Prescription medicine
Buspirone Brand names: Bucapsol; first approved as Buspar
Buspirone (Buspar) is a prescription medicine with an FDA approval on record since 1986. FDA's NDC Directory lists it from 47 generic labelers, and pharmacies paid $0.043 per buspirone HCl 15 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the buspirone FDA label on DailyMed (effective December 22, 2023, Unichem Pharmaceuticals (USA), Inc.); the NDA 18731 record on Drugs@FDA; every buspirone label on DailyMed.
Highlights of the record
FDA label of December 22, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageBuspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.
Forms and strengths
- 2.5 mg
- 5 mg
- 7.5 mg
- 10 mg
- 12.5 mg
- 15 mg
- 30 mg
Tablet; capsule.
On the market
- Earliest approval on file
- September 29, 1986 Buspar, Bristol Myers Squibb; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 22 first March 28, 2001; 17 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 47 of which 47 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.043 per tablet Buspirone HCl 15 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 10 since 2020 0 Class I among all firms' recalls; latest April 13, 2026
- FAERS reports
- 10,970 through July 30, 2026
What is buspirone used for?
From the label: indications and usageBuspirone hydrochloride tablets, USP 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, USP has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to Generalized Anxiety Disorder (GAD). Many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets, USP relieved anxiety in the presence of these coexisting depressive symptoms. […]
Conditions named in the indications of buspirone's FDA labels, with every medicine labeled for each:
From other buspirone labelsAnxiety: INDICATIONS AND USAGE Buspirone hydrochloride tablets, USP are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety.
Source: FDA drug label (Buspirone Hydrochloride), Unichem Pharmaceuticals (USA), Inc., effective December 22, 2023 (SPL set a6bdf140-075e-445e-a62d-633a4b97f3a8), via openFDA; the full label on DailyMed
Is there a generic for buspirone (Buspar)?
The FDA approved the first generic buspirone on March 28, 2001. 22 generic applications are approved; 17 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists buspirone from 47 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1986 earliest approval on file
- 2001 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for buspirone (Buspar)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.043 per Buspirone HCl 15 mg tablet, down 9% from $0.047 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Buspirone HCl 15 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Buspirone HCl 10 mg tablet | Generic | $0.0279 per tablet | $0.839 | -9% |
| Buspirone HCl 15 mg tablet | Generic | $0.043 per tablet | $1.29 | -9% |
| Buspirone HCl 30 mg tablet | Generic | $0.120 per tablet | $3.60 | -1% |
| Buspirone HCl 5 mg tablet | Generic | $0.022 per tablet | $0.658 | +0.4% |
| Buspirone HCl 7.5 mg tablet | Generic | $0.100 per tablet | $3.01 | -15% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has buspirone been recalled?
The FDA's Enforcement Report lists 10 recalls naming buspirone since 2020: 0 Class I (the most serious), 8 Class II, 2 Class III; 2 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 13, 2026 | Class III | Unichem Pharmaceuticals USA Inc. | Subpotent drug |
| October 27, 2023 | Class III | NCS Healthcare of Kentucky Inc | Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots |
| March 16, 2023 | Class II | Northwind Pharmaceuticals LLC | CGMP Deviations |
| February 7, 2023 | Class II | Accord Healthcare, Inc. | CGMP Deviations: recalling drug products following an FDA inspection. |
| May 5, 2021 | Class II | Oxford Pharmaceuticals, LLC | Presence of Foreign Tablets/Capsules |
| August 10, 2020 | Class II | Par Pharmaceutical Inc. | Failed Impurity /Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the buspirone label say about other medicines?
The buspirone label names 22 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name buspirone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amitriptyline | drug interactions | Amitriptyline After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max, AUC, and C min ) of amitriptyline or its metabolite nortriptyline were observed. |
| Carbamazepine | drug interactions | … substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. |
| Cimetidine | drug interactions | Other Drugs Cimetidine Coadministration of buspirone with cimetidine was found to increase C max (40%) and T max (2 fold), but had minimal effects on the AUC of buspirone. |
| Dexamethasone | drug interactions | Other Inhibitors and Inducers of CYP3A4 Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) … |
| Diazepam | drug interactions | Diazepam After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C max, AUC, and C min ) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache … |
| Diltiazem | drug interactions | Diltiazem and Verapamil In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and C max of buspirone 3.4-fold while diltiazem increased AUC and C max … |
| Erythromycin | drug interactions | Erythromycin In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations (5-fold increase in C max and 6-fold increase in AUC). |
| Flurazepam | drug interactions | Triazolam/Flurazepam Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine. |
| Haloperidol | drug interactions | Haloperidol In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. |
| Itraconazole | drug interactions | Itraconazole In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13-fold increase in C max and 19-fold increase in AUC). |
| Ketoconazole | drug interactions | Other Inhibitors and Inducers of CYP3A4 Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) … |
| Linezolid | contraindications | Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS , DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS ). |
| Methylene blue | contraindications | Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS , DOSAGE AND ADMINISTRATION and DRUG INTERACTIONS ). |
| Nefazodone | drug interactions | Nefazodone (See Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4) ) Trazodone There is one report suggesting that the concomitant use of trazodone hydrochloride and buspirone may have caused 3 to 6-fold elevations on SGPT (ALT) in a few patients. |
Every other medicine the buspirone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Nortriptyline | drug interactions | … parameters (C max, AUC, and C min ) of amitriptyline or its metabolite nortriptyline were observed. |
| Phenobarbital | drug interactions | … CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. |
| Phenytoin | drug interactions | … that induce CYP3A4, such as dexamethasone or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism. |
| Rifampin | drug interactions | Rifampin In a study in healthy volunteers, coadministration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in C max; |
| Ritonavir | drug interactions | Other Inhibitors and Inducers of CYP3A4 Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while … |
| Trazodone | drug interactions | Nefazodone (See Inhibitors and Inducers of Cytochrome P450 3A4 (CYP3A4) ) Trazodone There is one report suggesting that the concomitant use of trazodone hydrochloride and buspirone may have caused 3 … |
| Triazolam | drug interactions | Triazolam/Flurazepam Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine. |
| Verapamil | drug interactions | Diltiazem and Verapamil In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma … |
Other labels that name buspirone
- Amphetamine
- Atropine and diphenoxylate
- Citalopram
- Clomipramine
- Cobicistat, elvitegravir, emtricitabine and tenofovir alafenamide
- Cobicistat, elvitegravir, emtricitabine and tenofovir disoproxil
- Darunavir
- Deferasirox
- Desipramine
- Desvenlafaxine
- Dextroamphetamine
- Dronabinol
- Duloxetine
- Escitalopram
- Fluoxetine
- Fluvoxamine
- Isocarboxazid
- Levomilnacipran
- Lisdexamfetamine
- Lithium
- Methamphetamine
- Milnacipran
- Mirtazapine
- Paclitaxel
- Paroxetine
- Phenelzine
- Selegiline
- Sertraline
- Trimipramine
- Venlafaxine
- Vilazodone
- Vortioxetine
- Ziprasidone
Source: FDA drug label (Buspirone Hydrochloride), 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 for buspirone?
The FDA Adverse Event Reporting System holds 10,970 reports that list buspirone among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as buspirone?
10 other medicines are given the same way (oral) and in the same FDA class as buspirone or labeled mainly for the same use (anxiety), the same class first. Anxiety lists all 22 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Hydroxyzine | Anxiety | 59 labelers | $0.0326 per tablet 25 mg tablet | No current entry |
| Alprazolam | Anxiety | 30 labelers | $0.0236 per tablet 0.25 mg tablet | No current entry |
| Lorazepam | Anxiety | 33 labelers | $0.0344 per tablet 0.5 mg tablet | In shortage |
| Diazepam | Anxiety | 32 labelers | $0.0283 per tablet 10 mg tablet | No current entry |
| Chlordiazepoxide | Anxiety | 15 labelers | $0.158 per capsule 25 mg capsule | No current entry |
| Clorazepate | Anxiety | 8 labelers | $0.524 per tablet 3.75 mg tablet | No current entry |
| Oxazepam | Anxiety | 6 labelers | $0.725 per capsule 10 mg capsule | No current entry |
| Meprobamate | Anxiety | 3 labelers | $5.89 per tablet 400 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does buspirone compare with medicines for the same use?
11 side-by-side pages set buspirone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to buspirone
- 10 medicines for the same use
- Buspirone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other