Gepirone

Gepirone is used in adults to treat major depressive disorder.

Gepirone may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Gepirone is usually taken once a day with food at the same time each day.

You will need frequent medical tests.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

People with depression or mental illness may think about suicide. Some young people may have more thoughts about suicide when they first start taking a medicine to treat depression. Tell your doctor immediately if you notice any sudden changes in your mood or behavior, or have thoughts about suicide.

You should not use gepirone if you are allergic to it, or if you have:

• congenital long QT syndrome;
• heart rhythm disorder; or
• severe liver disease.

Some drugs should not be used with gepirone. Your treatment plan may change if you also take certain other medicines.

Do not use gepirone if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, and tranylcypromine. Wait at least 14 days after stopping an MAO inhibitor before you take gepirone.

Tell your doctor if you have ever had:

• bipolar disorder (manic depression) in you or a family member;
• heart problems, heart rhythm disorder;
• high blood pressure;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium); or
• kidney disease.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of gepirone on the baby.

Gepirone may harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you use gepirone during the third trimester of pregnancy, your baby could be born with life-threatening withdrawal symptoms and may need medical treatment for several weeks.

Ask a doctor if it is safe to breastfeed while using gepirone.

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

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when they first start a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Gepirone may cause serious side effects. Call your doctor at once if you have:

• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea;
• manic episodes--racing thoughts, increased energy, decreased need for sleep, risk-taking behavior, being agitated or talkative; or
• irregular heartbeats, dizziness, a light-headed feeling, like you might pass out.

Common side effects of gepirone may include:

• dizziness;
• headache;
• trouble sleeping; or
• nausea, stomach pain, upset stomach.

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.

Take the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Signs of an overdose may include vomiting, an irregular heartbeat, loss of consciousness, and seizures.

Follow your doctor's directions regarding any limits on food, drinks, or activities.

Gepirone can lead to a serious heart problem. Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Inform your doctor if you are using stimulant medicine, opioid medicine, herbal products, or medicines for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or to prevent nausea and vomiting. An interaction with gepirone could lead to a serious condition called serotonin syndrome.

Make sure to tell your doctor about all your current medicines. Many drugs can interact with gepirone, especially:

• nefazodone;
• St. John's wort;
• an antibiotic--clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;
• antifungal medicine--itraconazole, ketoconazole;
• antiviral medicine for HIV or hepatitis C--boceprevir, cobicistat, dasabuvir, elvitegravir, indinavir, lopinavir/ritonavir, nelfinavir, ombitasvir, paritaprevir, saquinavir, telaprevir, tipranavir;
• cancer medicine--apalutamide, enzalutamide, mitotane;
• seizure medicine--carbamazepine, oxcarbazepine, phenytoin, primidone;
• steroid medicine--dexamethasone, prednisone;
• an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others;
• a diuretic or "water pill";
• steroids (oral, nasal, inhaled, or injectable);
• migraine headache medicine; or
• medicine to treat anxiety, mood disorders, or mental illness such as schizophrenia.

This list is not complete and many other drugs may affect gepirone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.