The information below includes important safety information about buspirone, which is the generic version of the brand name drug BuSpar®. Buspirone is a prescription medication used for the treatment of generalized anxiety disorder (GAD) or the short-term relief of symptoms of anxiety and can be used off-label to augment treatment for unipolar depression. Read this information before you begin taking buspirone. You must notify your healthcare provider if you start or stop taking buspirone.

Do not take buspirone if you:

• Are allergic to buspirone, or any of the ingredients in buspirone
• Have severe liver or kidney problems
• Have benzodiazepine dependence
• Take St John’s Wort or 5-Hydroxytryptophan (5-HTP)
• Take any medicines for Parkinson’s Disease or depression called monoamine oxidase inhibitors (MAOI), or if you have stopped taking an MAOI in the last 14 days as they may cause a dangerous increase in blood pressure. MAOIs include, but are not limited to:
• isocarboxazid
• phenelzine
• rasagiline
• selegiline
• tranylcypromine
• Take other medication that may cause an increase in serotonin levels, such as
• linezolid
• methylene blue
• tryptophan

Before taking buspirone, inform your healthcare provider and pharmacist about all prescription medications you are taking or plan to take, including those to treat Parkinson’s Disease or psychiatric disorders (including antidepressants or amphetamines) to avoid a potentially life-threatening condition called Serotonin Syndrome or a dangerous increase in blood pressure. Inform your healthcare provider about any over-the-counter medications, vitamins, and natural supplements, such as St. John’s Wort, that you are taking or plan to take to help avoid potentially dangerous drug-drug interactions. Be sure to mention to your prescriber if you drink grapefruit juice or eat grapefruit regularly.

• Become severely ill and have some or all of these symptoms: agitation, hallucinations, coma, or other changes in mental status; coordination problems or muscle twitching (overactive reflexes); racing heartbeat, high or low blood pressure; sweating or fever; nausea, vomiting, or diarrhea; muscle tightness, as these may be the symptoms of a life-threatening condition called Serotonin Syndrome
• Develop restlessness or an inability to remain still, involuntary movements, hostility, or depression
• Have a rash, hives, swelling, or trouble breathing as these may be the symptoms of an allergic reaction
• Are pregnant, plan to become pregnant, or are breastfeeding

Until you experience how this medication affects you, do not drive a car, operate potentially dangerous machinery, or perform other dangerous activities.

You should take buspirone consistently, either always with or always without food.

During your treatment with buspirone, avoid drinking large amounts of grapefruit juice.

Avoid drinking alcohol while taking buspirone.

• Dizziness
• Drowsiness
• Diarrhea
• Nausea
• Headache
• Insomnia
• Mild congestion
• A very rare but serious side effect that may occur with buspirone therapy is serotonin syndrome. The symptoms of serotonin syndrome include, but are not limited to, a change in mental status, trouble speaking or swallowing, excessive sweating, tremors, involuntary muscle contractions, and increased body temperature. Seek emergent medical care if you are experiencing any of these symptoms as they could be a sign of a life-threatening condition.

If you miss a dose of buspirone, take it as soon as you remember. However, if it is almost time for your next dose, then skip the missed dose and continue your regular dosing schedule. Do not double your next dose or take more than what is prescribed.