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 →
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.
How to Take It
Start with 15 mg per day, split into two doses (7.5 mg twice a day). Your doctor may increase the dose by 5 mg every 2 to 3 days as needed. Do not take more than 60 mg per day. Take buspirone the same way each time, either always with food or always without food.
This is a plain-language summary of buspirone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if buspirone will harm your unborn baby. Buspirone may pass into breast milk.
This is a plain-language summary of buspirone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of buspirone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store buspirone at room temperature (68° to 77°F) in a closed container, away from light and moisture. Keep out of reach of children.
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
- Tiredness
Tiredness
759 reports
- Feeling sick to your stomach
Feeling sick to your stomach
744 reports
- Head pain
Head pain
675 reports
- Worry
Worry
636 reports
- Aches
Aches
541 reports
- Difficulty breathing
Difficulty breathing
518 reports
- Feeling sad
Feeling sad
477 reports
- Feeling unsteady
Feeling unsteady
472 reports
- Loose stools
Loose stools
465 reports
- Falling down
Falling down
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) 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.
What to do: You should generally avoid taking these two medications together to prevent severe and life-threatening side effects.
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.
What to do: Tell your doctor if you feel very restless, confused, or have a fast heartbeat. Your doctor will decide if it is safe for you to take both medicines.
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.
What to do: Talk to your doctor about the risks and watch for symptoms like confusion, sweating, or a fast heartbeat.
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.
What to do: Your doctor should consider starting with a lower dose of buspirone and monitor you closely for side effects.
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.
What to do: Watch for signs of too much serotonin, such as fever or a fast heartbeat, and tell your doctor if they occur.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is buspirone safe during pregnancy?
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.
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alprazolam
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amitriptyline
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amphetamine/dextroamphetamine
Adderall, Adderall XR
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aripiprazole
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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
Why some drugs demand precise dosing and monitoring
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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: May 3, 2019
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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