Buspirone

Before taking buspirone,

• tell your doctor and pharmacist if you are allergic to buspirone or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antihistamines; anticonvulsants such as carbamazepine (Tegretol), phenobarbital (Barbita, Luminal, Solfoton), and phenytoin (Dilantin); dexamethasone (Decadron, others); diazepam (Valium); diltiazem (Cardizem, Dilacor, Tiazac); erythromycin (E.E.S., E-Mycin, Erythrocin, others); haloperidol (Haldol); ketoconazole (Nizoral); itraconazole (Sporanox); MAO inhibitors [phenelzine (Nardil) and tranylcypromine (Parnate)]; muscle relaxants; nefazodone (Serzone); pain medications or narcotics; rifampin (Rifadin, Rimactane); ritonavir (Norvir); sedatives; sleeping pills; tranquilizers; trazodone (Desyrel); verapamil (Calan, Covera, Verelan); and vitamins.
• tell your doctor if you have or have ever had kidney or liver disease or a history of alcohol or drug abuse.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking buspirone, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking buspirone.
• you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.
• remember that alcohol can add to the drowsiness caused by this drug.

Serious side effects have been reported with buspirone. See the “Buspirone Precautions” section.

Common side effects of buspirone include the following:

• upset stomach
• vomiting
• constipation
• diarrhea
• stomach pain
• headache
• dry mouth
• depression
• excitement
• fatigue
• nervousness
• difficulty sleeping
• lightheadedness
• weakness
• numbness

This is not a complete list of buspirone side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Buspirone falls into category B. There are no well-done studies that have been done in humans with buspirone. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

• It is used to treat anxiety.
• It may be given to you for other reasons. Talk with the doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about buspirone, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about buspirone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using buspirone.

Review Date: October 4, 2017

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, III1 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. Autonomic hyperactivity: sweating, heart pounding or racing, cold, clammy hands, dry mouth, dizziness, lightheadedness, paresthesias (tingling in hands or feet), upset stomach, hot or cold spells, frequent urination, diarrhea, discomfort in the pit of the stomach, lump in the throat, flushing, pallor, high resting pulse and respiration rate.
3. Apprehensive expectation: anxiety, worry, fear, rumination, and anticipation of misfortune to self or others.
4. Vigilance and scanning: hyperattentiveness resulting in distractibility, difficulty in concentrating, insomnia, feeling "on edge," irritability, impatience.

The above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. However, mild depressive symptoms are common in GAD.

The effectiveness of Buspirone hydrochloride tablets in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. There is no body of evidence available that systematically addresses the appropriate duration of treatment for GAD. However, in a study of long-term use, 264 patients were treated with Buspirone hydrochloride tablets for 1 year without ill effect. Therefore, the physician who elects to use Buspirone hydrochloride tablets for extended periods should periodically reassess the usefulness of the drug for the individual patient.

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).

Controlled Substance Class

Buspirone hydrochloride is not a controlled substance.

Physical and Psychological Dependence

In human and animal studies, Buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. Human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. None of the subjects were able to distinguish between Buspirone hydrochloride tablets and placebo. By contrast, subjects showed a statistically significant preference for methaqualone and diazepam. Studies in monkeys, mice, and rats have indicated that Buspirone lacks potential for abuse.

Following chronic administration in the rat, abrupt withdrawal of Buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency.

Although there is no direct evidence that Buspirone hydrochloride tablets causes physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a CNS-active drug will be misused, diverted, and/or abused once marketed. Consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of Buspirone hydrochloride tablets misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

1. American Psychiatric Association, Ed.: Diagnostic and Statistical Manual of Mental DisordersIII, American Psychiatric Association May 1980.

Manufactured by:
Amneal Pharmaceuticals Pvt. Ltd.
Oral Solid Dosage Unit
Ahmedabad, 382213 INDIA

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev.04-2017-01

Refer to adult dosing.

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy

Analgesics (Opioid): CNS Depressants may enhance the CNS depressant effect of Analgesics (Opioid). Management: Avoid concomitant use of opioid analgesics and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Antidepressants (Serotonin Reuptake Inhibitor/Antagonist): BusPIRone may enhance the serotonergic effect of Antidepressants (Serotonin Reuptake Inhibitor/Antagonist). Management: The combination of a serotonin reuptake inhibitor,antagonist and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Antiemetics (5HT3 Antagonists): May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of BusPIRone. Isavuconazonium considerations are addressed in separate monographs. Exceptions: Isavuconazonium Sulfate. Consider therapy modification

Antipsychotic Agents: Serotonin Modulators may enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonin modulators may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification

Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of BusPIRone. Exceptions: Bepridil. Consider therapy modification

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy

Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dapoxetine: May enhance the adverse/toxic effect of Serotonin Modulators. Avoid combination

Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Grapefruit Juice: May increase the serum concentration of BusPIRone. Management: Monitor for increased therapeutic effects of buspirone if increased quantities of grapefruit juice are consumed. Periodic, small portions of grapefruit juice are likely of little concern, but large quantities should be avoided. Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates. Avoid combination

Ioflupane I 123: BusPIRone may diminish the diagnostic effect of Ioflupane I 123. Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Macrolide Antibiotics: May decrease the metabolism of BusPIRone. Exceptions: Azithromycin (Systemic); Fidaxomicin; Roxithromycin; Spiramycin. Consider therapy modification

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

MAO Inhibitors: BusPIRone may enhance the adverse/toxic effect of MAO Inhibitors. Specifically, blood pressure elevations been reported. Avoid combination

Metaxalone: May enhance the serotonergic effect of Serotonin Modulators. This could result in serotonin syndrome. Monitor therapy

Methotrimeprazine: May enhance the CNS depressant effect of CNS Depressants. CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification

Methylene Blue: BusPIRone may enhance the serotonergic effect of Methylene Blue. This could result in serotonin syndrome. Avoid combination

Methylphenidate: May enhance the adverse/toxic effect of Serotonin Modulators. Specifically, the risk of serotonin syndrome or serotonin toxicity may be increased. Monitor therapy

Metoclopramide: Serotonin Modulators may enhance the adverse/toxic effect of Metoclopramide. This may be manifest as symptoms consistent with serotonin syndrome or neuroleptic malignant syndrome. Monitor therapy

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Palbociclib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Monitor therapy

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy

Resveratrol: May increase the serum concentration of BusPIRone. Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of BusPIRone. Management: The degree to which rifampin alters buspirone concentrations warrants the consideration of an alternative to buspirone that is not metabolized by CYP3A4. If these agents are used together, buspirone dose adjustments may be needed. Consider therapy modification

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Selective Serotonin Reuptake Inhibitors: BusPIRone may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors. This may cause serotonin syndrome. Selective Serotonin Reuptake Inhibitors may decrease the metabolism of BusPIRone. Management: The combination of a selective serotonin reuptake inhibitor and buspirone should be undertaken with great caution. When combined treatment is clinically indicated, monitor closely for signs of serotonin toxicity/serotonin syndrome. Consider therapy modification

Serotonin Modulators: May enhance the adverse/toxic effect of other Serotonin Modulators. The development of serotonin syndrome may occur. Exceptions: Nicergoline; Tedizolid. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Stiripentol: May increase the serum concentration of CYP3A4 Substrates. Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy

Yohimbine: May diminish the therapeutic effect of Antianxiety Agents. Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification

Mental status, symptoms of anxiety, signs/symptoms of serotonin syndrome.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience fatigue, dizziness, anxiety, headache, or nausea. Have patient report immediately to prescriber signs of serotonin syndrome (dizziness, severe headache, agitation, hallucinations, tachycardia, abnormal heartbeat, flushing, tremors, sweating a lot, change in balance, severe nausea, or severe diarrhea), agitation, abnormal movements, twitching, change in balance, difficulty speaking, or difficulty swallowing (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Applies to buspirone: oral tablet

Along with its needed effects, buspirone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking buspirone:

• Chest pain
• confusion
• fast or pounding heartbeat
• fever
• incoordination
• mental depression
• muscle weakness
• numbness, tingling, pain, or weakness in the hands or feet
• skin rash or hives
• sore throat
• stiffness of the arms or legs
• uncontrolled movements of the body

Get emergency help immediately if any of the following symptoms of overdose occur while taking buspirone:

• Dizziness or lightheadedness especially when getting up from a sitting or lying position suddenly
• drowsiness (severe)
• loss of consciousness
• nausea or vomiting
• stomach upset
• very small pupils of the eyes

Some side effects of buspirone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Restlessness, nervousness, or unusual excitement

• Blurred vision
• clamminess or sweating
• decreased concentration
• diarrhea
• drowsiness
• dryness of the mouth
• muscle pain, spasms, cramps, or stiffness
• ringing in the ears
• trouble with sleeping, nightmares, or vivid dreams
• unusual tiredness or weakness

Applies to buspirone: compounding powder, oral tablet

Nervous system

Very common (10% or more): Dizziness (12%), drowsiness (10%)
Common (1% to 10%): Lightheadedness, decreased concentration, numbness, paresthesia, incoordination, headache, tremor, syncope, seizures
Rare (less than 0.1%): Cerebrovascular accident
Very rare (less than 0.01%): Serotonin syndrome, amnesia, cogwheel rigidity, dystonia/dystonic reactions, dyskinesias (acute and tardive), ataxias, parkinsonism, akathisia, restless leg syndrome
Postmarketing reports: Vertigo, extrapyramidal symptoms, transient difficulty with recall[Ref]

Cardiovascular

Common (1% to 10%): Tachycardia/palpitations, chest pain
Uncommon (0.1% to 1%): Hypotension, hypertension
Rare (less than 0.1%): Congestive heart failure, myocardial infarction, cardiomyopathy, bradycardia[Ref]

Dermatologic

Common (1% to 10%): Rash, sweating/clamminess
Uncommon (0.1% to 1%): Pruritus, flushing, easy bruising, hair loss, dry skin, facial edema, blisters
Rare (less than 0.1%): Acne, thinning of nails, ecchymosis, urticaria[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, dry mouth, abdominal/gastric distress, diarrhea, constipation, vomiting
Uncommon (0.1% to 1%): Flatulence, anorexia, increased appetite, salivation, irritable colon, rectal bleeding
Rare (less than 0.1%): Burning of the tongue[Ref]

Musculoskeletal

Common (1% to 10%): Musculoskeletal aches/pains
Uncommon (0.1% to 1%): Muscle cramps, muscle spasms, rigid/stiff muscles, arthralgias
Rare (less than 0.1%): Muscle weakness[Ref]

Ocular

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Eye redness and itching, conjunctivitis, eye pain, eye pressure, photophobia
Very rare (less than 0.01%): Visual changes (including tunnel vision)[Ref]

Other

Common (1% to 10%): Fatigue, weakness, tinnitus, sore throat
Uncommon (0.1% to 1%): Altered taste, altered smell, inner ear abnormality, edema, fever, roaring sensation in the head, malaise
Rare (less than 0.1%): Alcohol abuse, loss of voice, hiccoughs[Ref]

Psychiatric

Common (1% to 10%): Insomnia, nervousness, excitement, anger/hostility, confusion, depression, dream disturbances, attention disturbance, sleep disorder
Uncommon (0.1% to 1%): Depersonalization, dysphoria, noise intolerance, euphoria, akathisia, fearfulness, loss of interest, dissociative reaction, hallucinations, involuntary movements, slowed reaction time, suicidal ideation, decreased or increased libido
Rare (less than 0.1%): Claustrophobia, cold intolerance, stupor, slurred speech, psychosis, delayed ejaculation, impotence
Very rare (less than 0.01%): Depersonalization
Postmarketing reports: Emotional lability, restlessness[Ref]

Respiratory

Common (1% to 10%): Nasal congestion, pharyngolaryngeal pain
Uncommon (0.1% to 1%): Hyperventilation, shortness of breath, chest congestion
Rare (less than 0.1%): Epistaxis[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary frequency, urinary hesitancy, menstrual irregularity and spotting, dysuria
Rare (less than 0.1%): Amenorrhea, pelvic inflammatory disease, enuresis, nocturia
Very rare (less than 0.01%): Urinary retention[Ref]

Hepatic

Uncommon (0.1% to 1%): Increases in hepatic aminotransferases (SGOT, SGPT)[Ref]

Metabolic

Uncommon (0.1% to 1%): Weight gain, weight loss[Ref]

Endocrine

Rare (less than 0.1%): Galactorrhea, thyroid abnormality[Ref]

Hematologic

Rare (less than 0.1%): Eisonophilia, leukopenia, thrombocytopenia, bleeding disturbance[Ref]

Hypersensitivity

Postmarketing reports: Allergic reactions, angioedema[Ref]

Some side effects of buspirone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

-Mild to Moderate Renal Impairment: Dose adjustments may be required; however, no specific guidelines have been suggested. Caution is recommended.
-Severe Renal Impairment: Not recommended.

• Buspirone may be used for the treatment of anxiety.
• Experts are not sure exactly how buspirone works but think its anxiety-relieving effects may be due to its effects on serotonin and other neurotransmitter receptors such as dopamine.
• Buspirone belongs to the group of medicines known as anxiolytics.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• chest pain;

• shortness of breath; or

• a light-headed feeling, like you might pass out.

Common side effects may include:

• headache;

• dizziness, drowsiness;

• sleep problems (insomnia);

• nausea, upset stomach; or

• feeling nervous or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.