Hytrin Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Hypertension: The prevalence of adverse reactions have been ascertained from clinical studies conducted primarily in the United States. All adverse experiences (events) reported during these studies were recorded as adverse reactions. The prevalence rates presented as follows are based on combined data from 14 placebo-controlled studies 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 1 summarizes those adverse experiences reported for patients in these studies where the prevalence rate for 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 oedema, palpitations, and somnolence were the only symptoms that were significantly (p less than 0.05) more common in patients receiving terazosin than in patients receiving placebo. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials as in combination therapy trials (see Table 1).

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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 2. Overall, 9.9% of 859 patients taking terazosin discontinued therapy because of adverse effects, as compared with 4.2% of 506 patients taking placebo. (See Table 2.)

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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 studies or have been reported during marketing experience: Body as a Whole: chest pain, facial oedema, 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 tract infection, and urinary incontinence primarily reported in postmenopausal women.
Benign Prostatic Hyperplasia (BPH): Each selected adverse event in Table 3 was chosen on the basis of meeting one or more of the following criteria: incidence of ≥5% or clinical relevance in previous terazosin hypertension clinical studies; incidence of ≥5% in terazosin BPH clinical studies; it was a component of the dizziness-related adverse event complex, which includes dizziness, hypotension, postural hypotension, syncope and vertigo; or it was related to sexual function. (See Table 3.)

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The most common adverse events with terazosin were dizziness, asthenia, headache, postural hypotension, somnolence, nasal congestion and impotence. All but headache were significantly (P≤0.05) more frequent than with placebo.
Post Marketing Experience: Thrombocytopenia has been reported. Atrial fibrillation has been reported. Priapism has been reported. Anaphylaxis has been reported. Angioedema has been reported. Hypersensitivity 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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