Buspirone Adverse Reactions
- agitation
- angioedema
- ataxia
- blurred vision
- chest pain (unspecified)
- confusion
- diaphoresis
- dizziness
- drowsiness
- dyskinesia
- dystonic reaction
- ecchymosis
- emotional lability
- headache
- myalgia
- nasal congestion
- nausea/vomiting
- nightmares
- paresthesias
- restlessness
- serotonin syndrome
- tardive dyskinesia
- tinnitus
- tremor
- urinary retention
- urticaria
- vertigo
- visual impairment
- weakness
Buspirone Adverse Reactions
The most common adverse reactions occurring during therapy with buspirone are CNS effects such as dizziness (occurring in about 12% of patients), drowsiness (10%), headache (6%), and nausea/vomiting (6 - 8%). Some patients exhibited a syndrome of restlessness with nervousness (5%) and excitement (2%).
Less common adverse events occurring more frequently in buspirone treated patients than in placebo receiving patients include anger/hostility (agitation), confusion, blurred vision, myalgia, numbness, paresthesias, incoordination, tremor, weakness and diaphoresis.
In premarketing assessment adverse events were recorded by over 3500 patients. A causal relationship has not been established. Frequent adverse events are defined as those occurring in at least 1/100 patients. The most frequently reported adverse events, occurring in more than 1% of patients were chest pain (unspecified), nightmares, tinnitus, sore throat, and nasal congestion. For information on infrequent (occurring in < 1/100 but up to 1/1000) or rare (< 1/1000) events, refer to the manufacturers prescribing literature.
Postmarketing experience has shown an adverse experience profile similar to that of clinical trials. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reaction, ataxia, extrapyramidal symptoms, dyskinesias (acute and tardive dyskinesia), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, and visual changes (including tunnel vision type visual impairment). Because of the uncontrolled nature of these spontaneous reports, a causal relationship to buspirone treatment has not been determined.
[ Last revised: 2/12/2002 ]
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