BUSPAR FDA MedWatch Direct Reports Summary
These tables and charts are created from 793 voluntary U.S. reports for BUSPAR (BUSPIRONE HYDROCHLORIDE) reported by individuals to the FDA via the MedWatch Reporting System from 2004 through April 28, 2026.
For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS BUSPAR Report.
Top Adverse Effects Associated with BUSPAR (from U.S. FDA Medwatch Reports)
Side Effect # of FDA Reports 1 ANXIETY 90 2 DEPRESSION 61 3 NAUSEA 61 4 DRUG INEFFECTIVE 54 5 FATIGUE 54 6 HEADACHE 51 7 DIZZINESS 50 8 INSOMNIA 46 9 SUICIDAL IDEATION 43 10 VOMITING 42 11 SHORTNESS OF BREATH 36 12 PRODUCT SUBSTITUTION ISSUE 34 13 FEELING ABNORMAL 33 14 DIARRHEA 31 15 LACK OF STRENGTH AND ENERGY (ASTHENIA) 29 16 CONFUSIONAL STATE 29 17 PAIN 28 18 PANIC ATTACK 28 19 ITCHING 28 20 TREMOR 28 21 PALPITATIONS 24 22 JOINT PAIN 23 23 EXCESS SWEATING 21 24 PINS AND NEEDLES 21 25 THERAPY CESSATION 21
BUSPAR Total Medwatch Safety Reports by Patient Sex
| Male | Female | Unknown | Total |
|---|---|---|---|
| 176 | 552 | 65 | 793 |
| Medwatch Reporter Type | Count |
| Consumer | 522 |
| Physician | 24 |
| Pharmacist | 78 |
| Other Health Professional | 63 |
| Top Indications | |
Type of Outcome Reported
Serious: 542
Not Serious: 251
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.
Suspected Role
Primary Suspect: 793
Concomitant Drugs: 695
Note: A single MedWatch report can list more than one drug. This summary includes BUSPAR identified as the suspect drug or as a concomitantly taken drug.
For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.
NOTES
This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.
After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"
The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.
Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."
FDA uses the "MedDRA" classification system to describe reported adverse
reactions. MedDRA is a standardized medical terminology that facilitates
sharing of regulatory information internationally. In some cases, "patient
friendly" terms for the layman designated by MedDRA have been substituted
for medical jargon. Please
contact us
with questions about this report.