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Uroxatral

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Uroxatral

Uroxatral

Uroxatral Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Uroxatral (alfuzosin hcl) is prescribed to treat symptoms of an enlarged prostate (benign prostatic hyperplasia), which include painful or difficult urination, urination urgency or frequency. It is in a class of medications called alpha blockers. This medication is available in generic form. Common side effects include dizziness, headache and fatigue. Other side effects may occur.

Uroxatral is available as an extended-release 10 mg tablet, taken orally once daily. Tell your doctor if you are taking other alpha blockers, nitrates, antihypertensive medications, antifungals, or drugs to treat erectile dysfunction as adverse reactions may occur. 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.

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.

Uroxatral 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.

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) »

What is Patient Information Overview?

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

Uroxatral Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness/lightheadedness, headache, or decreased sexual ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 immediately if any of these unlikely but serious side effects occur: unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, persistent nausea/vomiting, dark urine.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat, chest pain.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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 Uroxatral (Alfuzosin HCl)»

What is Prescribing information?

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

Uroxatral FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The incidence of treatment-emergent adverse events 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 studies, 4% of patients taking UROXATRAL (alfuzosin HCl) 10 mg extended-release tablets withdrew from the study due to adverse events, compared with 3% in the placebo group.

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

Table 1 - Treatment-Emergent Adverse Events Occurring in ≥ 2% of UROXATRAL (alfuzosin hcl) -Treated Patients and More Frequently than with Placebo in 3-Month Placebo-Controlled Clinical Studies

Adverse Event 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 events, reported by between 1% and 2% of patients receiving

UROXATRAL (alfuzosin hcl) 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 Studies: The adverse reactions related to orthostasis that occurred in the double-blind phase 3 studies with alfuzosin 10 mg are summarized in Table 2. Approximately 20% to 30% of patients in these studies were taking antihypertensive medication.

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

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 (alfuzosin hcl) 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 (alfuzosin hcl) 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 (alfuzosin hcl) patients.

Post-Marketing Experience

The following adverse reactions have been identified during post approval use of UROXATRAL (alfuzosin hcl) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.

General disorders: edema

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

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

Vascular disorders: flushing

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-1 blockers [see WARNINGS AND PRECAUTIONS].

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

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Uroxatral - User Reviews

Uroxatral 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 Uroxatral 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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