Prescription medication · Azapirone Anxiolytic
buspirone
Also sold as BuSpar. Buspirone is used to manage anxiety disorders.
Data updated 2026-05-15
- 10,228
- FDA reportsModerately reported
- 17
- InteractionsSeveral interactions
- 2
- Recall records
What the data shows
buspirone (BuSpar) is a prescription Azapirone Anxiolytic, reported less often than most tracked drugs (10,228 FDA reports), with 17 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
buspirone (BuSpar) is a prescription Azapirone Anxiolytic. Buspirone is used to manage anxiety disorders.
Buspirone is a medicine that can help manage anxiety disorders. It can also provide short-term relief from anxiety symptoms.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.03/unit
Generic Available
Yes (15 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: BUSPIRONE HCL 10 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +0.5% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| May 22, 2024 | $0.0285/EA | - | 1 |
| December 18, 2024 | $0.0286/EA | +0.5% | 33 |
What it does
Buspirone is used to manage anxiety disorders.
Common side effects
Dizziness, Nausea, Headache
Key warnings
You should not take buspirone if you are taking a monoamine oxidase inhibitor (MAOI) antidepressant or have taken one in the past 14 days.
The sections below are summarized in plain English from buspirone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Buspirone affects certain chemicals in your brain that may be unbalanced. This helps to reduce anxiety. It is different from other anxiety medicines like benzodiazepines.
Side Effects (from patient reports)
Based on 10,228 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for buspirone, by number of reports
- Fatigue
Fatigue
759 reports
- Nausea
Nausea
744 reports
- Headache
Headache
675 reports
- Anxiety
Anxiety
636 reports
- Pain
Pain
541 reports
- Dyspnoea
Dyspnoea
519 reports
- Depression
Depression
477 reports
- Dizziness
Dizziness
472 reports
- Diarrhoea
Diarrhoea
465 reports
- Fall
Fall
389 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for buspirone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where buspirone sits
buspirone has more FDA adverse-event reports than 40% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is buspirone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 10,228 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2003–2025.
Total Reports
10,228
Reports Mentioning Death
694
6.8% of reports — not proof of cause
Hospitalization Reports
2,354
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FATIGUE | 759 |
| 2 | NAUSEA | 744 |
| 3 | HEADACHE | 675 |
| 4 | ANXIETY | 636 |
| 6 | PAIN | 541 |
| 7 | DYSPNOEA | 519 |
| 8 | DEPRESSION | 477 |
| 9 | DIZZINESS | 472 |
| 10 | DIARRHOEA | 465 |
| 12 | FALL | 389 |
| 14 | VOMITING | 323 |
| 15 | MALAISE | 321 |
| 16 | INSOMNIA | 319 |
| 17 | ARTHRALGIA | 313 |
| 18 | FEELING ABNORMAL | 312 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take buspirone if you are taking a monoamine oxidase inhibitor (MAOI) antidepressant or have taken one in the past 14 days. Do not start buspirone if you are being treated with linezolid or intravenous methylene blue because of the risk of serotonin syndrome. Serotonin syndrome is a very serious condition.
Known Drug Interactions
Product Clinical Comment on Concomitant Use [See Contraindications (4.1)] ; Predominant Effect/Risk [Hypertensive Reaction (HR) [See Warnings and Precautions (5.3)] ; or Serotonin Syndrome (SS) [See Warnings and Precautions (5.7)] ] Altretamine Use with caution If not otherwise specified in this table, consider avoiding concomitant use (see also information on medication-free intervals , use agent at the lowest appropriate dose, monitor for effects of the interaction, advise the patient to report potential effects, and be prepared to discontinue the agent and treat effects of the...
Mechanism: Combining these medications can cause a dangerous spike in blood pressure or a serious condition called serotonin syndrome.
Risk of serotonin syndrome with concomitant therapy with other serotonergic drugs such as SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St.
Mechanism: Both of these drugs increase a chemical in the brain called serotonin. Having too much serotonin can lead to a dangerous condition called serotonin syndrome.
Other Serotonergic Drugs Clinical Impact: Concomitant use of citalopram and other serotonergic drugs (including other SSRIs, SNRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.
Mechanism: Both of these medications increase a brain chemical called serotonin. Using them together can cause serotonin levels to rise too high.
buspirone, diazepam, estazolam, zolpidem ↑ sedatives/hypnotics Titration is recommended when co-administering darunavir/ritonavir with sedatives/hypnotics metabolized by CYP3A and a lower dose of the sedatives/hypnotics should be considered with monitoring for adverse events.
Mechanism: Darunavir blocks the enzyme that breaks down buspirone, which can lead to higher levels of the medication in your blood.
Examples other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.
Mechanism: Both of these medications increase a brain chemical called serotonin, which can cause an additive effect.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take buspirone with other anxiety medications?
How long does it take for buspirone to start working?
Can I drink alcohol while taking buspirone?
Will buspirone make me sleepy?
Can I stop taking buspirone suddenly?
Does buspirone have any drug interactions?
Can I drive while taking buspirone?
What should I do if I experience side effects?
Is buspirone addictive?
How often will I see my doctor while taking buspirone?
What are the common side effects of buspirone?
Does buspirone interact with other medications?
What drug class is buspirone?
What pregnancy or breastfeeding source fields are listed for buspirone?
Has buspirone been recalled?
Active Recalls
Subpotent drug
Unichem Pharmaceuticals USA Inc.
CGMP Deviations
Northwind Pharmaceuticals LLC
Related Medications in Azapirone Anxiolytic
Other drugs grouped near buspirone - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with buspirone →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with buspirone →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with buspirone →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with buspirone →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with buspirone →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for buspirone: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 10,228.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 6.79%.
- anastrozole Δ 0.01 pts · 35,161 reports · Aromatase Inhibitor 6.78%death share
- ziprasidone Δ 0.03 pts · 17,328 reports · Atypical Antipsychotic 6.76%death share
- oxcarbazepine Δ 0.06 pts · 31,347 reports · Anticonvulsant 6.73%death share
- omadacycline Δ 0.06 pts · 1,476 reports · Tetracycline Antibiotic 6.84%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for buspirone
The FDA label for buspirone (sold under brand names such as BuSpar) classifies it as a prescription-only medication in the Azapirone Anxiolytic class. Buspirone is used to manage anxiety disorders. Official labeling lists 6 commonly reported side effects, including Dizziness, Nausea, Headache.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 10,228 voluntary reports. The database also lists 17 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.03.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: May 3, 2019
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages