Trazodone is a serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in adults. It is available as tablets and oral solution. MedsAcross supplies Trazodone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
RALDESY TM is indicated for the treatment of major depressive disorder (MDD) in adults. RALDESY is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of major depressive disorder (MDD) in adults.
Source: US FDA prescribing information
The mechanism of trazodone’s antidepressant action is unclear, 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.
Source: US FDA prescribing information
Starting dosage: 150 mg orally in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dosage: 400 mg per day in divided doses. Administer RALDESY shortly after a meal or light snack. When discontinuing RALDESY, gradually reduce dose.
Source: US FDA prescribing information
RALDESY is 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. Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs.
Source: US FDA prescribing information
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. RALDESY is not approved for use in pediatric patients. 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 RALDESY 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.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: Suicidal Thoughts and Behaviors in Pediatric and Young Adults Patients Serotonin Syndrome Cardiac Arrythmias Orthostatic Hypotension and Syncope Increased Risk of Bleeding Priapism Activation of Mania or Hypomania Discontinuation Syndrome Potential for Cognitive and Motor Impairment Angle-Closure Glaucoma Hyponatremia Most common adverse reactions (incidence ≥ 5% and twice that of placebo) are: edema, blurred vision, syncope, drowsiness, fatigue, diarrhea, nasal congestion, weight loss.
Source: US FDA prescribing information
CNS Depressants: RALDESY may enhance effects of alcohol, barbiturates, or other CNS depressants. CYP3A4 Inhibitors: Consider RALDESY dose reduction based on tolerability. CYP3A4 Inducers: Increase in RALDESY dosage may be necessary. Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels. Warfarin: Monitor for increased or decreased prothrombin time. Table 3 displays clinically significant drug Interactions with RALDESY. Table 3: Clinically Significant Drug Interactions with RALDESY Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: The concomitant use of MAOIs and serotonergic drugs including RALDESY increases the risk of serotonin syndrome. Intervention: RALDESY is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
7 presentations of Trazodone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Trazodone 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Trazodone 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Trazodone 150 mg tabletOralGeneric name | — | US FDA | Available on request |
| Trazodone 300 mg tabletOralGeneric name | — | US FDA | Available on request |
| Raldesy TM 10 mg/mL oral solutionOral | Validus Pharmaceuticals | US FDA | Available on request |
| Trazodone 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Trazodone 75 mg tabletOralGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 24 December 1981 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Trazodone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 7 presentations of Trazodone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Trazodone, including Raldesy TM.
Yes. The US FDA first approved Trazodone on 24 December 1981, according to Drugs@FDA.
No listed presentation of Trazodone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Trazodone is classified under ATC code N06AX05 (Trazodone).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.