPENDAGES
  Rash 1% 1%
  Pruritus 1% 1%
MUSCULOSKELETAL SYSTEM
  Arthralgia/Arthritis 1% 0%
  Muscle Weakness 1% 0%
  Myalgia 1% 0%
CENTRAL & PERIPHERAL N.S.
  Headache 14% 16%
  Paresthesia 1% 1%
  Kinetic Disorders 1% 0%
  Ataxia 1% 0%
  Hypertonia 1% 0%
  Muscle Cramps 1% 0%
AUTONOMIC
  Mouth Dry 2% 2%
  Flushing 1% 0%
SPECIAL SENSES
  Vision Abnormal 2% 1%
  Conjunctivitis/Eye Pain 1% 1%
  Tinnitus 1% 0.30%
PSYCHIATRIC
  Somnolence 5% 1%
  Nervousness 2% 2%
  Depression 1% 1%
  Insomnia 1% 1%
  Sexual Dysfunction 2% 1%
CARDIOVASCULAR SYSTEM
  Dizziness 19% 9%
  Vertigo 2% 1%
  Postural Hypotension 0.30% 0%
  Edema 4% 3%
  Palpitation 2% 3%
  Arrhythmia 1% 0%
  Hypotension 1% 0%
  Tachycardia 0.30% 1%
  Peripheral Ischemia 0.30% 0%
SKIN & APPENDAGES  
  Rash 1% 1%
  Pruritus 1% 1%
MUSCULOSKELETAL SYSTEM
  Arthralgia/Arthritis 1% 0%
  Muscle Weakness 1% 0%
  Myalgia 1% 0%
CENTRAL & PERIPHERAL N.S.
  Headache 14% 16%
  Paresthesia 1% 1%
  Kinetic Disorders 1% 0%
  Ataxia 1% 0%
  Hypertonia 1% 0%
  Muscle Cramps 1% 0%
AUTONOMIC
  Mouth Dry 2% 2%
  Flushing 1% 0%
SPECIAL SENSES
  Vision Abnormal 2% 1%
  Conjunctivitis/Eye Pain 1% 1%
  Tinnitus 1% 0.30%
PSYCHIATRIC
  Somnolence 5% 1%
  Nervousness 2% 2%
  Depression 1% 1%
  Insomnia 1% 1%
  Sexual Dysfunction 2% 1%

Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin. The following adverse reactions occurred with a frequency of between 0.5% and 1%: syncope, hypoesthesia, increased sweating, agitation, increased weight. The following additional adverse reactions were reported by < 0.5% of 3960 patients who received doxazosin in controlled or open, short-or long-term clinical studies, including international studies. Cardiovascular System: angina pectoris, myocardial infarction, cerebrovascular accident; Autonomic Nervous System: pallor; Metabolic: thirst, gout, hypokalemia; Hematopoietic: lymphadenopathy, purpura; Reproductive System: breast pain; Skin Disorders: alopecia, dry skin, eczema; Central Nervous System: paresis, tremor, twitching, confusion, migraine, impaired concentration; Psychiatric: paroniria, amnesia, emotional lability, abnormal thinking, depersonalization; Special Senses: parosmia, earache, taste perversion, photophobia, abnormal lacrimation; Gastrointestinal System: increased appetite, anorexia, fecal incontinence, gastroenteritis; Respiratory System: bronchospasm, sinusitis, coughing, pharyngitis; Urinary System: renal calculus; General Body System: hot flushes, back pain, infection, fever/rigors, decreased weight, influenza-like symptoms.

CARDURA has not been associated with any clinically significant changes in routine biochemical tests. No clinically relevant adverse effects were noted on serum potassium, serum glucose, uric acid, blood urea nitrogen, creatinine or liver function tests. CARDURA has been associated with decreases in white blood cell counts (see PRECAUTIONS, Leukopenia/Neutropenia).

In post-marketing experience, the following additional adverse reactions have been reported: Autonomic Nervous System: priapism; Central Nervous System: hypoesthesia; Endocrine System: gynecomastia; Gastrointestinal System: vomiting; General Body System: allergic reaction; Heart Rate/Rhythm: bradycardia; Hematopoietic: leukopenia, thrombocytopenia; Liver/Biliary System: hepatitis, hepatitis cholestatic; Respiratory System: bronchospasm aggravated; Skin Disorders: urticaria; Special Senses: Intraoperative Floppy Iris Syndrome (see PRECAUTIONS, Cataract Surgery); Urinary System: hematuria, micturition disorder, micturition frequency, nocturia.

Read the entire FDA prescribing information for Cardura (Doxazosin Mesylate) »

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Cardura - User Reviews

Cardura User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Cardura sorted by most helpful. Patient Discussions FAQs

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.


Hypertension

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