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Antidepressive Agents, Second-Generation

Antidepressive Agents, Second-Generation, Serotonin Uptake Inhibitors, Serotonin Agents


Fluoxetin BMM Pharma, Fluoxetin Meda, Fluoxetin Mylan, Fluoxetin Orifarm, Fluoxetin STADA®, Fluoxetin Sandoz, Fluoxetin Selena, Fluoxetin Teva, Fluoxetin ratiopharm, Fluoxetine Accord, Fluoxetine Orion, Fluoxetine Vitabalans, Fontex®, Fontex® Basal, Prozac


fluoxetine, fluoxetine hydrochloride

Fluoxetine hydrochloride is the first agent of the class of antidepressants known as selective serotonin-reuptake inhibitors (SSRIs). Fluoxetine is a racemic mixture of the R- and S- enantiomers and are of equivalent pharmacologic activity. Despite distinct structural differences between compounds in this class, SSRIs possess similar pharmacological activity. As with other antidepressant agents, several weeks of therapy may be required before a clinical effect is seen. SSRIs are potent inhibitors of neuronal serotonin reuptake. They have little to no effect on norepinephrine or dopamine reuptake and do not antagonize α- or β-adrenergic, dopamine D2 or histamine H1 receptors. During acute use, SSRIs block serotonin reuptake and increase serotonin stimulation of somatodendritic 5-HT1A and terminal autoreceptors. Chronic use leads to desensitization of somatodendritic 5-HT1A and terminal autoreceptors. The overall clinical effect of increased mood and decreased anxiety is thought to be due to adaptive changes in neuronal function that leads to enhanced serotonergic neurotransmission. Side effects include dry mouth, nausea, dizziness, drowsiness, sexual dysfunction and headache. Side effects generally occur within the first two weeks of therapy and are usually less severe and frequent than those observed with tricyclic antidepressants. Fluoxetine may be used to treat major depressive disorder (MDD), moderate to severe bulimia nervosa, obsessive-compulsive disorder (OCD), premenstrual dysphoric disorder (PMDD), panic disorder with or without agoraphobia, and in combination with olanzapine for treatment-resistant or bipolar I depression. Fluoxetine is the most anorexic and stimulating SSRI.

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The T-value in the score for hazard refers to chronic toxicity. Underlying data for P, B and T are from Fass.se, see below.

Fluoxetine is a SSRI, selective serotonin reuptake inhibitor.

The concentrations analyzed in the environment in Sweden by several SSRIs exceed reported levels of environmental impact, especially for invertebrates. However, the studies reporting the lowest effect concentrations are questioned. Fluoxetine has been found in wild fish, but not at levels corresponding to therapeutic levels in humans.

Fluoxetine is included in the Stockholm County Council's table of pharmaceuticals with risk for negative environmental impact according to the environmental programme 2017-2021. The substance has been detected in treated wastewater in Stockholm County in the last five years (2012-2016).

Is recommended in The Wise List. Environmental classification of pharmaceuticals is taken into consideration, sometimes with other environmental aspects, when selecting pharmaceuticals for the Wise List. When comparable pharmaceuticals are equivalent to medical effects, safety and pharmaceutical efficacy, environmental impact and price are considered.

Below is Hazard and Risk from Fass environmental information for Fontex (fluoxetine) (downloaded 2018-07-10)

Persistence: "Fluoxetine disappeared from the total system with DT50 values of 32 days (lake sediment) and 114 days (creek sediment) which is likely due, in part, to unextractable binding to the sediment. Fluoxetine slowly disappears from water sediment systems. [---] Fluoxetine is potentially persistent.”

Bioaccumulation: "The log of the octanol water partition coefficients at pH values of 5, 7, and 9 were 0,73 to 1,06, 1,77 to 1,79, and 2,62 to 2,64, respectively."

Chronic toxicity: There is NOEC for 3 trophic levels, lowest NOEC for fish (Danio rerio) 3.2 microg/L.

PEC/PNEC is based on sales data in Sweden in year 2014. PEC/PNEC = 0.2 which gives the risk low.

Suggestions on how to reduce the release of fluoxetine
Concrete proposals on how to work to reduce emissions of environmentally harmful pharmaceuticals on the list have been developed in close cooperation with the Stockholm Drug and Therapeutics Committee's expert advice. The action proposals were developed from an environmental perspective. The patient's best always goes first and several pharmaceuticals on the list are also included in the Wise List. However, for such pharmaceuticals, there may be measures that could reduce the environmental impact.

Concrete proposal for fluoxetine
• In the first place, non pharmacological treatment and / or measures (eg, CBT and physical activity) taken alone or in combination with pharmaceuticals for the treatment of depression. Avoid overconsumption of alcohol.
• Fluoxetine is recommended in the Wise List primarily for children and adolescents in depression. Fluoxetine is recommended in the Wise List for the treatment of anxiety disorder and obsessive compulsive disorder and related conditions.
• Not recommended pharmaceutical for the elderly.
• Avoid randomized prescribing of SSRIs (eg fluoxetine). Evaluate and reconsider the treatment with SSRIs. Can the pharmaceutical be de-prescribed?
• Starter pack for fluoxetine is available within the reimbursement system.

Comparative assessment of environmental risk in the use of citalopram, escitalopram, sertraline, fluoxetine, venlafaxine, paroxetine and clomipramine in Sweden (Report Goodpoint 2018)
Overall, there is a risk profile for the studied antidepressants.


  1. Fass.se för vårdpersonal
  2. Goodpoint. Prioritering av läkemedel med miljörisk inom SLL. Stockholm: Goodpoint; 2016. Rapport LS 2016–0634.
  3. IVL Swedish Environmental Research Institute Ltd. Fick J, Lindberg RH, Kaj L, Brorström-Lundén E. Results from the Swedish National Screening Programme 2010. Subreport 3. Pharmaceuticals.
  4. IVL Swedish Environmental Research Institute Ltd Fick J, Lindberg RH, Fång J, Magnér J, Kaj L, Brorström-Lundén E. Screening 2014. Analysis of pharmaceuticals and hormones in samples from WWTPs and receiving waters. Rapport C 135.
  5. Gaworecki KM, Klaine SJ. Behavioral and biochemical responses of hybrid striped bass during and after fluoxetine exposure. Aquat Toxicol. 2008;88:207-13.
  6. Fick J, Lindberg RH, Tysklind M, Larsson DG. Predicted critical environmental concentrations for 500 pharmaceuticals. Regul Toxicol Pharmacol. 2010;58:516-23.
  7. SLL. Sammanställning av läkemedelsprovtagningar - Bearbetning av regional försäljningsstatistik av läkemedel samt datamaterial från Stockholms läns landstings mätprogram för läkemedelssubstanser i vattenmiljö, 2012–2016.
  8. Stockholms läns landsting. Förteckning över miljöbelastande läkemedel med åtgärdsförslag framtagen inom ramen för SLL:s miljöprogram 2017–2021.
  9. Goodpoint. Jämförande bedömning av miljörisk vid användning av citalopram, escitalopram, sertralin, fluoxetin, venlafaxin, paroxetin och klomipramin. Stockholm: Goodpoint; 2018.
  10. Stockholms läns landsting. Kloka Listan 2018.
  11. Stockholm County Council. The Wise List 2015.