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Author: Admin | 2025-04-28
Nails were reported rarely (less than 0.1%). During postmarketing use, allergic reactions (e.g., urticaria, angioedema) and ecchymosis have been reported. Because of the uncontrolled nature of these spontaneous postmarketing reports, a causal relationship to buspirone has not been determined.[28501]During premarketing evaluation of buspirone, adverse hematologic effects including eosinophilia, leukopenia, bleeding disturbance (unspecified), and thrombocytopenia were reported in less than 0.1% of patients.[28501]During clinical trials of buspirone in the treatment of anxiety, gastrointestinal (GI) disturbances, primarily nausea, were one of the most common adverse events causing discontinuation of treatment. In these clinical trials, the following adverse GI effects occurred in at least 1% of patients receiving buspirone and more frequently than with placebo: nausea (8%) and diarrhea (2%). During other premarketing evaluations, adverse GI effects reported in 0.1% to 1% of patients included elevated hepatic enzymes, flatulence, anorexia, appetite stimulation, hypersalivation, irritable colon, weight gain, weight loss, and rectal GI bleeding. Burning of the tongue was reported rarely (less than 0.1%).[28501]During premarketing evaluation of buspirone, the following adverse respiratory effects or infections were reported in at least 1% of patients: sore throat (pharyngitis) and nasal congestion. Adverse effects reported in 0.1% to 1% of patients included hyperventilation, dyspnea, chest congestion, and fever. Epistaxis and hiccups were reported rarely (less than 0.1%).[28501]During premarketing evaluation of buspirone, chest pain (unspecified) was reported in at least 1% of patients. Adverse cardiovascular effects reported in 0.1% to 1% of patients included syncope, hypotension, and hypertension. Rarely reported cardiovascular or cerebrovascular effects (less than 0.1%) included stroke, congestive heart failure, myocardial infarction, cardiomyopathy, and bradycardia.[28501]During clinical trials of buspirone in the treatment of anxiety, blurred vision occurred in 2% of patients receiving buspirone and more frequently than in patients receiving placebo. During other premarketing evaluations, adverse effects related to the special senses reported in 0.1% to 1% of patients included tinnitus, redness of the eyes, ocular pruritus, dysgeusia, parosmia, and conjunctivitis. Inner ear abnormality, ocular pain, photophobia, pressure on the eyes, and loss of voice were reported rarely (less than 0.1%). Visual impairment (including tunnel vision) has been reported during postmarketing use. Because of the uncontrolled nature of spontaneous postmarketing reports, a causal relationship to buspirone treatment has not been determined.[28501]During premarketing evaluation of buspirone, adverse endocrine effects including galactorrhea and thyroid abnormality (unspecified) were reported in less than 0.1% of patients.[28501]During premarketing evaluation of buspirone, the following adverse genitourinary effects or changes in sexual functioning were reported in 0.1% to 1% of patients: increased urinary frequency, urinary hesitancy, menstrual irregularity and spotting, dysuria, libido decrease, and libido increase. Rarely reported effects (less than 0.1%) included amenorrhea, pelvic inflammatory disease, enuresis, nocturia, ejaculation dysfunction (delayed ejaculation), and impotence (erectile dysfunction). Urinary retention has been reported during postmarketing use. Because of the uncontrolled nature of spontaneous postmarketing reports, a causal relationship to buspirone treatment has not been determined.[28501]During clinical trials of buspirone in the treatment of anxiety, weakness occurred in 2% of patients receiving buspirone and more frequently than in patients receiving placebo. During other premarketing evaluations,
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