Active substance
Sertraline
- SFDA 17
- US FDA 41
- Health Canada 54
- US price lines 9
- NHS prices 5
- WHO EML 1
- Safety 21
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| LUSTRAL 50MG TAB | 50 mg | Tablet · Oral use | 30 Blister | SAR 95.70 | NCE · Prescription | SPIMACO ADDWAEIH | Valid |
| Lustalin | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 180.55 | Generic · Prescription | Saudi Amarox | Valid |
| Lustalin | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 95.70 | Generic · Prescription | Saudi Amarox | Valid |
| Lustalin | 25 mg | Film-coated tablet · Oral use | 30 Blister | SAR 47.85 | Generic · Prescription | Saudi Amarox | Valid |
| RIASERTAL 100 mg film-coated tablet | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 191.40 | Generic · Prescription | RIYADH PHARMA | Valid |
| RIASERTAL 50 mg film-coated tablet | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 95.70 | Generic · Prescription | RIYADH PHARMA | Valid |
| SETRAL 100MG F.C. TABLETS | 100 mg | Film-coated tablet · Oral use | 10 Blister | SAR 27.20 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| SETRAL 50MG F.C. TABLETS | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 54.15 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| SETRAL 50MG F.C. TABLETS | 50 mg | Film-coated tablet · Oral use | 10 Blister | SAR 18.05 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| SOLOTIK 100MG F-C TABLETS | 100 mg | Film-coated tablet · Oral use | 30 Tablet Container | SAR 67.20 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| SOLOTIK 100MG F-C TABLETS | 100 mg | Film-coated tablet · Oral use | 15 Bottle | SAR 33.60 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| SOLOTIK 50MG F-C TABLETS | 50 mg | Film-coated tablet · Oral use | 30 Tablet Container | SAR 46.55 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| SOLOTIK 50MG F-C TABLETS | 50 mg | Film-coated tablet · Oral use | 15 Bottle | SAR 20.50 | Generic · Prescription | Hikma Pharmaceuticals PLC | Valid |
| Sertidep | 100 mg | Film-coated tablet · Oral use | 30 Blister | SAR 180.55 | Generic · Prescription | Apex Pharma | Valid |
| Sertidep | 50 mg | Film-coated tablet · Oral use | 30 Blister | SAR 95.70 | Generic · Prescription | Apex Pharma | Valid |
| Setral | 50 mg | Film-coated tablet · Oral use | 1000 Blister | SAR 1056.50 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| Setral | 100 mg | Film-coated tablet · Oral use | 1000 Blister | SAR 2191.05 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
Indications — CHI Daman Drug Formulary
ACUTE BIPOLAR I DEPRESSION; ALZHEIMER / DEMENTIA; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; BIPOLAR II DISORDER; DEPRESSION; FIBROMYALGIA; HUNTINGTON'S DISEASE-TICS; MENOPAUSE; MENSTRUAL DISORDERS; MULTIPLE SCLEROSIS; POLYCYTHEMIA VERA - PRURITUS; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| ZOLOFT | EQ 50MG BASE; EQ 100MG BASE; EQ 25MG BASE | tablet · oral | VIATRIS | Prescription | 30 Dec 1991 |
| ZOLOFT | EQ 20MG BASE/ML | concentrate · oral | VIATRIS | Prescription | 7 Dec 1999 |
| SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | concentrate · oral | STRIDES PHARMA | Prescription | 30 Jun 2006 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | HERITAGE | Prescription | 11 Aug 2006 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | STRIDES PHARMA | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | MACLEODS PHARMS | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | AUROBINDO PHARMA | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | INVAGEN PHARMS | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | LUPIN | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | tablet · oral | APPCO | Prescription | 6 Feb 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | SCIEGEN PHARMS | Prescription | 30 Apr 2007 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | GRANULES | Prescription | 8 Jan 2008 |
| SERTRALINE HYDROCHLORIDE | EQ 20MG BASE/ML | concentrate · oral | AUROBINDO PHARMA | Prescription | 31 Oct 2008 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | REYOUNG | Prescription | 4 Mar 2009 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | OXFORD PHARMS | Prescription | 21 Jul 2010 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE | tablet · oral | ACCORD HLTHCARE | Prescription | 7 Nov 2014 |
| SERTRALINE HYDROCHLORIDE | EQ 25MG BASE; EQ 50MG BASE; EQ 100MG BASE; EQ 75MG BASE | tablet · oral | ASCENT PHARMS INC | Prescription | 3 May 2021 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | ALMATICA | Prescription | 4 Oct 2021 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | ZENARA | Prescription | 16 Jul 2025 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | UMEDICA | Prescription | 20 Jan 2026 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | APPCO | Prescription | 20 Jan 2026 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | NOVITIUM PHARMA | Prescription | 20 Jan 2026 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | AMNEAL | Prescription | 28 Jan 2026 |
| SERTRALINE HYDROCHLORIDE | EQ 150MG BASE; EQ 200MG BASE | capsule · oral | ZYDUS LIFESCIENCES | Prescription | 29 Jan 2026 |
| ZOLOFT | EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | VIATRIS | Discontinued | 30 Dec 1991 |
16 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| AG-SERTRALINE | 02477882 | 25 MG | CAPSULE · ORAL | ANGITA PHARMA INC. |
| AG-SERTRALINE | 02477890 | 50 MG | CAPSULE · ORAL | ANGITA PHARMA INC. |
| AG-SERTRALINE | 02477904 | 100 MG | CAPSULE · ORAL | ANGITA PHARMA INC. |
| APO-SERTRALINE | 02238280 | 25 MG | CAPSULE · ORAL | APOTEX INC |
| APO-SERTRALINE | 02238281 | 50 MG | CAPSULE · ORAL | APOTEX INC |
| APO-SERTRALINE | 02238282 | 100 MG | CAPSULE · ORAL | APOTEX INC |
| AURO-SERTRALINE | 02390906 | 25 MG | CAPSULE · ORAL | AURO PHARMA INC |
| AURO-SERTRALINE | 02390914 | 50 MG | CAPSULE · ORAL | AURO PHARMA INC |
| AURO-SERTRALINE | 02390922 | 100 MG | CAPSULE · ORAL | AURO PHARMA INC |
| BIO-SERTRALINE | 02445042 | 25 MG | CAPSULE · ORAL | BIOMED PHARMA |
| BIO-SERTRALINE | 02445050 | 50 MG | CAPSULE · ORAL | BIOMED PHARMA |
| BIO-SERTRALINE | 02445069 | 100 MG | CAPSULE · ORAL | BIOMED PHARMA |
| M-SERTRALINE | 02530937 | 25 MG | CAPSULE · ORAL | MANTRA PHARMA INC |
| M-SERTRALINE | 02530945 | 50 MG | CAPSULE · ORAL | MANTRA PHARMA INC |
| M-SERTRALINE | 02530953 | 100 MG | CAPSULE · ORAL | MANTRA PHARMA INC |
| MAR-SERTRALINE | 02399415 | 25 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-SERTRALINE | 02399423 | 50 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-SERTRALINE | 02399431 | 100 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-SERTRALINE | 02402378 | 25 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SERTRALINE | 02402394 | 50 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| MINT-SERTRALINE | 02402408 | 100 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| NB-SERTRALINE | 02556235 | 25 MG | CAPSULE · ORAL | NB PHARMA INC. |
| NB-SERTRALINE | 02556243 | 50 MG | CAPSULE · ORAL | NB PHARMA INC. |
| NB-SERTRALINE | 02556251 | 100 MG | CAPSULE · ORAL | NB PHARMA INC. |
| NRA-SERTRALINE | 02488434 | 25 MG | CAPSULE · ORAL | NORA PHARMA INC |
29 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | SERTRALINE 150 MG CAPSULE | $1.2507 | per EA | 23 Sep 2026 |
| US NADAC | SERTRALINE 20 MG/ML ORAL CONC | $0.36502 | per ML | 23 Sep 2026 |
| US NADAC | SERTRALINE 200 MG CAPSULE | $1.73616 | per EA | 23 Sep 2026 |
| US NADAC | SERTRALINE HCL 100 MG TABLET | $0.05074 | per EA | 23 Sep 2026 |
| US NADAC | SERTRALINE HCL 25 MG TABLET | $0.02884 | per EA | 23 Sep 2026 |
| US NADAC | SERTRALINE HCL 50 MG TABLET | $0.03479 | per EA | 23 Sep 2026 |
| US NADAC | ZOLOFT 100 MG TABLET | $14.94336 | per EA | 23 Sep 2026 |
| US NADAC | ZOLOFT 25 MG TABLET | $15.17086 | per EA | 23 Sep 2026 |
| US NADAC | ZOLOFT 50 MG TABLET | $14.90731 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Sertraline 100mg tablets | £1.12 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sertraline 150mg tablets | £13.70 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sertraline 200mg tablets | £23.76 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sertraline 25mg tablets | £5.01 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Sertraline 50mg tablets | £1.00 | 28 tablet | 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.
WHO WHO Model List of Essential Medicines (2025)
- 24.3. Medicines for anxiety disorders · core (EML); complementary (EMLc)
Therapeutic equivalent to fluoxetine for Generalised anxiety disorder
Safety signals and safety-related labeling changes
- US FDA 6 Oct 2026 SERTRALINE HYDROCHLORIDE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 8 May 2025 PRAC signal: Multiple acyl-coenzyme A dehydrogenase deficiency
Action for MAH: update of the product information: Yes - EMA PRAC 16 Jan 2025 PRAC signal: Multiple acyl-coenzyme A dehydrogenase deficiency
Action for MAH: update of the product information: No - US FDA 18 Aug 2023 ZOLOFT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2023 ZOLOFT — safety-related labeling change
Labeling sections changed: Boxed Warning; Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 29 Sep 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - EMA PRAC 10 Mar 2022 PRAC signal: Pulmonary hypertension
Action for MAH: update of the product information: No - 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 14 May 2020 PRAC signal: Microscopic colitis
Action for MAH: update of the product information: Yes - EMA PRAC 12 Mar 2020 PRAC signal: Postpartum haemorrhage
Action for MAH: update of the product information: No - EMA PRAC 16 Jan 2020 PRAC signal: Microscopic colitis
Action for MAH: update of the product information: No - EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 16 May 2019 PRAC signal: Maculopathy
Action for MAH: update of the product information: Yes - EMA PRAC 17 Jan 2019 PRAC signal: Maculopathy
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.