Terazosin side effects

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Phone:617-525-6884

List of side effects

Benign prostatic hyperplasia

• Adverse events ≥ 1% and > placebo
• Other adverse events (BPH)
• Reasons for discontinuation of therapy (BPH)

Hypertension

• Adverse events ≥ 2% and > placebo
• Other adverse events
• Reasons for discontinuation of therapy

Post-marketing experience

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Benign prostatic hyperplasia

Adverse events ≥ 1% and > placebo

The following list 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:

• Body as a whole: asthenia, flu syndrome, headache
• Cardiovascular system: hypotension, palpitations, postural hypotension, syncope
• Digestive system: nauseau
• Metabolic and nutritional disorders: peripheral edema, weight gain
• Nervous system: dizziness, somnolence, vertigo
• Respiratory system: dyspnea, nasal congestion/rhinitis
• Special senses: blurred vision/amblyopia
• Urogenital system: impotence, urinary tract infection

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 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. Return to top

Other adverse events (BPH)

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. Return to top

Reasons for discontinuation of therapy (BPH)

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 as follows:

• Body as a whole: fever, headache
• Cardiovascular system: postural hypotension, syncope
• Digestive system: nauseau
• Metabolic and nutritional disorders: peripheral edema, weight gain
• Nervous system: dizziness, vertigo
• Respiratory system: dyspnea
• Special senses: blurred vision/amblyopia
• Urogenital system: urinary tract infection

Return to top

Hypertension

Adverse events ≥ 2% and > placebo

The following list summarizes those adverse events reported for patients in these trials when the incidence rate in the Terazosin group was at least 2% and was greater than that for the placebo group, or where the reaction is of clinical interest:

• Body as a whole: Asthenia, back pain, headache
• Cardiovascular system: palpations, postural hypotension, tachycardia
• Digestive system: nauseau
• Metabolic and nutritional disorders: edema. peripheral edema, weight gain
• Musculoskeletal system: pain-extremeties
• Nervous system: depression, dizziness, libido decreased, nervousness, paresthesia, somnolence
• Respiratory system: dyspnea, nasal congestion, sinusitis
• Special senses: blurred vision
• Urogenital system: impotence

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. Return to top

Other adverse events

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.

Return to top

Reasons for discontinuation of therapy

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 as follows:

• Body as a whole: Asthenia, headache
• Cardiovascular system: palpations, postural hypotension, syncope, tachycardia
• Digestive system: nauseau
• Metabolic and nutritional disorders: peripheral edema
• Musculoskeletal system: pain-extremeties
• Nervous system: dizziness, paresthesia, somnolence
• Respiratory system: dyspnea, nasal congestion
• Special senses: blurred vision

Return to top

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. Return to top

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The content of this page is taken from the FDA package insert for this drug and should not be edited.