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FDA Alerts
Suicidality
Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Bupropion is not approved for use in pediatric patients. (See Pediatric Use under Cautions.)
In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
Appropriately monitor and closely observe all patients who are started on bupropion therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)
There are many other drugs that can interact with bupropion. Tell your doctor about all
the prescription and over-the-counter medications you use. This includes vitamins, minerals,
herbal products, and drugs prescribed by other doctors. Do not start using a new medication
without telling your doctor.
Get emergency medical help if you have any of these signs of an allergic
reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms such as: mood or
behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable,
agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or
have thoughts about suicide or hurting yourself.
Call your doctor at once if you have a seizure (convulsions) or fast, uneven
heartbeats.
Less serious side effects may be more likely to occur, such as:
headache or migraine;
nausea, vomiting, constipation, dry mouth;
confusion, dizziness, tremors (shaking);
appetite changes, weight loss or gain;
mild itching or skin rash, increased sweating; or
loss of interest in sex.
This is not a complete list of side effects and others may occur. Tell
your doctor about any unusual or bothersome side effect.
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