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DESIPRAMINE HYDROCHLORIDE
At a glance
| Generic name | DESIPRAMINE HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
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 desipramine hydrochloride tablets 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. Desipramine 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 and fatigue
- Headache
- Nausea and vomiting
- Tremors
- Tachycardia
- Palpitations
- Weight gain or loss
Serious adverse events
- Sudden death
- Myocardial infarction
- Ventricular fibrillation
- Ventricular tachycardia
- Stroke
- Heart block
- Seizures
- Agranulocytosis
- Hepatitis
- Neuroleptic Malignant Syndrome
Key clinical trials
- Comparing Effectiveness of Duloxetine and Desipramine in Patients With Chronic Pain: A Pragmatic Trial Using Point of Care Randomization (PHASE4)
- Desipramine Hydrochloride and Filgrastim For Stem Cell Mobilization in Patients With Multiple Myeloma Undergoing Stem Cell Transplant (NA)
- Phase 2a Desipramine in Small Cell Lung Cancer and Other High-Grade Neuroendocrine Tumors (PHASE2)
- To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets (PHASE1)
- To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets (PHASE1)
- To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets (PHASE1)
- To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin Tablets (PHASE1)
- Efficacy of Antidepressants in Chronic Back Pain (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |