Does Buspirone Cause Headaches?
Yes, buspirone commonly causes headaches—this is a well-documented adverse effect occurring in 6% of patients in controlled trials, compared to 3% with placebo. 1
Evidence from FDA Drug Labeling
The FDA-approved prescribing information for buspirone explicitly lists headache among the "more commonly observed untoward events" that occur at higher rates than placebo. 1
Key findings from controlled clinical trials:
Headache occurred in 6% of buspirone-treated patients versus 3% with placebo in pooled data from 17 controlled trials involving 477 buspirone patients. 1
Headache was among the "miscellaneous disturbances" that led to treatment discontinuation in 1.1% of the 2,200 patients studied during premarketing trials. 1
The most common adverse events overall were dizziness (12%), nausea (8%), headache (6%), nervousness (5%), and lightheadedness (3%). 1
Clinical Context from Research Studies
Multiple independent research studies confirm headache as a frequent buspirone side effect:
A meta-analysis of 289 patients found headache among the most frequently reported adverse events for both twice-daily and three-times-daily buspirone dosing regimens. 2
A 1988 comprehensive review identified headaches as one of the most common adverse effects, alongside dizziness, nervousness, and lightheadedness. 3
A 1984 clinical review similarly listed headaches among the most common side effects. 4
Important Clinical Considerations
The headache side effect is generally mild and well-tolerated:
Adverse effects with buspirone are described as "minimal" in severity, and headaches seldom cause premature withdrawal from treatment. 4, 3
In a study of chronic tension-type headache patients treated with buspirone 30 mg daily, only 4 of 26 patients (15%) discontinued due to side effects, with nausea being more common than headache as a reason for discontinuation. 5
Paradoxical use in headache disorders:
Despite causing headaches as a side effect, buspirone has been investigated as a potential migraine prophylactic agent due to its 5-HT1A receptor agonist properties, with one open trial showing 76% of migraine patients improved on 15-20 mg daily. 6
However, this does not negate its potential to cause headaches in patients taking it for anxiety disorders. 6
Clinical Management Approach
When headaches develop on buspirone:
Assess whether the headache represents a new-onset problem or worsening of pre-existing headaches, as headaches are common in the general population. 1
Consider symptomatic treatment with acetaminophen or NSAIDs if not contraindicated while continuing buspirone, as the headache may resolve with continued use. 1
If headaches are persistent and bothersome, dose reduction or discontinuation may be necessary, weighing this against the therapeutic benefit for anxiety. 1