Arrow Fluoxetine

Quick links to important sections

Arrow Fluoxetine

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Arrow Fluoxetine

Quick Facts

Property Description
Active Ingredient Fluoxetine (as Hydrochloride)
Form Capsules, Tablets, Oral Solution
Pharmacological Class Selective Serotonin Reuptake Inhibitor (SSRI)
General Purpose Neurotransmitter modulator for mood stability
Origin Synthetic Compound (Phenylpropylamine derivative)

What Type of Medicine is Arrow Fluoxetine?

Arrow Fluoxetine is a prescription-only medicine (POM) officially classified as an antidepressant and a Selective Serotonin Reuptake Inhibitor (SSRI). This psychotropic medication is recognized within the medical community for its mechanism of action. The general therapeutic goal of this agent is to help stabilize emotional fluctuations, promoting overall mood stability and improving the patient’s capacity for emotional regulation. Fluoxetine is a compound used to address chemical imbalances related to mood and behavior. As a generic drug manufactured under the 'Arrow' brand, it contains the identical active compound, Fluoxetine, ensuring the same established pharmacological action as the original innovator product.

Composition, Origin, and Available Forms

The core constituent of the medicine is the active ingredient, Fluoxetine, commonly present as the Fluoxetine Hydrochloride salt. Fluoxetine is a synthetic compound, meaning it is chemically synthesized rather than being sourced from natural origins, and it is chemically derived from the Phenylpropylamine derivative family. For oral administration, the medication is supplied in various single-ingredient dosage forms, including traditional hard gelatin capsules, oral tablets, and an oral solution. This availability across solid and liquid preparations allows for flexibility in prescribing across different patient groups, including those in the pediatric population who may require the liquid form. The high-level composition combines the single active substance with pharmaceutical-grade excipients and binders necessary for the final formulation.

What side effects are possible with Arrow Fluoxetine?

Possible Side Effects and Safety Information

The official regulatory safety profile for Fluoxetine is structured to communicate adverse events based on frequency and affected body systems, derived from government labeling such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) Summary of Product Characteristics (SmPC).

Frequency-Classified Adverse Reactions

Adverse reactions are classified according to incidence rates documented in clinical trials and post-marketing surveillance:

  • Very Common (affecting more than 1 in 10 people): Examples include insomnia, headache, and diarrhoea.
  • Common (affecting 1 to 10 in 100 people): Documented effects span Nervous System (e.g., dizziness, tremor), Gastrointestinal Disorders (e.g., nausea), and Psychiatric Disorders (e.g., anxiety, nervousness).

Serious Adverse Reactions and Key Constraints

Official labeling documents the possibility of rare but clinically significant events. Serious adverse reactions include the potential for Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions, and severe cutaneous reactions such as Stevens-Johnson Syndrome. The medication is contraindicated for concurrent use with Monoamine Oxidase Inhibitors (MAOIs) due to the risk of serious, potentially fatal reactions.

Population-Specific and Time-Related Safety

Regulatory documents include specific warnings for certain groups. For the pediatric population, an increased risk of suicidal thinking and behavior is noted in official boxed warnings. Time-related safety patterns indicate that effects such as anxiety and insomnia may be more frequently observed at the start of treatment, while issues like sexual dysfunction may be associated with long-term exposure. Caution is also required in individuals with a history of seizures or significant hepatic impairment.

Overdose and Emergency Response

Overdose and when to seek help — official regulatory information for Arrow Fluoxetine

Overdose Scope

Domain Official Regulatory Statement
Documented overdose presentations Manifestations commonly include nausea, vomiting, somnolence (drowsiness), agitation, and tachycardia (rapid heart rate). Central nervous system effects may involve seizures, confusion, or features consistent with a Neuroleptic malignant syndrome-like reaction.
Physiological systems affected (as stated in label) The cardiovascular system is affected, with documented risks of ECG abnormalities, QT interval prolongation, and ventricular arrhythmias. The nervous system is also affected, with a risk of coma.
Dose-related or exposure-related factors (if applicable) Fatalities in pediatric patients have been reported, primarily complicated by mixed-drug ingestion alongside Fluoxetine.
Emergency-response statements (as written in official documents) Seek immediate medical attention for any suspected overdosage. Call emergency services immediately if the individual has collapsed, experienced a seizure, or cannot be awakened.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification (as defined in official documents) Severe or potentially life-threatening outcomes include coma, fatal dysrhythmias, and Torsades de pointes-type arrhythmias.
Overdose-context constraints (as defined in official documents) No specific antidote is known; therefore, treatment is limited to supportive and symptomatic care, with ECG monitoring ordinarily required.

Therapeutic Uses of Arrow Fluoxetine

Main uses of Arrow Fluoxetine

Arrow Fluoxetine is a medication belonging to the class of selective serotonin reuptake inhibitors (SSRIs). It is primarily used to manage several mental health conditions by helping to restore the balance of serotonin, a natural chemical in the brain.

Major Depressive Disorder

The medication is frequently used in the treatment of major depressive disorder. It is intended to help alleviate symptoms such as persistent low mood, loss of interest in daily activities, and changes in sleep or appetite. The goal of treatment is to support the gradual improvement of emotional well-being and daily functioning.

Obsessive-Compulsive Disorder (OCD)

Arrow Fluoxetine is used to manage the symptoms of obsessive-compulsive disorder. This includes reducing the frequency and intensity of persistent, unwanted thoughts (obsessions) and the repetitive behaviors (compulsions) that an individual feels driven to perform.

Bulimia Nervosa

This medication is also indicated for the treatment of bulimia nervosa. In this context, it is used to help reduce the cycles of binge-eating and purging behavior associated with the condition.

Panic Disorder

In some cases, the medication is used to treat panic disorder, which is characterized by sudden and repeated episodes of intense fear accompanied by physical symptoms. Treatment aims to reduce the frequency of panic attacks and the anxiety associated with the anticipation of future episodes.

Benefits and Expected Outcomes

Emotional Regulation

By increasing the availability of serotonin in the brain, Arrow Fluoxetine can help stabilize mood. Patients may find that they are better able to manage stress and emotional triggers as the medication takes effect.

Improved Quality of Life

Effective management of depression, anxiety, or compulsive behaviors can lead to improved social and occupational functioning. This may include a better ability to maintain relationships, perform at work or school, and participate in social activities.

Long-term Stability

Beyond the initial relief of acute symptoms, the medication is often used to provide long-term stability and reduce the risk of symptom recurrence. This consistent support allows individuals to engage more effectively in other forms of support, such as psychological counseling.

Eligibility and Restrictions for Use

Arrow Fluoxetine's eligibility is determined by specific regulatory criteria concerning age, concurrent medical conditions, and physiological status.

Populations for whom use is contraindicated:

  • Patients with known hypersensitivity to fluoxetine or any component of the formulation.
  • Patients who are concurrently taking, or have recently taken, a Monoamine Oxidase Inhibitor (MAOI), Pimozide, or Thioridazine. A mandated washout period is required before initiation or switching.

Age-Related Eligibility Rules:

  • Pediatric Use: Safety and effectiveness are not established for Major Depressive Disorder (MDD) in children under 8 years of age or for Obsessive-Compulsive Disorder (OCD) in children under 7 years of age.
  • Older Adults (Geriatric): Use is permitted, though regulatory guidelines recommend considering a lower or less frequent starting dosage.

Condition-Specific Eligibility Restrictions:

  • Hepatic Impairment: Patients with liver dysfunction, such as cirrhosis, require a lower or less frequent dosage than standard adult patients due to prolonged drug clearance.
  • Seizure History: Use requires caution in individuals with a history of seizures or unstable seizure disorders, and treatment must be discontinued if seizures develop.
  • Cardiac Risk: Caution is required in patients with conditions that increase the risk for QT prolongation or established heart disease.

Pregnancy and Lactation Eligibility Status:

  • Pregnancy: Should be used only if the regulatory-defined potential benefit justifies the potential risks to the fetus. It is generally not recommended in the late third trimester.
  • Nursing Mothers: Breastfeeding is not recommended by regulatory bodies due to the excretion of fluoxetine and its active metabolite into human milk.

What should I know about interactions with other medicines?

This section summarizes the clinically significant interactions for fluoxetine as documented in official regulatory labeling.

Contraindicated Combinations

Fluoxetine is contraindicated for use with certain medicines due to the high risk of serious adverse reactions. This includes:

  • Monoamine Oxidase Inhibitors (MAOIs), such as Linezolid or intravenous Methylene Blue: Use with these agents, or within 14 days of stopping an MAOI, is prohibited. Due to the long half-life of fluoxetine and its active metabolite, at least five weeks must pass after discontinuing fluoxetine before starting an MAOI.
  • Pimozide and Thioridazine: Concomitant use with these antipsychotic agents is contraindicated due to the risk of QTc interval prolongation. Thioridazine must not be used within five weeks of stopping fluoxetine.

Clinically Significant Interactions

  • Serotonergic Drugs: Caution is required when combining fluoxetine with other serotonergic agents (e.g., Triptans, Tricyclic Antidepressants, Tramadol, Tryptophan, St. John’s Wort) as co-administration increases the risk of Serotonin Syndrome.
  • CYP2D6 Substrates: Fluoxetine is a potent inhibitor of the CYP2D6 enzyme pathway, which can increase the blood concentrations of other medicines primarily metabolized by this enzyme (e.g., Flecainide, some Antipsychotics). Careful monitoring is warranted.
  • Drugs that Interfere with Hemostasis: Concomitant use with Warfarin, Aspirin, or NSAIDs may increase the risk of abnormal bleeding events.

Regulatory documents emphasize that the primary interaction risks stem from combined serotonergic activity and the drug's effect as an enzyme inhibitor, necessitating specific timing restrictions and avoidance of certain drug classes.

Mechanism of Action

Molecular Mechanism: Selective Reuptake Inhibition

Arrow Fluoxetine (Fluoxetine) functions as a Selective Serotonin Reuptake Inhibitor (SSRI), exerting its primary biological action by binding to the Serotonin Transporter ( SERT) protein on the presynaptic neuron. This binding immediately and selectively blocks the reuptake of the neurotransmitter serotonin (5-HT), preventing its clearance from the synapse. This action leads to a measurably higher concentration and longer duration of action for 5-HT within the synaptic cleft.


Functional Consequence: Delayed Neurobiological Adaptation

The prolonged increase in synaptic serotonin triggers a slower, adaptive neurobiological process required for the full expression of the downstream physiological changes. Initially, presynaptic 5 -HT1 A autoreceptors dampen the new signal, but they gradually desensitize over several weeks. This desensitization leads to a sustained, functional increase in serotonergic activity that ultimately culminates in altered function and sustained changes within the CNS pathways that mediate affective tone and stress signaling.

Dosage and Administration Information

Administration Route and Standard Frequency

Arrow Fluoxetine is administered solely via the oral route. The medicine may be taken with or without food, establishing a flexible intake context. Administration is typically scheduled once daily, often in the morning, although specific schedules can vary based on the dosage form and the condition being addressed. Daily doses exceeding 20 mg may be taken in divided doses (e.g., morning and noon).


Dosing Patterns

Dosing regimens depend on the specific use scenario. The following are standard adult starting doses and maximums:

  • Major Depressive Disorder (MDD) & Obsessive-Compulsive Disorder (OCD): Typically initiated at 20 mg daily, with a maximum daily dose of 80 mg.
  • Bulimia Nervosa: The standard therapeutic dose is 60 mg daily.
  • Panic Disorder: Initiation requires a gradual approach, starting at 10 mg daily for one week before increasing to the 20 mg daily target, with a maximum of 60 mg daily.

Formulations and Specific Usage Instructions

The immediate-release dosage forms include capsules, tablets, and an oral solution. If the 20 mg/5 mL oral solution is used, the liquid must be shaken and measured using a marked dosing device for accurate administration. A 90 mg delayed-release capsule is also an option for maintenance use, which is taken 7 days after the final 20 mg dose of the daily formulation.

Population Adjustments

A lower or less frequent dose is considered for older adults and patients diagnosed with hepatic impairment (liver cirrhosis) to compensate for decreased clearance of the active compound. Dosing for the pediatric population (ages 7 for OCD and 8 for MDD) begins at 10 mg daily.

Recent Clinical Evidence

Research evidence / Overview of Studies for Arrow Fluoxetine

Evidence for use in Major Depressive Disorder (MDD)

The research for Major Depressive Disorder primarily consists of Randomized Controlled Trials (RCTs) used to explore how symptoms change over time. Studies monitored outcomes across adults and youth (age 8 and older), focusing on symptom change and patterns of symptom recurrence. The research base for adults is established and consistent in volume. For younger populations, findings were more varied, and the evidence is sometimes categorized as moderate due to observed heterogeneity.

Evidence for use in Obsessive-Compulsive Disorder (OCD) and Bulimia Nervosa

For Obsessive-Compulsive Disorder, research includes RCTs that examined symptom intensity and variability in adults and youth (age 7 and older), measuring changes in obsessive and compulsive patterns. Research has also explored symptom stability during long-term maintenance phases. For Bulimia Nervosa, studies evaluated behavioral outcomes like the frequency of binge eating and purging episodes. In both conditions, findings describe group patterns observed in the studies.

Evidence for use in Panic Disorder and PMDD

Research for Panic Disorder involved RCTs monitoring outcomes related to episodic changes, specifically the frequency of full panic attacks and measures of daily functioning. For Premenstrual Dysphoric Disorder (PMDD), studies examined the severity of affective and physical symptoms during the luteal phase of the menstrual cycle, with research noting that measurements of symptom variables were observed for both continuous and intermittent dosing schedules.

What is Still Uncertain in the Research Record

Long-term effects are not fully established beyond the standard maintenance phase duration in many indications. Comparative evidence against all other treatment options is sometimes lacking, and data for certain patient subgroups, such as those with complex co-occurring conditions, remains insufficient. For specific cohorts, such as children and adolescents with MDD, findings were mixed, underscoring the need for ongoing research to understand observed variability in outcomes.

Key Studies & References

  1. Selective serotonin re-uptake inhibitors (SSRIs) versus placebo for obsessive compulsive disorder (OCD)

Frequently Asked Questions (FAQ)

Common questions about Arrow Fluoxetine (FAQ)


Q: How long does it typically take to notice the initial signs of improvement with Arrow Fluoxetine?

A: Studies and official information indicate that the medicine's full effects are not immediate. Initial signs of improvement may not be fully noticeable for several weeks of consistent administration as prescribed. The full therapeutic benefit for the condition being addressed may take a longer period to develop.


Q: What are the most commonly reported temporary side effects when starting this medicine?

A: According to official adverse event reports, some common effects such as insomnia (difficulty sleeping) and anxiety may be observed with greater frequency when treatment is first started. These initial effects are noted by regulatory documents to be common when starting therapy.


Q: Do the common side effects of Arrow Fluoxetine typically lessen or go away over time?

A: Regulatory documents suggest that some non-serious adverse reactions may improve over time. Specifically, effects like anxiety and insomnia are reported more frequently early in treatment. The higher frequency reported early in treatment indicates that these symptoms may lessen over time.


Q: What should be known about the sexual side effects that have been reported with Arrow Fluoxetine?

A: Official documents confirm that sexual dysfunction has been reported as a potential adverse reaction. For some individuals, this effect may become noticeable with long-term exposure to the medicine.


Q: Is it necessary to take Arrow Fluoxetine at a specific time of day (morning or evening)?

A: Regulatory information states that the medicine is typically taken once daily, and often this is scheduled in the morning. However, the regulatory guidance does not mandate a specific time of day for all patients or for all conditions being treated.


Q: Is a loss of focus or drowsiness a reported side effect that might affect daily activities like driving?

A: Official warnings state that side effects like dizziness and drowsiness may occur, which could impair a person's judgment, thinking, or motor skills. The potential for impairment is noted in official warnings regarding the performance of skilled tasks or the operation of machinery.


Q: What precautions are described regarding taking Arrow Fluoxetine with other supplements or herbal products?

A: Regulatory warnings advise caution when combining this medicine with any agent that increases serotonin levels. This caution explicitly includes certain herbal products, such as St. John’s Wort, due to the risk of interaction.


Q: Is a change in appetite or body weight a possible side effect of Arrow Fluoxetine?

A: Yes, official adverse reaction documents indicate that changes in body weight are a possible side effect. Reports have included both weight loss and weight gain associated with the use of this medicine.


Q: What symptoms are generally associated with Serotonin Syndrome?

A: Serotonin syndrome is a serious, rare condition described in official warnings. It is typically associated with a group of symptoms including mental status changes (e.g., agitation, hallucinations), autonomic instability (e.g., rapid heart rate or fluctuating blood pressure), and neuromuscular problems (e.g., incoordination or overactive reflexes).


Q: What is the information regarding the risk of low sodium levels (hyponatremia) while using this medicine?

A: Official documents include a warning about the potential risk of developing hyponatremia, which is a low level of sodium in the blood. This risk is specifically noted in older adults and in patients who are concurrently taking diuretic medications.


Q: What should be done if a dose of Arrow Fluoxetine is accidentally missed?

A: Official guidance provides specific instructions for managing a missed dose, which is determined by the time remaining until the next scheduled administration. These instructions are intended to avoid taking two doses too close together.


Q: What is the general method for stopping the use of Arrow Fluoxetine, and why is it important?

A: To minimize the risk of experiencing discontinuation symptoms, regulatory guidance indicates that treatment should be stopped by gradually reducing the dose. This process should only be undertaken as directed by a healthcare professional.


Q: What are the general symptoms associated with 'antidepressant discontinuation syndrome'?

A: Symptoms reported after stopping the medicine include sensory disturbances (such as tingling or electric shock sensations), dizziness, sleep disturbances, agitation, and anxiety. Regulatory documents note that these symptoms may occur upon discontinuation, especially if it is sudden.


Q: What is the advice regarding the consumption of alcohol while using Arrow Fluoxetine?

A: Official guidance advises the avoidance of alcohol consumption while using the medication. This caution is due to the potential for compounded effects on the central nervous system.


Q: Is Arrow Fluoxetine typically used for individuals who have bipolar disorder?

A: Official warnings note that this type of medication may potentially precipitate a manic or hypomanic episode in susceptible patients. This caution is particularly relevant for individuals who have or are at risk for Bipolar Disorder.


Q: Are there known considerations for people with certain eye conditions, like glaucoma?

A: Regulatory documents note that the drug can cause mydriasis, which is the dilation of the pupil. The official warnings state that caution is necessary in the presence of narrow-angle glaucoma due to this effect.


Q: Can Arrow Fluoxetine affect blood sugar levels in people with diabetes?

A: Yes, official safety information indicates that changes in blood glucose levels have been reported. For patients with diabetes, the observed changes in glucose levels may necessitate the adjustment of their diabetes medications.

How should Arrow Fluoxetine be stored and disposed of?

Storage and Disposal Requirements for Fluoxetine

Official regulatory guidelines mandate specific conditions for the storage and disposal of fluoxetine to maintain product quality and safety.


Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store at Controlled Room Temperature (20 C to 25 C)
Protection Keep protected from light and excessive moisture
Container Store in the tightly closed container it was supplied in
Child Safety Must be kept out of the sight and reach of children

Disposal Instructions

Expired or unused medication must not be disposed of in household waste or wastewater (e.g., flushing down the toilet). The correct procedure is to return the product to a pharmacy or follow local pharmaceutical waste regulations for safe and responsible disposal.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

Available in countries:

Equivalent of Arrow Fluoxetine found in:

A-Z Index: