Last reviewed 2026-04-20 · How we verify

nortriptyline HCl

Nortriptyline HCl, marketed by Zalicus, is a well-established treatment for depression with a strong presence in the market. A key strength of nortriptyline HCl is its key composition patent, which is set to expire in 2028, providing a period of exclusivity and protection against generic competition. The primary risk facing nortriptyline HCl is the eventual loss of patent protection in 2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Depression
• Endogenous Depression

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 nortriptyline 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. Nortriptyline 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

• Dry mouth
• Constipation
• Blurred vision
• Drowsiness
• Dizziness
• Weakness
• Fatigue
• Headache
• Nausea and vomiting
• Tremors
• Tachycardia
• Palpitation

Serious adverse events

• Myocardial infarction
• Stroke
• Heart block
• Seizures
• Agranulocytosis
• Bone marrow depression
• Paralytic ileus
• Brugada syndrome
• Angle-closure glaucoma
• Syndrome of inappropriate ADH secretion

Key clinical trials

• Procedural Framing and Epidural Steroid Injection Outcomes (NA)
• Vestibulodynia: Understanding Pathophysiology and Determining Appropriate Treatments (PHASE2)
• An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service (PHASE3)
• Management of Acute Tinnitus With Migraine Medications (PHASE4)
• Pediatric Concussion Outcomes (PHASE4)
• Nortriptyline for the Treatment of Functional Dyspepsia (PHASE3)
• RCT of Brain Longitudinal Biomarker Study (OPT-Neuro RCT) (PHASE4)
• Optimizing Outcomes of Treatment-Resistant Depression in Older Adults (PHASE4)

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:

• nortriptyline HCl CI brief — competitive landscape report
• nortriptyline HCl updates RSS · CI watch RSS
• Zalicus portfolio CI