pharmacopeia
GET
/api/v1/drug/trazodone

Boxed warning

SUICIDAL THOUGHTS and BEHAVIORS Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions ( 5.1 )] . Trazodone is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )] . WARNING: SUICIDAL THOUGHTS and BEHAVIORS See full prescribing information for complete boxed warning. Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients ( 5.1 ) Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors ( 5.1 ) Trazodone is not approved for use in pediatric patients ( 8.4 )

2D structure
2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-[1,2,4]triazolo[4,3-a]pyridin-3-one
SMILES C1CN(CCN1CCCN2C(=O)N3C=CC=CC3=N2)C4=CC(=CC=C4)Cl
InChIKey PHLBKPHSAVXXEF-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone's antidepressant effect is unknown.

Histamine H1 ReceptorMonoamine OxidaseSerotonin 5HT-3Serotonin Uptake

Indications

Sourced from openFDA
  • Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.ICD-10: F32.9

Contraindications

Sourced from openFDA
  • None ( 4 ). Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ).contraindicated

Dosage & administration

Sourced from openFDA

Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ( 2 ). Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ( 2 ). Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ( 2 ). When discontinued, gradual dose reduction is recommended ( 2 ). 2.1 Dose Selection An initial dose of 150 mg/day in divided doses is suggested. The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response. 2.2 Improtant Administration Instructions Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.

Warnings & precautions

Sourced from openFDA

Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents (e.g., SSRI, SNRI, triptans), but also when taken alone. If it occurs, discontinue trazodone and initiate supportive treatment ( 5.2 ). Cardiac Arrhythmias: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ( 5.3 ) Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension ( 5.4 ). Increased Risk of Bleeding: Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), other antiplatelet drugs, warfarin, and other anticoagulants may increase this risk ( 5.5 ). Priapism: Cases of painful and prolonged penile erections and priapism have been reported. Immediate medical attention should be sought if signs and symptoms of prolonged penile erections or priapism are observed ( 5.6 ). Activation of Mania or Hypomania: Screen for bipolar disorder and monitor for mania or hypomania ( 5.7 ). Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ( 5.9 ). Angle-Closure Glaucoma: Avoid use of antidepressants, including trazodone, in patients with untreated anatomically narrow angles. ( 5.10 ).

Adverse reactions

Sourced from openFDA

Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behavior in Children, Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions ( 5.1 )] Serotonin Syndrome [see Warnings and Precautions ( 5.2 )] Cardiac Arrythmias ( see Warnings and Precautions ( 5.3 )] Orthostatic Hypotension and Syncope [see Warnings and Precautions ( 5.4 )] Increased Risk of Bleeding [see Warnings and Precautions ( 5.5 )] Priapism [see Warnings and Precautions ( 5.6 )] Activation of Mania or Hypomania [see Warnings and Precautions ( 5.7 )] Discontinuation Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Cognitive and Motor Impairment [see Warnings and Precautions ( 5.9 )] Angle-Closure Glaucoma [see Warnings and Precautions ( 5.10 )] Hyponatremia [see Warnings and Precautions ( 5.11 )] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/ pregnancyregistry/ antidepressants/ Risk Summary Published prospective cohort studies, case series, and case reports over several decades with trazodone hydrochloride tablets use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data). Trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 times to 11 times the maximum recommended human dose (MRHD) of 400 mg/day in adults on a mg/m 2 basis. There was also an increase in congenital anomalies in the rabbit at approximately 7.3 times to 22 times the MRHD on a mg/m 2 basis (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption In humans, trazodone hydrochloride is absorbed after oral administration without selective localization in any tissue. When trazodone hydrochloride is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration.

Overdosage

Sourced from openFDA

Death from overdose has occurred in patients ingesting trazodone and other CNS depressant drugs concurrently (alcohol; alcohol and chloral hydrate and diazepam; amobarbital; chlordiazepoxide; or meprobamate). The most severe reactions reported to have occurred with overdose of trazodone alone have been priapism, respiratory arrest, seizures, and ECG changes, including QT prolongation. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions. There is no specific antidote for trazodone hydrochloride overdose. In managing overdosage, consider the possibility of multiple drug involvement. For current information on the management of poisoning or overdose, contact a poison control center (1-800-222-1222 or www.poison.org).

Approval history

Sourced from openFDA
  • Mar 25, 1987ANDAANDA071196Apotex Inc
  • Mar 25, 1987ANDAANDA071258Apotex
  • Dec 11, 1987ANDAANDA071524Teva Pharms Usa
  • Dec 11, 1987ANDAANDA071523Teva Pharms Usa
  • Mar 9, 1988ANDAANDA071525Pliva
  • Feb 2, 1989ANDAANDA072192Oxford Pharms
  • Feb 2, 1989ANDAANDA072193Oxford Pharms
  • Nov 26, 2024NDANDA218637Kamat

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.
15,321 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. 1Drug Ineffective1,1917.8%
  2. 2Fatigue1,1427.5%
  3. 3Nausea1,1117.3%
  4. 4Headache9136.0%
  5. 5Pain8165.3%
  6. 6Diarrhoea8045.2%
  7. 7Off Label Use7284.8%
  8. 8Vomiting6924.5%
  9. 9Insomnia6764.4%
  10. 10Depression6634.3%
  11. 11Dyspnoea6334.1%
  12. 12Dizziness6144.0%
  13. 13Fall6094.0%
  14. 14Asthenia5303.5%
  15. 15Anxiety5163.4%

Literature

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Recent PubMed references pinned to Trazodone 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 82 ClinicalTrials.gov registrations naming Trazodone as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Trazodone work?
The mechanism of trazodone's antidepressant action is not fully understood, but is thought to be related to its enhancement of serotonergic activity in the CNS. Trazodone is both a selective serotonin reuptake inhibitor (SSRI) and a 5HT2 receptor antagonist and the net result of this action on serotonergic transmission and its role in trazodone's antidepressant effect is unknown.
What is Trazodone used for?
According to FDA labeling, Trazodone carries indications including: Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ). Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Trazodone?
Trazodone is classified as Other antidepressants, Serotonin Reuptake Inhibitor, Adrenergic alpha1-Antagonists, Histamine H1 Receptor Antagonists, Monoamine Oxidase Inhibitors, Serotonin 5HT-3 Antagonists, Serotonin Uptake Inhibitors, Increased Central Nervous System Serotonin Activity.
What are the brand names for Trazodone?
Trazodone is marketed under brand names including Raldesy.
What are the contraindications for Trazodone?
Trazodone labeling lists contraindications including: None ( 4 ). Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs ( 4 ).. Always consult the full prescribing information and a clinician.
Note. Data for trazodone 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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