pharmacopeia
GET
/api/v1/drug/amitriptyline

Boxed warning

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 )

2D structure
N,N-dimethyl-3-(2-tricyclo[9.4.0.03,8]pentadeca-1(15),3,5,7,11,13-hexaenylidene)propan-1-amine
SMILES CN(C)CCC=C1C2=CC=CC=C2CCC3=CC=CC=C31
InChIKey KRMDCWKBEZIMAB-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors.

Monoamine OxidaseNorepinephrine UptakeSerotonin Uptake

Indications

Sourced from openFDA
  • For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

Contraindications

Sourced from openFDA
  • Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors.contraindicated

Dosage & administration

Sourced from openFDA

Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients, 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline hydrochloride at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance The usual maintenance dosage of amitriptyline hydrochloride is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms.

Warnings & precautions

Sourced from openFDA

Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term trials of 9 antidepressant drugs in over 4,400 patients.

Adverse reactions

Sourced from openFDA

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic: Paralytic ileus, hyperpyrexia; urinary retention, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth. Allergic: Skin rash; urticaria; photosensitization; edema of face and tongue. Hematologic: Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia.

Overdosage

Sourced from openFDA

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose, therefore, hospital monitoring is required as soon as possible. Manifestations Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram particularly in QRS axis or width, are clinically significant indicators of tricyclic antidepressant toxicity. In addition, a rightward axis shift in the terminal QRS complex together with a prolonged QT interval and sinus tachycardia are specific and sensitive indicators of first generation tricyclic overdose. The absence of these findings is not exclusionary. Prolonged PR interval, ST-T wave changes, ventricular tachycardia and fibrillation may also occur.

Approval history

Sourced from openFDA
  • Nov 29, 1977ANDAANDA085968Sandoz
  • Apr 10, 1978ANDAANDA086009Aurobindo Pharma Usa
  • Dec 10, 1986ANDAANDA071297Mylan Pharms Inc
  • Jul 14, 1987ANDAANDA089399Sun Pharm Inds Inc
  • Nov 10, 1988ANDAANDA071443Mylan
  • Oct 6, 2017ANDAANDA210086Zydus Pharms
  • Apr 7, 2020ANDAANDA212654Aiping Pharm Inc
  • Feb 19, 2021ANDAANDA213999Mankind Pharma

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
16,934 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Pain1,5989.4%
  2. 2Nausea1,4708.7%
  3. 3Headache1,4178.4%
  4. 4Fatigue1,3918.2%
  5. 5Dyspnoea1,3728.1%
  6. 6Dizziness1,1676.9%
  7. 7Diarrhoea1,1166.6%
  8. 8Malaise1,0566.2%
  9. 9Fall1,0296.1%
  10. 10Vomiting1,0086.0%
  11. 11Off Label Use1,0005.9%
  12. 12Arthralgia9415.6%
  13. 13Cognitive Disorder9235.5%
  14. 14Drug Ineffective8875.2%
  15. 15Anxiety8214.8%

Literature

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Recent PubMed references pinned to Amitriptyline as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 147 ClinicalTrials.gov registrations naming Amitriptyline as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Amitriptyline. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Amitriptyline work?
Mechanism-of-action classes: Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors; Serotonin Uptake Inhibitors.
What is Amitriptyline used for?
According to FDA labeling, Amitriptyline carries indications including: For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Amitriptyline?
Amitriptyline is classified as Non-selective monoamine reuptake inhibitors, Tricyclic Antidepressant, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Serotonin Uptake Inhibitors, Decreased Serotonin Degradation, Increased Central Nervous System Norepinephrine Activity.
What are the brand names for Amitriptyline?
Amitriptyline is marketed under brand names including Elavil.
What are the contraindications for Amitriptyline?
Amitriptyline labeling lists contraindications including: Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors.. Always consult the full prescribing information and a clinician.
Note. Data for amitriptyline is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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