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Hytrin (Terazosin Hydrochloride) - Side Effects and Adverse Reactions

 
 



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
     †Asthenia7.4%*3.3%
     Flu Syndrome2.4%1.7%
     Headache4.9%5.8%
CARDIOVASCULAR SYSTEM
     Hypotension0.6%0.6%
     Palpitations0.9%1.1%
     Postural Hypotension3.9%*0.8%
     Syncope0.6%0.0%
DIGESTIVE SYSTEM
     Nausea1.7%1.1%
METABOLIC AND NUTRITIONAL DISORDERS
     Peripheral Edema0.9%0.3%
     Weight Gain0.5%0.0%
NERVOUS SYSTEM
     Dizziness9.1%*4.2%
     Somnolence3.6%*1.9%
     Vertigo1.4%0.3%
RESPIRATORY SYSTEM
     Dyspnea1.7%0.8%
     Nasal Congestion/Rhinitis1.9%*0.0%
SPECIAL SENSES
     Blurred Vision/Amblyopia1.3%0.6%
UROGENITAL SYSTEM
     Impotence1.6%*0.6%
     Urinary Tract Infection1.3%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
     Fever0.5%0.0%
     Headache1.1%0.8%
CARDIOVASCULAR SYSTEM
     Postural Hypotension0.5%0.0%
     Syncope0.5%0.0%
DIGESTIVE SYSTEM
     Nausea0.5%0.3%
NERVOUS SYSTEM
     Dizziness2.0%1.1%
     Vertigo0.5%0.0%
RESPIRATORY SYSTEM
     Dyspnea0.5%0.3%
SPECIAL SENSES
     Blurred Vision/Amblyopia0.6%0.0%
UROGENITAL SYSTEM
     Urinary Tract Infection0.5%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
     †Asthenia11.3%*4.3%
     Back Pain2.4%1.2%
     Headache16.2%15.8%
CARDIOVASCULAR SYSTEM
     Palpitations4.3%*1.2%
     Postural Hypotension1.3%0.4%
     Tachycardia1.9%1.2%
DIGESTIVE SYSTEM
     Nausea4.4%*1.4%
METABOLIC AND NUTRITIONAL DISORDERS
     Edema0.9%0.6%
     Peripheral Edema5.5%*2.4%
     Weight Gain0.5%0.2%
MUSCULOSKELETAL SYSTEM
     Pain-Extremities3.5%3.0%
NERVOUS SYSTEM
     Depression0.3%0.2%
     Dizziness19.3%*7.5%
     Libido Decreased0.6%0.2%
     Nervousness2.3%1.8%
     Paresthesia2.9%1.4%
     Somnolence5.4%*2.6%
RESPIRATORY SYSTEM
     Dyspnea3.1%2.4%
     Nasal Congestion5.9%*3.4%
     Sinusitis2.6%1.4%
SPECIAL SENSES
     Blurred Vision1.6%*0.0%
UROGENITAL SYSTEM
     Impotence1.2%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
     Asthenia1.6%0.0%
     Headache1.3%1.0%
CARDIOVASCULAR SYSTEM
     Palpitations1.4%0.2%
     Postural Hypotension0.5%0.0%
     Syncope0.5%0.2%
     Tachycardia0.6%0.0%
DIGESTIVE SYSTEM
     Nausea0.8%0.0%
METABOLIC AND NUTRITIONAL DISORDERS
     Peripheral Edema0.6%0.0%
NERVOUS SYSTEM
     Dizziness3.1%0.4%
     Paresthesia0.8%0.2%
     Somnolence0.6%0.2%
RESPIRATORY SYSTEM
     Dyspnea0.9%0.6%
     Nasal Congestion0.6%0.0%
SPECIAL SENSES
     Blurred Vision0.6%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).



REPORTS OF SUSPECTED HYTRIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Hytrin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Hytrin side effects / adverse reactions in 67 year old male

Reported by a consumer/non-health professional from Singapore on 2012-04-03

Patient: 67 year old male

Reactions: Urticaria

Suspect drug(s):
Hytrin



Possible Hytrin side effects / adverse reactions in 82 year old male

Reported by a health professional (non-physician/pharmacist) from Singapore on 2012-04-03

Patient: 82 year old male

Reactions: Angioedema

Suspect drug(s):
Hytrin



Possible Hytrin side effects / adverse reactions in 69 year old male

Reported by a consumer/non-health professional from Singapore on 2012-04-03

Patient: 69 year old male

Reactions: Pruritus

Suspect drug(s):
Hytrin



See index of all Hytrin side effect reports >>

Drug label data at the top of this Page last updated: 2006-12-15

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