Finished product reference

Trazodone Hydrochloride

Tablet · Oral · 50 mg

List code
1242
Boxed warning

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 . Trazodone is not approved for use in pediatric patients .

What it is and how it works

Mechanism of Action 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.

Indications

Trazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) . Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.

Dosage and administration (summary)

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 . Trazodone hydrochloride tablets should be taken shortly after a meal or light snack . Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed . When discontinued, gradual dose reduction is recommended . 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.

Contraindications

Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs . Trazodone hydrochloride tablets are contraindicated in: Patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome .

Warnings and precautions

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 . 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 Orthostatic Hypotension and Syncope: Warn patients of risk and symptoms of hypotension .

Pregnancy

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…

Storage and supply

Product: 50090-6603 NDC: 50090-6603-0 90 TABLET in a BOTTLE

Source: Trazodone Hydrochloride (Trazodone Hydrochloride) — US FDA prescribing information, 2026-07-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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