Nefazodone Hydrochloride, Oral

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KEY POINTS

• This medicine is taken by mouth to treat depression. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause severe liver damage or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antidepressant

Generic and brand names: nefazodone hydrochloride, oral

What is this medicine used for?

This medicine is taken by mouth to treat depression.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A stroke or transient ischemic attack (TIA)
• Heart disease or a heart attack
• High or low blood pressure
• Kidney disease
• Liver disease
• Mental health problems such as bipolar disorder, paranoia, or schizophrenia
• Seizures
• Thoughts of suicide

This medicine has been reported to cause liver failure. People who have liver problems should not take this medicine. Talk with your healthcare provider about this.

Do not take this medicine if you are currently taking any of these medicines: carbamazepine (Tegretol, Carbatrol) alprazolam (Xanax), triazolam (Halcion), pimozide (Orap), or an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), and tranylcypromine (Parnate).

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or take it longer than prescribed. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually. Stopping too quickly may cause withdrawal symptoms.

Check with your healthcare provider before using this medicine in children under age 18.

You may take this medicine with or without food. Take it with a full glass of water.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider. Do not stop taking this medicine without your healthcare provider's approval. You may need to reduce your dose slowly to avoid withdrawal symptoms.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, nausea, vomiting, seizures.

What should I watch out for?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or if your dose changes. Talk with your provider about this.

Behavior changes may be caused by the medicine or by depression or another mental health problem. Contact your provider right away if you or your family notice any disturbing changes in your thoughts or behavior, such as:

• More outgoing or aggressive behavior than normal
• Confusion
• Hallucinations
• Worsening of depression
• Suicidal thoughts

You may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests. This medicine may cause severe liver damage in some people. Contact your provider right away if you have symptoms of liver damage such as dark urine, yellowing of the skin and eyes, unexplained tiredness, pain in the upper right part of the stomach, loss of appetite, nausea, or vomiting.

It may take several weeks before you start to feel better. Do not stop taking this medicine unless your healthcare provider tells you to do so. You may have withdrawal symptoms if you stop this medicine abruptly.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may make you dizzy or drowsy or cause blurred vision. Do not drive or operate machinery unless you are fully alert.

You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Men: Rarely, this medicine may cause a painful erection of the penis that will not return to normal. If you have an erection lasting more than 4 hours, contact your healthcare provider or get medical care right away. It can lead to permanent erectile dysfunction if not treated.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain; chills; dark urine; fast or irregular heartbeat; hallucinations; heavy sweating; high fever; fainting; loss of bladder control; mouth sores; muscle or joint pain; new or sudden changes in mood, behaviors, thoughts, or feelings; numbness or tingling in the hands or feet; persistent headache; prolonged erection; rash; seizures; severe drowsiness; severe muscle stiffness; severe restlessness or panic attacks; thoughts of suicide; trouble concentrating or memory problems; trouble urinating; trouble walking or loss of balance; twitching or involuntary movement of your body or face; unexplained sore throat; unusual bruising or bleeding; unusual excitement; unusual tiredness or weakness; worsening depression; yellowing of your eyes or skin.

Other: Abnormal dreams; bloating; change in sense of taste; change in sexual ability or desire; constipation; diarrhea; mild dizziness; mild drowsiness; dry mouth; mild headache; increased appetite; nausea; trouble sleeping; vision problems; weight gain or loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Abiraterone (Zytiga)
• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), lisinopril (Prinivil, Zestril), and others
• Allergy, cold, or cough medicines and decongestants
• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), tamsulosin (Flomax), and others
• Angiotensin receptor blockers (ARBs) such as candesartan (Atacand), irbesartan (Avapro), losartan (Cozaar), valsartan (Diovan), and others
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), diazepam (Valium), lorazepam (Ativan), and others
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), procainamide, propafenone (Rythmol), and others
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), and others
• Antidepressants such as citalopram (Celexa), fluoxetine (Prozac), nortriptyline (Pamelor), sertraline (Zoloft), and others
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), hydroxyzine (Vistaril), and others
• Antipsychotic medicines such as haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), thioridazine, and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), primidone (Mysoline), valproic acid (Depacon, Depakene, Depakote), and others
• Aspirin and other salicylates
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), and others
• Bosentan (Tracleer)
• Bupropion (Aplenzin, Buproban, Forfivo, Wellbutrin, Zyban)
• Buspirone
• Calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Cartia, Tiazac), nifedipine (Adalat CC, Procardia), verapamil (Calan, Covera, Verelan), and others
• Cancer medicines such as crizotinib (Xalkori), dasatinib (Sprycel), imatinib (Gleevec), nilotinib (Tasigna), and others
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Altoprev), and simvastatin (Zocor)
• Cimetidine (Tagamet)
• Colchicine (Colcrys)
• Corticosteroids such as budesonide (Entocort, Rhinocort, Uceris) and fluticasone (Flonase, Flovent, Veramyst)
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Digoxin (Lanoxin)
• Doxepin (Silenor)
• Eplerenone (Inspra)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Everolimus (Afinitor, Zortress)
• HIV medicines such efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), lopinavir/ritonavir (Kaletra), ritonavir (Norvir), and others
• Hormonal birth control implants, IUDs, patches, pills, shots, and vaginal rings, and hormones such as conjugated estrogens (Premarin), estradiol (Climara, Estrace, Estraderm, Vivelle), medroxyprogesterone (Depo-Provera, Provera), norethindrone (Aygestin, Micronor), and others
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune) and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), dabigatran (Pradaxa), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Metoclopramide (Metozolv, Reglan)
• Migraine medicines such as almotriptan (Axert), dihydroergotamine (D.H.E. 45, Migranal), sumatriptan (Alsuma, Imitrex, Sumavel), zolmitriptan (Zomig), and others
• Milnacipran (Savella)
• Muscle relaxants such as carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), orphenadrine (Norflex), and others
• Natural remedies such as kava, SAMe, St. John's wort, valerian, and others
• Nausea medicines such as dolasetron (Anzemet), droperidol (Inapsine), ondansetron (Zofran), prochlorperazine (Compro), and others
• Pain medicines such as buprenorphine (Buprenex, Butrans), fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), oxycodone (OxyContin, Roxicodone), and others
• Parkinson’s disease medicines such as entacapone (Comtan), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), ropinirole (Requip), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Ranolazine (Ranexa)
• Salmeterol (Serevent)
• Sleeping pills such as eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Ticagrelor (Brilinta)

Ask your healthcare provider or pharmacist if you need to avoid products that contain grapefruit, Seville oranges, and tangelos while you are taking this medicine. These fruits and juices can affect the way this medicine works and may increase your risk of serious side effects.

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.