Fluoxetine 10mg Tablets

Fluoxetine 10mg Tablets, also available as capsules, are a prescription-only generic equivalent of Prozac® 10mg, containing fluoxetine hydrochloride equivalent to fluoxetine 10mg per unit. Fluoxetine belongs to the selective serotonin reuptake inhibitor (SSRI) class of antidepressants — one of the most widely prescribed antidepressant classes in the world. The 10mg strength is the lowest commercially available dose, commonly used for treatment initiation, dose titration, or for patients requiring a lower therapeutic dose. Generic fluoxetine 10mg tablets and capsules are marketed internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide under multiple brand and generic names.

Product Information

Fluoxetine 10mg vs 20mg — What Is the Difference?

The 10mg starting dose is particularly recommended in elderly patients, patients with hepatic impairment, and those with significant anxiety symptoms who may be sensitive to SSRI initiation effects.

Generic Manufacturers

Generic fluoxetine 10mg is manufactured by a wide range of pharmaceutical companies globally, including:

• Teva Pharmaceuticals (USA, UK, EU)
• Sandoz / Novartis (USA, UK, EU, AU)
• Mylan / Viatris (USA, UK, EU)
• Aurobindo Pharma (USA, UK, EU)
• Dr. Reddy's Laboratories (USA, UK, EU)
• Accord Healthcare (UK, EU)
• Hikma Pharmaceuticals (USA, UK)
• Sun Pharmaceutical (USA, UK, EU)

Pack sizes, dosage form (tablet vs capsule), excipients and availability vary by manufacturer and market. Always refer to the manufacturer-specific product information.

Fluoxetine 10mg is prescribed for the following conditions depending on market-specific approved labeling:

Major Depressive Disorder (MDD) Fluoxetine 10mg is commonly used as an initiation dose for the treatment of major depressive disorder in adults and, in some markets, adolescents aged 8 years and older. The 10mg starting dose allows tolerability assessment before titration to the standard 20mg maintenance dose.

Obsessive-Compulsive Disorder (OCD) Fluoxetine is indicated for OCD in adults and children aged 7 years and older in certain markets. The 10mg dose may be used during initiation prior to titration.

Panic Disorder Fluoxetine is used in the treatment of panic disorder with or without agoraphobia. A low starting dose is recommended to minimise initial anxiogenic effects associated with SSRI initiation in panic disorder patients.

Bulimia Nervosa Fluoxetine 60mg per day is the approved dose for bulimia nervosa in most markets; the 10mg tablet allows flexible up-titration from lower initiating doses.

Premenstrual Dysphoric Disorder (PMDD) In the USA, fluoxetine (marketed as Sarafem®) is approved for PMDD. The 10mg strength is used in initiation phases.

United States: Fluoxetine is FDA-approved for major depressive disorder, OCD, panic disorder, bulimia nervosa and PMDD (as Sarafem® for PMDD). The 10mg capsule and tablet are available from multiple FDA-approved generic manufacturers. The product carries an FDA Black Box Warning regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults during initial treatment.

United Kingdom / EU: Fluoxetine is indicated for major depressive disorder, OCD and bulimia nervosa. MHRA-approved generic fluoxetine 10mg capsules and tablets are available. The drug is subject to EMA-aligned labeling in EU member states. A patient information leaflet (PIL) and summary of product characteristics (SPC) are available for each authorised product.

Australia: Fluoxetine 10mg Australia products are listed on the Australian Register of Therapeutic Goods (ARTG). Generic fluoxetine is PBS-subsidised for approved indications subject to patient eligibility. Consult your prescriber or pharmacist regarding PBS authority requirements.

UAE / Gulf: Fluoxetine products are registered with the UAE Ministry of Health and Prevention (MOHAP). Availability of the specific 10mg strength varies by registered product. Fluoxetine is a prescription-only medicine (POM) in all GCC states. Consult a UAE-licensed physician before ordering.

Germany: Fluoxetin 10mg is available in Germany as tablets and capsules from multiple approved manufacturers. All products are prescription-only (rezeptpflichtig). The 10mg strength is used for initiation and for patients requiring a lower maintenance dose. German-language package inserts (Beipackzettel) are included with all authorised products.

France: Fluoxétine 10mg is available as tablets and capsules in France, subject to prescription and reimbursement conditions. All products carry French-language patient information leaflets.

Russia: Флуоксетин 10 мг is available in Russia under multiple brand and generic names, all requiring a valid prescription. Product registration is overseen by the Ministry of Health of the Russian Federation.

South Korea: 플루옥세틴 10mg is registered for prescription use in South Korea per MFDS-approved labeling. Available from Korean and international generic manufacturers.

Always follow the prescribing information for your country and the guidance of your licensed healthcare professional.

Black Box Warning (USA): Antidepressants, including fluoxetine, may increase the risk of suicidal thoughts and behaviours in children, adolescents and young adults (aged 18–24) during initial treatment. Patients should be monitored closely for worsening of depression, emergence of suicidal thinking or behaviour, and unusual changes in mood or behaviour. This warning applies particularly during dose initiation and adjustment periods.

Serotonin Syndrome: Fluoxetine may cause serotonin syndrome, particularly when co-administered with other serotonergic agents including MAOIs, triptans, tramadol or lithium. Fluoxetine and its active metabolite norfluoxetine have an exceptionally long half-life — full washout may take 5 weeks or more.

Drug Interactions: Fluoxetine is a potent inhibitor of CYP2D6 and a moderate inhibitor of CYP3A4. Significant interactions exist with tricyclic antidepressants, antipsychotics, antiarrhythmics, warfarin and other drugs. Always perform a full medication reconciliation before prescribing.

Discontinuation: Due to the long half-life, fluoxetine is generally associated with a lower risk of discontinuation syndrome compared to shorter-acting SSRIs, but dose changes should still be managed under medical supervision.

Supply, pack size and product formulation vary by manufacturer and country. This page is for informational purposes only and does not constitute medical advice. Always follow your prescriber's guidance and local product labeling.