|
Patient Information Sheet
Nefazodone hydrochloride
This is a summary for patients of the most important information
about nefazodone. For details, talk to your healthcare professional.
FDA ALERT [7/2005] – Suicidal Thoughts or Actions in
Children and Adults
Patients
with depression or other mental illnesses often think about or
attempt suicide. Closely watch anyone taking antidepressants,
especially early in treatment or when the dose is changed.
Patients who become irritable or anxious, or have new or
increased thoughts of suicide or other changes in mood or
behavior (or their care givers) should contact their healthcare
professional right away.
Children
Taking antidepressants may increase
suicidal thoughts and actions in about 1 out of 50 people 18
years or younger. Although nefazodone is prescribed for
children, FDA has not approved nefazodone for use in children.
Adults
Several recent scientific
publications report the possibility of an increased risk for
suicidal behavior in adults who are being treated with
antidepressant medications. Even before these reports became
available, FDA began a complete review of all available data to
determine whether there is an increased risk of suicidal
thinking or behavior in adults being treated with
antidepressant medications. It is expected that this review
will take a year or longer to complete. In the meantime, FDA is
highlighting that adults being treated with antidepressant
medication, particularly those being treated for depression,
should be watched closely for worsening of depression and for
increased suicidal thinking or behavior.
This information reflects FDA’s preliminary analysis of data
concerning this drug. FDA is considering, but has not reached a
final conclusion about, this information. FDA intends to update
this sheet when additional information or analyses become
available.
FDA approved labeling for nefazodone contains a serious warning
about the risk of liver failure.
WARNING: LIFE THREATENING LIVER FAILURE
Nefazodone may cause serious liver problems, which may lead to
death. Patients with active liver disease or with high levels on
liver function tests should not take nefazodone. Call your
healthcare professional right away if you get any of the following
symptoms while taking nefazodone because you may be getting a liver
problem:
- Yellowing of the skin or whites of eyes (jaundice)
- Unusually dark urine
- Loss of appetite that lasts several days or longer
- Nausea or lower stomach (abdominal) pain
|
What Is Nefazodone?
Nefazodone is a medicine that is used to treat depression.
Who Should Not Take Nefazodone?
Never take nefazodone if you:
- Have liver problems
- Are allergic to the medicine Desyrel (trazodone)
- Take the following medicines:
- Halcion (triazolam), a drug to treat trouble sleeping. Nefazodone can increase the amount of Halcion in your body,
causing serious side effects.
- Orap (pimozide), a drug to treat Tourette’s syndrome,
because it can result in serious heartbeat problems.
- Tegretol (carbamazepine), a drug to control seizures. Tegretol can reduce the amount of nefazodone in your body so
that it does not help your depression.
- Take another drug used to treat depression, called a Monoamine
Oxidase Inhibitor (MAOI), or if you have stopped taking a MAOI in
the last 14 days. Taking nefazodone close in time to a MAOI can
result in serious, sometimes fatal, reactions, including:
- High body temperature
- Coma
- Seizures (convulsions)
MAOI drugs include Nardil (phenelzine sulfate), Parnate (tranylcypromine
sulfate), Marplan (isocarboxazid), and other brands.
What Are The Risks?
- Life-threatening liver failure. See Warning.
- Suicidal thought or actions. See FDA Alert.
- Low blood pressure (postural hypotension) and fainting. Low
blood pressure can be serious for people with heart problems,
strokes, dehydration, and who take medicines to control blood
pressure.
- Mania: You may become hyperactive, excitable or elated.
- Seizures. You may have a seizure (convulsion), even if you are
not taking nefazodone close in time with a MAOI.
- An erection that won't go away (priapism). Get medical help
right away for an erection that lasts for more than 4 hours.
- Other side effects include sleepiness, dry mouth, nausea,
dizziness, constipation, weakness, lightheadedness, vision
problems, and confusion
- Tell your healthcare professional about all your medical
conditions especially if you have or have had heart problems, a
heart attack, a stroke, or mania; if you are pregnant or plan to
become pregnant; or if you are breast-feeding or plan to
breast-feed your baby.
Are There Any Interactions With Medicines Or
Foods?
- Nefazodone can interact with Xanax (alprazolam), an
anti-anxiety medicine. Your dose of Xanax should be decreased if
used with nefazodone.
- Nefazodone may interact with medicines other than the ones
already mentioned in this information sheet, causing serious side
effects. Tell your healthcare professional about all the
medicines, vitamins, and herbal supplements you take, especially
medicines for mental illness, depression, seizures, and
immunosuppressants.
- If you plan to drink alcohol, talk to your healthcare
professional.
How Do I Take Nefazodone?
Nefazodone is taken by mouth, with or without food, twice a day.
Is There Anything Else I Need To Know?
You can get more information about antidepressants at:
www.fda.gov/cder/drug/antidepressants/default.htm
Questions? Call Drug Information, 1-888-INFO-FDA
(automated) or 301-827-4570
druginfo@fda.hhs.gov Back
to Top
Back to
Nefazodone
Date created: May 2005; Updated: May 9, 2007 |
|