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 | Body System | Terazosin
(N = 636) | Placebo
(N = 360) |
|
† Includes weakness, tiredness, lassitude and fatigue.
* p ≤ 0.05 comparison between groups.
|
| BODY AS A WHOLE | | |
| †Asthenia | 7.4%* | 3.3% |
| Flu Syndrome | 2.4% | 1.7% |
| Headache | 4.9% | 5.8% |
| CARDIOVASCULAR SYSTEM | | |
| Hypotension | 0.6% | 0.6% |
| Palpitations | 0.9% | 1.1% |
| Postural Hypotension | 3.9%* | 0.8% |
| Syncope | 0.6% | 0.0% |
| DIGESTIVE SYSTEM | | |
| Nausea | 1.7% | 1.1% |
| METABOLIC AND NUTRITIONAL DISORDERS | | |
| Peripheral Edema | 0.9% | 0.3% |
| Weight Gain | 0.5% | 0.0% |
| NERVOUS SYSTEM | | |
| Dizziness | 9.1%* | 4.2% |
| Somnolence | 3.6%* | 1.9% |
| Vertigo | 1.4% | 0.3% |
| RESPIRATORY SYSTEM | | |
| Dyspnea | 1.7% | 0.8% |
| Nasal Congestion/Rhinitis | 1.9%* | 0.0% |
| SPECIAL SENSES | | |
| Blurred Vision/Amblyopia | 1.3% | 0.6% |
| UROGENITAL SYSTEM | | |
| Impotence | 1.6%* | 0.6% |
| Urinary Tract Infection | 1.3% | 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 | 0.5% | 0.0% |
| Headache | 1.1% | 0.8% |
| CARDIOVASCULAR SYSTEM | | |
| Postural Hypotension | 0.5% | 0.0% |
| Syncope | 0.5% | 0.0% |
| DIGESTIVE SYSTEM | | |
| Nausea | 0.5% | 0.3% |
| NERVOUS SYSTEM | | |
| Dizziness | 2.0% | 1.1% |
| Vertigo | 0.5% | 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 | Body System | Terazosin
(N = 859) | Placebo
(N = 506) |
|
† Includes weakness, tiredness, lassitude and fatigue.
* Statistically significant at p = 0.05 level.
|
| BODY AS A WHOLE | | |
| †Asthenia | 11.3%* | 4.3% |
| Back Pain | 2.4% | 1.2% |
| Headache | 16.2% | 15.8% |
| CARDIOVASCULAR SYSTEM | | |
| Palpitations | 4.3%* | 1.2% |
| Postural Hypotension | 1.3% | 0.4% |
| Tachycardia | 1.9% | 1.2% |
| DIGESTIVE SYSTEM | | |
| Nausea | 4.4%* | 1.4% |
| METABOLIC AND NUTRITIONAL DISORDERS | | |
| Edema | 0.9% | 0.6% |
| Peripheral Edema | 5.5%* | 2.4% |
| Weight Gain | 0.5% | 0.2% |
| MUSCULOSKELETAL SYSTEM | | |
| Pain-Extremities | 3.5% | 3.0% |
| NERVOUS SYSTEM | | |
| Depression | 0.3% | 0.2% |
| Dizziness | 19.3%* | 7.5% |
| Libido Decreased | 0.6% | 0.2% |
| Nervousness | 2.3% | 1.8% |
| Paresthesia | 2.9% | 1.4% |
| Somnolence | 5.4%* | 2.6% |
| RESPIRATORY SYSTEM | | |
| Dyspnea | 3.1% | 2.4% |
| Nasal Congestion | 5.9%* | 3.4% |
| Sinusitis | 2.6% | 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 | 1.6% | 0.0% |
| Headache | 1.3% | 1.0% |
| CARDIOVASCULAR SYSTEM | | |
| Palpitations | 1.4% | 0.2% |
| Postural Hypotension | 0.5% | 0.0% |
| Syncope | 0.5% | 0.2% |
| Tachycardia | 0.6% | 0.0% |
| DIGESTIVE SYSTEM | | |
| Nausea | 0.8% | 0.0% |
| METABOLIC AND NUTRITIONAL DISORDERS | | |
| Peripheral Edema | 0.6% | 0.0% |
| NERVOUS SYSTEM | | |
| Dizziness | 3.1% | 0.4% |
| Paresthesia | 0.8% | 0.2% |
| Somnolence | 0.6% | 0.2% |
| RESPIRATORY SYSTEM | | |
| Dyspnea | 0.9% | 0.6% |
| Nasal Congestion | 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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