Relafin

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Relafin

What is Relafin? Definition, Composition, and Class

Property Description
Active ingredient Fluvoxamine maleate
Form Tablet, Extended-release capsule
Pharmacological class Selective Serotonin Reuptake Inhibitor (SSRI)
Common use Modulates mood and thought patterns
Origin Synthetic organic compound

Relafin, containing Fluvoxamine maleate, is a prescription-only medication specifically recognized as an Antidepressive Agent that operates within the central nervous system to help stabilize mood and regulate thought patterns. This synthetic compound is placed within the Selective Serotonin Reuptake Inhibitor (SSRI) pharmacological class. Pharmacological studies have confirmed that this class of agents is designed for targeted action on specific neurotransmitter systems. Understanding this classification confirms Relafin's general purpose is to support balanced serotonergic neurotransmission, distinguishing it as a targeted psychotropic medication used when focused modulation of mood and emotional processing is clinically indicated.

The therapeutic effect of Relafin is derived from its sole active substance, Fluvoxamine maleate, which is a single-agent product of synthetic organic origin. The substance is structurally categorized as an aralkylketone derivative, setting it chemically apart from other SSRIs. This core compound is formulated for oral administration and is available in two distinct dosage forms: a standard immediate-release tablet and an extended-release capsule. The availability of both forms, differing in their solid vehicle system design, allows for flexibility in maintaining consistent therapeutic levels. This structural and formulational distinction is an important factor in the drug's overall profile compared to other compounds in the SSRI class.

What side effects are possible with Relafin?

The official safety profile for Relafin (Fluvoxamine maleate) is organized by government regulatory agencies based on frequency and affected body systems.

Frequency-Classified Adverse Reactions

The most frequently reported adverse reactions, classified as Very Common (ge 10% ) in regulatory documents, include nausea, headache, insomnia, and somnolence (drowsiness). Reactions classified as Common (1% to le 10% ) include anxiety, agitation, tremor, dizziness, dry mouth, constipation, vomiting, sweating (hyperhidrosis), and various sexual dysfunctions (e.g., abnormal ejaculation, decreased libido). Less frequent, Uncommon (0.1% to le 1% ) effects may involve confusional states or extrapyramidal symptoms, while Rare (0.01% to le 0.1% ) reports include seizures and abnormal hepatic function.

Serious Safety Considerations

The labeling includes warnings for clinically significant adverse reactions. These include the potential for Serotonin Syndrome, an increased risk of suicidal thoughts and behavior in children, adolescents, and young adults (ages le 24), and an elevated risk of abnormal bleeding or hemorrhage. Rare but serious events like Hyponatremia (low sodium levels) and the activation of Mania/Hypomania are also documented.

Population and Exposure Constraints

Specific safety considerations apply to certain groups: the elderly population may face an increased risk of hyponatremia, and individuals with hepatic impairment may require caution due to decreased drug clearance. Time-related safety patterns are noted, with the risk of suicidal thinking and behavior being specifically heightened during the initial months of therapy and following dose changes. Abrupt discontinuation of the medicine is associated with the reporting of discontinuation symptoms.

Overdose and Emergency Response

Overdose and When to Seek Help

This information describes the documented overdose profile for Relafin (nabumetone) based on official government regulatory sources.

Documented Overdose Manifestations

Symptoms reported in regulatory documents following an acute overdose generally involve the central nervous system and gastrointestinal tract, and may include:

  • Lethargy and drowsiness
  • Nausea and vomiting
  • Epigastric (stomach) pain

Potential for Serious Complications

While an overdose may be reversible with supportive care, serious complications have been reported and require immediate clinical attention. These include gastrointestinal bleeding, acute kidney injury, seizures, respiratory depression, hypotension, and coma.

Immediate Emergency Action

Always seek immediate emergency medical attention for any suspected overdose.

  • Contact Poison Help (or your national poison control center) immediately.
  • Call emergency services (such as 911) immediately if the individual has collapsed, is experiencing a seizure, has trouble breathing, or cannot be awakened.

Treatment and Management

Management of Relafin overdose is primarily supportive and symptomatic. There is no specific antidote available. Regulatory guidelines state that procedures such as administering activated charcoal or inducing vomiting may be considered to reduce drug absorption if the overdose was taken less than four hours prior to intervention.

Therapeutic Uses of Relafin

What Relafin Treats: Main Uses and Benefits

The therapeutic application of Relafin (Fluvoxamine maleate) is generally used in areas involving certain distressing symptoms, targeting symptom clusters that create noticeable functional strain. This medication is commonly used to help with conditions marked by heightened emotional and cognitive stress.

Relafin is considered relevant for the chronic management of Obsessive-Compulsive Disorder (OCD), Social Anxiety Disorder, and Major Depressive Disorder, among other related conditions. It plays a role in managing intrusive, recurring, and distressing thoughts, as well as the symptoms of persistent sadness and excessive fear.

“In therapeutic contexts, the focus is on providing support that helps ease the overall symptom burden, contributing to a sense of stability during periods of heightened discomfort.”

The medication is applied across domains where additional symptomatic support is needed, assisting with easing these distressing symptoms which may interfere with function. This provides supportive relief when symptoms become more noticeable, may help patients cope more steadily with symptom fluctuations.


Quick Fact: Focus on Intrusive Thoughts

Regulatory References

  1. NIH MedlinePlus overview on Fluvoxamine

Eligibility and Restrictions for Use

Who Can and Cannot Use Relafin?

Relafin (Fluvoxamine maleate) eligibility is strictly defined by regulatory authorities based on age, organ function, reproductive status, and co-administered medications.

Contraindicated Populations (Must Not Use):

Category Contraindicated Populations
Hypersensitivity Patients with known sensitivity to fluvoxamine or its excipients.
Comedicinal Use Patients taking a Monoamine Oxidase Inhibitor (MAOI) or restricted drugs like tizanidine, pimozide, or alosetron

Age and Pediatric Eligibility:

  • Adults (18+): Approved for use in adults for Obsessive-Compulsive Disorder (OCD).
  • Pediatric (OCD): Approved for OCD in children and adolescents aged 8 to 17 years (immediate-release tablets).
  • Use Not Established: Safety and efficacy are not established in children under 8 years of age or for the extended-release capsule in the pediatric population.

Conditional Use and Restrictions:

Eligibility requires caution and monitoring for specific populations as stated in official labeling:

  • Organ Function: Patients with impaired liver or kidney function require careful monitoring and may need a lower starting dose.
  • Comorbidities: Use should be avoided in those with unstable epilepsy and used with caution in patients with a history of mania.
  • Reproductive Status: Relafin is secreted into human breast milk and should not be used during breastfeeding. Safety during pregnancy is not established.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail specific drug-drug interactions, primarily emphasizing combinations that affect bleeding risk or alter the efficacy or safety of co-administered medicines.

Clinically Significant Interactions

The following interaction categories require close monitoring, precautionary measures, or, in some cases, avoidance, based on official regulatory labeling:

  • Anticoagulants and Antiplatelet Agents: Co-administration with Warfarin or other agents that interfere with hemostasis carries a synergistic risk of serious gastrointestinal bleeding. Close monitoring is essential.
  • Other Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Use with other NSAIDs, including over-the-counter products containing aspirin, ibuprofen, or naproxen, should be avoided due to the increased risk of adverse effects.
  • Antihypertensive Agents (ACE-inhibitors, ARBs): The anti-hypertensive effect of these medicines may be diminished. Caution is required, especially in elderly, volume-depleted, or renally impaired patients, where monitoring of blood pressure and renal function is necessary.
  • Diuretics (Furosemide, Thiazides): The natriuretic (salt-excreting) and diuretic effects may be reduced due to inhibition of renal prostaglandin synthesis. Patients must be monitored for signs of renal failure and the continued effectiveness of the diuretic.
  • Lithium: NSAIDs can elevate plasma Lithium levels and reduce its renal clearance, which requires careful observation for signs of Lithium toxicity.
  • Methotrexate: Concomitant use may enhance Methotrexate toxicity. Caution should be used, and monitoring is recommended.

Mechanism of Action

How Relafin Works: Mechanism of Action

1. Metabolic Activation and Enzyme Targeting

The compound is an orally administered prodrug that undergoes biotransformation in the liver. This process generates the active metabolite (6-MNA), which functions as a competitive inhibitor by binding to the Cyclooxygenase (COX-1 and COX-2) enzymes. This mechanistic domain involves the initial step of enzymatic conversion followed by the suppression of the prostanoid biosynthesis pathway.


2. Disrupting the Prostaglandin Synthesis Pathway

The core mechanism acts within the Arachidonic Acid Cascade. By inhibiting the COX enzymes, the drug restricts the formation of autocoid mediators, including Prostaglandins. These mediators contribute to the activation and sensitization of primary afferent nerve terminals and promote localized changes in vascular tone.


3. Peripheral Signal Modulation

Inhibition of prostaglandin production results in a reduction of specific signaling primarily at peripheral sites of tissue activity. This mechanism modulates excessive chemical mediator activity, affecting signaling cascades that influence localized vascular and neuronal responses.

Dosage and Administration Information

Relafin (Fluvoxamine maleate) is a medication administered through the oral route in two main dosage forms: the immediate-release tablet and the extended-release capsule. Usage protocols specify administration patterns and handling constraints.


Official Administration Guidelines

Feature General Instructions
Route of Administration The medication is taken orally.
Standard Daily Dosing The typical adult starting dose is 50 mg (IR tablet) or 100 mg (ER capsule). Doses are increased gradually, with the total daily dose not generally exceeding 300 mg.
Frequency and Timing The medicine is often taken once daily, preferably at bedtime. Total daily doses over 100 mg (IR) or 150 mg should be administered in divided doses.
Relationship to Food Relafin may be taken with or without food.

Procedural Constraints and Special Populations

Both dosage forms are swallowed whole; however, the extended-release capsule is subject to a strict constraint and must not be crushed, chewed, or opened to ensure the intended release profile is maintained. If a dose is missed, standard guidance advises skipping the missed dose and continuing with the regular schedule, rather than taking two doses simultaneously.

Specific adjustments to the regimen are required for certain populations. Older adults typically initiate therapy with a lower starting dose and a slower dose increase (titration) compared to younger adults. Similarly, patients with hepatic impairment (reduced liver function) often require a lower starting dose and slower titration due to the medicine's clearance profile.

The treatment course often involves long-term use and necessitates periodic reassessment. When discontinuing the medication, the established protocol involves a gradual dose reduction (tapering) to manage the cessation process safely.

Recent Clinical Evidence

Research evidence / Overview of Studies for Relafin

Research concerning Relafin (fluvoxamine maleate) has focused on its clinical evaluation for specific conditions, primarily through Randomized Controlled Trials (RCTs), systematic reviews, and meta-analyses. This overview describes the structure of the studies conducted, the populations included, and the areas where the evidence remains limited, without offering any clinical advice or making claims about personal outcomes.

Evidence for use in Obsessive-Compulsive Disorder (OCD)

Research for Relafin related to OCD includes findings from short-term, placebo-controlled RCTs that involved both adults and pediatric patients (children and adolescents).

  • What Researchers Studied: Studies monitored changes in obsessive and compulsive symptom intensity over defined time intervals, mostly in the acute treatment phase, typically lasting around 10 weeks. Researchers used standardized tools, such as the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), to measure how symptoms evolved in the observed populations.
  • What the Studies Reported: Multiple regulatory summaries report data on measured outcomes related to Y-BOCS scores and response rates when comparing the study drug to placebo. Systematic reviews explored comparisons of measured symptom change between the study drug and certain other medications studied for this condition.

Evidence for use in Social Anxiety Disorder (SAD)

Research evaluating Social Anxiety Disorder (also known as Social Phobia) includes findings from placebo-controlled RCTs and observational extension studies.

  • What Researchers Studied: Studies in adult outpatients examined the effect on anxiety symptom severity using specific scales, such as the Liebowitz Social Anxiety Scale (LSAS), and measures of functional impairment. Most primary studies assessed outcomes over a period of approximately 10 to 12 weeks.
  • What the Studies Reported: Clinical trials documented observed measurements related to LSAS scores and rates of clinical improvement when comparing the study drug to placebo. Findings from extension phases of acute trials and observational surveys have been reported, documenting patient status for periods up to 53 weeks.

What Research Gaps and Uncertainties Exist

Research on any medicine necessarily has limitations and gaps that require ongoing investigation:

  • Short Duration of Primary Data: The primary body of evidence across all indications is derived from short-term trials (typically 8–12 weeks), which assess acute symptom reduction. The primary data are not typically designed to assess the long-term maintenance of effect and relapse prevention beyond this initial phase.
  • Subgroup Findings are Uncertain: Sample sizes were modest for certain specific patient subgroups, meaning the evidence quality varies across these groups, and definite conclusions about response patterns are not fully established. Research provides context but not individual predictions, as study results reflect the specific conditions under which they were conducted.

Key Studies & References Fluvoxamine Maleate Tablets U.S. Prescribing Information (FDA Label)

Frequently Asked Questions (FAQ)

Common questions about Relafin (FAQ)

Q: How quickly can someone expect Relafin to start working?

Regulatory documents indicate that the medicine typically takes about one week of daily dosing to reach steady-state levels in the bloodstream. While maximum concentrations occur quickly after each dose, the full anticipated effect may take longer to be achieved. This reflects the time needed to build up a stable amount of the medicine in the body.

Q: How long do the effects of a single dose of Relafin typically last?

According to official information, the half-life of the active substance ranges between approximately 15 and 24 hours, depending on the specific component. This measurement indicates how long it takes the body to eliminate half of the drug. The elimination half-life may be longer in older adults.

Q: Does Relafin stay in your system for a long time after you stop taking it?

This medication is generally cleared from the body within a few days, as the half-life of the active ingredient is typically between 15 and 24 hours. The need for a gradual dose reduction (tapering) when stopping the medication relates to managing the body's adjustment to the drug’s absence, rather than just the time needed for physical clearance.

Q: Can I take Relafin with common cold and flu medications?

Official documents note that caution is required when combining Relafin with common cold and flu medications. Specifically, some cough suppressants, like Dextromethorphan, can increase the risk of a serious condition called Serotonin Syndrome. Caution is also advised regarding any product that increases the risk of bleeding.

Q: Is it safe to use Relafin if I already take a daily vitamin or supplement?

Regulatory documents state that caution is advised when combining Relafin with vitamins or supplements. Specific herbal supplements, such as St. John’s Wort, are strongly advised against because they can significantly increase the risk of Serotonin Syndrome. It is necessary that all supplements are reviewed by a healthcare provider.

Q: What is the risk of an allergic reaction to Relafin?

Official safety data reports that cutaneous hypersensitivity reactions, which are types of allergic reactions affecting the skin, are uncommon, occurring in 0.1% to 1% of users. These reactions can include rash, itching (pruritus), or swelling (edema). Any signs of a severe allergic reaction are considered a medical emergency and necessitate contacting a healthcare professional immediately.

Q: Can Relafin affect my ability to drive or operate machinery?

The official prescribing information states that caution is required regarding performing activities that require full mental alertness, such as driving or operating hazardous machinery. This warning is due to the potential for common side effects like dizziness and drowsiness. The regulatory guidance specifies that these activities should be avoided until the individual is aware of how the medication affects them.

Q: Is Relafin safe to use for people with kidney problems?

For the NSAID component of Relafin, official information indicates that use is not recommended in patients with advanced kidney disease. For those with moderate or severe kidney impairment, specific adjustments to the treatment regimen and careful monitoring of kidney function may be necessary as part of the protocol defined by a healthcare professional.

Q: Where can I find official documents or research about Relafin?

Official regulatory documents and research overviews, such as the full Prescribing Information and Medication Guides, are available on government-run resources. You can typically find this information on sites like the FDA’s Drugs@FDA database or the National Institutes of Health’s (NIH) DailyMed service.

Q: Does Relafin have a potential for dependence or addiction?

Regulatory information indicates that the SSRI component of Relafin (Fluvoxamine) is not classified as a controlled substance by the US government. Therefore, it is not generally associated with potential for abuse, physical dependence, or addiction.

Q: Can Relafin interact with caffeine or energy drinks?

According to the official product information, the SSRI component of Relafin (Fluvoxamine) can interact with caffeine. This interaction may result in enhanced effects of caffeine, potentially causing symptoms such as jitters, anxiety, or insomnia.

Q: Do I need to avoid any specific foods while taking Relafin?

The need to avoid specific foods is generally connected to potential drug interactions. Official regulatory documents describe the need to avoid foods high in tyramine if the drug is taken with St. John’s Wort, due to the risk of dangerously high blood pressure.

Q: Does Relafin interact with herbal supplements like St. John's Wort?

Yes, official sources state that the herbal supplement St. John’s Wort is contraindicated (advised against) with the SSRI component of this drug. This combination significantly increases the risk of developing Serotonin Syndrome.

Q: Is Relafin considered a narcotic or opioid?

According to the FDA, the SSRI component (Fluvoxamine) is classified as a Selective Serotonin Reuptake Inhibitor. It is not listed as a controlled substance and is not considered a narcotic or opioid.

Q: Can I take Relafin before a planned surgery or dental procedure?

The medication is associated with an increased risk of bleeding events, especially for the NSAID component. Due to this risk, specific guidance may be required before any planned surgery or dental procedure. Any decision to stop the medication is a matter of professional medical judgment and requires consultation with a healthcare provider.

Q: Are there any warnings about using Relafin while pregnant or breastfeeding?

Official warnings address use during pregnancy and breastfeeding. Exposure late in the third trimester may cause adverse neonatal effects, such as respiratory issues or feeding difficulty, requiring prolonged monitoring. The importance of the drug to the mother is a documented factor for consideration in the clinical decision regarding nursing, as the drug is excreted into human milk.

Q: How does the FDA classify the safety of Relafin?

The US FDA no longer uses the former letter categories (A, B, C, D, X) to classify drug safety. The current labeling provides a narrative summary of the risks, a discussion of supporting data, and clinical considerations for making prescribing decisions.

Q: Is it okay to drink a small amount of alcohol while taking Relafin?

Regulatory documents state that alcohol consumption should be avoided while taking Relafin. Combining the drug with alcohol can increase central nervous system side effects, such as dizziness, drowsiness, and impaired thinking or judgment.

Q: Can Relafin interact with diabetes medication?

Due to how the drug is metabolized, regulatory documents note that caution is required when combining it with other medicines. The SSRI component can interact with other drugs that are processed by the same liver enzymes, while the NSAID component requires careful monitoring when used with drugs that affect kidney function.

Q: Can Relafin be used to treat chronic pain?

The NSAID component of this medication (Nabumetone) is indicated in official documentation for the symptomatic treatment of signs and symptoms of chronic painful conditions. These indications include Osteoarthritis and Rheumatoid Arthritis.

Q: Can Relafin be taken by people with high blood pressure?

Official warnings state that the NSAID component of the drug can either lead to new high blood pressure (hypertension) or worsen existing hypertension. For this reason, close monitoring of blood pressure is a defined component of the treatment protocol outlined in official sources.

Q: Are there specific symptoms that mean I should stop taking Relafin right away?

Yes, the regulatory labeling lists severe symptoms that are considered a medical emergency and necessitate contacting a healthcare professional immediately. These include signs of Serotonin Syndrome, such as confusion, hallucination, or seizures, as well as any signs of abnormal bleeding or hemorrhage.

Q: Does Relafin have a 'Black Box Warning' listed in its official information?

Yes, the official labeling for the SSRI component (Fluvoxamine) includes a Boxed Warning, often referred to as a Black Box Warning. This warning highlights the increased risk of suicidal thinking and behavior in children, adolescents, and young adults up to 24 years of age.

Q: Is it true that Relafin can be used for arthritis pain?

Official documentation indicates that the NSAID component of this medication is indicated for the symptomatic relief of signs and symptoms related to arthritis pain. Specifically, the indications listed are Rheumatoid Arthritis and Osteoarthritis.

Q: Is Relafin a non-steroidal anti-inflammatory drug (NSAID)?

The name Relafin is associated with two different pharmaceutical components found in regulatory documents. Fluvoxamine is classified as a Selective Serotonin Reuptake Inhibitor (SSRI), while Nabumetone is classified as a Non-Steroidal Anti-Inflammatory Drug (NSAID). The exact classification depends on the specific active ingredient in the product being used.

How should Relafin be stored and disposed of?

Storage and Disposal of Relafen (Nabumetone)

Relafen tablets must be stored at controlled room temperature, specifically between 20 C and 25 C (68°F and 77°F). The medication must be kept in its original container, which should be tightly closed to protect the product from moisture and excessive heat. The product is not to be frozen and should not be stored in high-humidity areas like a bathroom.

For safety, the medication must be stored out of the sight and reach of children in a secure location.

When disposing of unused or expired Relafen, the preferred method is a community drug take-back program. If a program is unavailable, the product should be mixed with an undesirable substance (such as dirt or coffee grounds) and sealed in a container before being placed in household trash. Relafen is not to be flushed down the toilet.

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

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