Terazosin Hydrochloride (Page 5 of 6)

Hypertension

The prevalence of adverse reactions has been ascertained from clinical trials conducted primarily in the United States. All adverse experiences (events) reported during these trials were recorded as adverse reactions. The prevalence rates presented below are based on combined data from fourteen placebo-controlled trials involving once-a-day administration of terazosin capsules, as monotherapy or in combination with other antihypertensive agents, at doses ranging from 1 to 40 mg. Table 3 summarizes those adverse experiences reported for patients in these trials where the prevalence rate in the terazosin group was at least 5%, where the prevalence rate for the terazosin group was at least 2% and was greater than the prevalence rate for the placebo group, or where the reaction is of particular interest. Asthenia, blurred vision, dizziness, nasal congestion, nausea, peripheral edema, palpitations and somnolence were the only symptoms that were significantly (p < 0.05) more common in patients receiving terazosin capsules than in patients receiving placebo. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials.

TABLE 3. Adverse Reactions During Placebo-Controlled Trials Hypertension

*
Body System	Terazosin (N = 859)	Placebo (N = 506)
BODY AS A WHOLE
*†Asthenia Back Pain Headache	11.3% * 2.4% 16.2%	4.3% 1.2% 15.8%
CARDIOVASCULAR SYSTEM
Palpitations Postural Hypotension Tachycardia	4.3% * 1.3% 1.9%	1.2% 0.4% 1.2%
DIGESTIVE SYSTEM
Nausea	4.4% *	1.4%
METABOLIC AND NUTRITIONAL DISORDERS
Edema Peripheral Edema Weight Gain	0.9% 5.5% * 0.5%	0.6% 2.4% 0.2%
MUSCULOSKELETAL SYSTEM
Pain – Extremities	3.5%	3.0%
NERVOUS SYSTEM
Depression Dizziness Libido Decreased Nervousness Paresthesia Somnolence	0.3% 19.3% * 0.6% 2.3% 2.9% 5.4% *	0.2% 7.5% 0.2% 1.8% 1.4% 2.6%
RESPIRATORY SYSTEM
Dyspnea Nasal Congestion Sinusitis	3.1% 5.9% * 2.6%	2.4% 3.4% 1.4%
SPECIAL SENSES
Blurred Vision	1.6% *	0.0%
UROGENITAL SYSTEM
Impotence	1.2%	1.4%

†Includes weakness, tiredness, lassitude, and fatigue.

*Statistically significant at p=0.05 level.

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 terazosin capsules. The following additional adverse reactions were reported by at least 1% of 1987 patients who received terazosin in controlled or open, short- or long-term clinical trials studies or have been reported during marketing experience:

Body as a Whole

Chest pain, facial edema, fever, abdominal pain, neck pain, shoulder pain.

Cardiovascular System

Arrhythmia, vasodilation.

Digestive System

Constipation, diarrhea, dry mouth, dyspepsia, flatulence, vomiting.

Metabolic/Nutritional Disorders

Gout.

Musculoskeletal System

Arthralgia, arthritis, joint disorder, myalgia.

Nervous System

Anxiety, insomnia.

Respiratory System

Bronchitis, cold symptoms, epistaxis, flu symptoms, increased cough, pharyngitis, rhinitis.

Skin and Appendages

Pruritus, rash, sweating.

Special Senses

Abnormal vision, conjunctivitis, tinnitus.

Urogenital System

Urinary frequency, urinary incontinence primarily reported in postmenopausal women, urinary tract infection.

The adverse reactions were usually mild or moderate in intensity but sometimes were serious enough to interrupt treatment. The adverse reactions that were most bothersome, as judged by their being reported as reasons for discontinuation of therapy by at least 0.5% of the terazosin group and being reported more often than in the placebo group, are shown in Table 4.

TABLE 4. Discontinuation During Placebo-Controlled Trials Hypertension

Body System	Terazosin (N = 859)	Placebo (N = 506)
BODY AS A WHOLE
Asthenia Headache	1.6% 1.3%	0.0% 1.0%
CARDIOVASCULAR SYSTEM
Palpitations Postural Hypotension Syncope Tachycardia	1.4% 0.5% 0.5% 0.6%	0.2% 0.0% 0.2% 0.0%
DIGESTIVE SYSTEM
Nausea	0.8%	0.0%
METABOLIC AND NUTRITIONAL DISORDERS
Peripheral Edema	0.6%	0.0%
NERVOUS SYSTEM
Dizziness Paresthesia Somnolence	3.1% 0.8% 0.6%	0.4% 0.2% 0.2%
RESPIRATORY SYSTEM
Dyspnea Nasal Congestion	0.9% 0.6%	0.6% 0.0%
SPECIAL SENSES
Blurred Vision	0.6%	0.0%