Nefazodone (Oral route)
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 Patients who develop evidence of hepatocellular injury should be withdrawn from the drug .
Serotonin/Norepinephrine Reuptake Inhibitor
Uses of This Medicine:
Nefazodone is used to treat mental depression.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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.
- Ergoloid Mesylates
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.
- Ado-Trastuzumab Emtansine
- Amtolmetin Guacil
- Brentuximab Vedotin
- Choline Salicylate
- Doxorubicin Hydrochloride Liposome
- Flufenamic Acid
- Ibuprofen Lysine
- Iobenguane I 123
- Mefenamic Acid
- Methylene Blue
- Niflumic Acid
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
- Vincristine Sulfate Liposome
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.
- 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.
Other medical problems—
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
Proper Use of This Medicine:
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.
- For mental depression:
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.
Precautions While Using This Medicine:
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.
Side Effects of This Medicine:
- More common
- Blurred vision or other changes in vision
- clumsiness or unsteadiness
- lightheadedness or fainting
- ringing in the ears
- skin rash or itching
- Less common
- Bladder pain
- bloody or cloudy
- cough or hoarseness
- excessive muscle tone
- eye pain
- feeling dizzy
- frequent urge to urinate
- itching of the vagina or genital area
- muscle stiffness
- muscle tension or tightness
- pain during sexual intercourse
- painful, burning, or difficult urination
- shortness of breath, tightness in chest, or wheezing
- stomach pain
- thick, white vaginal discharge with no odor or with a mild odor
- troubled breathing
- bleeding from the rectum
- bloody or black, tarry stools
- change in sexual desire or performance
- chest pain
- double vision
- dryness of eye
- ear pain
- fast heartbeat
- fever, chills, or sore throat
- hallucinations (seeing, hearing, or feeling things that are not there)
- increased sense of hearing
- increased sensitivity to sun
- irritation or soreness of mouth
- joint or muscle pain or stiffness
- kidney stones
- large pupils of eyes
- lower back, side, or stomach pain
- menstrual changes
- mood or mental changes
- nerve pain or twitching
- pelvic pain
- problems in speaking
- problems with urination
- prolonged, painful, inappropriate penile erection
- red or irritated eyes
- sensitivity of eyes to light
- swelling of face
- swollen glands
- talking, feeling, and acting with excitement and activity you cannot control
- unusual bleeding or bruising
- unusual feeling of well-being
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- Incidence not known
- Blistering, peeling, or loosening of skin
- light-colored stools
- dark urine
- decreased urine output
- increased thirst
- lack of appetite
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle pain or cramps
- muscle spasm or jerking of all extremities
- muscle stiffness
- pain, warmth, or burning in fingers, toes, and legs
- red skin lesions, often with a purple center
- sore throat
- sudden loss of consciousness
- More common
- Abnormal dreams
- dryness of mouth
- flushing or feeling of warmth
- increased appetite
- increased cough
- memory problems
- swelling of arms or legs
- tingling, burning, or prickly sensations
- trouble in sleeping
- Less common or rare
- Breast pain
- generalized slowing of mental and physical activity
- increased thirst
- loss of strength or energy
- muscle weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- Incidence not known
- Unexpected or excess milk flow from breasts
- swelling of the breasts or breast soreness in males
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014