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Hytrin

Hytrin

SIDE EFFECTS

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)
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%*
Includes weakness, tiredness, lassitude and fatigue.
* p ≤ 0.05 comparison between groups.

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)
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%
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. 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%

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).

Read the Hytrin (terazosin hcl) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Concomitant administration of HYTRIN (terazosin hcl) with a phosphodiesterase-5 (PDE-5) inhibitor can result in additive blood pressure lowering effects and symptomatic hypotension (see DOSAGE AND ADMINISTRATION).

In controlled trials, HYTRIN (terazosin hcl) tablets have been added to diuretics, and several beta-adrenergic blockers; no unexpected interactions were observed. HYTRIN (terazosin hcl) tablets have also been used in patients on a variety of concomitant therapies; while these were not formal interaction studies, no interactions were observed. HYTRIN (terazosin hcl) tablets have been used concomitantly in at least 50 patients on the following drugs or drug classes: 1) analgesic/anti-inflammatory (e.g., acetaminophen, aspirin, codeine, ibuprofen, indomethacin); 2) antibiotics (e.g., erythromycin, trimethoprim and sulfamethoxazole); 3) anticholinergic/sympathomimetics (e.g., phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride); 4) antigout (e.g., allopurinol); 5) antihistamines (e.g., chlorpheniramine); 6) cardiovascular agents (e.g., atenolol, hydrochlorothiazide, methyclothiazide, propranolol); 7) corticosteroids; 8) gastrointestinal agents (e.g., antacids); 9) hypoglycemics; 10) sedatives and tranquilizers (e.g., diazepam).

Use with Other Drugs

In a study (n=24) where terazosin and verapamil were administered concomitantly, terazosin's mean AUC0-24 increased 11% after the first verapamil dose and after 3 weeks of verapamil treatment it increased by 24% with associated increases in Cmax (25%) and Cmin (32%) means. Terazosin mean Tmax decreased from 1.3 hours to 0.8 hours after 3 weeks of verapamil treatment. Statistically significant differences were not found in the verapamil level with and without terazosin. In a study (n=6) where terazosin and captopril were administered concomitantly, plasma disposition of captopril was not influenced by concomitant administration of terazosin and terazosin maximum plasma concentrations increased linearly with dose at steady-state after administration of terazosin plus captopril (see DOSAGE AND ADMINISTRATION).

Read the Hytrin Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 12/15/2010
This monograph has been modified to include the generic and brand name in many instances.

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