Last reviewed 2026-04-20 · How we verify

AMITRIPTYLINE HYDROCHLORIDE

Amitriptyline Hydrochloride is a marketed drug primarily indicated for the treatment of symptoms of depression. A key strength is its established presence in the market, with a key composition patent expiring in 2028, providing some protection against generic competition. The primary risk is the eventual loss of exclusivity post-2028, which could lead to increased competition from generics.

At a glance

Approved indications

• Symptoms of 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 amitriptyline 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. Amitriptyline 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

• Drowsiness
• Dry mouth
• Constipation
• Blurred vision
• Dizziness
• Bloating
• Vivid dreams
• Impotence
• Tremor
• Confusion
• Nasal congestion
• Anorexia

Serious adverse events

• Myocardial infarction
• Stroke
• Heart block
• Granulocytopenia
• Agranulocytosis
• Bone marrow depression
• Hepatic dysfunction
• Jaundice
• Paralytic ileus
• Syndrome of inappropriate ADH secretion

Drug interactions

• topiramate
• P450 2D6 inhibitors (e.g., quinidine, cimetidine, SSRIs)
• monoamine oxidase inhibitors
• guanethidine or similarly acting compounds
• thyroid medication
• alcohol, barbiturates, and other CNS depressants
• disulfiram
• anticholinergic agents or sympathomimetic drugs, including epinephrine

Key clinical trials

• Responding With Evidence and Access for Childhood Headaches (NA)
• Evaluating Use of Topical Imipramine and Amitriptyline in Reducing Ultraviolet B Light-Induced Redness in Patients With Rosacea (PHASE2)
• Efficacy of Two Doses of Duloxetine and Amitriptyline in Subjects With Refractory Chronic Cough (PHASE2)
• Efficacy of Two Doses of Duloxetine & Amitriptyline in Interstitial Lung Disease-related Cough (PHASE2)
• Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy (NA)
• Efficacy of Amitriptyline for Painful Bladder Syndrome (PBS) (PHASE3)
• Multiprofen-CC to Reduce Pain in Hand Arthritis (PHASE3)
• Effectiveness of AI-Guided Exercise and Pain Neuroscience Education for Fibromyalgia (FIBROIA) (NA)

Primary sources

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