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Uroxatral

Last reviewed on RxList: 1/18/2017
Uroxatral Side Effects Center

Last reviewed on RxList 10/6/2016

Uroxatral (alfuzosin hcl) is an alpha blocker prescribed to treat symptoms of an enlarged prostate (benign prostatic hyperplasia), which include painful or difficult urination, urination urgency or frequency. Uroxatral is available in generic form. Common side effects of Uroxatral include:

Get medical help right away if you have very serious side effects of Uroxatral including:

  • severe dizziness,
  • fainting,
  • fast/irregular heartbeat, or
  • chest pain.

Uroxatral is available as an extended-release 10 mg tablet, taken orally once daily. Uroxatral may interact with alcohol, atenolol, arsenic trioxide, cimetidine, conivaptan, diltiazem, droperidol, enoxacin, imatinib, isoniazid, antibiotics, antidepressants, antifungals, anti-malaria medications, nitrate heart medications, heart or blood pressure medications, heart rhythm medicines, HIV/AIDS medicines, medicines to prevent or treat nausea and vomiting, medicines to treat psychiatric disorders migraine headache medicines, or narcotics. Tell your doctor all medications and supplements you use. Uroxatral is not indicated for use in women. Do not crush, chew, or split the extended-release tablets as this will release the whole drug at once, increasing the risk of side effects.

Our Uroxatral 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.

Uroxatral 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.

Stop using alfuzosin and call your doctor at once if you have a serious side effect such as:

  • new or worsening chest pain;
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • feeling like you might pass out; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • headache;
  • tired feeling; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

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 Uroxatral (Alfuzosin HCl)

Uroxatral 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 has been ascertained from 3 placebo-controlled clinical trials involving 1,608 men where daily doses of 10 and 15 mg alfuzosin were evaluated. In these 3 trials, 473 men received UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets. In these trials, 4% of patients taking UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets withdrew from the trial due to adverse reactions, compared with 3% in the placebo group.

Table 1 summarizes adverse reactions that occurred in ≥2% of patients receiving UROXATRAL, and at a higher incidence than that of the placebo group. In general, the adverse reactions seen in long-term use were similar in type and frequency to the events described below for the 3-month trials.

Table 1 : Adverse Reactions Occurring in ≥2% of UROXATRAL-Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Trials

Adverse Reaction Placebo
(n=678)
UROXATRAL
(n=473)
Dizziness 19 (2.8%) 27 (5.7%)
Upper respiratory tract infection 4 (0.6%) 14 (3.0%)
Headache 12 (1.8%) 14 (3.0%)
Fatigue 12 (1.8%) 13 (2.7%)

The following adverse reactions, reported by between 1% and 2% of patients receiving UROXATRAL and occurring more frequently than with placebo, are listed alphabetically by body system and by decreasing frequency within body system:

Body as a whole: pain

Gastrointestinal system: abdominal pain, dyspepsia, constipation, nausea

Reproductive system: impotence

Respiratory system: bronchitis, sinusitis, pharyngitis

Signs and Symptoms of Orthostasis in Clinical Trials: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 trials with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these trials were taking antihypertensive medication.

Table 2: Number (%) of Patients with Symptoms Possibly Associated with Orthostasis in 3-Month Placebo-Controlled Clinical Trials

Symptoms Placebo
(n=678)
UROXATRAL
(n=473)
Dizziness 19 (2.8%) 27 (5.7%)
Hypotension or postural hypotension 0 2 (0.4%)
Syncope 0 1 (0.2%)

Testing for blood pressure changes or orthostatic hypotension was conducted in three controlled studies. Decreased systolic blood pressure (≤90 mm Hg, with a decrease ≥20 mm Hg from baseline) was observed in none of the 674 placebo patients and 1 (0.2%) of the 469 UROXATRAL patients. Decreased diastolic blood pressure (≤50 mm Hg, with a decrease ≥15 mm Hg from baseline) was observed in 3 (0.4%) of the placebo patients and in 4 (0.9%) of the UROXATRAL patients. A positive orthostatic test (decrease in systolic blood pressure of ≥20 mm Hg upon standing from the supine position) was seen in 52 (7.7%) of placebo patients and in 31 (6.6%) of the UROXATRAL patients.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of UROXATRAL. 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.

General disorders: edema

Cardiac disorders: tachycardia, chest pain, angina pectoris in patients with pre-existing coronary artery disease, atrial fibrillation

Gastrointestinal disorders: diarrhea

Hepatobiliary disorders: hepatocellular and cholestatic liver injury (including cases with jaundice leading to drug discontinuation)

Respiratory system disorders: rhinitis

Reproductive system disorders: priapism

Skin and subcutaneous tissue disorders: rash, pruritis, urticaria, angioedema, toxic epidermal necrolysis

Vascular disorders: flushing

Blood and lymphatic system disorders: thrombocytopenia

During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in some patients on or previously treated with alpha adrenergic antagonists [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Uroxatral (Alfuzosin HCl)

Related Resources for Uroxatral

Read the Uroxatral User Reviews »

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

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