Metamizol Stada

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Metamizol Stada

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Overview of Metamizol Stada

Property Description
Active ingredient Sodium Metamizole (Dipyrone)
Form Oral drops solution, Tablet
Pharmacological class Non-opioid analgesic, Antipyretic, Spasmolytic
Common purpose Pain relief, Fever reduction
Origin Synthetic pyrazolone derivative

Entity and Classification

Metamizol Stada is a medication defined by its single active ingredient, Sodium Metamizole, which is classified as a potent non-opioid analgesic and antipyretic. The substance is also internationally recognized as Dipyrone and belongs to the chemical class of synthetic pyrazolone derivatives. This classification confirms the medicine’s unique standing apart from both narcotic pain relievers and traditional non-steroidal anti-inflammatory drugs. The drug’s therapeutic profile is further distinguished by its reliable spasmolytic activity, an effect in easing discomfort associated with involuntary muscle tension.


Composition and Primary Purpose

The formulation of Metamizol Stada contains only the active substance Sodium Metamizole, which functions as a pro-drug that is readily converted into active metabolites once administered. The medicine is prepared for oral administration and is commercially available in primary dosage forms such as tablets and as an oral drops solution. Manufactured and supplied by Stada Arzneimittel AG, the availability in both solid and liquid forms offers administrative flexibility.

The primary purpose of Metamizol Stada is to provide effective relief from acute pain and to rapidly reduce a high fever. The drug’s strong effectiveness is recognized for its reliable use for reducing fever and providing analgesia. The medicine is highly capable of managing severe discomfort. Its mechanism is thought to be predominantly centrally focused, which provides a unique therapeutic option for managing acute pain and fever.

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What side effects are possible with Metamizol Stada?

Possible side effects and safety information

Metamizol Stada, containing Sodium Metamizole (Dipyrone), is associated with adverse reactions classified by their frequency and effect on specific system-organ classes, as documented in official government regulatory texts. The medicine's safety profile is defined by the potential for several serious, though rare, adverse reactions, primarily affecting the blood system and immune response.

Serious Adverse Reactions and Blood System Disorders

The most significant safety concern listed in regulatory labeling is the risk of Agranulocytosis, a severe reduction in specific white blood cells. This condition is classified as Rare in official documents, meaning it may affect up to 1 in 1,000 patients. Other serious disorders affecting blood components include Leukopenia (also Rare), and reactions such as Pancytopenia and Aplastic Anaemia, which are reported at a Not Known frequency. Agranulocytosis can occur at any time during treatment and is not dependent on the dose or duration of exposure.

Hypersensitivity and Organ System Effects

Metamizole is associated with severe hypersensitivity reactions which can escalate to Anaphylactic Shock; these are classified as Very Rare. Severe, blistering skin reactions, including Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), are also documented as Very Rare. Hypotensive reactions (low blood pressure) are classified as Uncommon. Effects on the gastrointestinal system, hepatobiliary system, and renal system, such as Drug-induced Hepatitis and Acute Renal Failure, are listed at a Not Known frequency.

Population and Contextual Safety Notes

The regulatory label includes specific safety constraints for certain populations. The medicine is generally restricted or contraindicated in individuals with severe hepatic or renal impairment due to reduced clearance of metabolites. Caution is advised in older adults and patients with a history of asthma or chronic urticaria who are at higher risk of non-tolerance or hypersensitivity reactions. A harmless red colouration of the urine (Chromaturia) due to a metabolite may be observed.

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Overdose and Emergency Response

Overdose and when to seek help

Documented Overdose Manifestations

The official regulatory profile for Metamizol overdose details severe systemic effects resulting from acute high-dose exposure. Documented clinical manifestations include significant gastrointestinal toxicity (nausea, vomiting, abdominal pain) and pronounced Central Nervous System effects, such as somnolence, vertigo, and potentially severe outcomes like convulsions and coma. The profile emphasizes life-threatening risks, including severe haemodynamic instability characterized by a critical drop in blood pressure, tachycardia, and circulatory shock. Furthermore, acute exposure may affect major organs, documenting the risk of acute kidney failure and hepatic injury.


Emergency Actions and Supportive Management

Immediate medical attention must be sought for any suspected overdose. Regulator-mandated action also requires patients to stop taking the medicine immediately and consult a physician if they experience symptoms of severe blood dyscrasia, such as fever or mucosal sores indicative of agranulocytosis. Treatment is officially defined as symptomatic and supportive, as no specific antidote is known. Procedures to limit absorption, such as activated charcoal or gastric lavage, and measures to accelerate elimination, such as haemodialysis, are documented management strategies. Close monitoring of vital signs and immediate complete blood cell count testing are required in these emergency situations.

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Therapeutic Uses of Metamizol Stada

What Metamizol Stada Treats: Main Uses and Benefits


The medicine is applied across domains where additional symptomatic support is needed and is relevant when symptoms create noticeable interference with comfort and function. Metamizol (Dipyrone) is commonly used to help treat severe pain and fever that cannot be controlled with other medications, confirming its role across multiple therapeutic domains.

The medication is commonly used across conditions presenting with acute episodes and significant symptomatic burden. It is relevant in conditions characterized by periods of heightened symptoms, including those related to acute pain, spasm-related symptoms, and unstable fever states.

“The medication provides supportive relief when symptoms interfere with routine activities, assisting with the complex symptom cluster associated with spasm.”

The medication is considered relevant in clinical settings that involve acute or unstable symptom patterns, assisting with the relief of symptoms related to physical discomfort and systemic imbalance. The core benefit contributes to easing the overall symptom load and supports general well-being during symptomatic phases.

Quick Fact: Relief for Visceral Spasm

Metamizol Stada is considered relevant for easing symptoms related to heightened physiological activity, especially in spasm-related conditions, which may assist with symptomatic relief during colic attacks.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Metamizol Stada?

The eligibility for Metamizol Stada (Sodium Metamizole) is strictly defined by regulatory authorities based on contraindications and population restrictions.

Absolute Contraindications

The medicine must not be used in patients with specific conditions, including a history of agranulocytosis caused by metamizole or other pyrazolones, known impaired bone marrow function, or established diseases of the haematopoietic system. Use is also contraindicated in individuals with analgesic asthma, acute intermittent hepatic porphyria, or glucose-6-phosphate dehydrogenase deficiency.

Age and Physiological Restrictions

Metamizol Stada is absolutely contraindicated in infants below the age of 3 months or weighing less than 5 kg. For children and adolescents (3 months to 14 years), use is established but requires dosage determined by body weight, while use is standard for those ge 15 years. The medicine is contraindicated during the third trimester of pregnancy and is not recommended during the first six months or while breastfeeding (lactation).

Conditional Use Populations

Use is not recommended or requires strict caution in patients with impaired renal function (kidneys), impaired hepatic function (liver), or pre-existing circulatory instability (e.g., hypotension). Older adults may require special consideration due to potential delayed excretion of the drug’s metabolites.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the official interaction information for Sodium Metamizole (Metamizol Stada) as documented in government regulatory sources.

Interaction Scope

Category Official Regulatory Documentation
Interacting substances and categories Specific listed drugs include Chlorpromazine, Cyclosporine, Valproate, Bupropion, Methadone, and Acetylsalicylic acid (ASA). Affected classes include Immunosuppressants and Antidepressants.
Mechanistic basis of interactions (only if stated in label) Pharmacokinetic interaction via enzyme induction of CYP2B6, CYP3A4, and CYP2C19, and a Pharmacodynamic interference at a target site.
Timing-based interaction rules (if applicable) For low-dose ASA used for cardiovascular protection, regulatory documents note that timing separation may be required to mitigate inhibition of the antiplatelet effect.
Interaction-related restrictions Restriction on co-administration with Chlorpromazine. Requirement to manage or monitor co-administration with listed CYP substrates due to reduced plasma concentrations.

Interaction Classifications (High-Level)

Category Classification Details (as defined in official documents)
Interaction severity classification Contraindicated/Prohibited Combination (Chlorpromazine); Clinically Significant Interaction requiring monitoring (CYP substrates); Interaction requiring timing management (ASA).
Regulatory basis Based on formal updates to the Summary of Product Characteristics (SmPC) across European regulatory networks and government-published clinical safety data.
Interaction-context constraints The interaction with ASA is constrained by its use for cardiovascular protection. The interaction with CYP substrates is constrained by the need to maintain therapeutic efficacy of the co-administered drug.

Official interaction statements:

  • Co-administration with Chlorpromazine is officially restricted due to the potential for severe additive hypothermia.
  • Metamizole is documented as an enzyme inducer, resulting in a reduction in plasma concentrations for co-administered drugs like Cyclosporine, Valproate, and Bupropion.
  • The regulatory label notes that Metamizole may inhibit the antiplatelet effect of low-dose Acetylsalicylic acid (ASA), requiring potential administration spacing.
  • Product information specifies that Metamizole may potentiate the effects of alcohol.

Connection to the overall interaction profile (2–4 sentences): The regulatory profile establishes that the product’s interaction structure is predominantly defined by pharmacokinetic induction and pharmacodynamic interference. Official labeling classifies these interactions based on severity, ranging from prohibited combinations to constraints that mandate monitoring of drug concentrations or timing separation, as specified by government authorities.

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Mechanism of Action

Metamizol Stada, containing the active ingredient metamizole (dipyrone), functions as a non-opioid pyrazolone derivative that exerts its effects via multiple mechanisms, primarily within the central nervous system (CNS). Metamizole is metabolized into the active compounds 4-methylaminoantipyrine ( MAA) and 4-aminoantipyrine ( AA). These metabolites interact with cyclooxygenase (COX) activity, displaying a complex profile that involves the inhibition of COX-1, COX-2, and potentially COX-3. This interaction profile leads to the modulation of prostaglandin synthesis, key lipid mediators in fever and pain signaling pathways. The mechanism also includes the promotion of nitric oxide ( NO) release and potential interaction with central transient receptor potential (TRP) channels. The cumulative effect of these molecular interactions alters hypothalamic activity, resetting the thermoregulatory center and functionally raising the nociceptive threshold in the CNS, thereby modulating core body temperature and the processing of afferent signals.

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Dosage and Administration Information

Instruction Map: How to use Metamizol Stada

This map describes the high-level instructions for administering metamizole (sodium metamizole/dipyrone).


Administration Scope

Property Instruction
Route of Administration The medicine is approved for oral (tablets or drops), intravenous (IV), intramuscular (IM), and rectal routes, depending on the dosage form.
Dosing Schedule (Adults ge 15 years or > 53 kg) The dose starts at the lowest effective amount. The maximum single oral dose is 1,000 mg (1 g). The maximum total daily dose by the oral route is 4,000 mg (4 g), while the maximum parenteral dose does not exceed 5,000 mg (5 g).
Timing in relation to meals Specific labeling does not mandate a specific relationship to food intake.
Preparation Requirements For parenteral use, the solution for injection can be diluted with solutions such as Saline 0.9%, Glucose 5%, or Ringer's lactate solution, and is administered immediately after mixing.
Age-group administration rules Pediatric Dosing (up to 14 years) is calculated at 8 –16 mg per kg of body weight as a single dose. Repeated high doses are avoided in patients with reduced renal or hepatic function.
Missed-dose rules Standard practice involves adherence to a 6–8 hour interval between doses.
Special procedural conditions The intravenous injection is given very slowly to meet administration requirements. The route is deep intramuscular or slow intravenous.

Instruction Classifications (High-Level)

Classification Pattern/Type
Administration method type Oral and Parenteral (IV/IM)
Frequency pattern Intermittent use, administered up to 4 times daily (QID).
Use-context constraints Dose-limiting to 4,000 mg daily (oral) and procedural regarding the slow rate of IV injection.

Connection to the overall use protocol

The use protocol establishes defined numerical constraints for both single and daily dosing across various administration routes, from oral to parenteral. The protocol includes the 6–8 hour waiting period and follows specific preparation and technique rules, particularly for injectable forms, to standardize the medicine's delivery.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Metamizol Stada

The available research provides context for how Metamizol Stada (Sodium Metamizole/Dipyrone) has been studied in several clinical scenarios. This evidence highlights what has been observed so far, what was measured, and where knowledge gaps remain. Research findings describe group patterns and contribute to the broader evidence landscape but do not determine whether an individual will respond similarly.


Evidence for Use in Acute Pain Management

Research has explored the drug's activity for conditions associated with acute pain using Short-term Randomized Controlled Trials (RCTs) and supporting Systematic Reviews. These studies included populations such as adult patients and those in specific post-operative settings. Research examined outcomes related to physical discomfort, primarily focusing on how symptoms are measured using scales for pain intensity and severity. Studies reported measurements of changes in the patients’ perceived discomfort, including patterns observed in the time related to initial symptom change following administration. Research is limited in providing insight into the applicability of these findings to chronic or non-episodic pain.


Evidence for Use in Reducing High Fever

Research has examined the drug's activity for conditions associated with high fever, which is relevant in research contexts involving systemic or functional imbalance. Research was conducted using Short-term RCTs and Systematic Reviews, and studies monitored populations that included both adults and children. The primary outcomes measured in these trials were related to the change in body temperature and the duration of the measurement interval. The findings describe patterns in the time taken to observe a symptom change in temperature, but the certainty remains low regarding sustained fever management.


Evidence for Use in Spasm-Related Symptoms

Studies monitored the drug's activity for conditions characterized by episodic or acute manifestations, specifically focusing on the spasmolytic property in contexts like visceral discomfort. Research examined outcomes related to symptom variability, such as the frequency and intensity of the spasm. The evidence quality varies across studies, and many of the trials used sample sizes that were modest. There is limited information for long-term outcomes, and the drug’s activity outside of acute, severe spasm episodes is not well defined by the existing research structure.

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Frequently Asked Questions (FAQ)

Common questions about Metamizol Stada (FAQ)


Q: What should I do if I miss a dose of Metamizol Stada?

Official guidance indicates patients should adhere to the prescribed dosing schedule if a dose is missed. It is specified that a double dose should not be taken to compensate for the one missed. The product's regulatory summary requires adherence to the 6–8 hour waiting period between doses.


Q: Does Metamizol Stada interact with my regular vitamins or supplements?

Official regulatory documents and the product information primarily detail interactions with other medications (drug-drug interactions). There is no specific information documented in these sources regarding interactions with non-drug products such as standard vitamins or dietary supplements.


Q: Can Metamizol Stada make me feel dizzy or sleepy?

Official product information notes that adverse effects can include somnolence (sleepiness) and vertigo (dizziness). While the frequency of these effects may be classified as Not Known or Uncommon, depending on the specific product SmPC, awareness of these potential effects is part of the product's safety information.


Q: How long after I take the tablet should I expect the pain relief to start working?

Metamizole is recognized as having a rapid onset of action. Regulatory documents note that the main active compounds typically reach their highest concentration in the blood within 1 to 2 hours after oral administration. Furthermore, information related to injectable forms indicates that an effect may be observed within 30 minutes of administration.


Q: Is Metamizol Stada addictive or habit-forming?

Metamizol Stada is classified by regulatory authorities as a non-opioid analgesic. Official safety information and warnings do not include the specific precautions that are typical for medications with a high potential for abuse, dependence, or habit formation.


Q: What are the ingredients in the tablet other than the active one?

The formulation of Metamizol Stada contains the active ingredient, sodium metamizole, along with several inactive components known as excipients. The complete and mandatory list of all ingredients is documented in the specific Summary of Product Characteristics (SmPC) for the product.


Q: Can I drive or operate machinery while taking this medicine?

Official product labeling includes a dedicated warning regarding the ability to drive or use machines. If adverse effects such as dizziness or somnolence (sleepiness) occur, the ability to concentrate and react may be impaired. Patients are advised to use caution when performing tasks that require full attention if these side effects occur.


Q: What country or region is this medication regulated in?

This medicine is regulated across the European Economic Area (EEA), and its marketing authorization (approval for sale) is issued by national regulatory bodies in these countries. The product is manufactured and supplied by Stada Arzneimittel AG, and its regulatory status is tracked by European authorities.

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How should Metamizol Stada be stored and disposed of?

How to Store and Dispose of Metamizol Stada?

This section defines the mandatory, government-documented requirements for protecting and discarding the medicine to ensure product stability and public safety.

Classification Official Regulatory Wording
Child Protection Keep out of the sight and reach of children.
Environmental Protection Do not dispose of the medicine via wastewater or household trash.
Temperature & Light Store in the original package in order to protect from light. For some liquid forms, do not store above 25 C after first opening.
Stability after Opening For certain liquid forms, the stability after first opening is officially designated as 28 days.
Disposal Requirement Dispose of unused or expired medicinal product according to local regulations.

All Metamizol Stada formulations must be stored in the original packaging to protect them from environmental degradation. For liquid forms, the container must be closed well after each administration to preserve product quality during the designated in-use period. Proper disposal requires users to utilize established pharmaceutical take-back programs and not dispose of the medicine in common trash or wastewater.

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

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