Active substance
Trazodone
- US FDA 36
- Health Canada 21
- US price lines 6
- NHS prices 7
- Safety 6
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | 100MG; 150MG; 300MG | tablet · oral | APOTEX INC | Prescription | 25 Mar 1987 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | APOTEX | Prescription | 25 Mar 1987 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | TEVA PHARMS USA | Prescription | 11 Dec 1987 |
| TRAZODONE HYDROCHLORIDE | 100MG | tablet · oral | TEVA PHARMS USA | Prescription | 11 Dec 1987 |
| TRAZODONE HYDROCHLORIDE | 150MG | tablet · oral | PLIVA | Prescription | 9 Mar 1988 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | OXFORD PHARMS | Prescription | 2 Feb 1989 |
| TRAZODONE HYDROCHLORIDE | 100MG; 25MG; 75MG | tablet · oral | OXFORD PHARMS | Prescription | 2 Feb 1989 |
| TRAZODONE HYDROCHLORIDE | 100MG; 50MG; 150MG | tablet · oral | SUN PHARM INDUSTRIES | Prescription | 24 Mar 1993 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | TORRENT | Prescription | 27 Nov 2013 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | ACCORD HLTHCARE | Prescription | 8 Sep 2017 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | ZYDUS PHARMS | Prescription | 10 Oct 2017 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | AUROBINDO PHARMA | Prescription | 5 Feb 2020 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | CROSSMEDIKA SA | Prescription | 20 May 2024 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | GRANULES | Prescription | 8 Aug 2024 |
| TRAZODONE HYDROCHLORIDE | 50MG; 100MG; 150MG; 300MG | tablet · oral | GRAVITI PHARMS | Prescription | 27 Aug 2024 |
| RALDESY | 10MG/ML | solution · oral | KAMAT | Prescription | 26 Nov 2024 |
| DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | PRAGMA | Discontinued | 24 Dec 1981 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | WATSON LABS | Discontinued | 10 Oct 1986 |
| TRAZODONE HYDROCHLORIDE | 100MG | tablet · oral | WATSON LABS | Discontinued | 10 Oct 1986 |
| TRAZODONE HYDROCHLORIDE | 100MG | tablet · oral | ALVOGEN | Discontinued | 18 Apr 1988 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | ALVOGEN | Discontinued | 18 Apr 1988 |
| TRAZODONE HYDROCHLORIDE | 100MG | tablet · oral | AIPING PHARM INC | Discontinued | 30 Apr 1990 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | RISING | Discontinued | 30 Apr 1990 |
| TRAZODONE HYDROCHLORIDE | 50MG | tablet · oral | NATCO | Discontinued | 27 Feb 1991 |
| TRAZODONE HYDROCHLORIDE | 100MG | tablet · oral | NATCO | Discontinued | 27 Feb 1991 |
11 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AG-TRAZODONE | 02537907 | 50 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-TRAZODONE | 02537915 | 100 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| AG-TRAZODONE | 02537923 | 150 MG | TABLET · ORAL | ANGITA PHARMA INC. |
| APO-TRAZODONE D TABLETS 150MG | 02147653 | 150 MG | TABLET · ORAL | APOTEX INC |
| APO-TRAZODONE TABLETS 100MG | 02147645 | 100 MG | TABLET · ORAL | APOTEX INC |
| APO-TRAZODONE TABLETS 50MG | 02147637 | 50 MG | TABLET · ORAL | APOTEX INC |
| JAMP TRAZODONE | 02442809 | 50 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP TRAZODONE | 02442817 | 100 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP TRAZODONE | 02442825 | 150 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| PMS TRAZODONE HCL TAB 100MG | 01937235 | 100 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS TRAZODONE HCL TAB 50MG | 01937227 | 50 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-TRAZODONE | 02237339 | 75 MG | TABLET · ORAL | PHARMASCIENCE INC |
| TEVA-TRAZODONE | 02144263 | 50 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-TRAZODONE | 02144271 | 100 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TEVA-TRAZODONE | 02144298 | 150 MG | TABLET · ORAL | TEVA CANADA LIMITED |
| TRAZODONE | 02348772 | 50 MG | TABLET · ORAL | SANIS HEALTH INC |
| TRAZODONE | 02348780 | 100 MG | TABLET · ORAL | SANIS HEALTH INC |
| TRAZODONE | 02348799 | 150 MG | TABLET · ORAL | SANIS HEALTH INC |
| TRAZODONE-100 | 02164361 | 100 MG | TABLET · ORAL | PRO DOC LIMITEE |
| TRAZODONE-150 D | 02164388 | 150 MG | TABLET · ORAL | PRO DOC LIMITEE |
| TRAZODONE-50 | 02164353 | 50 MG | TABLET · ORAL | PRO DOC LIMITEE |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | RALDESY 10 MG/ML SOLUTION | $1.54111 | per ML | 23 Sep 2026 |
| US NADAC | RALDESY 10 MG/ML SOLUTION | $2.45747 | per ML | 23 Sep 2026 |
| US NADAC | TRAZODONE 100 MG TABLET | $0.05126 | per EA | 23 Sep 2026 |
| US NADAC | TRAZODONE 150 MG TABLET | $0.08645 | per EA | 23 Sep 2026 |
| US NADAC | TRAZODONE 300 MG TABLET | $0.49767 | per EA | 23 Sep 2026 |
| US NADAC | TRAZODONE 50 MG TABLET | $0.03074 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Trazodone 100mg capsules | £1.96 | 56 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 100mg tablets | £26.75 | 56 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 100mg/5ml oral solution sugar free | £155.00 | 120 ml | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 150mg tablets | £1.71 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 50mg capsules | £1.94 | 84 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 50mg tablets | £23.43 | 84 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Trazodone 50mg/5ml oral solution sugar free | £3.68 | 120 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
Safety signals and safety-related labeling changes
- EMA PRAC 1 Oct 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: Yes - EMA PRAC 11 Jun 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - US FDA 18 Oct 2018 DESYREL — safety-related labeling change
Labeling sections changed: Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 16 May 2013 PRAC signal: Postural hypotension and somnolence at high starting dose
Action for MAH: update of the product information: Yes - EMA PRAC 3 Oct 2012 PRAC signal: Postural hypotension and somnolence at high starting dose
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.