Prescription medicine
Trazodone Brand names: Raldesy; first approved as Desyrel
Trazodone (Desyrel) is a prescription medicine with an FDA approval on record since 1981. FDA's NDC Directory lists it from 38 generic labelers, and pharmacies paid $0.0307 per trazodone 50 mg tablet in the October 7, 2026 NADAC survey; its other strengths are brand-only, $2.00 per mL (Raldesy 10 mg/mL solution).
- Generic listed
- Boxed warning
Check it at the source: the trazodone FDA label on DailyMed (effective January 22, 2026, Zydus Pharmaceuticals USA Inc.); the NDA 18207 record on Drugs@FDA; every trazodone label on DailyMed.
Highlights of the record
FDA label of January 22, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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
Used for
From the label: indications and usageTrazodone is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 150 mg
- 300 mg
- 10 mg/ml
Tablet; film-coated tablet; solution.
On the market
- Earliest approval on file
- December 24, 1981 Desyrel, Pragma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 25 first October 10, 1986; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 39 of which 38 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 13, 2029 Desyrel tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.0307 per tablet Trazodone 50 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 1 Class I among all firms' recalls; latest August 24, 2026; 3 more by firms not listed as its makers
- FAERS reports
- 15,550 through July 30, 2026
What is trazodone used for?
From the label: indications and usageTrazodone 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.
Conditions named in the indications of trazodone's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin Reuptake Inhibitor.
Source: FDA drug label (Trazodone Hydrochloride), Zydus Pharmaceuticals USA Inc., effective January 22, 2026 (SPL set 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9), via openFDA; the full label on DailyMed
What does the patient leaflet for trazodone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about trazodone hydrochloride tablets?Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about: All risks and benefits of treatment with antidepressant medicines All treatment choices for depression or other serious mental illnesses Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. How can I watch for and try to prevent suicidal thoughts and actions? Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms. […]
From the patient leaflet: What should I avoid while taking trazodone hydrochloride tablets?Do not drive, operate heavy machinery, or do other dangerous activities until you know how trazodone hydrochloride tablets affect you. Trazodone hydrochloride tablets can slow your thinking and motor skills. Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking trazodone hydrochloride tablets until you talk with your healthcare provider. Trazodone hydrochloride tablets may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.
From the patient leaflet: How should I store trazodone hydrochloride tablets?Store trazodone hydrochloride tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep in tight container Keep out of the light Safely throw away medicine that is out of date or no longer needed. Keep trazodone hydrochloride tablets and all medicines out of the reach of children.
Source: FDA drug label (Trazodone Hydrochloride), Zydus Pharmaceuticals USA Inc., effective January 22, 2026 (SPL set 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9), via openFDA; the full label on DailyMed
Is there a generic for trazodone (Desyrel)?
The FDA approved the first generic trazodone on October 10, 1986. 25 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists trazodone from 38 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Desyrel tablets: the compound patent runs to March 13, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1981 earliest approval on file
- 1986 first generic approved
- 2029 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for trazodone (Desyrel)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0307 per Trazodone 50 mg tablet, down 10% from $0.0341 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Trazodone 50 mg tablet (generic)
- Raldesy 10 mg/mL solution (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Trazodone 100 mg tablet | Generic | $0.0513 per tablet | $1.54 | -12% |
| Trazodone 150 mg tablet | Generic | $0.0864 per tablet | $2.59 | -18% |
| Trazodone 300 mg tablet | Generic | $0.498 per tablet | $14.93 | -15% |
| Trazodone 50 mg tablet | Generic | $0.0307 per tablet | $0.922 | -10% |
| Raldesy 10 mg/mL solution | Brand | $2.00 per mL | n/a | -19% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has trazodone been recalled?
The FDA's Enforcement Report lists 8 recalls naming trazodone since 2013: 1 Class I (the most serious), 6 Class II, 1 Class III; 3 still ongoing. 3 of them are by firms that FDA's NDC Directory does not list as a maker of trazodone and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| August 24, 2026 | Class II | Teva Pharmaceuticals USA, Inc | Presence of Foreign Tablets/Capsules |
| January 26, 2026 | Class II | Granules Pharmaceuticals Inc. | Presence of Foreign Tablets/Capsules |
| December 19, 2025 | Class III | Zydus Pharmaceuticals (USA) Inc | Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. |
| March 15, 2021 | Class II | Cardinal Health Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. |
| December 7, 2020 | Class I | AVKARE Inc. | Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility. |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as DEXAMETHASONE, Tablet, 1 mg, NDC 00054418125, Pedigree: AD37088_1, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; traZODone HCl Tablet, 50 mg may be potentially mislabeled as AMANTADINE HCL, Tablet, 100 mg, NDC 00832011100, Pedigree: AD54475_1, EXP … |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; traZODone HCl Tablet, 150 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 00135051001, Pedigree: AD21858_1 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the trazodone label say about other medicines?
The trazodone label names 32 other medicines in its interaction, contraindication or warning sections. The labels of 42 other medicines name trazodone. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Class 3 antiarrhythmics: amiodarone, sotalol; |
| Aspirin | warnings and precautions | 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 ). |
| Buspirone | drug interactions | Examples triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort Antiplatelet Agents and Anticoagulants Clinical Impact Serotonin release by platelets plays an important role in hemostasis. … |
| Carbamazepine | drug interactions | Examples rifampin, carbamazepine, phenytoin, St. John's wort Digoxin and Phenytoin Clinical Impact Digoxin and phenytoin are narrow therapeutic index drugs. Concomitant use of trazodone can increase digoxin or phenytoin concentrations. … |
| Chlorpromazine | drug interactions | Antipsychotics: ziprasidone, chlorpromazine, thioridazine; |
| Clarithromycin | drug interactions | Examples; itraconazole, ketoconazole, clarithromycin, indinavir |
| Clopidogrel | drug interactions | Examples; warfarin, rivaroxaban, dabigatran, clopidogrel |
| Dabigatran | drug interactions | Examples; warfarin, rivaroxaban, dabigatran, clopidogrel |
| Digoxin | drug interactions | Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). |
| Disopyramide | drug interactions | Examples; Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; Antibiotics: gatifloxacin |
| Fentanyl | drug interactions | Examples triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort Antiplatelet Agents and Anticoagulants Clinical Impact Serotonin release by platelets plays an important role in hemostasis. … |
| Gatifloxacin | drug interactions | Antibiotics: gatifloxacin |
| Isocarboxazid | drug interactions | Examples; isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine |
| Itraconazole | drug interactions | Examples; itraconazole, ketoconazole, clarithromycin, indinavir |
Every other medicine the trazodone label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ketoconazole | drug interactions | Examples; itraconazole, ketoconazole, clarithromycin, indinavir |
| Linezolid | contraindications | … stopping, monoamine oxidase inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 … |
| Lithium | drug interactions | Examples triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. … |
| Methylene blue | contraindications | … inhibitors (MAOIs), including MAOIs such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see Warnings and Precautions ( 5.2 ), Drug Interactions ( 7.1 … |
| Phenelzine | drug interactions | Examples; isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine |
| Phenytoin | drug interactions | Digoxin or Phenytoin: Monitor for increased digoxin or phenytoin serum levels ( 7 ). |
| Procainamide | drug interactions | Examples; Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; … |
| Quinidine | drug interactions | Examples; Class 1A antiarrhythmics: quinidine, procainamide, disopyramide; Class 3 antiarrhythmics: amiodarone, sotalol; Antipsychotics: ziprasidone, chlorpromazine, thioridazine; … |
| Rifampin | drug interactions | Examples rifampin, carbamazepine, phenytoin, St. John's wort Digoxin and Phenytoin Clinical Impact Digoxin and phenytoin are narrow therapeutic index drugs. … |
| Rivaroxaban | drug interactions | Examples; warfarin, rivaroxaban, dabigatran, clopidogrel |
| Selegiline | drug interactions | Examples; isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine |
| Sotalol | drug interactions | Class 3 antiarrhythmics: amiodarone, sotalol; |
| Thioridazine | drug interactions | Antipsychotics: ziprasidone, chlorpromazine, thioridazine; |
| Tramadol | drug interactions | Examples triptans, antidepressants (tricyclic and serotonin uptake inhibitors), fentanyl, lithium, tramadol, tryptophan, buspirone, and St. … |
| Tranylcypromine | drug interactions | Examples; isocarboxazid, moclobemide, phenelzine, selegiline, tranylcypromine |
| Voriconazole | warnings and precautions | … that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 … |
| Warfarin | drug interactions | … trazodone and antiplatelet agents and anticoagulants. For patients taking warfarin, carefully monitor the international normalized ratio (INR) when initiating or discontinuing trazodone [see Warnings … |
| Ziprasidone | drug interactions | Antipsychotics: ziprasidone, chlorpromazine, thioridazine; |
Other labels that name trazodone
Source: FDA drug label (Trazodone Hydrochloride), Zydus Pharmaceuticals USA Inc., effective January 22, 2026 (SPL set 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9), via openFDA; the full label on DailyMed
What do FAERS reports show for trazodone?
The FDA Adverse Event Reporting System holds 15,550 reports that list trazodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,593 are coded as a death and 5,279 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as trazodone?
30 other medicines are given the same way (oral) and in the same FDA class as trazodone or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Fluoxetine | Depression | 59 labelers | $0.0519 per capsule 40 mg capsule | No current entry |
| Sertraline | Depression | 48 labelers | $0.0507 per tablet 100 mg tablet | No current entry |
| Paroxetine | Depression | 45 labelers | $0.0611 per tablet 20 mg tablet | No current entry |
| Escitalopram | Depression | 44 labelers | $0.0632 per tablet 20 mg tablet | No current entry |
| Citalopram | Depression | 35 labelers | $0.026 per tablet 10 mg tablet | No current entry |
| Fluoxetine and olanzapine | Depression | 3 labelers | $3.44 per unit 3-25 mg | No current entry |
| Nefazodone | Depression | 2 labelers | $1.17 per tablet 100 mg tablet | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does trazodone compare with medicines for the same use?
14 side-by-side pages set trazodone beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to trazodone
- 30 medicines for the same use
- Other serotonin reuptake inhibitors
- the pharmacologic class, with prices and generics
- Trazodone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other