Terazosin (Page 3 of 5)

ADVERSE REACTIONS

Benign Prostatic Hyperplasia

The incidence of treatment-emergent adverse events has been ascertained from clinical trials conducted worldwide. All adverse events reported during these trials were recorded as adverse reactions. The incidence rates presented below are based on combined data from six placebo-controlled trials involving once-a-day administration of terazosin at doses ranging from 1 to 20 mg. Table 1 summarizes those adverse events reported for patients in these trials when the incidence rate in the terazosin group was at least 1%, and was greater than that for the placebo group, or where the reaction is of clinical interest. Asthenia, postural hypotension, dizziness, somnolence, nasal congestion/rhinitis, and impotence were the only events that were significantly (p ≤ 0.05) more common in patients receiving terazosin than in patients receiving placebo. The incidence of urinary tract infection was significantly lower in the patients receiving terazosin than in patients receiving placebo. An analysis of the incidence rate of hypotensive adverse events (see PRECAUTIONS) adjusted for the length of drug treatment has shown that the risk of the events is greatest during the initial seven days of treatment, but continues at all time intervals.

TABLE 1. Adverse Reactions During Placebo-Controlled Trials Benign Prostatic Hyperplasia

*
Includes weakness, tiredness, lassitude, and fatigue.

p ≤ 0.05 comparison between groups.

Body System

Terazosin

(N = 636)

Placebo

(N = 360)

BODY AS A WHOLE

*Asthenia

Flu Syndrome

Headache

7.4%†

2.4%

4.9%

3.3%

1.7%

5.8%

CARDIOVASCULAR SYSTEM

Hypotension

Palpitations

Postural Hypotension

Syncope

0.6%

0.9%

3.9%†

0.6%

0.6%

1.1%

0.8%

0.0%

DIGESTIVE SYSTEM

Nausea 1.7% 1.1%

METABOLIC AND NUTRITIONAL DISORDERS

Peripheral Edema

Weight Gain

0.9%

0.5%

0.3%

0.0%

NERVOUS SYSTEM

Dizziness

Somnolence

Vertigo

9.1%†

3.6%†

1.4%

4.2%

1.9%

0.3%

RESPIRATORY SYSTEM

Dyspnea

Nasal Congestion/Rhinitis

1.7%

1.9%†

0.8%

0.0%

SPECIAL SENSES

Blurred Vision/Amblyopia 1.3% 0.6%

UROGENITAL SYSTEM

Impotence

Urinary Tract Infection

1.6%†

1.3%

0.6%

3.9%†

Additional adverse events have been reported, but these are, in general, not distinguishable from symptoms that might have occurred in the absence of exposure to terazosin. The safety profile of patients treated in the long-term open-label study was similar to that observed in the controlled studies.

The adverse events were usually transient and mild or moderate in intensity, but sometimes were serious enough to interrupt treatment. In the placebo-controlled clinical trials, the rates of premature termination due to adverse events were not statistically different between the placebo and terazosin groups. The adverse events that were 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 2.

TABLE 2. Discontinuation During Placebo-Controlled Trials Benign Prostatic Hyperplasia
Body System

Terazosin

(N = 636)

Placebo

(N = 360)

BODY AS A WHOLE

Fever

Headache

0.5%

1.1%

0.0%

0.8%

CARDIOVASCULAR SYSTEM

Postural Hypotension

Syncope

0.5%

0.5%

0.0%

0.0%

DIGESTIVE SYSTEM

Nausea 0.5% 0.3%

NERVOUS SYSTEM

Dizziness

Vertigo

2.0%

0.5%

1.1%

0.0%

RESPIRATORY SYSTEM

Dyspnea 0.5% 0.3%

SPECIAL SENSES

Blurred Vision/Amblyopia 0.6% 0.0%

UROGENITAL SYSTEM

Urinary Tract Infection 0.5% 0.3%

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, 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 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

*
Includes weakness, tiredness, lassitude, and fatigue.

Statistically significant at p=0.05 level.

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%

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. 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 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. Discontinuations 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%

Post-marketing Experience

Post-marketing experience indicates that in rare instances patients may develop allergic reactions, including anaphylaxis, following administration of terazosin hydrochloride. There have been reports of priapism and thrombocytopenia during post-marketing surveillance. Atrial fibrillation has been reported.

During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy (see PRECAUTIONS).

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