· Brand: Bucapsol
Buspirone Side Effects: Common, Serious & FDA Warnings
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Quick answer
Based on 10,000+ FDA adverse event reports, the most-reported buspirone reactions include fatigue, nausea, and headache. FDA reports 2 active Class II recalls of buspirone, primarily for failed dissolution specifications. The FDA-approved label does not carry a boxed warning.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.
Common Side Effects of Buspirone
The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for buspirone. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.
| Reaction | Reports | % of total |
|---|---|---|
| Fatigue | 780 | 7.4% |
| Nausea | 769 | 7.3% |
| Headache | 695 | 6.6% |
| Anxiety | 657 | 6.2% |
| Pain | 556 | 5.3% |
| Dyspnoea | 545 | 5.1% |
| Depression | 493 | 4.7% |
| Diarrhoea | 483 | 4.6% |
| Dizziness | 485 | 4.6% |
| Product Dose Omission Issue | 461 | 4.4% |
Serious Outcomes and FDA Warnings
FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.
| Outcome flag | Reports | % of total |
|---|---|---|
| Serious reports (any flag) | — | — |
| Hospitalization | — | — |
Buspirone Recalls
FDA enforcement actions matched to buspirone via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2026-05-13 | Subpotent drug Unichem Pharmaceuticals USA Inc. | Class III | 10,875 Bottles | Ongoing |
| 2023-05-03 | CGMP Deviations Northwind Pharmaceuticals LLC | Class II | 6 bottles | Ongoing |
Show 8 closed recalls (2021 to 2023)
Includes resolved and terminated recalls matched to buspirone. Most recent first.
| Date | Reason | Class | Quantity | Status |
|---|---|---|---|---|
| 2023-11-29 | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots NCS Healthcare of Kentucky Inc | Class III | 1,344 cards | Terminated |
| 2023-11-29 | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots NCS Healthcare of Kentucky Inc | Class III | 12 cards | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 25,812 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 24,408 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 23,784 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 3,784 bottles | Terminated |
| 2023-03-08 | CGMP Deviations: recalling drug products following an FDA inspection. Accord Healthcare, Inc. | Class II | 10992 bottles | Terminated |
| 2021-06-09 | Presence of Foreign Tablets/Capsules Oxford Pharmaceuticals, LLC | Class II | 6,864 bottles | Resolved |
Buspirone Shortages
FDA-listed shortages of buspirone products. Strength and dosage-form level detail.
No active or recent shortages of buspirone are listed. We refresh this view daily.
Is Buspirone Safe?
Buspirone is FDA-approved and the label does not carry a boxed warning.
As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.
FDA-Approved Indications
Buspirone is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.
INDICATIONS AND USAGE Buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. The efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD).Show full Indications and Usage
Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. The patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. Generalized Anxiety Disorder (300.02) is described in the American Psychiatric Association’s Diagnostic and Statistical Manual, III 1 as follows: Generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three of the four following categories: 1. Motor tension: shakiness, jitteriness, jumpiness, trembling, tension, muscle aches, fatigability, inability to relax, eyelid twitch, furrowed brow, strained face, fidgeting, restlessness, easy startle. 2. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate. 3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others. 4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling “on edge,” irritability, impatience. The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD. The effectiveness of buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.
Frequently Asked Questions
What are the most-reported side effects of buspirone?
Fatigue, nausea, and headache are among the most-reported reactions in FDA FAERS data for buspirone. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.
Is buspirone the same as Bucapsol?
Buspirone is the generic name; Bucapsol is a brand name for the same active ingredient. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.
Has buspirone been recalled?
Yes. Buspirone has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by CGMP deviations, contamination or foreign material, and subpotent or out-of-spec content. See the recalls table on this page for current counts, firm names, dates, and lot quantities.
What are buspirone's current ongoing recalls about?
Active buspirone recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are subpotent or out-of-spec content and CGMP deviations. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.
What do FDA recall classes mean?
Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.
Data Sources & Methodology
How each section of this page is sourced, and how often the data is refreshed.
| Source | Endpoint | Refresh |
|---|---|---|
| FAERS reactions | openFDA /drug/event.json count API. Aggregated per drug per reaction term; we do not store individual reports. | Daily |
| Recalls | openFDA /drug/enforcement.json. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here. | 6 hours |
| Shortages | FDA Drug Shortages list. | Daily |
| Boxed warnings & label sections | openFDA /drug/label.json. Labels are stable; monthly cadence is sufficient. | Monthly |
| Condition categories | Synonym-mapped from drug_labels.indications. Methodology at /methodology/. | Per-drug |
What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.