Refalgin

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Refalgin

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 Refalgin

What is Refalgin? (Identity and General Purpose)

Property Description
Active Ingredient Metamizole sodium (Dipyrone)
Form Primarily Oral Tablets
Pharmacological Class Non-opioid Analgesic, Antipyretic, Spasmolytic
General Purpose Relief of severe pain, high fever, and smooth muscle spasms
Origin Synthetic, Pyrazolone Derivative

Refalgin is a pharmaceutical product defined by its composition, which includes the active ingredient Metamizole sodium. It is a single-ingredient, synthetic medication classified as a non-opioid analgesic, typically manufactured as oral tablets often containing 500 mg of the substance.

Refalgin: A Non-Opioid Analgesic of the Pyrazolone Class

The core chemical entity of Refalgin is the active compound Metamizole sodium, also frequently recognized by its non-proprietary name, Dipyrone. The compound belongs to the pyrazolone derivative family, placing it within the larger grouping of non-opioid analgesics. This substance is recognized for providing significant pain relief that often exceeds that of conventional over-the-counter agents. This chemical structure distinguishes it as an atypical analgesic, positioning it differently from classical NSAIDs.

Composition and General Therapeutic Purpose

The purpose of Refalgin is rooted entirely in the therapeutic effects mediated by the Metamizole sodium compound, which functions as a pro-drug. The medication delivers a unique combination of therapeutic benefits: a strong analgesic effect (pain relief), effective antipyretic effect (fever reduction), and a distinct spasmolytic effect (muscle relaxation). The compound possesses antispasmodic properties, which indicates that the drug helps ease discomfort associated with involuntary muscle cramps and spasms. The active substance is entirely synthetic and is not derived from natural sources, making it a pure pharmaceutical entity used for the acute symptomatic relief of severe pain, such as that experienced during a renal colic episode.

Regulatory References

  1. Ficha Técnica Metamizol (AEMPS SmPC)

What side effects are possible with Refalgin?

Refalgin's official safety profile, based on regulatory documentation for Metamizole sodium, is primarily defined by the potential for rare but serious adverse reactions affecting the blood and immune systems.

Documented Adverse Reactions and Frequency

Adverse effects are categorized according to frequency established by regulatory authorities. The most critical safety concerns are related to haematological disorders and severe hypersensitivity.

Classification Representative Reactions
Rare (1 in 1,000 to 1 in 10,000) Agranulocytosis, Leukopenia, Anaphylactoid reactions, Rash
Very Rare (less than 1 in 10,000) Aplastic anaemia, Pancytopenia, Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN)
Uncommon (1 in 100 to 1 in 1,000) Isolated Hypotension, Fixed Drug Eruption
Not Known Acute Kidney Injury, Gastrointestinal bleeding

Serious Safety Considerations

The most serious adverse reactions documented in regulatory sources include agranulocytosis, a potentially fatal disorder of the white blood cells, and severe immune responses like anaphylactic shock or life-threatening skin disorders such as SJS and TEN. Regulatory labels note that the onset of agranulocytosis is unpredictable and may occur at any time during exposure to the drug.

Population-Specific Constraints

The medicine is subject to regulatory constraints for specific populations. Use is restricted for individuals with pre-existing haematopoietic disorders (conditions affecting blood cell formation) and is generally contraindicated in patients with known analgesic asthma or certain immune-related conditions, due to an increased risk of severe hypersensitivity. Caution is also stated for use in patients with severe renal or hepatic impairment, as reduced organ function may affect the clearance of the substance.

Overdose and Emergency Response

Overdose of Refalgin (Metamizole sodium) is officially documented to present with specific clinical manifestations. These can include gastrointestinal toxicity, nausea, vomiting, headache, dizziness (vertigo), and somnolence. In severe cases, the official profile highlights the risk of life-threatening systemic outcomes, including acute liver failure, severe cutaneous adverse reactions (such as SJS/TEN), and cardiovascular complications like anaphylactic shock.

The most critical concern documented in regulatory statements is the potential for agranulocytosis (a sharp decrease in white blood cells). Immediate medical attention is required, and the medicine must be stopped, if any signs suggestive of this condition are observed. These key emergency triggers include the onset of a high fever, chills, a persistent sore throat, or the appearance of painful sores on mucosal surfaces (e.g., in the mouth). A blood cell count is required for immediate assessment if these symptoms develop.

As no specific antidote is known for Metamizole sodium, regulatory guidance focuses on general symptomatic and supportive treatment. Procedural measures to limit drug absorption, such as gastrointestinal decontamination or the use of activated charcoal, are officially described for managing acute overdose.

Therapeutic Uses of Refalgin

What Refalgin Treats: Main Uses and Benefits

Refalgin is commonly used in situations involving certain distressing symptoms, primarily for providing supportive relief from acute and chronic manifestations of gastroesophageal reflux. It is relevant for easing symptoms related to acid regurgitation, heartburn, and gastrointestinal irritation. Applied across domains where additional symptomatic support is needed, this short-term assistance helps address symptom clusters that may become intense or disruptive. Alginates can serve as part of symptomatic management, helping to ease symptoms related to acid reflux and indigestion.

The medication is commonly used to help with acute heartburn, contributing to the comfort of individuals with conditions involving episodic or fluctuating manifestations (GERD), is applied in addressing reflux-linked symptoms such as cough and hoarseness, and provides supportive relief when taking certain medications that may cause gastrointestinal irritation. Used in settings where short-term symptom stabilization is important, this supportive approach helps maintain functional stability and supports general well-being during symptomatic phases where symptoms may intensify temporarily.


Quick Fact: Relevant for Easing Symptoms of Heartburn and Reflux-Related Cough

Eligibility and Restrictions for Use

This section summarizes the official population eligibility rules for Refalgin (Metamizole sodium) as stated by governmental regulatory authorities.


Eligibility Scope

Classification Population/Condition Regulatory Status
Contraindicated History of agranulocytosis (of any cause) Absolute Prohibition
Contraindicated Hypersensitivity to Metamizole or any pyrazolone derivatives Absolute Prohibition
Contraindicated Third trimester of pregnancy Absolute Prohibition
Contraindicated Infants under 3 months or less than 5 kg Absolute Prohibition
Contraindicated Acute intermittent hepatic porphyria or G6PD deficiency Absolute Prohibition
Restricted Use Severe renal or hepatic impairment Use only with reduced dose
Restricted Use Breastfeeding Not recommended; single dose requires discarding milk for 48 hours
Restricted Use Older adults Dose reduction required for prolonged elimination

Official Eligibility Statements

  • Use is restricted to adults and adolescents 15 years of age or older (over 53 kg).
  • The medicine must not be used in patients with a history of impaired bone marrow function or diseases of the haematopoietic system.
  • Eligibility for children under 15 years is conditional on the use of weight-appropriate formulations.

Connection to the overall eligibility profile: Regulatory documents establish who can and cannot use the medicine by defining absolute contraindications for populations with specific blood disorders, metabolic defects, and those in the late stages of pregnancy. Eligibility for other high-risk groups, such as those with organ impairment, is restricted to conditional use requiring dose adjustment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Refalgin (Metamizole sodium) has officially documented interaction potential based on its effects on hepatic enzymes and other medicines.

Pharmacokinetic Interactions

Metamizole is documented as a moderate to strong inducer of multiple Cytochrome P450 (CYP) enzymes, including CYP3A4, CYP2B6, and CYP2C19. This enzyme induction can lead to a clinically significant reduction in the plasma exposure (AUC/Cmax) of co-administered medicines that are substrates for these enzymes. This outcome is officially noted for drugs such as:

  • Ciclosporin (resulting in reduced serum levels)
  • Midazolam (resulting in substantially reduced exposure)
  • Bupropion and Oral Hormonal Contraceptives (potential reduction in efficacy)

Pharmacodynamic Interactions

Interacting Substance Official Interaction Statement
Acetylsalicylic Acid (Aspirin) Inhibits the antiplatelet effect of low-dose Aspirin, particularly relevant in patients using it for vascular disease.
Methotrexate Co-administration carries an additive risk for severe haematologic toxicity (e.g., bone marrow aplasia).
Chlorpromazine Co-administration may result in additive hypothermia (low body temperature).

Timing and Substance Constraints

The regulatory profile includes specific constraints: it is recommended to administer Aspirin at least 30 minutes prior to Refalgin to mitigate the pharmacodynamic interference. Furthermore, official documentation requires the avoidance of alcohol consumption during treatment.

Mechanism of Action

How Refalgin Works: The Mechanism of Action

Refalgin's mechanism is purely peripheral, based on physical and mechanical barrier formation within the gastrointestinal lumen, without systemic absorption. The non-absorbed nature of the components restricts the mechanism to the gastrointestinal tract.

Physical Barrier Formation

The primary action involves the sodium alginate and calcium carbonate components reacting with the highly acidic gastric environment. This process creates a buoyant, low-density gel, or 'raft,' that traps carbon dioxide released from the reaction of sodium bicarbonate with the acid. This raft floats rapidly to the top of the gastric contents. This physical contact-shielding functions as a mechanical barrier that limits the upward movement of gastric contents, including acid and pepsin, toward the esophagus.

Mucosal Shielding and Gas Dynamics Modulation

Beyond the raft, the alginate provides a direct physical shield that adheres to the esophageal and gastric mucosal lining. This physical shielding contributes to the contact-shielding of the mucosa from chemical exposure to gastric acid and digestive enzymes. The formulation also includes simethicone, which modulates surface tension in the stomach, reducing gas bubbles and facilitating the coalescence and release of trapped gas, thereby modulating intragastric pressure.

Dosage and Administration Information

Official Administration Guidelines

Refalgin, based on the active ingredient Metamizole sodium, is administered based on established parameters governing routes, dosing limits, and procedural constraints.

Dosing and Administration Scope

Instruction Category Description
Route of Administration The approved routes include Oral, Intravenous (IV), Intramuscular (IM), and Rectal administration.
Standard Oral Dosing The single adult oral dose is 500 mg to 1000 mg; the maximum daily dosage must not exceed 4000 mg (4 g).
Frequency and Timing Doses are scheduled for as-needed (p.r.n.) use, with a required minimum interval of six to eight hours between administrations.
Administration Context Oral forms are taken with sufficient liquid and may be administered independent of food intake.

Procedural Constraints and Adjustments

Specific procedural rules dictate usage. For the injectable form, IV administration must be slow, typically occurring over three to five minutes. This is a standard technical administration technique.

Dosage adjustments are utilized for specific patient populations. Older adults generally require a dose reduction or an extended interval between doses. Similarly, for patients with renal or hepatic impairment, the regimen is modified to compensate for reduced drug clearance, often involving a prolongation of the time between administrations. In the event of a missed dose, the standard procedure is to take the next dose at the regularly scheduled time, skipping the missed administration without taking a double dose.

Recent Clinical Evidence

Research evidence / Overview of Studies for Refalgin (Alginate Formulations)

This section outlines the structure of research available for alginate formulations (Refalgin), describing the types of studies conducted, the outcomes they measured, and areas where evidence remains limited or uncertain. This is purely an overview of the research and should not be used as clinical advice or guidance.


Research Examining Outcomes Related to Heartburn and Reflux Symptoms

Research has been conducted using systematic reviews and meta-analyses, which aggregate data from numerous short-term Randomized Controlled Trials (RCTs). These trials were used in research exploring how symptoms change over time in adult patients with Gastroesophageal Reflux Disease (GERD). The trials primarily measured patient-reported outcomes related to perceived discomfort, using symptom scoring systems to explore outcomes associated with heartburn and regurgitation. Researchers also conducted studies examining objective outcomes, such as monitoring the presence of acid and non-acid reflux events in the esophagus using specialized MII-pH technology.

Studies have explored short-term symptom changes, typically over periods of one to four weeks. In studies comparing alginate formulations to a placebo or simple antacids, the research describes patterns observed in the studies, examining changes in scores related to perceived discomfort. When research examined comparisons against acid-suppressing therapies (like PPIs), findings were mixed; some trials reported patterns where scores were less frequently at the predefined study endpoint with the alginate, while others described similar rates in the observed outcomes.

Studies Exploring Responses in Specialized Populations

The evidence base includes research that was evaluated in certain populations with unique needs. For instance, pregnant women were studied in research exploring short-term changes in outcomes related to physical discomfort. A distinct body of research was evaluated in infants and young children, typically under one year of age, experiencing frequent regurgitation, using caregiver-reported outcomes to describe perceived discomfort.

Long-Term Observation and Follow-up Intervals

Most primary clinical studies exploring short-term symptom changes in adults were designed for acute or short-term treatment periods, with follow-up durations that were limited, generally lasting only a few weeks. As a result, there is limited information for long-term outcomes related to the sustained use of alginate formulations. Research has not extensively established the durability of the observed short-term patterns or what the evolution is during continuous, long-term use. This means that data are still emerging, and long-term effects are not fully established.

What is Still Uncertain in the Research Landscape

A key limitation is the observed heterogeneity across study results, meaning evidence quality varies across studies. Furthermore, comparative evidence (e.g., against other major treatment classes) is lacking for certain specific symptom patterns, and data for certain subgroups (such as children beyond infancy or patients with multiple comorbidities) remain insufficient. The evidence highlights what has been observed so far; research does not provide individual predictions.

Key Studies & References

  1. The effects of alginate on the acid and non-acid gastroesophageal reflux: a review of the literature

Frequently Asked Questions (FAQ)

Common questions about Refalgin (FAQ)


Q: How quickly can one generally expect Refalgin to start working?

Official documents indicate that a noticeable analgesic effect can generally be expected approximately 30 to 60 minutes after the oral administration of the medicine.


Q: Is Refalgin considered a long-term treatment or short-term?

Refalgin is typically documented for the short-term management of acute, severe pain and fever. Due to the potential for rare, serious side effects, regulatory documents often caution regarding its use in prolonged or chronic therapy.


Q: Does Refalgin cause fatigue or drowsiness?

Yes, regulatory documents and associated clinical summaries list drowsiness (somnolence) and fatigue as side effects that have been reported in connection with the medication's use.


Q: Is there a known interaction between Refalgin and alcohol?

Official product information advises that the consumption of alcohol should be avoided during treatment.


Q: Is Refalgin safe to take if I am taking supplements like vitamins or herbs?

Regulatory guidance advises that individuals should inform their healthcare provider of all co-administered substances. This includes any herbal tonics, supplements, vitamins, and other non-prescription medicines, due to the potential for interactions with the active substance.


Q: Is it necessary to have certain tests before starting Refalgin?

Use of Refalgin is restricted for individuals with certain pre-existing conditions, such as specific blood disorders (haematopoietic disorders). Due to these contraindications, a healthcare professional typically assesses these conditions to determine a patient's eligibility for use.


Q: What happens if Refalgin is stopped suddenly?

Regulatory information for this medication, which is a non-opioid analgesic, does not contain warnings regarding specific withdrawal symptoms or rebound effects associated with suddenly stopping the medication.


Q: What is the official storage recommendation for Refalgin tablets?

The official guidelines require Refalgin tablets to be stored below 30 C and protected from light and moisture. Additionally, regulatory documents state that for certain liquid preparations, any unused portion must be discarded 28 days after opening.


Q: Does Refalgin need to be taken with food?

Official administration guidelines state that oral forms of the medication may be taken independent of food intake. This indicates that administration may occur with a meal, immediately afterward, or on an empty stomach.


Q: What are the most commonly reported side effects of Refalgin?

While the most serious adverse reactions are rare, regulatory documents and associated clinical summaries categorize non-severe effects such as nausea, vomiting, headache, dizziness, and rash as being commonly reported by patients.


Q: What foods or beverages might interfere with Refalgin?

Regulatory documents primarily detail specific drug-drug interactions and require the avoidance of alcohol consumption. No other common foods or non-alcoholic beverages are specifically listed in official documents as causing pharmacological interference.


Q: Are there any major safety warnings associated with Refalgin that I should be aware of?

The most serious safety consideration documented in regulatory sources is the rare but potentially fatal risk of agranulocytosis, which is a severe blood disorder. Official information advises patients to be aware of and report symptoms of this and other severe hypersensitivity reactions.


Q: How long does the effect of Refalgin typically last?

The documented duration of the analgesic effect of the active substance typically lasts between 4 and 6 hours. This duration aligns with the required minimum interval between administrations.


Q: Can Refalgin cause issues with kidney function?

Regulatory documents classify the occurrence of serious renal disorders, including acute renal failure and interstitial nephritis, as very rare potential adverse effects. The official eligibility profile includes restrictions for patients with pre-existing severe kidney impairment.


Q: What types of research have been done on Refalgin's long-term safety?

Safety research for prolonged use is primarily based on pharmacovigilance reports, which involve the collection and review of adverse events and case series. Regulatory authorities use these data for periodic reassessments of the drug's safety profile during extended therapy.


Q: Why is Refalgin sometimes used in combination with other treatments?

The active substance in Refalgin is noted in pharmacological reviews as offering therapeutic synergy with other pain relief agents. This characteristic supports its use in various multimodal pain management protocols.


Q: Are there official Patient Information Leaflets (PILs) for Refalgin available online?

Yes, official patient information leaflets (PILs) published by manufacturers for Metamizole-containing products are often made available online. These documents can be found on regulatory agency websites or through manufacturers' official documentation.


Q: Can Refalgin be used for headache relief?

Regulatory documents state the medication is indicated for the relief of severe pain and high fever. While a headache is a form of pain, the official purpose generally specifies relief for pain classified as severe, such as colic or post-operative pain.


Q: Why does the packaging of Refalgin contain certain warnings?

Packaging warnings are mandated by regulatory authorities to instruct patients about the potential for rare but serious adverse reactions. The intent is for patients to be aware of risks like agranulocytosis and the symptoms requiring immediate medical attention.


Q: Are there different strengths or formulations of Refalgin?

Yes, the medication is available in multiple formulations, including oral tablets, oral drops (liquid solution), suppositories, and solutions for injection used for intravenous or intramuscular administration.


Q: Does Refalgin contain lactose or gluten?

The specific inclusion of excipients like lactose or gluten depends on the formulation and the manufacturer. Official product data sheets (SmPCs) are required by regulatory agencies to clearly state if these substances are present.


Q: What is the difference between Refalgin and a generic alternative?

Generic alternatives are required by regulatory agencies to contain the same active ingredient, strength, dosage form, and route of administration as the brand-name product. Agencies ensure that generic medicines have the same established risks and benefits.


Q: Is the research on Refalgin still ongoing?

Yes, regulatory agencies conduct ongoing reviews of the medicine's safety and efficacy profile, and clinical researchers continue to explore various aspects of the drug’s use and risk factors through ongoing clinical trials and systematic reviews.


Q: Why is Refalgin restricted in certain patient groups?

Regulatory restrictions are based on the documented, rare risk of severe adverse reactions, such as agranulocytosis, or the increased risk of severe hypersensitivity reactions in patients with certain pre-existing conditions like haematopoietic disorders.


Q: Do health professionals consider Refalgin a 'new' drug?

The active substance in Refalgin has been in use for many decades globally, establishing it as a well-known medication. Therefore, based on its established history, it is not generally classified as a 'new' drug.


Q: Is Refalgin available over the counter in some countries?

The regulatory status of the active substance varies significantly by country. While it has been withdrawn or is prescription-only in some nations, it remains available, including in some cases over the counter, in many others across Europe, Asia, and South America.


Q: Is Refalgin known to cause any skin reactions or rashes?

Regulatory documentation notes the potential for skin reactions, including common rashes (maculopapular eruptions) and, more rarely, severe life-threatening skin disorders. These severe disorders, like Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), are categorized as rare to very rare adverse effects.

How should Refalgin be stored and disposed of?

Refalgin (Metamizole sodium) must be stored and disposed of according to strict regulatory guidelines to maintain its stability and ensure public safety.

Storage Requirements

  • Temperature and Light: Store the product below 30 C and ensure it is protected from light and moisture. Do not store the medicine in the freezer.
  • Container: The product must be kept in its original container with the container tightly closed to preserve its quality up to the expiration date.
  • Child Safety: All medicines must be stored out of the sight and reach of children.
  • Stability: For certain liquid preparations, regulatory documents require discarding any unused portion 28 days after opening.

Disposal Instructions

  • Environmental Protection: Do not dispose of unused or expired Refalgin in drains or household waste to avoid release into the environment.
  • Official Procedure: The proper method is disposal via a recognized drug take-back program or by returning the product to a pharmacy disposal point, in accordance with local and national regulations.

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

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