Buspirone Hydrochloride Medication Guide

Conditions This Medication May Treat

Based on Bridgeway's clinical use. See the FDA "Uses" section below for approved indications.

Anxiety Disorders

Uses (FDA Indications) (FDA source)

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). 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. …

Warnings & Precautions (FDA source)

WARNINGS The administration of buspirone hydrochloride tablets to a patient taking a monoamine oxidase inhibitor (MAOI) may pose a hazard. There have been reports of the occurrence of elevated blood pressure when buspirone hydrochloride has been added to a regimen including an MAOI. Therefore, it is recommended that buspirone hydrochloride tablets not be used concomitantly with an MAOI. Serotonin Syndrome The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs SSRIs, and other serotonergic drugs, including buspirone, alone but particularly with concomitant use of other serotonergic drugs (including triptans), with drugs that impair metabolism of serotonin (in particular, MAOIs, including reversible MAOIs such as linezolid and intravenous methylene blue), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular changes (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for emergence of serotonin syndrome. The concomitant use of buspirone with MAOIs intended to treat depression is contraindicated. Buspirone should also not be started in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. There have been no reports involving the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a reversible MAOI such as linezolid or intravenous methylene blue in a patient taking buspirone. …

Common Side Effects (FDA source)

ADVERSE REACTIONS (See also PRECAUTIONS .) Commonly Observed The more commonly observed untoward events associated with the use of buspirone hydrochloride tablets not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement. Associated with Discontinuation of Treatment One guide to the relative clinical importance of adverse events associated with buspirone hydrochloride tablets is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the buspirone hydrochloride tablets premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary. Incidence in Controlled Clinical Trials The table that follows enumerates adverse events that occurred at a frequency of 1% or more among buspirone hydrochloride patients who participated in 4-week, controlled trials comparing buspirone hydrochloride with placebo. The frequencies were obtained from pooled data for 17 trials. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. Comparison of the cited figures, however, does provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied. …

Drug Interactions (FDA source)

Drug Interactions

Interactions With Other Medications We Cover

FDA label text for Buspirone Hydrochloride or a related medication mentions the following combinations. Check any two medications with our interaction tool →

• Buspirone Hydrochloride + Amphetamine — Moderate
• Buspirone Hydrochloride + Dextroamphetamine Sulfate — Moderate
• Buspirone Hydrochloride + Lisdexamfetamine Dimesylate — Moderate
• Buspirone Hydrochloride + Fluoxetine Hydrochloride — Moderate
• Buspirone Hydrochloride + Fluvoxamine Maleate — Moderate
• Buspirone Hydrochloride + Venlafaxine Hydrochloride — Moderate
• Buspirone Hydrochloride + Clomipramine Hydrochloride — Moderate
• Buspirone Hydrochloride + Sertraline Hydrochloride — Minor
• Buspirone Hydrochloride + Escitalopram Oxalate — Minor
• Buspirone Hydrochloride + Citalopram Hydrobromide — Minor
• Buspirone Hydrochloride + Paroxetine Hydrochloride — Minor
• Buspirone Hydrochloride + Duloxetine Hydrochloride — Minor
• Buspirone Hydrochloride + Lithium Carbonate — Minor
• Buspirone Hydrochloride + Mirtazapine — Minor
• Buspirone Hydrochloride + Trazodone Hydrochloride — Minor

About this interaction data. These interactions were identified by automatically scanning FDA prescribing-label text for medications in Bridgeway's library. This is not a complete list and is not a substitute for review by your prescriber or pharmacist, who use comprehensive clinical databases. Always share your full medication list with your care team. How we source this data →

Contraindications (FDA source)

CONTRAINDICATIONS Buspirone hydrochloride tablets are contraindicated in patients hypersensitive to buspirone hydrochloride. 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 WARNINGS , DOSAGE AND ADMINISTRATION AND DRUG INTERACTIONS )

Use in Specific Populations (FDA source)

Pregnancy: Teratogenic Effects Pregnancy Category B No fertility impairment or fetal damage was observed in reproduction studies performed in rats and rabbits at buspirone doses of approximately 30 times the maximum recommended human dose. In humans, however, adequate and well-controlled studies during pregnancy have not been performed. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Most-Reported Adverse Events (FAERS)

Of 10,969 adverse-event reports mentioning Buspirone Hydrochloride submitted to the FDA, the most frequently reported reactions are:

• Fatigue — 800 reports
• Nausea — 798 reports
• Headache — 731 reports
• Drug Ineffective — 670 reports
• Anxiety — 668 reports
• Dyspnoea — 583 reports
• Pain — 578 reports
• Diarrhoea — 511 reports
• Depression — 503 reports
• Dizziness — 500 reports

Source: FDA Adverse Event Reporting System (FAERS). These are voluntary, unverified reports from patients and providers worldwide — they do not mean the medication caused the reaction, and report counts reflect how widely a drug is used as much as its safety profile.

Recent FDA Recalls

There are 2 ongoing FDA recalls involving Buspirone Hydrochloride. See full medication safety feed →