Can Buspirone Cause Hand Shaking (Tremor)?
Yes, buspirone can cause tremor as an adverse effect, occurring in approximately 1% of patients in controlled clinical trials.
Evidence from FDA Drug Labeling
The FDA-approved prescribing information for buspirone explicitly lists tremor as a neurological adverse event occurring in 1% of patients in placebo-controlled trials 1. This represents the most authoritative source for establishing this adverse effect.
Frequency and Clinical Context
In the premarketing evaluation involving over 3,500 subjects:
- Tremor occurred in 1% of patients taking buspirone in controlled 4-week trials
- The incidence was higher than placebo (tremor occurred in <1% of placebo patients)
- Tremor is classified under "Neurological" adverse events in the official labeling 1
Additional Movement-Related Adverse Effects
Beyond tremor, buspirone can cause other movement-related side effects:
- Incoordination (1%)
- Paresthesia (1%)
- Involuntary movements (reported as infrequent: 1/100 to 1/1,000 patients) 1
Postmarketing and Real-World Evidence
More recent pharmacovigilance data confirms tremor as a significant adverse event. A 2026 analysis of the FDA Adverse Event Reporting System (FAERS) database covering Q1 2006 to Q1 2025 identified tremor as the 5th most frequently reported adverse event (n=71) associated with buspirone 2. This real-world data reinforces the FDA labeling information.
Rare but Serious Movement Disorders
While uncommon, buspirone has been associated with persistent movement disorders including:
- Dystonia and dyskinesia 3
- Exacerbation of pre-existing movement disorders 3
- Extrapyramidal symptoms (reported postmarketing) 1
A 1993 case series documented two patients who developed persistent movement disorders after prolonged buspirone treatment, including cervical-cranial dystonia with tremors in one patient receiving 40 mg/day 3.
Clinical Implications
When to Suspect Buspirone-Related Tremor
- Tremor typically appears during treatment (median time to onset for adverse events: 10 days) 2
- Consider buspirone as a cause when tremor develops after initiation or dose increase
- Monitor for other neurological symptoms (dizziness, incoordination, involuntary movements)
Management Considerations
- Tremor was not among the most common reasons for drug discontinuation in clinical trials (which were primarily CNS disturbances like dizziness, insomnia, and nervousness at 3.4%) 1
- If tremor is bothersome, dose reduction or discontinuation should be considered
- Use caution in patients with pre-existing movement disorders, as buspirone may exacerbate these conditions 3
Drug Interactions Increasing Risk
When buspirone is combined with other serotonergic agents, the risk of adverse effects including tremor may increase. A case report documented severe tremor as part of serotonin syndrome when buspirone was combined with paroxetine 4.
Bottom Line
Tremor is a documented adverse effect of buspirone occurring in approximately 1% of patients, as confirmed by both FDA labeling and real-world pharmacovigilance data. While generally mild and less common than other side effects like dizziness or nausea, clinicians should be aware of this potential adverse effect and monitor patients accordingly, particularly those with pre-existing movement disorders or those taking other serotonergic medications.