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Prozac (Fluoxetine Hydrochloride) - Summary



Prozac® (fluoxetine hydrochloride) is a psychotropic drug for oral administration. It is also marketed for the treatment of premenstrual dysphoric disorder (Sarafem®, fluoxetine hydrochloride).

Prozac is indicated for the following:


Prozac is indicated for the treatment of major depressive disorder.


Prozac is indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.


Prozac is indicated for the treatment of binge-eating and vomiting behaviors in patients with moderate to severe bulimia nervosa.


Prozac is indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks, and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks.

See all Prozac indications & dosage >>


Media Articles Related to Prozac (Fluoxetine)

Prozac improves learning and memory in Huntington's disease
Source: The Doctors Lounge - Neurology
Scientists in Melbourne found that fluoxetine improves depression, learning and memory in Huntington's disease.

Antidepressants linked with risk of birth defects
Source: Clinical Trials / Drug Trials News From Medical News Today [2015.07.09]
Women who use the SSRIs paroxetine and fluoxetine in early pregnancy may be at higher risk of having infants with birth defects, according to new research.

more news >>

Published Studies Related to Prozac (Fluoxetine)

Comparable efficacy and safety of 8 weeks treatment with agomelatine 25-50mg or fluoxetine 20-40mg in Asian out-patients with major depressive disorder. [2014]
CONCLUSIONS: Agomelatine and fluoxetine are equally effective in the treatment of

Fluoxetine in progressive multiple sclerosis (FLUOX-PMS): study protocol for a randomized controlled trial. [2014]
BACKGROUND: Currently available disease-modifying treatments acting by modifying the immune response are ineffective in progressive multiple sclerosis (MS), which is caused by a widespread axonal degeneration. Mechanisms suspected to be involved in this widespread axonal degeneration are reduced axonal energy metabolism, axonal glutamate toxicity, and reduced cerebral blood flow...

A randomized, double-blind, clinical trial comparing the efficacy and safety of Crocus sativus L. with fluoxetine for improving mild to moderate depression in post percutaneous coronary intervention patients. [2014]
(PCI)... CONCLUSION: Short-term therapy with saffron capsules showed the same

Augmentation of fluoxetine with lovastatin for treating major depressive disorder, a randomized double-blind placebo controlled-clinical trial. [2013]
BACKGROUNDS: There are contradictory evidence about the effect of statins on depression. This 6-week-randomized placebo-controlled clinical trial assessed the efficacy and safety of lovastatin as an adjuvant agent for treating major depressive disorder (MDD)... DISCUSSION: These results suggest that lovastatin as an adjuvant treatment may be effective for treating patients with MDD.

Efficacy of vitamin C as an adjunct to fluoxetine therapy in pediatric major depressive disorder: a randomized, double-blind, placebo-controlled pilot study. [2013]
double-blind, placebo-controlled pilot trial... CONCLUSIONS: These preliminary results suggest that vitamin C may be an effective

more studies >>

Clinical Trials Related to Prozac (Fluoxetine)

The Effects of Multiple Dose Fluoxetine and Metabolites on CYP1A2, CYP2C19, CYP2D6 and CYP3A4 Activity [Not yet recruiting]
Inhibitory drug-drug interactions (DDIs) are a considerable concern as inhibition of drug's clearance can lead to increased plasma concentrations and subsequent adverse events and toxicities. Fluoxetine (Prozac®) is a widely prescribed antidepressant, but is also a potent inhibitor of cytochrome P450 (CYP) enzymes. Fluoxetine was chosen as the model inhibitor for this study because it is a clinically important inhibitor of multiple CYP enzymes with varying potencies for each isoform. From in vitro data, fluoxetine is predicted to be a moderate inhibitor of CYP2D6, but a strong inhibitor of CYP2C19 and CYP3A4. However, in vivo fluoxetine causes a potent interaction with CYP2D6 and a weak-to-no interaction with CYP3A4. The magnitude of the in vivo interaction of fluoxetine with CYP2C19 is not known. This in vitro-to-in vivo discrepancy is of concern for two reasons: 1) In clinical drug development, in vivo drug-drug interactions are tested only when in vitro experiments predict a risk for in vivo DDIs and 2) Because in vivo DDI's are tested using a rank order approach of going from the most potent in vitro interaction to the least potent until no interaction in vivo is observed. In this study the interaction between fluoxetine and CYP3A4, CYP2C19 and CYP2D6 will be quantified simultaneously and the quantitative in vitro-to-in vivo predictions tested. Fluoxetine will be orally administered daily for 14 days and CYP1A2, CYP3A4, CYP2C19 and CYP2D6 activity will be tested in the end of fluoxetine dosing using a cocktail of CYP probes including caffeine, midazolam, omeprazole and dextromethorphan. Lovastatin will be administered on a separate day and used as a second CYP3A4 probe to test whether CYP3A4 inhibition by fluoxetine depends on the contribution of intestinal CYP3A4 to the probe clearance. Plasma and urine samples will be collected for 12 and 24 hrs, respectively, during the control sessions (before fluoxetine administration) and for 24 hrs during the treatment sessions (fluoxetine multiple dose). The concentrations of each of the probe drugs and their metabolites (when applicable) as well as fluoxetine and its metabolites will be measured in the collected samples and pharmacokinetic analysis will be performed. The primary outcome measures for CYP inhibition will be the increase in the area under plasma concentrations time curve (AUC) of each of the probes. The null hypothesis of this study is that the area under plasma concentrations time curves (AUCs) of caffeine, dextromethorphan, omeprazole, midazolam or lovastatin are the same between the control session and the fluoxetine session. Because lovastatin has the greatest variability in its baseline pharmacokinetics the study was powered based on the specific null hypothesis for lovastatin. The alternative hypothesis is that fluoxetine decreases the clearance of the probe drugs resulting in a significant increase in the AUCs between the control and study sessions.

Efficacy of Fluoxetine in Reducing Ictal Hypoventilation in Patients With Partial Epilepsy [Recruiting]
The purpose of this study is to determine the effects of fluoxetine on breathing mechanisms during seizures. Patients with partial epilepsy commonly have changes in their breathing mechanisms during seizures. These changes may increase the risk of serious side effects from seizures, including sudden unexplained death in epilepsy (SUDEP), which affects 2-10 per 1000 patients with epilepsy each year. Fluoxetine (Prozac) may help to stimulate breathing through its actions in the brain and has been shown to improve breathing changes seen with seizures in certain animals. Fluoxetine is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). It works by increasing the amount of serotonin, a natural substance in the brain, at synapses, the junctions at which nerve cells in the brain communicate. Fluoxetine is currently approved by the United States Food and Drug Administration (FDA) for the treatment of patients with Major Depressive Disorder, Obsessive Compulsive Disorder, Bulimia Nervosa, Panic Disorder and Premenstrual Dysphoric Disorder.

Fasting Study of Fluoxetine Capsules 40 mg and Prozac Pulvules 40 mg [Completed]
The objective of this study is to investigate the bioequivalence of Mylan's fluoxetine hydrochloride 40 mg capsules to Dista's Prozac 40 mg pulvules following a single, oral 40 mg (1 x 40 mg) dose administration under fasting conditions.

Comparison of Fluoxetine, Calcium and Placebo for the Treatment of Moderate to Severe Premenstrual Syndrome (PMS) [Recruiting]
The purpose of this study is to compare the efficacy of calcium carbonate to fluoxetine in the treatment of moderate to severe PMS. Second, to compare each active agent to a placebo control. Third, to evaluate the efficacy of each treatment for specific symptom clusters (i. e. affective and somatic). Fourth, to determine whether the addition of calcium to on going fluoxetine treatment leads to additional therapeutic benefit.

Fluoxetine in Multiple System Atrophy Patients [Recruiting]
This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 15 centers and 88 patients of both sexes.

The primary objective of the trial is to evaluate the effect of a selective inhibitor of serotonin reuptake, the Fluoxétine, at a higher dose (40 mg/day) than usually recommended for depressed patients, after three months in patients suffering from an atypical Parkinson's disease called Multiple System Atrophy, compared to the placebo effect.

Secondary objectives of the trial are the evaluation of the effects of Fluoxétine after six weeks at the dose of 20 mg/day, after six months at the dose of 40mg/day, and assess the effects on mortality, quality of life, autonomic disorders, particularly orthostatic hypotension, mood and others symptoms such as sleep, apathy, pain and fatigue.

more trials >>

Reports of Suspected Prozac (Fluoxetine) Side Effects

Foetal Exposure During Pregnancy (402)Drug Ineffective (74)Talipes (55)Ventricular Septal Defect (46)Atrial Septal Defect (44)Anxiety (42)Depression (40)Cleft Palate (35)Suicidal Ideation (33)Weight Increased (32)more >>


Based on a total of 51 ratings/reviews, Prozac has an overall score of 7.25. The effectiveness score is 7.88 and the side effect score is 7.25. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.

Prozac review by 35 year old female patient

Overall rating:  
Effectiveness:   Highly Effective
Side effects:   No Side Effects
Treatment Info
Condition / reason:   Depression
Dosage & duration:   20mg. taken once a day for the period of past 3 years
Other conditions:   High cholesterol
Other drugs taken:   Lovastatin
Reported Results
Benefits:   Within a few days, my mood, self-esteem, attitude and over-all well-being improved tremendously! I went from feeling suicidal and not being able to funtion properly in order to take care of myself or my family, to feeling better than I had since I was in my teens. I began to lose some of the weight I had gained from being depressed. I was in a wonderful mood and I had so much more energy than I had in years. My overall experience with Prozac has been perfect!
Side effects:   I have had no known side effects to this date. I do watch out for muscle cramps that last more than a week and I have blood work done once a year to ensure that my kidneys are not being affected.
Comments:   I started on 10 mgs. once a day and when that was tolerated well I went up to 40 mgs. This caused some insomnia and nervousness so my Dr. lowered it to 20 mgs. a day. There are still times I get depressed for a few days but that only happens once or twice a year and it is mild. I am looking at being on Prozac as long as my body toleates it, due to once being taken off I went into a fast downward spiral and had to begin again.


Prozac review by 17 year old female patient

Overall rating:  
Effectiveness:   Moderately Effective
Side effects:   Mild Side Effects
Treatment Info
Condition / reason:   depression
Dosage & duration:   80mg taken trice a day for the period of 3 years
Other conditions:   anorexia
Other drugs taken:   zyprexa, motilium, pharmaton, letter, etc.
Reported Results
Benefits:   I felt better mood, optimism towards life in general, greater control of portion sizes. My recovery from anorexia was not easy, so I had a few months of moderate bulimia. It was then that my dosage grew bigger: 3 pills of 20 mg per day, though some days I would have 4 pills.
Side effects:   don't recall
Comments:   it takes very long, and requires a very large amount of patience.


Prozac review by 31 year old female patient

Overall rating:  
Effectiveness:   Ineffective
Side effects:   Extremely Severe Side Effects
Treatment Info
Condition / reason:   Severe Anxiety
Dosage & duration:   20 mg per day taken once per day for the period of one week
Other conditions:   none
Other drugs taken:   Diazepam
Reported Results
Benefits:   This medication did not make me sedated or cause constipation like the last one I tried and I had no trouble getting to sleep at night.
Side effects:   On the first day of taking this medication, I became extremely high and anxious within an hour of taking it. I then went on a major shopping spree, had major increased energy and talked a lot more then I usually do. By the second night, I started crying and could not stop and my teeth would not stop chattering. Over the next few days I became like a zombie during the day, but by night I would be a crying shaking mess. On the last day of taking this medication I was truly suicidal and I was not even depressed when I started this medication a week earlier. This medication was to treat severe anxiety only, and it did help for this, but made me severely depressed as a consequence. This medication may be very beneficial for some people, but it did not work for me.
Comments:   I started taking one 10mg tablet of Fluoxetine in the morning for three days and then changed to one 20mg tablet in the morning

See all Prozac reviews / ratings >>

Page last updated: 2015-07-09

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