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Hytrin

Last reviewed on RxList: 1/18/2017
Hytrin Side Effects Center

Last reviewed on RxList 9/28/2016

Hytrin (terazosin hydrochloride) is an alpha-adrenergic blocker used to treat hypertension (high blood pressure) and benign prostatic hyperplasia (enlarged prostate). Hytrin is available in generic form. Common side effects of Hytrin include:

  • fatigue,
  • nausea,
  • weakness,
  • drowsiness,
  • blurred vision,
  • headache,
  • stuffy nose,
  • difficulty breathing, or
  • impotence.
  • Lightheadedness or dizziness upon standing may also occur, especially after the first dose of Hytrin, and shortly after taking the drug during the first week of treatment.

Tell your doctor if you have any serious side effects of Hytrin including:

  • fainting,
  • fast or irregular heartbeat,
  • burning or tingling in the hands or feet,
  • sexual function problems,
  • swelling of the ankles/hands/feet, or
  • unexpected weight gain.

To treat benign prostatic hyperplasia, the starting dose of Hytrin is 1 mg at bedtime, with dosage gradually increased to 10 mg. To treat hypertension, the starting dose is 1 mg at bedtime. The usual recommended dose range is 1 mg to 5 mg administered once a day; some patients benefit from doses as high as 20 mg per day. Hytrin may interact with sildenafil, tadalafil, vardenafil, or other blood pressure medications. Tell your doctor all medications you use. Hytrin should be used only when prescribed during pregnancy. It is not known if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Hytrin (terazosin hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Hytrin Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • fast or pounding heartbeats or fluttering in your chest;
  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild dizziness;
  • weakness, drowsiness;
  • blurred vision;
  • nausea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hytrin (Terazosin Hcl)

Hytrin Professional Information

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 entire FDA prescribing information for Hytrin (Terazosin Hcl)

Related Resources for Hytrin

Read the Hytrin User Reviews »

© Hytrin Patient Information is supplied by Cerner Multum, Inc. and Hytrin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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