Fluoxetine
The first SSRI (Eli Lilly Prozac, FDA 1987). Ultra-long half-life (4-6 days), FDA-approved for pediatric MDD.
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WHAT IS FLUOXETINE?
Detailed overview
Fluoxetine is the SSRI-class pioneer (Eli Lilly Prozac, FDA 1987), the first clinically successful serotonin-selective drug. Ultra-long PK (parent 4-6 days, active metabolite norfluoxetine 4-16 days) means slow steady-state (4-5 weeks) but milder discontinuation syndrome (auto-taper). The ONLY SSRI with FDA approval for PEDIATRIC MDD (age 8+), plus OCD and bulimia nervosa. Stark 2003 (PMID 14692046) trial documented pediatric MDD efficacy. Generic, affordable. Strong CYP2D6 inhibitor causing clinically significant interactions.
Data console
Lab data
Safety
Side effects, stop signs, contraindications
Side effects · 7
- Serotonin syndrome (potentially life-threatening): agitation, hyperthermia, myoclonus, hyperreflexia, diarrhea – risk increases with MAOIs, triptans, tramadol, or other serotonergic agents.
- FDA boxed warning: increased suicidal thoughts and behavior in children, adolescents, and young adults (<25), especially in the first weeks of treatment and at dose changes – close monitoring required.
- GI and activating effects: nausea, diarrhea, anorexia (tends toward weight loss), plus insomnia and nervousness, which are more common with fluoxetine than other SSRIs (dose in the morning).
- Sexual dysfunction (15-30%): decreased libido, delayed ejaculation/orgasm, anorgasmia – common, often persistent, and a frequent reason for poor adherence.
- Induction of mania or hypomania in patients with unrecognized bipolar disorder – screening for bipolarity is advised before starting.
- Hyponatremia / SIADH (mainly in the elderly and with diuretics) and increased bleeding tendency (impaired platelet serotonin), especially with NSAIDs, aspirin, or anticoagulants.
- QT prolongation (dose-dependent) and rare seizures at high doses; discontinuation syndrome that, due to the 4-6 day half-life, is milder and later-onset than with short-acting SSRIs.
Contraindications · 2
- MAOi within 14 days (or 5 weeks after fluoxetine stop – due to long half-life)
- Concurrent pimozide, thioridazine
Related Pharmaceuticals
Same therapeutic category
Studies
Related research and clinical findings
Vortioxetine for Major Depressive Disorder in Adolescents: 12-Week Randomized, Placebo-Controlled, Fluoxetine-Referenced, Fixed-Dose Study.
Findling RL, DelBello MP, Zuddas A
Comparative efficacy of 21 antidepressants for MDD
Cipriani A, Furukawa TA, Salanti G et al.
Fluoxetine in obsessive-compulsive disorder: pooled-trial efficacy and tolerability
Tollefson GD, Rampey AH Jr, Potvin JH et al.
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Educational drug info from official sources (PubMed, FDA, EMA). Does NOT replace medical consultation or the SmPC. Talk to your doctor!
The information here is for educational and scientific purposes only. Medication use requires medical consultation and a prescription. The indications, dose ranges, and side effects listed here do NOT replace the official Summary of Product Characteristics (SmPC) or consultation with a physician. Do not start or stop any medication on your own. In an emergency, call your local emergency number.