TOFRANIL- imipramine hydrochloride tablet, sugar coated 
SpecGx LLC


Medication Guide - Tofranil™ (tō-ˈfrā-nil)
imipramine hydrochloride tablets USP

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member’s, healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

1.    Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2.    Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

3.    How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:

Who should not take Tofranil?

Do not take Tofranil if you:

What else do I need to know about antidepressant medicines?

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Tofranil is a trademark of Mallinckrodt Inc.

Manufactured by
Patheon Inc.
Whitby, Ontario, Canada
L1N 5Z5

Manufactured for
SpecGx LLC
Webster Groves, MO 63119 USA  

Rev 09/2017


Revised: 9/2021
SpecGx LLC