What the label lists and what reports show
Buspirone side effects
Buspirone's FDA label lists its adverse reactions in its own words. FAERS holds 10,970 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (800 reports).
- Generic listed
Check it at the source: the buspirone FDA label on DailyMed (effective December 22, 2023, Unichem Pharmaceuticals (USA), Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactions(See also PRECAUTIONS ) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Associated with Discontinuation of Treatment One guide to the relative clinical importance of adverse events associated with buspirone hydrochloride is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone hydrochloride premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. …
TREATMENT-EMERGENT ADVERSE EXPERIENCE INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS Events reported by at least 1% of buspirone patients are included.
| Adverse Experience | Buspirone (n = 477) | Placebo (n = 464) |
|---|---|---|
| Tachycardia/Palpitations | 1 | 1 |
| Dizziness | 12 | 3 |
| Drowsiness | 10 | 9 |
| Nervousness | 5 | 1 |
| Insomnia | 3 | 3 |
| Lightheadedness | 3 | - |
| Decreased concentration | 2 | 2 |
| Excitement | 2 | - |
| Anger/Hostility | 2 | - |
| Confusion | 2 | - |
| Depression | 2 | 2 |
| Blurred vision | 2 | - |
| Nausea | 8 | 5 |
| Dry mouth | 3 | 4 |
| Abdominal/gastric distress | 2 | 2 |
| Diarrhea | 2 | - |
| Constipation | 1 | 2 |
| Vomiting | 1 | 2 |
| Musculoskeletal aches/pains | 1 | - |
| Numbness | 2 | - |
| Paresthesia | 1 | - |
| Incoordination | 1 | - |
| Tremor | 1 | - |
| Skin rash | 1 | - |
| Headache | 6 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Unichem Pharmaceuticals (USA), Inc., effective December 22, 2023 (SPL set a6bdf140-075e-445e-a62d-633a4b97f3a8), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,970 reports list buspirone among the medicines taken, each a report of something that happened, not proof the medicine caused it; 721 are coded as a death and 2,508 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Buspirone: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions