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Cardura (Doxazosin Mesylate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

A. Benign Prostatic Hyperplasia

The incidence of adverse events has been ascertained from worldwide clinical trials in 965 BPH patients. The incidence rates presented below (Table 3) are based on combined data from seven placebo-controlled trials involving once-daily administration of CARDURA (doxazosin mesylate) in doses of 1–16 mg in hypertensives and 0.5–8 mg in normotensives. The adverse events when the incidence in the CARDURA group was at least 1% are summarized in Table 3. No significant difference in the incidence of adverse events compared to placebo was seen except for dizziness, fatigue, hypotension, edema and dyspnea. Dizziness and dyspnea appeared to be dose-related.

TABLE 3
ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES
BENIGN PROSTATIC HYPERPLASIA
CARDURAPLACEBO
Body System(N=665)(N=300)
BODY AS A WHOLE
Back Pain1.8%2.0%
Chest Pain1.2%0.7%
Fatigue  8.0% 1 1.7%
Headache9.9%9.0%
Influenza-like Symptoms1.1%1.0%
Pain2.0%1.0%
CARDIOVASCULAR SYSTEM
Hypotension1.7%0.0%
Palpitation1.2%0.3%
DIGESTIVE SYSTEM
Abdominal Pain2.4%2.0%
Diarrhea2.3%2.0%
Dyspepsia1.7%1.7%
Nausea1.5%0.7%
METABOLIC AND NUTRITIONAL DISORDERS
Edema2.7%0.7%
NERVOUS SYSTEM
DizzinessIncludes vertigo15.6%9.0%
Mouth Dry1.4%0.3%
Somnolence3.0%1.0%
RESPIRATORY SYSTEM
Dyspnea 2.6%0.3%
Respiratory Disorder1.1%0.7%
SPECIAL SENSES
Vision Abnormal1.4%0.7%
UROGENITAL SYSTEM
Impotence1.1%1.0%
Urinary Tract Infection1.4%2.3%
SKIN & APPENDAGES
Sweating Increased1.1%1.0%
PSYCHIATRIC DISORDERS
Anxiety1.1%0.3%
Insomnia1.2%0.3%

1 p ≤0.05 for treatment differences

In these placebo-controlled studies of 665 CARDURA patients treated for a mean of 85 days, additional adverse reactions have been reported. These are less than 1% and not distinguishable from those that occurred in the placebo group. Adverse reactions with an incidence of less than 1% but of clinical interest are (CARDURA vs. placebo): Cardiovascular System: angina pectoris (0.6% vs. 0.7%), postural hypotension (0.3% vs. 0.3%), syncope (0.5% vs. 0.0%), tachycardia (0.9% vs. 0.0%); Urogenital System: dysuria (0.5% vs. 1.3%), and Psychiatric Disorders: libido decreased (0.8% vs. 0.3%). The safety profile in patients treated for up to three years was similar to that in the placebo-controlled studies.

The majority of adverse experiences with CARDURA were mild.

B. Hypertension

CARDURA has been administered to approximately 4000 hypertensive patients, of whom 1679 were included in the hypertension clinical development program. In that program, minor adverse effects were frequent, but led to discontinuation of treatment in only 7% of patients. In placebo-controlled studies adverse effects occurred in 49% and 40% of patients in the doxazosin and placebo groups, respectively, and led to discontinuation in 2% of patients in each group. The major reasons for discontinuation were postural effects (2%), edema, malaise/fatigue, and some heart rate disturbance, each about 0.7%.

In controlled hypertension clinical trials directly comparing CARDURA to placebo, there was no significant difference in the incidence of side effects, except for dizziness (including postural), weight gain, somnolence and fatigue/malaise. Postural effects and edema appeared to be dose-related. The prevalence rates presented below are based on combined data from placebo-controlled studies involving once-daily administration of doxazosin at doses ranging from 1–16 mg. Table 4 summarizes those adverse experiences (possibly/probably related) reported for patients in these hypertension studies where the prevalence rate in the doxazosin group was at least 0.5% or where the reaction is of particular interest.

TABLE 4
ADVERSE REACTIONS DURING PLACEBO-CONTROLLED STUDIES
HYPERTENSION
DOXAZOSINPLACEBO
(N=339)(N=336)
CARDIOVASCULAR SYSTEM
  Dizziness19%9%
  Vertigo2%1%
  Postural Hypotension0.3%0%
  Edema4%3%
  Palpitation2%3%
  Arrhythmia1%0%
  Hypotension1%0%
  Tachycardia0.3%1%
  Peripheral Ischemia0.3%0%
SKIN & APPENDAGES
  Rash1%1%
  Pruritus1%1%
MUSCULOSKELETAL SYSTEM
  Arthralgia/Arthritis1%0%
  Muscle Weakness1%0%
  Myalgia1%0%
CENTRAL & PERIPHERAL N.S.
  Headache14%16%
  Paresthesia1%1%
  Kinetic Disorders1%0%
  Ataxia1%0%
  Hypertonia1%0%
  Muscle Cramps1%0%
AUTONOMIC
  Mouth Dry2%2%
  Flushing1%0%
SPECIAL SENSES
  Vision Abnormal2%1%
  Conjunctivitis/Eye Pain1%1%
  Tinnitus1%0.3%
PSYCHIATRIC
  Somnolence5%1%
  Nervousness2%2%
  Depression1%1%
  Insomnia1%1%
  Sexual Dysfunction2%1%
GASTROINTESTINAL
  Nausea3%4%
  Diarrhea2%3%
  Constipation1%1%
  Dyspepsia1%1%
  Flatulence1%1%
  Abdominal Pain0%2%
  Vomiting0%1%
RESPIRATORY
  Rhinitis3%1%
  Dyspnea1%1%
  Epistaxis1%0%
URINARY
  Polyuria2%0%
  Urinary Incontinence1%0%
  Micturition Frequency0%2%
GENERAL
  Fatigue/Malaise12%6%
  Chest Pain2%2%
  Asthenia1%1%
  Face Edema1%0%
  Pain2%2%

Additional adverse reactions have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to doxazosin. The following adverse reactions occurred with a frequency of between 0.5% and 1%: syncope, hypoesthesia, increased sweating, agitation, increased weight. The following additional adverse reactions were reported by <0.5% of 3960 patients who received doxazosin in controlled or open, short- or long-term clinical studies, including international studies. Cardiovascular System: angina pectoris, myocardial infarction, cerebrovascular accident; Autonomic Nervous System: pallor; Metabolic: thirst, gout, hypokalemia; Hematopoietic: lymphadenopathy, purpura; Reproductive System: breast pain; Skin Disorders: alopecia, dry skin, eczema; Central Nervous System: paresis, tremor, twitching, confusion, migraine, impaired concentration; Psychiatric: paroniria, amnesia, emotional lability, abnormal thinking, depersonalization; Special Senses: parosmia, earache, taste perversion, photophobia, abnormal lacrimation; Gastrointestinal System: increased appetite, anorexia, fecal incontinence, gastroenteritis; Respiratory System: bronchospasm, sinusitis, coughing, pharyngitis; Urinary System: renal calculus; General Body System: hot flushes, back pain, infection, fever/rigors, decreased weight, influenza-like symptoms.

CARDURA has not been associated with any clinically significant changes in routine biochemical tests. No clinically relevant adverse effects were noted on serum potassium, serum glucose, uric acid, blood urea nitrogen, creatinine or liver function tests. CARDURA has been associated with decreases in white blood cell counts (see PRECAUTIONS).

In post-marketing experience the following additional adverse reactions have been reported: Autonomic Nervous System: priapism; Central Nervous System: hypoesthesia; Endocrine System: gynecomastia; Gastrointestinal System: vomiting; General Body System: allergic reaction; Heart Rate/Rhythm: bradycardia; Hematopoietic: leukopenia, thrombocytopenia; Liver/Biliary System: hepatitis, hepatitis cholestatic; Respiratory System: bronchospasm aggravated; Skin Disorders: urticaria; Special Senses: Intraoperative Floppy Iris Syndrome (see PRECAUTIONS, Cataract Surgery); Urinary System: hematuria, micturition disorder, micturition frequency, nocturia.



REPORTS OF SUSPECTED CARDURA SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cardura. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cardura side effects / adverse reactions in 76 year old male

Reported by a pharmacist from Italy on 2011-10-11

Patient: 76 year old male

Reactions: Syncope, Joint Injury, Face Injury

Adverse event resulted in: hospitalization

Suspect drug(s):
Valsartan and Hydrochlorothiazide
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2011-05-22

Cardura
    Dosage: 4 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01
    End date: 2011-05-22

Other drugs received by patient: Allopurinol



Possible Cardura side effects / adverse reactions in 70 year old male

Reported by a consumer/non-health professional from Colombia on 2011-10-13

Patient: 70 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Cardura



Possible Cardura side effects / adverse reactions in 76 year old male

Reported by a pharmacist from Italy on 2011-10-13

Patient: 76 year old male

Reactions: Syncope, Joint Injury, Face Injury

Adverse event resulted in: hospitalization

Suspect drug(s):
Cardura
    Dosage: 4 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2008-01-01

Valsartan and Hydrochlorothiazide
    Dosage: 1 df, daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01

Other drugs received by patient: Allopurinol



See index of all Cardura side effect reports >>

Drug label data at the top of this Page last updated: 2008-05-30

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