Drugs
Bupropion hydrochloride (marketed as the antidepressant Wellbutrin) Information
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Please see Antidepressant Use in Children, Adolescents, and Adults |
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 bupropion is prescribed for children, FDA has not approved bupropion 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.
Other Information
Bupropion is marketed under these names:
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Wellbutrin
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Wellbutrin SR
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Wellbutrin XL
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Zyban
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bupropion hydrochloride
Adverse reactions or quality problems experienced with the use of this Product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax, using the contact information at the bottom of this sheet.
Related Information
- Public Health Advisory: FDA Requires New Boxed Warnings for the Smoking Cessation Drugs Chantix and Zyban
7/1/2009 - Information for Healthcare Professionals: Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
7/1/2009 - Bupropion hydrochloride (marketed as the antidepressant Wellbutrin) - Healthcare Professional Sheet text version
7/8/2005 - Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications
6/30/2005 - Antidepressant Use in Children, Adolescents, and Adults
- Medication Guide for Antidepressant Drugs (PDF - 28KB)
Labeling and Regulatory History from Drugs@FDA
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