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Buspirone

Buspirone is an anti-anxiety medicine used to treat anxiety disorders and provide short-term relief of anxiety symptoms, including Generalized Anxiety Disorder (GAD).

Brand names BusparBucapsol
Rx Forms 2
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 181 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 2
Buspirone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Buspirone is a prescription anti-anxiety medicine for generalized anxiety disorder and short-term anxiety symptoms. It acts mainly on serotonin receptors and is a familiar, less sedating alternative to benzodiazepines, on the market since about 1986 and available as a generic. Most people tolerate it well, it carries none of the dependence concerns of benzodiazepines, and the side effects people notice most are dizziness, nausea and headache. The serious risk is serotonin syndrome, a potentially life-threatening reaction (agitation, high fever, racing heart, stiff or twitching muscles), so never combine it with an MAOI antidepressant. It builds up over a few weeks, so it does little if taken only when anxiety spikes.

Clinical pearls

  • Take it the same way every time, always with food or always without, because food changes how much your body absorbs.
  • Skip large amounts of grapefruit juice, which can push buspirone levels up and bring on more dizziness or drowsiness.
  • Make sure any prescriber starting erythromycin, itraconazole, diltiazem, verapamil or rifampin knows you take buspirone, since each can sharply shift its levels.
  • If you are hospitalized, remind staff you take buspirone before they give linezolid or intravenous methylene blue, both serotonin syndrome risks.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet, Capsule
Earliest FDA record1994
Companies listing it with the FDA45
FDA label last updatedMay 15, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide — a plain-language walkthrough of Buspirone, written from its FDA label.

What Buspirone is used for

▾

Buspirone is approved to treat anxiety disorders and to provide short-term relief of anxiety symptoms across its tablet and capsule formulations.

  • Generalized Anxiety Disorder (GAD): Buspirone's effectiveness has been demonstrated in controlled clinical trials for GAD — persistent, hard-to-control anxiety lasting at least a month, with symptoms such as muscle tension, restlessness, worry, difficulty concentrating, and a racing heart.
  • Anxiety symptoms with co-existing mild depression: Clinical trials showed buspirone relieved anxiety even when mild depressive symptoms were present alongside the anxiety disorder.
  • Short-term anxiety relief: Buspirone tablets and capsules are indicated for short-term symptom relief; everyday stress and tension that don't meet the criteria for an anxiety disorder generally do not require treatment with an anxiolytic.

How Buspirone works

▾

Buspirone's exact mechanism is not fully known. It binds strongly to serotonin receptors (5-HT1A) in the brain and has moderate affinity for dopamine (D2) receptors. Unlike benzodiazepine-type anti-anxiety medications, buspirone does not act on GABA receptors, so it does not produce muscle-relaxing or anti-seizure effects and is much less sedating than traditional anxiolytics.

Because it works differently from benzodiazepines, buspirone does not produce the same immediate calming effect — it generally takes a few weeks of consistent use before the full benefit is felt. It also does not appear to carry the same potential for dependence seen with benzodiazepines.

Buspirone dosage

▾

Buspirone is taken by mouth in divided doses, typically twice a day. Your prescriber will usually start you at a lower dose and may gradually increase it over time to find the right level for you. Food significantly increases how much buspirone your body absorbs, so consistency matters — pick one approach (always with food or always without food) and stick to it every day. Follow your prescriber's instructions carefully; do not adjust your dose on your own.

Dosing details from the FDA-approved label

From the Buspirone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Initial dose (adults)
    • 15 mg daily (7.5 mg two times per day)
    • To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed
    • Maximum: The maximum daily dosage should not exceed 60 mg per day
    • In clinical trials allowing dose titration, divided doses of 20 to 30 mg per day were commonly employed; take consistently, either always with or always without food
  • Patients who have difficulty swallowing capsules
    • Buspirone hydrochloride capsules can be opened and the contents sprinkled on a small amount (about 1-2 tablespoons) of applesauce
    • The drug-applesauce mixture should be swallowed immediately
    • Applies to capsules
  • Switching to or from an MAOI antidepressant
    • At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of buspirone
    • At least 14 days should be allowed after stopping buspirone before starting an MAOI antidepressant
  • Patient already receiving buspirone who requires urgent linezolid or intravenous methylene blue
    • Buspirone should be stopped promptly and linezolid or intravenous methylene blue can be administered
    • Monitor for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first
    • Buspirone may be resumed 24 hours after the last dose
    • Only if acceptable alternatives are not available and benefits outweigh the risks of serotonin syndrome
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION The recommended initial dose is 15 mg daily (7.5 mg b.i.d.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day, as needed. The maximum daily dosage should not exceed 60 mg per day. In clinical trials allowing dose titration, divided doses of 20 mg to 30 mg per day were commonly employed. The bioavailability of buspirone is increased when given with food as compared to the fasted state (see CLINICAL PHARMACOLOGY ). Consequently, patients should take buspirone in a consistent manner with regard to the timing of dosing; either always with or always without food. When buspirone is to be given with a potent inhibitor of CYP3A4, the dosage recommendations described in the PRECAUTIONS: Drug Interactions section should be followed. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Antidepressant At least 14 days should elapse between discontinuation of an MAOI intended to treat depression and initiation of therapy with buspirone hydrochloride tablets, USP. Conversely, at least 14 days should be allowed after stopping buspirone hydrochloride tablets, USP before starting an MAOI antidepressant (see CONTRAINDICATIONS and DRUG INTERACTIONS ). Use of buspirone hydrochloride tablets, USP with (Reversible) MAOIs, Such as Linezolid or Methylene Blue Do not start buspirone hydrochloride tablets, USP in a patient who is being treated with a reversible MAOI such as linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, non-pharmacological interventions, including hospitalization, should be considered (see CONTRAINDICATIONS and DRUG INTERACTIONS ). In some cases, a patient already receiving therapy with buspirone hydrochloride tablets, USP may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, buspirone hydrochloride tablets, USP should be stopped promptly, and linezolid or intravenous methylene blue can be administered.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Buspirone side effects

▾

Common side effects

  • Dizziness or lightheadedness
  • Nausea
  • Headache
  • Nervousness or excitement
  • Drowsiness
  • Dry mouth
  • Fatigue or weakness

When to get medical help

  • Signs of serotonin syndrome — agitation, hallucinations, rapid heartbeat, high fever, muscle stiffness or twitching, loss of coordination, nausea, vomiting, or diarrhea — seek emergency help immediately
  • Unusually elevated blood pressure, especially if you are also taking an MAOI-type antidepressant
  • Involuntary muscle movements or movement problems — contact your doctor promptly
  • Suicidal thoughts — get medical help right away
  • Seizures — call emergency services immediately

The most commonly reported side effects with buspirone include:

  • Dizziness or lightheadedness
  • Nausea
  • Headache
  • Nervousness or feeling excited/restless
  • Drowsiness
  • Dry mouth
  • Fatigue or weakness
  • Blurred vision

More serious reactions — such as signs of serotonin syndrome (agitation, hallucinations, rapid heartbeat, high fever, muscle twitching, loss of coordination) or unusual involuntary muscle movements — require immediate medical attention. Suicidal thoughts and seizures have also been reported and warrant emergency care right away.

Buspirone warnings and precautions

▾
  • Serotonin syndrome: Combining buspirone with MAOIs or other serotonergic drugs can trigger a potentially life-threatening reaction. Symptoms include agitation, hallucinations, rapid heartbeat, fever, severe muscle stiffness, twitching, and loss of coordination. Seek emergency help immediately if these occur.
  • MAOI interaction: Never take buspirone at the same time as an MAOI antidepressant. At least 14 days must pass between stopping one drug and starting the other, in either direction. This includes reversible MAOIs like linezolid and intravenous methylene blue.
  • Elevated blood pressure: Adding buspirone to an MAOI regimen has been associated with dangerous spikes in blood pressure.
  • Liver and kidney impairment: Buspirone levels can rise dramatically in people with liver or kidney disease, increasing the risk of side effects. Use with extra caution and follow your prescriber's guidance closely.
  • No antipsychotic effect: Buspirone has no antipsychotic activity and should never replace appropriate antipsychotic treatment.

Buspirone interactions

▾

Buspirone interacts with several important medications and foods. Always tell your prescriber and pharmacist everything you take:

  • MAOI antidepressants (e.g., phenelzine, tranylcypromine) — contraindicated; can cause dangerous blood pressure spikes and serotonin syndrome
  • Linezolid and intravenous methylene blue (reversible MAOIs) — contraindicated during buspirone use; risk of serotonin syndrome
  • Grapefruit juice — can raise buspirone blood levels significantly; avoid consuming large amounts
  • Erythromycin (antibiotic) — raises buspirone levels several-fold; dose adjustment required
  • Itraconazole (antifungal) — raises buspirone levels dramatically; dose adjustment required
  • Diltiazem and verapamil (heart/blood pressure medications) — raise buspirone levels; watch for increased side effects
  • Rifampin (antibiotic) — greatly reduces buspirone levels, potentially making it less effective
  • Nefazodone (antidepressant) — can increase buspirone levels up to 50-fold; use only at very low buspirone doses if combination is necessary
  • Haloperidol (antipsychotic) — buspirone may increase haloperidol blood levels
  • Warfarin (blood thinner) — one report of prolonged clotting time; monitor carefully

Interactions listed in the FDA-approved label

From the Buspirone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • MAO inhibitors (including linezolid and intravenous methylene blue): Use of MAOIs intended to treat depression with buspirone or within 14 days of stopping buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure; starting buspirone in a patient treated with linezolid or intravenous methylene blue is also contraindicated. Use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.
  • Diltiazem and verapamil: Increased plasma buspirone concentrations (verapamil increased AUC and Cmax of buspirone 3.4-fold; diltiazem increased AUC 5.5-fold and Cmax 4-fold). Subsequent dose adjustment may be necessary and should be based on clinical assessment.
  • Erythromycin: Increased plasma buspirone concentrations (5-fold increase in Cmax and 6-fold increase in AUC) with an increased incidence of side effects attributable to buspirone. If used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended; adjust either drug based on clinical assessment.
  • Grapefruit juice: Increased plasma buspirone concentrations (4.3-fold increase in Cmax; 9.2-fold increase in AUC). Patients should be advised to avoid drinking such large amounts of grapefruit juice.
  • Itraconazole: Increased plasma buspirone concentrations (13-fold increase in Cmax and 19-fold increase in AUC) with an increased incidence of side effects attributable to buspirone. If used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended; adjust either drug based on clinical assessment.
  • Nefazodone: Marked increases in plasma buspirone concentrations (up to 20-fold in Cmax and up to 50-fold in AUC) and decreases of about 50% in the metabolite 1-PP; lightheadedness, asthenia, dizziness, and somnolence were experienced. If used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended; adjust either drug based on clinical assessment.
  • Rifampin: Decreased plasma concentrations of buspirone (83.7% decrease in Cmax; 89.6% decrease in AUC) and its pharmacodynamic effects. If used in combination, the buspirone dosage may need adjusting to maintain anxiolytic effect.
  • Other CYP3A4 inhibitors and inducers (ketoconazole, ritonavir, dexamethasone, phenytoin, phenobarbital, carbamazepine): Inhibitors may increase plasma buspirone concentrations; inducers may increase the rate of buspirone metabolism. With a potent inhibitor, a low dose of buspirone used cautiously is recommended; with a potent inducer, the buspirone dosage may need adjusting to maintain anxiolytic effect.
  • Haloperidol: Concomitant administration resulted in increased serum haloperidol concentrations; clinical significance is not clear.
  • Other psychotropics / CNS-active drugs: Effects of concomitant use with most other psychotropic drugs have not been studied. Concomitant use with other CNS-active drugs should be approached with caution.
Read the label’s full interactions text

Drug Interactions Psychotropic Agents MAO Inhibitors The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated. 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 CONTRAINDICATIONS , WARNINGS , PRECAUTIONS AND DOSAGE AND ADMINISTRATION ). 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. 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, and nausea) were observed. Haloperidol In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear. Nefazodone (see Inhibitors and Inducers of Cytochrome P450 3A4 [CYP3A4] ) Trazodone There is one report suggesting that the concomitant use of Desyrel ® (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿155 supplements and herbs with documented Buspirone interactions, ranked by severity Check Buspirone against a supplement or herb →

Before taking Buspirone

▾
  • Do not take buspirone if you are allergic to it or any of its ingredients.
  • Tell your doctor if you have liver disease — buspirone can build up to 13 times higher levels than normal in people with hepatic impairment.
  • Tell your doctor if you have kidney disease — buspirone levels can rise up to 4 times higher in people with reduced kidney function.
  • Tell your doctor about all prescription and over-the-counter medications, supplements, and herbal products you take, especially antidepressants, antipsychotics, antifungals, antibiotics, or heart medications.
  • Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
  • Use with extra caution if you take other drugs that act on the central nervous system.
  • Do not start buspirone within 14 days of stopping an MAOI antidepressant, and do not start an MAOI within 14 days of stopping buspirone.

Buspirone overdose

▾

Taking too much buspirone can cause nausea, vomiting, dizziness, drowsiness, and stomach distress. If you or someone else may have taken too much, seek emergency medical attention right away — there is no specific antidote, and treatment focuses on supportive care and monitoring of breathing, pulse, and blood pressure.

What Buspirone does in the body

▾

Buspirone relieves anxiety without the heavy sedation, muscle relaxation, or anticonvulsant effects associated with benzodiazepines. It does not significantly bind to benzodiazepine receptors or affect GABA activity. Its anxiety-relieving effects are believed to relate to its activity at serotonin (5-HT1A) and dopamine (D2) receptors, though the precise relationship between these receptor effects and clinical benefit is not yet fully established.

How your body processes Buspirone

▾

Buspirone is rapidly absorbed after oral dosing, with peak blood levels reached within about 40–90 minutes. Food increases the amount absorbed, so consistency with food timing is important. It is extensively broken down (metabolized) by the liver — primarily by an enzyme called CYP3A4 — and only a tiny fraction of the original drug circulates unchanged. The average half-life (the time for blood levels to drop by half) is roughly 2–3 hours after a single dose, though repeated dosing can lead to somewhat higher levels than expected. About 29–63% of the dose is eliminated in urine within 24 hours, mostly as metabolites, with the rest passing through stool.

How to store Buspirone

▾

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 25°C (77°F); excursions permitted between 15° C to 30° C (59° F to 86° F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

155

Supplements & herbs that interact with Buspirone

155 supplements and herbal products have documented interactions with Buspirone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 4
  • Moderate · 108
  • Minor · 43
ACTIVATED CHARCOAL Major GRAPEFRUIT Major LITHIUM Major ST. JOHN'S WORT Major 5-HTP Moderate ACACIA RIGIDULA Moderate ACETYL-L-CARNITINE Moderate ADRAFINIL Moderate +147 more
Every supplement checked against Buspirone — ranked by severity The full interaction hub: 4 major · 108 moderate · 43 minor · every one linked to its full report. Check Buspirone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Buspirone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Buspirone — the kind of thing our pharmacy team would talk through with you at the counter.

How long does buspirone take to start working?

▾
Buspirone isn't a quick-fix medication — it generally takes a few weeks of consistent daily use before you notice a real improvement in your anxiety. This is different from benzodiazepines, which work quickly. Stick with it as prescribed and let your doctor know at your follow-up how you're feeling; they may adjust your dose if needed.

Should I take buspirone with food or on an empty stomach?

▾
Either can work, but the key is to pick one and be consistent every single day. Food significantly increases how much buspirone your body absorbs — so if you start taking it with food, always take it with food. Switching back and forth could cause your levels to fluctuate and affect how well it works.

Can I take buspirone with my other medications?

▾
There are some important interactions to know about. Most critically, buspirone should never be combined with MAOI-type antidepressants — you need at least 14 days between them. Certain antibiotics, antifungals, and heart medications can also raise buspirone levels significantly. Always give your pharmacist and doctor a full list of everything you take, including supplements, so they can check for interactions.

What side effects should I expect, and which ones should I call my doctor about?

▾
The most common side effects are dizziness, nausea, headache, and nervousness — these often improve as your body adjusts. If you experience agitation, hallucinations, a racing heart, fever, or muscle twitching, get emergency help right away, as these could be signs of a rare but serious reaction called serotonin syndrome. Also call your doctor if you notice unusual muscle movements or any thoughts of self-harm.

Is buspirone habit-forming like some other anti-anxiety drugs?

▾
Buspirone works very differently from benzodiazepines — it doesn't act on the same receptors that are linked to dependence and withdrawal with drugs like diazepam. That said, always take it exactly as prescribed and talk to your doctor before stopping, rather than stopping on your own.

What should I avoid while taking buspirone?

▾
Avoid drinking large amounts of grapefruit juice — it can raise buspirone levels in your blood quite significantly. Also avoid starting any MAOI antidepressant without first discussing the timing with your doctor, since you need a 14-day gap in either direction. Tell every prescriber you see that you're taking buspirone so they can check for interactions before adding new medications.

Is Buspirone available over the counter?

▾
No. Buspirone is a prescription medicine: every Buspirone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Buspirone first available?

▾
The earliest FDA record we hold for Buspirone is from 1994: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Buspirone was first used.

Who makes Buspirone?

▾
45 companies currently list Buspirone products in the FDA's NDC Directory, including Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Buspirone on HelloPharmacist

📊Buspirone supplement interactions155 checked — ranked by severity 🌿Drug & Supplement CheckerBuspirone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Buspirone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Buspirone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Buspirone forms and strengths (how it comes)

Buspirone is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
How this form is used
What it may be used for
  • Buspirone HCL tablets are indicated for the management of anxiety disorders or short-term relief of anxiety symptoms
  • Buspirone Hydrochloride tablets are indicated for the management of anxiety disorders or short-term relief of anxiety symptoms, including Generalized Anxiety Disorder (GAD)
Important instructions
  • Buspirone HCL and Buspirone Hydrochloride tablets are taken by mouth, typically in divided doses twice daily
  • Take Buspirone HCL and Buspirone Hydrochloride tablets consistently — always with food or always without food — to keep absorption steady
  • Buspirone Hydrochloride tablets: wait at least 14 days after stopping an MAOI antidepressant before starting, and at least 14 days after stopping this tablet before starting an MAOI
  • Buspirone HCL tablets: follow your prescriber's instructions for any dose adjustments, especially if you take CYP3A4-interacting medications
Available strengths 7 strengths
2.5 mg 5 mg 7.5 mg 10 mg 12.5 mg 15 mg
Show 1 more strength Show fewer strengths
30 mg
539 FDA-listed product records ⓘ

Capsule

By mouth
Brands Bucapsol
How this form is used
What it may be used for
  • Buspirone Hydrochloride capsules are indicated for the management of anxiety disorders or short-term relief of anxiety symptoms, including Generalized Anxiety Disorder (GAD)
Important instructions
  • Buspirone Hydrochloride capsules are taken by mouth, typically in divided doses twice daily
  • Take Buspirone Hydrochloride capsules consistently — always with food or always without food
  • Buspirone Hydrochloride capsules may be opened and the contents sprinkled on a small amount (about 1–2 tablespoons) of applesauce for patients who have difficulty swallowing capsules — swallow the mixture immediately
  • Buspirone Hydrochloride capsules: wait at least 14 days after stopping an MAOI antidepressant before starting, and at least 14 days after stopping this capsule before starting an MAOI
Available strengths 4 strengths
5 mg 7.5 mg 10 mg 15 mg
10 FDA-listed product records ⓘ

Buspirone on the U.S. market: products, makers and brands

How Buspirone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

45 companies list 276 Buspirone product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 1994. Brand names on the directory include Buspar, Bucapsol; the rest are generics.

2
Dose forms ⓘ
45
Labelers (makers, repackagers, distributors)
3
Brand names
276
FDA-listed product records ⓘ
1994
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (17) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack14%
Aphena Pharma Solutions - Tennessee, LLC7%
A-S Medication Solutions7%
Remedyrepack Inc.5%
Epic Pharma, Llc4%
Proficient Rx LP4%
Other makers59%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Buspirone is used (Medicaid data)

A general measure of how commonly Buspirone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Buspirone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

5,180,004
Medicaid prescriptions filled (Q1–Q4 2025)
$64.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Buspirone prescribed? Of the 1,601 medications we measure, Buspirone ranks #42 by Medicaid prescriptions — more than 97% of them.

Where Buspirone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #42 of 1,601
#37 Amoxicillin / Clavulan... 5,453,053 Rx #38 Prednisone 5,404,950 Rx #39 Montelukast 5,399,653 Rx #40 Azithromycin 5,254,152 Rx #41 Loratadine 5,204,681 Rx #42 Buspirone 5,180,004 Rx #43 Aripiprazole 5,031,681 Rx #44 Diclofenac Topical (ar... 4,673,607 Rx #45 Diclofenac Topical (ac... 4,673,607 Rx #46 Diclofenac 4,673,607 Rx #47 Lamotrigine 4,467,083 Rx

Utilization by Buspirone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 10 mg oral tablet is the most-dispensed Buspirone product — about 35% of these Medicaid prescriptions.

buspirone hydrochloride 10 MG Oral Tablet Most dispensed

1,809,402 Medicaid prescriptions (Q1–Q4 2025) 35% of Buspirone prescriptions shown $19M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 28 of 267 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866083

buspirone hydrochloride 15 MG Oral Tablet

1,335,378 Medicaid prescriptions (Q1–Q4 2025) 26% of Buspirone prescriptions shown $15.6M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 35 of 254 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866018

buspirone hydrochloride 5 MG Oral Tablet

1,064,009 Medicaid prescriptions (Q1–Q4 2025) 21% of Buspirone prescriptions shown $9.9M gross reimbursement (before rebates) ≈ $9.28 per prescription (gross)

Summed across the 24 of 216 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866094

buspirone hydrochloride 30 MG Oral Tablet

549,391 Medicaid prescriptions (Q1–Q4 2025) 11% of Buspirone prescriptions shown $9.3M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 20 of 165 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866090

buspirone hydrochloride 7.5 MG Oral Tablet

420,498 Medicaid prescriptions (Q1–Q4 2025) 8% of Buspirone prescriptions shown $6.8M gross reimbursement (before rebates) ≈ $16 per prescription (gross)

Summed across the 10 of 70 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 866111

buspirone hydrochloride 15 MG Oral Capsule

1,326 Medicaid prescriptions (Q3–Q4 2025) <1% of Buspirone prescriptions shown $3.5M gross reimbursement (before rebates) ≈ $2,629 per prescription (gross)

Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2708993

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Buspirone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 118 of 976 listed Buspirone NDCs with Medicaid activity.

Compare Buspirone products

A representative set of FDA-listed product records for Buspirone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 124 of 276 products — FDA National Drug Code Directory. See every product, package size and price: browse all 276 Buspirone NDCs →

Buspirone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 4 Buspirone recalls since July 2021, covering 9 product listings. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class III Apr 13, 2026 · Unichem Pharmaceuticals USA Inc.
Subpotent drug
  • busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area, Meerut Road, Ghazibad - 201 003, India Manufactured for: Unichem Pharmaceu… Lots: Lot: ZBUL25001, Exp 12/31/2027 FDA record D-0511-2026 →
Ongoing Class II Mar 16, 2023 · Northwind Pharmaceuticals LLC
CGMP Deviations
  • BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52 Lots: Lot#: F117312201, Exp. Date 06/30/2024 FDA record D-0549-2023 →
Class III Oct 27, 2023 · Terminated · NCS Healthcare of Kentucky Inc
Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
  • Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141. Lots: Lot#: a) 8255-3012, Exp 08/31/2024; b) 8255-3012, Exp 08/31/2024 FDA record D-0114-2024 →
  • Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangar… Lots: Lot#: a) 7718-3008, Exp 08/31/2024; b) 7718-3008, Exp 08/31/2024 FDA record D-0113-2024 →
Class II Feb 7, 2023 · Terminated · Accord Healthcare, Inc.
CGMP Deviations: recalling drug products following an FDA inspection.
  • BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382… Lots: Batches: P2105551, Exp. Date 7/31/2024; FDA record D-0379-2023 →
  • BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-38… Lots: Batches: P2105472, Exp. Date 4/30/2024; FDA record D-0378-2023 →
  • BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-38… Lots: Batches: P2105483, Exp. Date 7/31/2024; FDA record D-0377-2023 →
  • BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b) 500 Tablets NDC 16729-200-16 UPC 3 16729 20016 5; Manufactured for: Accord Hea… Lots: Batches: a) P2200530, Exp. Date 12/31/2024; b) P2105583, Exp. Date 6/30/2024; FDA record D-0376-2023 →
  • BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-3… Lots: Batches: P2105532, Exp. Date 6/30/2024; P2200348, Exp. Date 12/31/2024; FDA record D-0375-2023 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Buspirone RxCUI 1827 2 dose forms · 11 strengths

Look up RxCUI 1827 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Buspirone brand names

Buspirone is sold under 2 brand names in the FDA directory — Buspar, Bucapsol. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Buspar Bucapsol

Who makes Buspirone: manufacturers and labelers

45 companies list Buspirone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Aphena Pharma Solutions - Tennessee, LLC, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 38 Aphena Pharma Solutions - Tennessee, LLC 20 A-S Medication Solutions 18 Remedyrepack Inc. 13 Epic Pharma, Llc 12 Proficient Rx LP 12 Direct_Rx 8 Cardinal Health 107, LLC 7 PD-Rx Pharmaceuticals, Inc. 7 Asclemed USA, Inc. 6 NuCare Pharmaceuticals, Inc. 6 Unichem Pharmaceuticals (USA), Inc. 6 Apnar Pharma Lp 5 Accord Healthcare Inc. 5 Advagen Pharma Ltd 5 AiPing Pharmaceutical, Inc. 5 Aurobindo Pharma Limited 5 Golden State Medical Supply, Inc. 5 NCS HealthCare of KY, LLC dba Vangard Labs 5 Northwind Health Company, LLC 5 Radha Pharmaceuticals, Inc. 5 Rising Pharma Holdings, Inc. 5 Strides Pharma Inc. 5 Strides Pharma Science Limited 5

…and 21 more on the FDA NDC directory.

Buspirone drug class (RxNorm)

Buspirone belongs to the Azaspirodecanedione derivatives class.

Drug family (ATC) Azaspirodecanedione derivatives

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Buspirone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective May 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Buspirone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Buspirone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
181
Finished products in the current FDA directory
276
Companies listing them (makers, repackagers, distributors)
45
FDA labeler codes behind them ⓘ
50
Linked representative label ⓘ
Boswell Pharmacy Services d/b/a BPS Wholesale
Linked label effective
May 15, 2024
Composite sections available
19
Linked SPL Set ID
18e90d65-4a3a-864e-e063-6294a90ae99d
Linked SPL Document ID
18e9092c-7992-80e0-e063-6294a90a73fb
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Boswell Pharmacy Services d/b/a BPS Wholesale is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →