Last reviewed 2026-04-20 · How we verify

Tofranil (IMIPRAMINE)

Imipramine (Tofranil) is a marketed antidepressant that operates by blocking the reuptake of serotonin, with a key composition patent expiring in 2028. Its primary competitive advantage lies in its well-established mechanism and long history of use, though it faces significant competition from off-patent, same-class drugs such as desipramine, clomipramine, trimipramine, amitriptyline, and nortriptyline, which are widely available in generic forms. The primary risk to Imipramine's market position is the extensive availability of these generics, which may erode its market share and revenue potential.

At a glance

Approved indications

• Depression
• Childhood Enuresis

Boxed warnings

• Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of imipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed 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. Imipramine hydrochloride is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk , PRECAUTIONS: Information for Patients , and PRECAUTIONS: Pediatric Use )

Common side effects

• nervousness
• sleep disorders
• tiredness
• mild gastrointestinal disturbances
• constipation
• convulsions
• anxiety
• emotional instability
• syncope
• collapse
• angle-closure glaucoma

Drug interactions

• Tricyclic Antidepressants (TCAs)
• Quinidine
• Cimetidine
• Selective Serotonin Reuptake Inhibitors (SSRIs) - Fluoxetine, Sertraline, Paroxetine
• Phenothiazines
• Type 1C Antiarrhythmics - Propafenone, Flecainide
• Hepatic Enzyme Inducers - Barbiturates, Phenytoin
• Anticholinergic Drugs (including antiparkinsonism agents)

Key clinical trials

• Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea (PHASE2)
• The Effect of Topical Imipramine on Photodynamic Therapy-Mediated Immunosuppression on Forearms or Face on US Veterans (PHASE2)
• Investigator-Initiated Study of Imipramine Hydrochloride and Lomustine in Recurrent Glioblastoma (PHASE2)
• Bio-significance of LPC16:0 in Fibromyalgia
• Testing Use of Topical Imipramine in Reducing Ultraviolet B Induced Microvesicle Particle Release in Photosensitive Subjects (PHASE1)
• Neuroregulators for the Treatment of Diseases Associated With Esophageal-brain-gut Axis Communication Abnormalities. (NA)
• New Treatment for Nocturnal Enuresis in Children (NA)
• The Effect of Topical Imipramine on Pain and Effectiveness of Topical Photodynamic Therapy (PHASE1)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Tofranil CI brief — competitive landscape report
• Tofranil updates RSS · CI watch RSS