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Cardura XL (Doxazosin Mesylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The incidence of adverse events 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 these studies, CARDURA XL was initiated at a dose of 4mg, which could be increased by the investigator to 8mg after seven weeks if an adequate response was not seen (see Clinical Pharmacology; Clinical Studies). Similarly, doxazosin IR was begun at a dose of 1mg, which was increased in all patients to 2mg after 1 week, followed by the option to increase to 4mg after 4 weeks, and 8mg after 7 weeks.

In these two studies, 6% of patients receiving CARDURA XL 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 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 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 and More Frequently Than with Placebo in the Two Controlled Clinical Studies
Body SystemCARDURA XL
(N = 666)
Doxazosin IR
(N = 651)
Placebo
(N = 156)
BODY AS A WHOLE
  Abdominal Pain1.8%2.3%0.6%
  Astdenia3.9%6.9%1.3%
  Back Pain2.9%1.7%2.6%
  Headache6.0%5.1%4.5%
CARDIOVASCULAR
  Hypotension1.7%1.8%0.0%
  Postural Hypotension1.2%2.2%0.6%
DIGESTIVE
  Dyspepsia1.4%1.2%0.0%
  Nausea1.2%2.3%0.6%
MUSCULOSKELETAL
  Myalgia1.4%0.5%0.0%
NERVOUS
  Dizziness5.3%9.1%1.9%
  Somnolence1.5%1.2%0.0%
  Vertigo1.5%4.1%0.6%
RESPIRATORY
  Dyspnea1.2%1.2%0.0%
  Respiratory Tract Infection4.8%4.5%1.9%
UROGENITAL
  Urinary Tract Infection1.4%0.8%0.6%

Additional adverse events reported with CARDURA XL 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; Musculo-skeletal System: arthralgia; Nervous System: libido decreased; Urogenital System: impotence; dysuria. Of these, the following events were reported more frequently with CARDURA XL 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; 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.

Drug label data at the top of this Page last updated: 2006-01-04

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