Metamizol Teva

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Metamizol Teva

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Overview of Metamizol Teva

Property Description
Active ingredient Sodium Metamizole (Dipyrone)
Form Tablets, oral drops, solution for injection
Pharmacological class Non-opioid analgesic and antipyretic
General purpose Relief of severe acute pain and high fever
Origin Synthetic drug

What is Metamizol Teva and its Active Ingredient?

Metamizol Teva is a synthetic drug and a prescription-only pharmaceutical preparation manufactured by Teva Pharmaceutical Industries Ltd. The medicine is a monocomponent product, containing the sole active ingredient, Sodium Metamizole, which is also identified by the international non-proprietary name (INN) Dipyrone or Sulpyrine. The substance is highly water-soluble, which facilitates its formulation into various dosage forms, including traditional oral preparations like tablets and oral drops, and solutions for rapid delivery via the parenteral route through solution for injection. This versatility in forms permits administration both orally and through injection, allowing medical professionals to select the optimal route for patients.

Pharmacological Classification: Non-Opioid Analgesic and Antipyretic

The core identity of Metamizol Teva is rooted in its primary pharmacological classification as a powerful non-opioid analgesic and an effective antipyretic. Chemically, Sodium Metamizole belongs to the distinct class of pyrazolone derivatives. This classification is clinically recognized for delivering potent central pain relief that is fundamentally different from the mechanism of traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The drug’s potent effects lead to its functional comparison with NSAIDs, though its anti-inflammatory action is considered secondary and notably limited in contrast to its central effects on pain and temperature regulation.

General Therapeutic Purpose

The fundamental general purpose of Metamizol Teva is to provide rapid and comprehensive symptomatic relief, utilizing its combined analgesic and antipyretic actions. It is an established intervention used when pain is identified as severe acute pain, such as post-operative discomfort or acute colic, or when high body temperature requires rapid reduction. The medication's primary benefit is providing powerful relief through this potent analgesic and antipyretic action.

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What side effects are possible with Metamizol Teva?

Possible Side Effects and Safety Information

Metamizol (Sodium Metamizole or Dipyrone) has an official safety profile structured around the documented incidence of adverse reactions affecting several System-Organ Classes. The frequency classification for these effects is determined by regulatory standards, such as those used by the European Medicines Agency (EMA).

Classification Example Adverse Reactions (SOC)
Rare (1/10,000 to <1/1,000) Agranulocytosis, leukopenia, anaphylactic shock
Uncommon (1/1,000 to <1/100) Hypotension (isolated), skin rash, fixed drug eruption
Very Rare (<1/10,000) Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), acute renal failure
Not Known Drug-induced liver injury, acute hepatitis

Serious Adverse Reactions officially documented include Agranulocytosis (a severe decrease in white blood cells), Anaphylactic Shock, and severe cutaneous reactions like SJS/TEN. Cases of acute liver failure have also been reported.

System-Organ Classes affected include Blood and Lymphatic System Disorders, Immune System Disorders, Vascular Disorders, Renal and Urinary Disorders, and Hepatobiliary Disorders.

Time- and Exposure-Related Patterns: Regulatory documents note that agranulocytosis is not related to the dose used and may occur at any time during treatment or even shortly after stopping the medicine. Hypotensive reactions are more frequently documented when the solution for injection is administered too rapidly.

Safety Restrictions: Use is formally restricted in patients with a prior history of Metamizole-induced agranulocytosis or in those with impaired haematopoiesis. The risk of lethal outcome associated with agranulocytosis is documented as being higher in older adults. Additionally, Metamizole may interfere with the anti-platelet effect of low-dose aspirin when co-administered.

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Overdose and Emergency Response

Overdose and when to seek help

The following information on Metamizol overdose and emergency response is strictly derived from authoritative government regulatory documents.

Overdose Scope

  • Documented overdose presentations: Acute toxic manifestations often begin with gastrointestinal symptoms, including nausea, severe stomach pain, and vomiting, progressing to central nervous system effects such as drowsiness, somnolence, vertigo, and potentially convulsions or coma.
  • Physiological systems affected: Severe intoxication is documented to affect the Cardiovascular System (Hypotension, Shock, Cardiac Arrest), Renal System (Acute renal failure), and the Central Nervous System.
  • Dose-related or exposure-related factors: High exposure levels resulting from the ingestion of substantial amounts of the drug can lead to the saturation of elimination pathways and heightened toxicity.
  • Population-specific overdose notes: Patients with pre-existing impaired hepatic or renal function face an increased risk of severe outcomes, including critical renal complications.

Overdose Classifications (High-Level)

  • Severity classification: Overdose is classified in regulatory documentation as having the potential for severe or life-threatening outcomes, requiring urgent clinical management.
  • Regulatory basis: This information is consistent with official statements found in Summary of Product Characteristics (SmPC) and similar government prescribing information documents.
  • Overdose-context constraints: No specific antidote is known for Metamizole sodium overdose.

Resulting Overdose Structure

  • Official overdose statements:
    • Seek immediate medical attention for any suspected overdose due to the high risk of shock or systemic collapse.
    • Management is exclusively symptomatic and supportive treatment, focused on maintaining vital functions.
    • Procedures to limit drug absorption, such as activated charcoal or gastric lavage, may be used if implemented shortly after ingestion.
    • In cases of severe renal compromise, Haemodialysis is documented as a measure to accelerate the elimination of metabolites.

The regulatory documentation defines the Metamizol overdose profile by focusing on the acute toxic progression from CNS and GI symptoms to severe systemic complications, most notably shock and renal failure. This explicit documentation of life-threatening risks mandates the regulatory requirement to seek immediate medical attention and defines the management strategy as strictly supportive, procedural, and requiring continuous hospital monitoring.

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Therapeutic Uses of Metamizol Teva

What Metamizol Teva Treats: Main Uses and Benefits

The core therapeutic role of Metamizol (Dipyrone) involves managing specific symptomatic domains.

Metamizol is commonly used to help with a group of symptoms that may become intense or disruptive, particularly severe acute pain, pain associated with smooth muscle spasm (colic), and high or persistent fever that may be less responsive to other treatments. The medication is applicable across conditions presenting with acute episodes, often applied in clinical settings that involve acute or unstable symptom patterns, such as postoperative recovery, acute injury, and episodes of renal or biliary colic.

This symptomatic support may assist with easing the overall symptom load during periods of heightened distress. The aim is supportive relief in contexts involving heightened systemic burden:

“Symptomatic relief supports general well-being during symptomatic phases.”


Quick Fact: Relevant for Severe Pain, Colic, and High Fever The medication is considered relevant for easing symptoms related to physical discomfort (pain) and systemic imbalance (fever), supporting patients during episodes of heightened discomfort.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Metamizol Teva?

The population eligibility for using Metamizol Teva (Sodium Metamizole/Dipyrone) is strictly defined by regulatory authorities and is determined by age, medical history, and physiological status.

Contraindicated Populations (Must Not Use)

Official labeling mandates that Metamizol Teva is contraindicated and must not be used by specific groups, including:

  • Patients with known hypersensitivity to Metamizole or other pyrazolones.
  • Individuals with a history of agranulocytosis or pre-existing diseases of the hematopoietic system.
  • Patients diagnosed with acute intermittent hepatic porphyria or G6PD deficiency.
  • Patients with analgesic-induced asthma or unstable circulatory situations.
  • Infants under 3 months of age or weighing less than 5 kg.
  • Pregnant women during the third trimester.

Age and Condition Restrictions

While adults and adolescents (15 years) are generally eligible, use in children and infants (3 months) is allowed, provided dosing is strictly based on body weight. Patients with impaired hepatic or renal function must avoid multiple high doses due to reduced elimination of metabolites. For lactating women, use is not recommended, and following a single dose, breastmilk must be discarded for 48 hours.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

Metamizol (Sodium Metamizole) has officially documented interaction patterns that affect the concentration and actions of co-administered medicines, as detailed in regulatory information.


Official Restrictions and Constraints

Classification Constraint Affected Substances
Formal Contraindication Co-administration is prohibited due to the risk of severe toxicity. Methotrexate, Other Pyrazolone Derivatives
Timing-Based Rule Mandatory separation in administration time is required. Low-dose Acetylsalicylic Acid (Aspirin)

Interaction Patterns Affecting Drug Exposure

Metamizol is documented as a moderate to strong inducer of CYP2B6 and CYP3A4 enzymes, which results in pharmacokinetic interactions. This induction leads to a reduction in the plasma concentration (exposure) of other medicines that are substrates of these enzymes, potentially reducing their systemic effect. Affected medicines include Ciclosporin, Bupropion, Efavirenz, Methadone, Tacrolimus, and Sertraline.

Conversely, co-administration with Methotrexate causes an increase in Methotrexate exposure due to decreased renal clearance, leading to heightened haematological toxicity.

Pharmacodynamic Interactions

Metamizol officially interferes with the anti-platelet effect of low-dose Acetylsalicylic Acid used for cardioprotection. The co-administration of Metamizol with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) increases the documented risk of nephrotoxicity. Additionally, official labeling notes additive effects with alcohol, primarily involving the central nervous system.

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Mechanism of Action

Peripheral Enzyme Inhibition and Prostaglandin Synthesis

Metamizol is a prodrug that undergoes hydrolysis into the active metabolites 4-methylaminoantipyrine (4-MAA) and 4-aminoantipyrine (4-AA). Its primary peripheral action involves the inhibition of cyclooxygenase (COX) enzymes, particularly the COX-3 isoform, which is considered highly sensitive to its metabolites. This enzymatic interference blocks the conversion of arachidonic acid, resulting in a systemic decrease in the synthesis and release of prostaglandins at sites of chemical signaling.


Modulation of Central Nervous System Pathways

Beyond peripheral effects, Metamizol metabolites exhibit significant activity within the central nervous system (CNS). This activity is not mediated solely by COX inhibition. Mechanistically, Metamizol modulates descending inhibitory pathways and may interfere with specific opioid and cannabinoid receptor systems in the spinal cord and periaqueductal gray matter. This CNS action directly alters the nociceptive threshold, influencing the processing and transmission of afferent signals.

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Dosage and Administration Information

How to Use Metamizol Teva

The administration of Metamizol Teva (Sodium Metamizole/Dipyrone) is structured by guidelines defining the appropriate routes, precise dosing limits, and procedural conditions for use. The medicine is intended for short-term administration only.


Administration Routes and Forms

Metamizol is approved for multiple routes, which permits flexible use based on clinical need. These routes include Oral use (as tablets or oral drops), Intravenous (IV) injection/infusion, Intramuscular (IM) injection, and Rectal administration (suppositories). The parenteral routes (IV/IM) are generally reserved for acute situations where oral administration is not feasible.


Standard Dosing and Frequency

Prescribing parameters provide clear numerical limits for administration.

Dosing Parameter Standard Adult Instruction Frequency Rule
Single Dose Up to 1,000 mg (oral) A dose may be repeated up to 4 times daily.
Maximum Daily Dose 4,000 mg (oral) Doses are separated by a minimum of 6-8 hours.

For pediatric patients, the single dose is calculated based on body weight, typically 8-16 mg per kg body weight. The lowest effective dose is selected for all patients.


Procedural Requirements

Specific procedural rules apply to the injectable solution. For IV administration, the injection is given very slowly, at a rate not to exceed 1 ml/minute, and the patient should be lying down. The solution may be diluted with standard solutions (e.g., 0.9% saline) but is administered immediately. Additionally, for older adults or patients with renal or hepatic impairment, multiple high doses are avoided.

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Recent Clinical Evidence

Research evidence / Overview of studies for Metamizol Teva


Evidence for Use in Severe Acute Pain

The research base includes short-term, randomized controlled trials (RCTs) and systematic reviews. This evidence was used in research exploring how symptoms change over time in periods of heightened discomfort. Studies explored populations of adults who experienced pain similar to that studied in contexts like dental extractions or acute low back pain.

Research examined outcomes related to physical discomfort, primarily through measuring the degree of pain intensity change and the proportion of participants who reported reaching a specified change in symptom scores over a brief interval. Follow-up durations were limited, and studies provide limited insight into the compound's use over extended periods.


Evidence for Use in High or Persistent Fever (Antipyresis)

Metamizol Teva was studied for outcomes related to high or persistent fever, and research has been evaluated in comparative RCTs and studies observing responses over defined time intervals. Research examined outcomes related to systemic or functional imbalance by measuring the mean change in baseline temperature at short, set time points (like 60 minutes or 120 minutes) following administration.

Studies focused heavily on febrile children, where most of the comparative evidence exists. Research exploring fever-related outcomes is limited in the general adult population, as direct comparative evidence is lacking. Findings were mixed in observational studies involving critically ill adults, and consistency of the data in this group appears low.


Evidence in Other Clinical Contexts

Research examined Metamizol Teva in patients with chronic cancer-related pain; this evidence is derived from systematic reviews that aggregate a small number of underlying studies. Research explored whether the compound was associated with changes in concomitant use of opioid medications (opioid-sparing outcomes).

A consistent limitation across multiple indications is the reliance on studies with limited follow-up durations and modest sample sizes. Long-term effects are not fully established, and existing studies provide limited insight into the compound's measured changes in symptoms when applied over weeks or months.

Key Studies & References

  1. Spasmolytic Effect of Metamizole - Summary of Clinical and Pharmacological Effects (2019)
  2. Antipyretic effect of ibuprofen and dipyrone in febrile children - Randomized Controlled Trial (2011)
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Frequently Asked Questions (FAQ)

Common questions about Metamizol Teva (FAQ)


Q: Are there foods or drinks that should be avoided when taking Metamizol Teva?

According to official product information, there is a warning of a potential for additive effects if Metamizol is consumed with alcohol, which can affect the central nervous system. Specific constraints related to food consumption or non-alcoholic drinks are generally not highlighted in regulatory documents.


Q: Is Metamizol Teva available over-the-counter in some countries?

The regulatory status of Metamizol Teva can vary widely across different countries. While it is classified as a prescription-only medicine in many regions, official sources indicate that its availability, including whether it is prescription-only or over-the-counter, is subject to local health authority regulations.


Q: Are there specific symptoms that mean Metamizol Teva must be stopped?

Official regulatory warnings state that if signs associated with agranulocytosis are noticed, it is necessary to stop treatment and seek urgent medical attention. These serious symptoms include the onset of fever, chills, sore throat, or painful sores developing on the moist inner body surfaces (mucosa). In these serious situations, urgent medical attention is required.


Q: How does Metamizol Teva compare to opioids in its pain-relief mechanism?

Metamizol Teva is officially classified as a non-opioid analgesic, meaning it is chemically different from traditional opioids. However, studies show that its powerful pain-relieving mechanism involves activity in the central nervous system that includes the modulation of pain pathways, potentially interfering with some opioid receptor systems.


Q: Why do some people say Metamizol Teva is controversial?

Regulatory warnings and official documents highlight the rare but severe adverse effect of agranulocytosis, which is a severe decrease in white blood cells. This serious risk has historically led to the medicine being banned or withdrawn from the market in some countries, which is the primary reason for the drug’s varied regulatory status and public discussion in different regions.


Q: How quickly can someone generally expect Metamizol Teva to start working?

According to the official product information, the onset of pain relief is typically reported to begin between 30 to 60 minutes after taking the medicine orally. The duration of its primary effect usually lasts for approximately 6 to 8 hours.


Q: Does Metamizol Teva cause drowsiness or affect driving?

Official labeling generally indicates that, when used at recommended doses, there is typically no known impairment of concentration or reaction ability. However, as with any medicine that acts on the central nervous system, individuals should be aware of the possibility of mild effects.


Q: Is it normal to feel a stomach ache after taking Metamizol Teva?

Gastrointestinal disorders, such as nausea or mild abdominal discomfort, are included in the list of possible documented side effects. Official information notes that Metamizol is generally recognized to have a favorable gastric tolerability profile compared to non-steroidal anti-inflammatory drugs (NSAIDs).


Q: Why is Metamizol Teva not approved in the United States?

The drug is not approved for use in humans in the United States. This regulatory decision is primarily linked to concerns over the rare but severe risk of agranulocytosis, which is a life-threatening reduction in white blood cells.


Q: Can Metamizol Teva interact with blood pressure medication?

Regulatory documents indicate that Metamizol can act as a liver enzyme inducer, potentially reducing the concentration of other co-administered medicines in the blood. Since some blood pressure medications are metabolized by these same enzymes, professional consultation is recommended to check for potential interactions before concurrent use.


Q: What happens if someone accidentally takes too much Metamizol Teva?

In the event of an accidental overdose, documented effects can include signs like nausea, vomiting, stomach pain, dizziness, and sometimes effects on kidney function. If more than the prescribed amount is taken, immediate medical attention is required.


Q: Does Metamizol Teva change the way birth control pills work?

Metamizol is documented as an inducer of the CYP3A4 enzyme, which can increase the speed at which certain other medicines are broken down by the body. Because some oral contraceptives rely on this same enzyme pathway, regulatory information suggests a potential for decreased effectiveness. A professional consultation is recommended for clarification.


Q: What are the most commonly reported mild side effects of Metamizol Teva?

Official documentation often prioritizes reporting severe and rare effects, such as blood disorders. Regulatory labeling lists less common adverse effects, which may include isolated hypotension (low blood pressure), skin rash, and gastrointestinal effects such as nausea or vomiting.


Q: What is the general difference between the effect of Metamizol Teva and paracetamol?

Both Metamizol and paracetamol (acetaminophen) are classified as non-opioid medicines used to treat pain and fever. The general difference lies in their chemical classification; Metamizol is a pyrazolone derivative and is noted to have a potent effect mediated through the central nervous system, separate from paracetamol's mechanism.


Q: Is it necessary to have routine blood tests while on Metamizol Teva?

Regulatory information does not require routine blood tests for all patients using Metamizol Teva. However, if severe symptoms of blood disorders develop (such as unexplained fever or sore throat), regulatory information indicates that a complete blood count is necessary.


Q: Can Metamizol Teva cause dependency or addiction?

According to official product labeling, Metamizol Teva is classified as a non-opioid analgesic. Dependency or addiction are not generally listed as recognized risks associated with its use in authoritative regulatory documentation.


Q: Can Metamizol Teva affect heart rhythm?

Regulatory labeling notes the possibility of hypotension (low blood pressure) as an uncommon effect, particularly when the intravenous form is administered too quickly. Some post-marketing reports have documented other cardiac effects, including chest pain or disturbances in heart rhythm, which are generally categorized as very rare.


Q: Is it possible to develop a tolerance to Metamizol Teva?

Official clinical information does not generally list the development of tolerance as a common clinical concern for patients. However, some non-clinical studies have explored the possibility of a reduced response to repeated use, though this is not a major warning in the patient information.


Q: What is the half-life of Metamizol Teva's active component?

According to official pharmacokinetic studies, the half-life of the primary active substance, known as 4-MAA, is typically reported to be in the range of 2 to 4 hours. The half-life refers to the time it takes for half of the substance to be eliminated from the bloodstream.


Q: Does Metamizol Teva contain lactose or gluten?

The full list of inactive ingredients, known as excipients, is included in the official regulatory documents for each specific product formulation. For clarification regarding specific ingredients like lactose or gluten, it is necessary to review the official Product Information Leaflet or Summary of Product Characteristics for the exact version of Metamizol Teva being used.


Q: Why is Metamizol Teva used for pain that hasn't responded to other treatments?

Official regulatory indications define the use of Metamizol Teva for severe acute pain or high fever. It is often specified for use in situations where these conditions have failed to respond adequately to other common, less potent therapeutic measures, such as basic non-prescription painkillers.

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How should Metamizol Teva be stored and disposed of?

Storage and Disposal Requirements

Official regulatory documents define specific conditions for storing and disposing of Metamizol Teva to maintain product stability and protect the environment. The medicine must be kept in its properly labeled container, stored in a cool and dark place, and protected from heat and sources of ignition.

Storage Constraints

  • Child Safety: The product must be stored locked up and kept out of the sight and reach of children.
  • Container Integrity: The container must be kept tightly closed when not in use.
  • In-Use Stability: Multi-dose forms, such as oral drops, have a limited shelf life (e.g., 3 months) after the first opening, while single-use ampoules must be discarded immediately after use.

Disposal Instructions

Disposal must adhere to regulatory guidelines to prevent environmental harm. Metamizol products are classified as toxic to aquatic life, meaning they must not be thrown away with household waste or disposed of via wastewater. Unused or expired medicine should be returned to a pharmacist or disposed of through an approved waste disposal plant.

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

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