A small number of children, teenagers, and young adults (up to 24 years of age) who took antidepressants (‘mood elevators’) such as nefazodone during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, there are also risks when depression is not treated in children and teenagers. Talk to your child’s doctor about these risks and whether your child should take an antidepressant. Children younger than 18 years of age should not normally take nefazodone, but in some cases, a doctor may decide that nefazodone is the best medication to treat a child’s condition.

You should know that your mental health may change in unexpected ways when you take nefazodone or other antidepressants even if you are an adult over 24 years of age. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and frenzied abnormal excitement. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Your healthcare provider will want to see you often while you are taking nefazodone, especially at the beginning of your treatment. Be sure to keep all appointments for office visits with your doctor.

The doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with nefazodone. Read the information carefully and ask your doctor or pharmacist if you have any questions. You also can obtain the Medication Guide from the FDA website: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm.

No matter what your age, before you take an antidepressant, you, your parent, or your caregiver should talk to your doctor about the risks and benefits of treating your condition with an antidepressant or with other treatments. You should also talk about the risks and benefits of not treating your condition. You should know that having depression or another mental illness greatly increases the risk that you will become suicidal. This risk is higher if you or anyone in your family has or has ever had bipolar disorder (mood that changes from depressed to abnormally excited) or mania (frenzied, abnormally excited mood) or has thought about or attempted suicide. Talk to your doctor about your condition, symptoms, and personal and family medical history. You and your doctor will decide what type of treatment is right for you.

Nefazodone may cause liver damage, which can be severe or life-threatening. Tell your doctor if you have or have ever had liver disease. If you experience any of the following symptoms, call your doctor immediately: nausea, vomiting, loss of appetite, extreme tiredness, lack of energy, yellowing of the skin or eyes, unusual bleeding or bruising, dark-colored urine, pain in the upper right part of the stomach, or flu-like symptoms.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain tests to check your body’s response to nefazodone.

Nefazodone is used to treat depression. Nefazodone is in a class of medications called serotonin modulators. It works by increasing the amounts of certain natural substances in the brain that are needed to maintain mental balance.

Nefazodone comes as a tablet to take by mouth. It is usually taken two times a day with or without food. Take nefazodone at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take nefazodone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of nefazodone and gradually increase your dose, not more than once every week.

It may take several weeks or longer for you to feel the full benefit of nefazodone. Continue to take nefazodone even if you feel well. Do not stop taking nefazodone without talking to your doctor. If your doctor tells you to stop taking nefazodone, your doctor will probably want to decrease your dose gradually.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking nefazodone,

• Tell your doctor and pharmacist if you are allergic to nefazodone, trazodone (Desyrel), or any other medications.
• Tell your doctor if you are taking astemizole (Hismanal) (not available in the U.S.), carbamazepine (Tegretol), cisapride (Propulsid) (not available in the U.S.), pimozide (Orap), terfenadine (Seldane) (not available in the U.S.);or triazolam (Halcion).Your doctor will probably tell you not to take nefazodone.
• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: alprazolam (Xanax), anticoagulants (‘blood thinners’) such as warfarin (Coumadin); buspirone (BuSpar); cholesterol-lowering medications (statins) such as atorvastatin (Lipitor), lovastatin (Mevacor), and simvastatin (Zocor); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); haloperidol (Haldol); medications for high blood pressure, medications for seizures, medications to treat anxiety; muscle relaxants; propranolol (Inderal); sedatives; sleeping pills; tacrolimus (Prograf); or tranquilizers. . If you have recently stopped taking fluoxetine (Prozac, Sarafem), your doctor may tell you to wait several weeks before beginning to take nefazodone. Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, EMSAM, Zelapar) or tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• Tell your doctor if you have or have ever had seizures; a heart attack, chest pain, a stroke, or other types of heart disease.
• Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking nefazodone, call your doctor.
• If you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nefazodone.
• You should know that this medication may make you drowsy or affect your judgment, thinking, or motor skills. Do not drive a car or operate machinery until you know how this medication affects you.
• Avoid drinking alcohol while taking nefazodone.
• You should know that nefazodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking nefazodone. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• You should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Nefazodone may cause side effects. Call your doctor if any of these symptoms are severe or do not go away:

• Headache
• Difficulty concentrating
• Dry mouth
• Heartburn
• Flushing or feeling warm
• Pain, burning, numbness, or tingling in the hands or feet
• Constipation

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNINGS or SPECIAL PRECAUTIONS sections, call your doctor immediately:

• Rash
• Hives
• Itching
• Difficulty breathing or swallowing
• Swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• Hoarseness
• Slow heartbeat
• Memory problems
• Blurred vision or vision changes
• Confusion
• Seizures
• Painful erection of the penis lasting more than 4 hours

Nefazodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• Nausea
• Vomiting
• Drowsiness

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.