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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 hydrochloride than in patients receiving placebo. Similar adverse reaction rates were observed in placebo-controlled monotherapy trials as in combination therapy trials (see Table 1).
Click on icon to see table/diagram/imageThe 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 hydrochloride group and being reported more often than in the placebo group, are shown in Table 2. Overall, 9.9% of 859 patients taking terazosin hydrochloride discontinued therapy because of adverse effects, as compared with 4.2% of 506 patients taking placebo. (See Table 2.)
Click on icon to see table/diagram/imageAdditional 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 hydrochloride.
The following additional adverse reactions were reported by at least 1% of 1987 patients who received terazosin hydrochloride in controlled or open, short- or long-term clinical studies 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 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: 1) incidence of ≥ 5% or clinical relevance in previous terazosin hydrochloride hypertension clinical studies; 2) incidence ≥ 5% in terazosin hydrochloride BPH clinical studies; 3) it was a component of the dizziness-related adverse event complex, which includes dizziness, hypotension, postural hypotension, syncope and vertigo; or 4) it was related to sexual function. (See Table 3.)
Click on icon to see table/diagram/imageThe most common adverse events with terazosin hydrochloride 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 also been reported. Anaphylaxis has rarely 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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