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Cardura XL

Last reviewed on RxList: 3/9/2017
Cardura XL Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 03/08/2017

Cardura XL (doxazosin mesylate) Extended Release Tablets is an 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 of Cardura XL include:

  • dizziness,
  • lightheadedness,
  • headache,
  • tired feeling,
  • drowsiness,
  • stomach upset or pain,
  • nausea,
  • runny nose,
  • decreased sexual ability or interest, or
  • an empty tablet shell in your stool (this is harmless).

Tell your doctor if you have any serious side effects Cardura XL including:

  • fainting,
  • shortness of breath,
  • weakness,
  • yellowing eyes or skin,
  • dark urine,
  • easy bleeding or bruising,
  • fever, or
  • persistent sore throat.

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.

Cardura XL Consumer Information

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)

Cardura XL Professional Information

SIDE EFFECTS

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]. 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. 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: gastrointestinal obstruction, 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]; 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)

Related Resources for Cardura XL

Read the Cardura XL User Reviews »

© Cardura XL Patient Information is supplied by Cerner Multum, Inc. and Cardura XL Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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