Active substance
Fluoxetine
- SFDA 16
- US FDA 76
- Health Canada 33
- US price lines 8
- NHS prices 9
- WHO EML 4
- Safety 17
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| ANXETIN 20MG CAPSULES | 20 mg | Capsule · Oral use | 20 Blister | SAR 37.65 | Generic · Prescription | DAR ALDAWA | Valid |
| ANXETIN 20MG CAPSULES | 20 mg | Capsule · Oral use | 500 Blister | SAR 529.65 | Generic · Prescription | DAR Al DAWA | Valid |
| FLOZAK | 20 mg | Capsule, hard · Oral use | 30 Bottle | SAR 83.85 | Generic · Prescription | RIYADH PHARMA | Valid |
| FLUOXETIN HEXAL 20MG CAPSULES | 20 mg | Capsule · Oral use | 20 Blister | SAR 33.85 | Generic · Prescription | HEXAL | Valid |
| FLUZYN 20MG CAPSULES | 20 mg | Capsule · Oral use | 14 Blister | SAR 28.70 | Generic · Prescription | OMAN PHARMACEUTICAL PRODUCTS | Valid |
| Fluxetyl | 4 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 22.15 | Prescription | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Valid |
| LINZ 20 MG CAPSULE | 20 mg | Capsule, hard · Oral use | 30 Blister | SAR 84.45 | Generic · Prescription | Tabuk Pharmaceutical Manufacturing Company | Valid |
| OXETINE 20MG F.C. TABLETS | 20 mg | Film-coated tablet · Oral use | 30 Blister | SAR 37.35 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| Oxetine | 20 mg | Film-coated tablet · Oral use | 1000 Blister | SAR 1055.95 | Generic · Prescription | The Jordanian Pharmaceutical Manufacturing Medical Equipment Co. Ltd. (JPM) | Valid |
| PROZAC 20MG CAPSULES | 20 mg | Capsule, hard · Oral use | 28 Blister | SAR 92.05 | NCE · Prescription | LILLY FRANCE | Valid |
| SALIPAX 20 | 20 mg | Capsule · Oral use | 30 Blister | SAR 84.45 | Generic · Prescription | ACINO PHARMA AG | Valid |
| EVOREX 20MG CAP | 20 mg | Capsule · Oral use | 30 Blister | SAR 68.40 | Generic · Prescription | Jazeera Pharmaceutical Industries (JPI) | Withdrawn by MAH · Not Marketed |
| FLUOXONE 20MG COATED TABLETS | 20 mg | Coated tablet · Oral use | 30 Blister | SAR 40.20 | Generic · Prescription | S.M.B. | Withdrawn by MAH · Not Marketed |
| FLUTIN 20MG CAPSULE | 20 mg | Capsule · Oral use | 30 Blister | SAR 71.05 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| FLUTIN 20MG-5ML SYRUP | 4 mg | Syrup · Oral use | 1 Bottle | SAR 30.45 | Generic · Prescription | Gulf Pharmaceutical Industries (Julphar) | Withdrawn by MAH · Not Marketed |
| FLUXETYL 20MG CAPSULES | 20 mg | Capsule · Oral use | 28 Blister | SAR 60.45 | Generic · Prescription | KUWAIT SAUDI PHARMACEUTICAL INDUSTRIES | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
ABDOMINAL SPASM; ACUTE BIPOLAR I DEPRESSION; ANXIETY DISORDERS; ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD); AUTISM SPECTRUM DISORDER; BIPOLAR II DISORDER; DEPRESSION; FIBROMYALGIA; HUNTINGTON'S DISEASE-TICS; IRRITABLE BOWEL SYNDROME; MENOPAUSE; MENSTRUAL DISORDERS; MULTIPLE SCLEROSIS; NARCOLEPSY AND CATAPLEXY; RAYNAUD'S PHENOMENON
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | SENORES PHARMS | Prescription | 2 Aug 2001 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | solution · oral | TEVA | Prescription | 2 Aug 2001 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | TEVA | Prescription | 29 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | MARKSANS PHARMA | Prescription | 29 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | capsule · oral | TEVA PHARMS USA | Prescription | 29 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | capsule · oral | LANDELA PHARM | Prescription | 30 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | tablet · oral | DR REDDYS | Prescription | 30 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE; EQ 10MG BASE; EQ 40MG BASE | capsule · oral | IVAX SUB TEVA PHARMS | Prescription | 31 Jan 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | solution · oral | SOLIS PHARMS | Prescription | 7 Feb 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | solution · oral | SCIEGEN PHARMS | Prescription | 27 Jun 2002 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | solution · oral | LANNETT CO INC | Prescription | 9 Feb 2007 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | AUROBINDO PHARMA | Prescription | 31 Jan 2008 |
| FLUOXETINE HYDROCHLORIDE | EQ 20MG BASE/5ML | solution · oral | AUROBINDO PHARMA | Prescription | 19 Mar 2009 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | ALEMBIC PHARMS LTD | Prescription | 19 Mar 2009 |
| FLUOXETINE HYDROCHLORIDE | EQ 90MG BASE | capsule, delayed rel pellets · oral | DR REDDYS LABS LTD | Prescription | 22 Mar 2010 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | HERITAGE | Prescription | 1 Oct 2012 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE; EQ 40MG BASE | capsule · oral | SCIEGEN PHARMS | Prescription | 16 Mar 2015 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | tablet · oral | PH HEALTH | Prescription | 19 Aug 2016 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | tablet · oral | TORRENT | Prescription | 21 Oct 2016 |
| FLUOXETINE HYDROCHLORIDE | EQ 10MG BASE; EQ 20MG BASE | tablet · oral | ALEMBIC | Prescription | 5 Apr 2017 |
| FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | tablet · oral | PH HEALTH | Prescription | 16 Nov 2017 |
| FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | tablet · oral | ADAPTIS | Prescription | 20 Nov 2017 |
| FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | tablet · oral | SOMERSET THERAPS LLC | Prescription | 21 Nov 2018 |
| FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | tablet · oral | SCIEGEN PHARMS | Prescription | 10 Jan 2019 |
| FLUOXETINE HYDROCHLORIDE | EQ 60MG BASE | tablet · oral | DR REDDYS | Prescription | 25 Jan 2019 |
51 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-FLUOXETINE | 02216353 | 10 MG | CAPSULE · ORAL | APOTEX INC |
| APO-FLUOXETINE | 02216361 | 20 MG | CAPSULE · ORAL | APOTEX INC |
| APO-FLUOXETINE | 02231328 | 20 MG / 5 ML | SOLUTION · ORAL | APOTEX INC |
| AURO-FLUOXETINE | 02385627 | 10 MG | CAPSULE · ORAL | AURO PHARMA INC |
| AURO-FLUOXETINE | 02385635 | 20 MG | CAPSULE · ORAL | AURO PHARMA INC |
| BIO-FLUOXETINE | 02448424 | 10 MG | CAPSULE · ORAL | BIOMED PHARMA |
| BIO-FLUOXETINE | 02448432 | 20 MG | CAPSULE · ORAL | BIOMED PHARMA |
| FLUOXETINE | 02286068 | 10 MG | CAPSULE · ORAL | SANIS HEALTH INC |
| FLUOXETINE | 02286076 | 20 MG | CAPSULE · ORAL | SANIS HEALTH INC |
| FLUOXETINE | 02374447 | 10 MG | CAPSULE · ORAL | SIVEM PHARMACEUTICALS ULC |
| FLUOXETINE | 02374455 | 20 MG | CAPSULE · ORAL | SIVEM PHARMACEUTICALS ULC |
| JAMP FLUOXETINE SOLUTION | 02546752 | 20 MG / 5 ML | SOLUTION · ORAL | JAMP PHARMA CORPORATION |
| JAMP-FLUOXETINE | 02386402 | 20 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| JAMP-FLUOXETINE | 02401894 | 10 MG | CAPSULE · ORAL | JAMP PHARMA CORPORATION |
| M-FLUOXETINE | 02529432 | 10 MG | CAPSULE · ORAL | MANTRA PHARMA INC |
| M-FLUOXETINE | 02529440 | 20 MG | CAPSULE · ORAL | MANTRA PHARMA INC |
| MAR-FLUOXETINE | 02392909 | 10 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MAR-FLUOXETINE | 02392917 | 20 MG | CAPSULE · ORAL | MARCAN PHARMACEUTICALS INC |
| MINT-FLUOXETINE | 02380560 | 10 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| MINT-FLUOXETINE | 02380579 | 20 MG | CAPSULE · ORAL | MINT PHARMACEUTICALS INC |
| NRA-FLUOXETINE | 02503875 | 10 MG | CAPSULE · ORAL | NORA PHARMA INC |
| NRA-FLUOXETINE | 02503883 | 20 MG | CAPSULE · ORAL | NORA PHARMA INC |
| ODAN-FLUOXETINE | 02459361 | 20 MG / 5 ML | SOLUTION · ORAL | ODAN LABORATORIESLTD |
| PMS-FLUOXETINE | 02177579 | 10 MG | CAPSULE · ORAL | PHARMASCIENCE INC |
| PMS-FLUOXETINE | 02177587 | 20 MG | CAPSULE · ORAL | PHARMASCIENCE INC |
8 more — full table
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | FLUOXETINE 20 MG/5 ML SOLUTION | $0.20327 | per ML | 23 Sep 2026 |
| US NADAC | FLUOXETINE DR 90 MG CAPSULE | $30.68175 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 10 MG CAPSULE | $0.03529 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 10 MG TABLET | $0.06978 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 20 MG CAPSULE | $0.02932 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 20 MG TABLET | $0.08383 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 40 MG CAPSULE | $0.05186 | per EA | 23 Sep 2026 |
| US NADAC | FLUOXETINE HCL 60 MG TABLET | $0.18175 | per EA | 23 Sep 2026 |
| NHS Drug Tariff | Fluoxetine 10mg capsules | £3.08 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 10mg tablets | £61.73 | 30 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 20mg capsules | £0.98 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 20mg dispersible tablets sugar free | £3.44 | 28 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 20mg/5ml oral solution | £6.30 | 70 ml | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 20mg/5ml oral solution sugar free | £13.12 | 70 ml | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 30mg capsules | £1.43 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 40mg capsules | £1.54 | 30 capsule | 1 Oct 2026 |
| NHS Drug Tariff | Fluoxetine 60mg capsules | £1.34 | 30 capsule | 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)
- 2.3. Medicines for other common symptoms in palliative care · core
Palliative care
Oral > Solid: 20 mg (as hydrochloride) - 24.2.1. Medicines for depressive disorders · core (EML); complementary (EMLc)
Depressive disorders
Oral > Solid: 20 mg (as hydrochloride) - 24.3. Medicines for anxiety disorders · core (EML); complementary (EMLc)
Generalised anxiety disorder; Social anxiety disorder; Panic disorder
Oral > Solid: 20 mg (as hydrochloride) - 24.4. Medicines for obsessive compulsive disorders · core (EML); complementary (EMLc)
Obsessive-compulsive disorder
Oral > Solid: 20 mg (as hydrochloride)
Safety signals and safety-related labeling changes
- US FDA 22 Jan 2025 SYMBYAX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 18 Aug 2023 FLUOXETINE HYDROCHLORIDE — 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 PROZAC — safety-related labeling change
Labeling sections changed: 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 - US FDA 20 Sep 2021 SARAFEM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - 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 - EMA PRAC 16 May 2019 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: Yes - EMA PRAC 31 Oct 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - EMA PRAC 6 Sep 2018 PRAC signal: Persistent sexual dysfunction after drug withdrawal
Action for MAH: update of the product information: No - US FDA 24 Mar 2017 PROZAC WEEKLY — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 2 Sep 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
Action for MAH: update of the product information: No - EMA PRAC 13 May 2016 PRAC signal: Risk of autism spectrum disorders (ASD) after maternal use of SSRI/SNRI
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.