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Cardura XL

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Cardura XL

Cardura XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cardura XL (doxazosin mesylate) Extended Release Tablets alpha-adrenergic blocker used to treat hypertension (high blood pressure) or to improve urination in men with benign prostatic hyperplasia (enlarged prostate). Common side effects include dizziness, headache, drowsiness, stomach upset/pain, or decreased sexual ability/interest.

The initial dose of Cardura XL is 4 mg given once daily, taken with breakfast. The maximum recommended dose is 8 mg. Cardura XL may interact with sildenafil, tadalafil, vardenafil, or other blood pressure medications, including diuretics. Tell your doctor all medications and supplements you use. During pregnancy, Cardura XL should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Cardura XL (doxazosin mesylate) Extended Release Tablets 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 XL 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 XL (Doxazosin Mesylate Extended Release Tablets) »

What is Patient Information Overview?

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

Cardura XL Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, lightheadedness, or drowsiness 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.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

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, 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 XL (Doxazosin Mesylate Extended Release Tablets)»

What is Prescribing information?

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

Cardura XL FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The incidence of adverse events was derived from two controlled efficacy and safety trials involving 1473 BPH patients. In Study 1, CARDURA XL (doxazosin mesylate extended release tablets) (n=317) was compared to doxazosin IR tablets (n=322) and to placebo (n=156). In Study 2, CARDURA XL (doxazosin mesylate extended release tablets) (n=350) was compared just to doxazosin IR tablets (n=330). In both these studies, CARDURA XL (doxazosin mesylate extended release tablets) 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 PHARMACOLOGY; Clinical Studies). 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.

In these two studies, 6% of patients receiving CARDURA XL (doxazosin mesylate extended release tablets) withdrew from the study due to adverse events, compared to 7% receiving doxazosin IR, and 3% receiving placebo. The most commonly reported adverse events leading to discontinuation in the CARDURA XL (doxazosin mesylate extended release tablets) group were: dizziness, dyspnea, asthenia, headache, hypotension, postural hypotension, and somnolence.

The incidence rates presented below (Table 4) are based on combined data from the two controlled studies (Studies 1 and 2). Adverse events with an incidence in the CARDURA XL (doxazosin mesylate extended release tablets) group of at least 1% and reported more frequently than with placebo are summarized in Table 4.

TABLE 4 :Treatment-Emergent Adverse Events Occurring in ≥ 1% of BPH Patients Treated with CARDURA XL (doxazosin mesylate extended release tablets) and Reported More Frequently Than with Placebo in the Two Controlled Clinical Studies

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%
  Back Pain 2.9% 1.7% 2.6%
  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 (doxazosin mesylate extended release tablets) at an incidence of less than 1% 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. Of these, the following events were reported more frequently with CARDURA XL (doxazosin mesylate extended release tablets) than with placebo: syncope, tachycardia, palpitations, and 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 13-week controlled trials.

In post-marketing experience, the following additional adverse reactions have been reported with doxazosin IR: 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; Special Senses: blurred vision, Intraoperative Floppy Iris Syndrome (see PRECAUTIONS, Cataract Surgery); 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.

Read the entire FDA prescribing information for Cardura XL (Doxazosin Mesylate Extended Release Tablets) »

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Cardura XL - User Reviews

Cardura XL 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 XL 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.


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