Label Changes for:

Uroxatral (alfuzosin HCl extended release tablets)

May 2009

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- May 2009

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.

ADVERSE EVENTS

Postmarketing Experience

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