What is Nefazodone?

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Not approved for use in pediatric patients. Cases of life-threatening hepatic failure have been reported. Treatment should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. Patients should be advised to be alert for signs and symptoms of liver dysfunction and to report them to their doctor immediately if they occur. Patients who develop evidence of hepatocellular injury should be withdrawn from the drug .

Nefazodone is used to treat mental depression.

This medicine is available only with your doctor's prescription.

Take this medicine only as directed by your doctor. Do not take more or less of it and do not take it more or less often than your doctor ordered.

Sometimes this medicine must be taken for several weeks before you begin to feel better.

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For mental depression:
    • Adults (18 years of age and older)—To start, 200 milligrams (mg) a day, divided into two doses. Your doctor may increase the dose if needed.
    • Older adults—To start, 100 mg a day, divided into two doses. Your doctor may increase the dose if needed.
    • Children up to 18 years of age—Use and dose must be determined by the doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Studies on nefazodone have been done only in adult patients, and there is no specific information comparing use of this medicine in children up to 18 years of age with use in other age groups.

Nefazodone must be used with caution in children with depression. Studies have shown occurrences of children thinking about suicide or attempting suicide in clinical trials for this medicine. More study is needed to be sure nefazodone is safe and effective in children.

The relationship of age to the effects of nefazodone has not been systematically studied in older people. However, blood levels of nefazodone have been found to be higher in older patients. An older adult may require a lower dose of nefazodone than a younger adult.

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Astemizole
• Bromopride
• Carbamazepine
• Cisapride
• Colchicine
• Conivaptan
• Dihydroergotamine
• Dronedarone
• Eletriptan
• Eliglustat
• Eplerenone
• Ergoloid Mesylates
• Ergonovine
• Ergotamine
• Flibanserin
• Furazolidone
• Isavuconazonium Sulfate
• Isocarboxazid
• Ivabradine
• Linezolid
• Lomitapide
• Lovastatin
• Lurasidone
• Maraviroc
• Methylergonovine
• Metoclopramide
• Naloxegol
• Nimodipine
• Phenelzine
• Pimozide
• Ranolazine
• Safinamide
• Silodosin
• Simvastatin
• Terfenadine
• Tolvaptan
• Tranylcypromine
• Triazolam
• Venetoclax

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Acalabrutinib
• Aceclofenac
• Acemetacin
• Ado-Trastuzumab Emtansine
• Alfentanil
• Almotriptan
• Amiodarone
• Amitriptyline
• Amoxapine
• Amphetamine
• Amtolmetin Guacil
• Apalutamide
• Apixaban
• Aprepitant
• Aripiprazole
• Aspirin
• Atorvastatin
• Avanafil
• Axitinib
• Bedaquiline
• Benzhydrocodone
• Benzphetamine
• Bosutinib
• Brentuximab Vedotin
• Brexpiprazole
• Brigatinib
• Bromfenac
• Bromocriptine
• Bufexamac
• Buprenorphine
• Bupropion
• Butorphanol
• Cabazitaxel
• Cabozantinib
• Calcifediol
• Cariprazine
• Celecoxib
• Ceritinib
• Choline Salicylate
• Cilostazol
• Clonixin
• Clopidogrel
• Clorgyline
• Clozapine
• Cobimetinib
• Codeine
• Copanlisib
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Daclatasvir
• Dasatinib
• Deflazacort
• Delamanid
• Desvenlafaxine
• Dexibuprofen
• Dexketoprofen
• Dextroamphetamine
• Diclofenac
• Diflunisal
• Digoxin
• Dihydrocodeine
• Dipyridamole
• Dipyrone
• Docetaxel
• Dolasetron
• Domperidone
• Donepezil
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Droperidol
• Droxicam
• Duvelisib
• Edoxaban
• Elagolix
• Encorafenib
• Enzalutamide
• Eptifibatide
• Erlotinib
• Eszopiclone
• Etodolac
• Etofenamate
• Etoricoxib
• Everolimus
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Fluoxetine
• Flurbiprofen
• Fluticasone
• Fosaprepitant
• Granisetron
• Hydrocodone
• Hydromorphone
• Hydroxytryptophan
• Ibrutinib
• Ibuprofen
• Idelalisib
• Ifosfamide
• Iloperidone
• Indomethacin
• Iobenguane I 123
• Iobenguane I 131
• Iproniazid
• Irinotecan
• Irinotecan Liposome
• Ivacaftor
• Ivosidenib
• Ixabepilone
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lorcaserin
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Macitentan
• Manidipine
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Meperidine
• Metaxalone
• Methadone
• Methamphetamine
• Methylene Blue
• Midazolam
• Midostaurin
• Mifepristone
• Milnacipran
• Mirtazapine
• Moclobemide
• Morniflumate
• Morphine
• Morphine Sulfate Liposome
• Nabumetone
• Nalbuphine
• Naproxen
• Naratriptan
• Nepafenac
• Neratinib
• Nialamide
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Olaparib
• Oxaprozin
• Oxycodone
• Oxymorphone
• Oxyphenbutazone
• Palbociclib
• Palonosetron
• Panobinostat
• Parecoxib
• Pargyline
• Paroxetine
• Pazopanib
• Pentazocine
• Phenylbutazone
• Piketoprofen
• Pimavanserin
• Piperaquine
• Piroxicam
• Ponatinib
• Pranoprofen
• Prasugrel
• Procarbazine
• Proglumetacin
• Propyphenazone
• Proquazone
• Quetiapine
• Rasagiline
• Reboxetine
• Regorafenib
• Remifentanil
• Retapamulin
• Ribociclib
• Rivaroxaban
• Rizatriptan
• Rofecoxib
• Romidepsin
• Ruxolitinib
• Salicylic Acid
• Salmeterol
• Salsalate
• Selegiline
• Sertraline
• Sibutramine
• Sildenafil
• Simeprevir
• Sodium Salicylate
• Sonidegib
• Sufentanil
• Sulindac
• Sumatriptan
• Sunitinib
• Suvorexant
• Tacrolimus
• Tadalafil
• Tamsulosin
• Tapentadol
• Temsirolimus
• Tenoxicam
• Tezacaftor
• Thiotepa
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Toloxatone
• Toremifene
• Trabectedin
• Tramadol
• Trazodone
• Valbenazine
• Valdecoxib
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vilazodone
• Vincristine
• Vincristine Sulfate Liposome
• Vinflunine
• Vorapaxar
• Vortioxetine
• Ziprasidone
• Zolmitriptan
• Zolpidem

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alprazolam
• Aripiprazole Lauroxil
• Buspirone
• Cyclosporine
• Foxglove
• Ginkgo
• Haloperidol
• Methylprednisolone
• Pravastatin
• Ritonavir
• St John's Wort

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Convulsions (seizures) (history of)—The risk of seizures may be increased

• Dehydration or
• Hypovolemia (low blood volume)—May increase the chance that low blood pressure (hypotension) will occur

• Heart disease or
• Stroke (or history of)—Nefazodone may make these conditions worse by causing low blood pressure (hypotension)

• Liver function problems—If your liver does not function well, due to liver problems or liver disease and you take nefazodone, the amount of nefazodone in your blood may be too high. This may cause serious disease or damage in your liver.

• Liver function problems when taking this medicine before and you had to stop taking it—You may have a greater chance of having liver problems if you take nefazodone again. Tell your doctor immediately if you have taken this medicine before.

• Mania (a type of mental illness) (history of)—Nefazodone may cause this problem to recur

It is important that your doctor check your progress at regular visits to allow dosage adjustments and to help reduce side effects.

Do not take astemizole, cisapride, pimozide, or terfenadine while you are taking nefazodone. If you do, you may develop a very serious change in the rhythm of your heartbeat.

Do not take carbamazepine while you are taking nefazodone. It may cause the medicine to not work or to not work as well.

This medicine may cause serious problems with your liver. Call your doctor right away for any of the following problems. Abdominal pain, nausea, vomiting, yellow eyes or skin, dark colored urine, light-colored stools, feeling very tired or weak

Do not take a monoamine oxidase (MAO) inhibitor (furazolidone, phenelzine, procarbazine, selegiline, tranylcypromine) while you are taking or less than 7 days after taking nefazodone. Do not take nefazodone less than 14 days after taking an MAO inhibitor. If you do, you may develop convulsions (seizures), extremely high fever, or other serious unwanted effects.

Nefazodone may cause some people to be agitated, irritable or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

This medicine may add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

This medicine may cause some people to become dizzy or drowsy, or to have blurred vision or other vision changes. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert and able to see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dryness of the mouth. For temporary relief, use sugarless gum or candy, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth feels dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.