Piralgin

Quick links to important sections

Piralgin

Medically reviewed

Marina Burgos

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 Piralgin

Property Description
Active ingredient Metamizole sodium (Dipyrone/Analgin)
Form Tablet, Injection solution, Suppository
Pharmacological class Non-opioid analgesic, Antipyretic
General purpose Alleviation of acute pain and high fever
Origin Synthetic (Chemically synthesized)

Piralgin: Definition and Pharmacological Class

Piralgin is a synthetic medicinal preparation whose active component is Metamizole sodium, an ingredient recognized as Dipyrone or Analgin. Chemically, it belongs to the Pyrazolone derivative family and is formally classified as a potent non-opioid analgesic and antipyretic. The compound is a non-narcotic agent, differentiating it from controlled pain relievers. Under the ATC classification group N02BB: Pyrazolones, the drug's primary pharmacological role is the management of both pain and fever symptoms, a function recognized within pharmacological classification systems.


Composition, Forms, and General Purpose

The Piralgin preparation is fundamentally composed of its active ingredient, Metamizole sodium, combined with basic pharmaceutical excipients for solid forms or an aqueous solution base for liquid administration. The medicine is available in several dosage forms, typically including the orally administered tablet, the solution for injection (ampoule) for parenteral routes, and the rectal suppository. Metamizole sodium is noted for its high efficacy, providing potent relief for pain syndromes and acting as a strong fever reducer. This therapeutic profile defines the drug's general purpose: to rapidly and effectively alleviate acute pain and to successfully reduce excessively high body temperature associated with febrile states.


Metamizole Sodium: Unique Efficacy Profile

The distinguishing characteristic of Metamizole sodium is its powerful dual efficacy, which combines strong pain relief with pronounced fever reduction. This substance achieves its effect through a mechanism that primarily acts centrally to modulate the body’s pain and temperature signals. Furthermore, the substance possesses a mild spasmolytic (anti-spasmodic) property that aids in relieving pain associated with smooth muscle tension and cramping. This pharmacological characteristic contributes to its broad utility in managing diverse types of acute discomfort, making it a powerful option when standard non-opioid medications fall short.

What side effects are possible with Piralgin?

Possible Side Effects and Safety Information: Piralgin

This section outlines the officially documented side effects and safety profile of Piralgin (Metamizole), as categorized and published by government regulatory authorities.

Key Adverse Reactions and Frequencies

Adverse reactions are formally categorized by the body system affected and the frequency with which they occur:

  • Rare (Less than 1 in 1,000 patients): Leukopenia (decreased white blood cells), allergic skin reactions (e.g., rash).
  • Very Rare / Not Known: Agranulocytosis (a severe decrease in a type of white blood cell, potentially fatal), anaphylactic shock (severe allergic reaction), acute liver failure, and severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson syndrome.

System-Organ Classifications (SOC)

Documented side effects involve several body systems:

  • Blood and the Lymphatic System: Includes agranulocytosis and aplastic anaemia.
  • Immune System: Includes hypersensitivity reactions and anaphylaxis.
  • Hepatobiliary Disorders: Includes liver damage and acute hepatitis.
  • Skin and Subcutaneous Tissue: Includes severe blistering and skin reactions (SCARs).

Safety Restrictions and Monitoring

The official label includes specific restrictions and required actions to manage risk:

  • Contraindications: Piralgin is contraindicated in patients with a history of agranulocytosis caused by Metamizole, impaired blood cell production, or third-trimester pregnancy.
  • Required Action: If signs of agranulocytosis occur (such as fever, chills, sore throat, or painful mouth sores), the medication must be stopped immediately, and a blood count should be performed urgently.
  • Population-Specific Concerns: Use during the third trimester of pregnancy is advised against due to potential risks to the fetus. Caution is advised for elderly patients and those with hepatic or renal impairment.

Exposure-Related Safety Notes

Agranulocytosis can occur at any time during treatment and is not necessarily related to the dose used. Liver injury has been documented with both acute, rapid onset and during prolonged use.

Overdose and Emergency Response

The official regulatory profile for Piralgin (Metamizole sodium) overdose is defined by its potential for delayed severe effects and the necessity for immediate, specialized supportive care.

Overdose Scope

Domain Official Regulatory Statement
Documented Manifestations Acute ingestion may initially present with gastrointestinal toxicity (e.g., nausea, vomiting) and CNS effects like dizziness or headache. Symptoms of poisoning may have a delayed onset of several hours.
Severe Outcomes Life-threatening consequences documented in severe intoxication include tonic-clonic convulsive seizure, critical hypotension leading to shock, and severe metabolic acidosis.
Help-Seeking Action Individuals must call a POISON CENTER or physician immediately upon suspected overdose or accidental high-dose ingestion (e.g., above 7.5 g).
Management & Monitoring Due to the potential for delayed complications, medical observation for at least 48 hours is required. Management is strictly symptomatic and supportive, as regulatory documents state no specific antidote is available. Procedures such as forced diuresis or haemodialysis are described for enhanced elimination in severe cases.

Connection to the Overall Overdose Profile: The regulatory definition emphasizes that the core risk is not only the immediate presentation but also the delayed escalation to severe systemic events. Regulators thus mandate that the immediate action is seeking professional emergency help, which allows for the required minimum 48-hour medical monitoring and access to documented supportive elimination procedures.

Therapeutic Uses of Piralgin

Piralgin (Metamizole sodium) is commonly used to provide symptomatic relief across several key therapeutic domains where patients experience heightened discomfort or distress. The medication is generally applied in clinical settings that involve acute or disruptive symptom patterns, offering supportive symptom management when short-term assistance is needed.

The medication is utilized for the treatment of severe pain and high fever that may be unresponsive to other measures in various therapeutic contexts.

This medication plays a role in managing pronounced symptoms, helping to ease the overall burden of acute episodes. It is commonly used to help with moderate to severe acute pain, pain accompanied by smooth muscle spasm (colic), and excessively high fever. Piralgin supports the patient during difficult episodes by contributing to easing the overall symptom load.

Therapeutic Scope and Support

Piralgin is generally applied when symptoms become more disruptive, such as the postoperative or post-traumatic discomfort associated with injury, the episodic pain of renal colic, or the systemic imbalance caused by high fever. Its use helps address symptom clusters that create noticeable functional strain, providing supportive relief when symptoms interfere with routine activities.

Supportive Focus: Spasm-Associated Pain
The medication may assist with managing discomfort associated with tension, which is relevant for easing symptoms linked to organ-specific functional stress, often seen in acute colic episodes.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Piralgin — Official Regulatory Information

Regulatory documents define eligibility for Piralgin (Metamizole sodium) based on hematological history, hypersensitivity risk, and patient status.


Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults and adolescents ≥ 15 years of age. Children ≥ 3 months or ≥ 5 kg body weight [2.1].
Populations for whom use is not recommended Pregnancy during the first six months. Breastfeeding, due to high drug concentration in milk (if used once, discard milk for 48 hours) [1.7, 2.4].
Populations for whom use is contraindicated Individuals with a history of agranulocytosis induced by Metamizole or other pyrazolone derivatives [1.3, 2.3]. Patients with known analgesic-induced asthma syndrome [1.3]. Infants below 3 months or 5 kg [2.1]. Third trimester of pregnancy [1.3, 1.7, 2.4].

Eligibility-Related Restrictions

Category Official Regulatory Statement
Condition-Specific Rules Contraindicated in impaired bone marrow function or diseases of the hematopoietic system [1.3, 2.3]. Contraindicated in acute intermittent hepatic porphyria or G6PD deficiency [1.3].
Organ Function/Geriatrics Dose must be reduced for the elderly and those with hepatic or renal impairment; multiple high doses must be avoided [1.3].
Conditional Use Use requires caution (conditional use) in patients with pre-existing arterial hypotension or unstable circulation [1.3].

Connection to the overall eligibility profile: Regulatory documents define eligibility based on specific, non-negotiable prohibitions related to hematological risk and hypersensitivity, alongside age-related rules and mandated conditional use restrictions for impaired organ function and unstable circulatory states. These clear constraints determine who is officially permitted to use the medicine under labeled conditions.

What should I know about interactions with other medicines?

Piralgin (Metamizole sodium) has officially documented interaction patterns primarily rooted in its effect as a moderate to strong enzyme inducer. This mechanism means that co-administration can lead to a significant pharmacokinetic interaction, specifically decreasing the plasma concentrations and systemic exposure of several other medicines.

Substances affected by this reduction in exposure include immunosuppressants like Cyclosporine and Tacrolimus, as well as agents such as Bupropion, Methadone, and certain anti-HIV medicines like Efavirenz. Reduced exposure may lead to these co-administered drugs being less effective.

A distinct pharmacodynamic interaction exists with low-dose Acetylsalicylic acid (ASA), where Metamizole can inhibit the desired antiplatelet effect. Regulatory guidance dictates that separation of administration timing must be considered to mitigate this interference.

Furthermore, combining Piralgin with other agents may carry an additive toxicological risk. Official labeling notes an increased risk of severe haematotoxicity when co-administered with Methotrexate. Two combinations are strictly restricted: the co-administration of Metamizole with Chlorpromazine is formally contraindicated due to the potential for severe hypothermia, and alcohol consumption is restricted due to documented additive effects.

Mechanism of Action

Piralgin's mechanism of action, driven by Metamizole sodium, is defined by its selective, multi-target action on central signaling pathways and smooth muscle contractility, resulting in defined physiological changes.


Central Inhibition of Thermoregulation and Nociceptive Signaling

The drug's active metabolites rapidly target the Central Nervous System (CNS), primarily inhibiting the Cyclooxygenase-3 ( COX-3) isoenzyme in the hypothalamus and spinal cord. This action restricts the synthesis of the mediator Prostaglandin E2 ( PGE2). By decreasing central PGE2 levels, the drug initiates the resetting of the hypothalamic temperature set-point and reduces pain signal transmission, affecting both physiological pathways simultaneously.


Activation of Intrinsic Pain Control Systems

A unique aspect of the mechanism involves the drug's metabolites acting as agonists on central receptors, including Cannabinoid type 1 ( CB1) and Opioidergic receptors. This engagement activates the descending antinociceptive system, which is the body's intrinsic mechanism for inhibiting nociceptive transmission in the spinal cord. This central modulation contributes to the drug's overall inhibitory action on nociception, independent of peripheral inflammation.


Modulation of Visceral Smooth Muscle Tension

Piralgin also exerts a direct, peripheral action on smooth muscle tension on involuntary muscle cells, such as those in the digestive and urinary tracts. This mechanism involves the inhibition of intracellular calcium (Ca^2+) release from stores necessary for muscle contraction. By modulating Ca^2+ mobilization, the drug results in the relaxation of smooth muscle fibers, modulating muscle tone and tension within these organs.

Dosage and Administration Information

Piralgin is a fixed-dose combination medication with established parameters for use.

Administration Protocol

The medicine is administered via the Oral route, typically as a tablet, or via the Rectal route as a suppository. It is generally taken with water. The administration protocol governs the proper consumption of the drug components, which include Metamizole, Codeine, Paracetamol, Phenobarbital, and Caffeine.

Official Dosing and Frequency

The standard dosage for an adult is one unit (e.g., tablet or suppository) per dose. The dosing schedule involves taking the medicine at specified intervals (e.g., every 6 to 8 hours), with a strict limit on the maximum number of doses to be consumed within a 24-hour period (e.g., typically no more than three or four doses).

Procedural Constraint Standard Instruction
Route Oral (Tablet) or Rectal (Suppository)
Dose Limit Do not exceed the maximum number of doses specified for a 24-hour period.
Duration Limit Use is typically restricted to a short duration (e.g., up to 3 to 5 consecutive days).
Age Rules Use is generally restricted or contraindicated in pediatric populations, particularly children below 12 years of age, due to components like Codeine and Phenobarbital.

Procedural Summary

Guidelines indicate that users should adhere to the minimum time interval between doses. If a dose is missed, the standard procedure is to take the missed dose as soon as it is remembered, unless it is nearly time for the next scheduled dose. In that case, the missed dose is skipped to avoid a double dose. These steps are designed to ensure the medication is used according to the established regimen.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Piralgin

Evidence for Use in Acute Pain

Research into Metamizole sodium's use for acute pain is primarily based on Randomized Controlled Trials (RCTs) and Systematic Reviews that synthesize data from many individual trials. This research examined patient-reported outcomes related to physical discomfort and systemic or functional imbalance. Researchers was studied for populations of adults experiencing various types of acute discomfort, including pain experienced after surgical procedures (postoperative pain) and acute or subacute low back pain. The outcomes related to acute pain was monitored over defined short-term observation periods, typically assessing single-dose effects within the first few hours, though LBP trials extended to intermediate-term follow-up.

Studies conducted during periods of increased symptom activity described patterns observed when the medication was evaluated in these patient groups. Findings describe patterns observed in the studies, such as the proportion of participants reaching a pre-defined level of change on pain scales following administration of the study drug. Systematic reviews described measurements and data related to pain scores in observed populations.

Evidence for Management of High Fever

The evidence supporting the evaluation of Metamizole for high fever is based on Randomized Controlled Trials and subsequent Systematic Reviews that research examined Metamizole alongside other drugs. This research focused on conditions characterized by functional limitations related to systemic imbalance and physiological strain. The research monitored how the body's temperature changed in observed populations, including both adults and pediatric patients (children) presenting with febrile states. The primary outcomes monitored included objective measurements such as the change in body temperature from baseline and the duration of temperature monitoring.

Key Uncertainties and Research Gaps

Certainty remains low for the specialized application in pain associated with spasm (colic), given the limitations of the research conducted in this area. Furthermore, research describing long-term outcomes or durability of patterns remains limited across all uses. Data for certain groups remain insufficient, and the results apply only to the specific populations studied in the trials. There is a continuing need for larger, multi-center studies to specifically address these gaps and provide further insight into specialized uses of the medication.

Key Studies & References

  1. N02BB Metamizole sodium - Anatomical Therapeutic Chemical (ATC) Classification System

Frequently Asked Questions (FAQ)

Common questions about Piralgin (FAQ)


Q: How does Piralgin differ from common non-prescription painkillers like ibuprofen or acetaminophen?

A: Piralgin's active ingredient, Metamizole, is described in official documents as a non-opioid analgesic that also possesses antipyretic (fever-reducing) and spasmolytic (anti-spasm) properties. Regulatory reviews indicate that the safety profile of Piralgin is described as having potential risks, such as a rare risk of severe blood disorders, which differs from that of traditional NSAIDs.


Q: Are there different brand names for the same medicine as Piralgin?

A: Yes. Piralgin contains the active ingredient Metamizole sodium, which is known and marketed under several other trade names globally. Common names for this ingredient include Dipyrone, Analgin, Novalgin, and Nolotil, though the specific brand name used depends on the region.


Q: Is Piralgin available over the counter, or is it prescription-only in most regions?

A: The regulatory status of Piralgin (Metamizole) is not uniform and varies significantly across different countries. In some regions, it is available over-the-counter (OTC), but in many others, it is strictly classified as prescription-only. Some authorities have also withdrawn market authorization in their respective regions.


Q: What is the expected time frame for Piralgin to start working?

A: Official regulatory texts describe that the onset of a clear effect is generally expected to begin approximately 30 to 60 minutes after the medicine is taken. This information is based on the data provided to regulatory bodies.


Q: How long does the pain-relieving effect of Piralgin usually last?

A: The duration of the pain-relieving effect is implied by the regulatory instructions for use. Official dosing schedules require a minimum interval between each dose, which is typically set at 6 to 8 hours. This interval is consistent with the generally expected duration of the medicine's effect before the next dose may be considered.


Q: What symptoms should prompt a person to stop taking Piralgin and seek medical attention?

A: Regulatory instructions describe that the medication should be stopped immediately and a medical review sought if signs of a severe adverse reaction occur. These signs include symptoms that might suggest a severe blood disorder, such as fever, chills, sore throat, or painful mouth sores. Other serious symptoms that require medical attention include fatigue, nausea, anorexia, and jaundice, which may suggest a liver injury.


Q: Does Piralgin cause drowsiness or affect alertness?

A: Somnolence, a state of drowsiness, is listed as one of the less common adverse events that has been documented in clinical surveillance reports for Piralgin. This potential effect is relevant to consider when performing tasks that require concentration.


Q: Is it common to feel nauseous when first taking Piralgin?

A: Nausea is listed among the adverse events that are commonly reported with Piralgin (Metamizole) in authoritative reviews of safety data. This frequency categorization is based on official reporting patterns.


Q: Are allergic reactions a frequent concern with Piralgin?

A: Allergic reactions are a potential adverse event described for Piralgin, though severe reactions are categorized as Very Rare or Not Known frequency events in regulatory documents. These reactions include potentially fatal ones, such as anaphylactic shock.


Q: Can Piralgin be taken with common over-the-counter cold and flu medicines?

A: Piralgin (Metamizole) is known to affect the liver enzymes responsible for processing many other medications. Official documents warn of interactions with specific prescription drugs, and official labeling states that co-administration guidance must be followed regarding any non-prescription medicines.


Q: Is there a known risk of dependence or addiction with Piralgin?

A: Piralgin's active component, Metamizole, is formally classified by international pharmacological groups as a non-opioid analgesic. It is classified as a non-narcotic agent, which differentiates the medicine from controlled substances that are associated with a known risk of dependence.


Q: Can Piralgin be used for muscle spasms as well as pain?

A: Yes, official documents and regulatory reviews confirm that the active ingredient in Piralgin possesses a mild spasmolytic, or anti-spasm, property. This characteristic helps relieve pain that is specifically associated with smooth muscle tension and cramping.


Q: Are there any research findings about the long-term safety profile of Piralgin?

A: Regulatory reviews acknowledge that research describing long-term outcomes or the durability of observed patterns remains limited across all uses of Piralgin. This is a recognized gap in the current body of evidence from clinical studies.


Q: What is the official stance on using Piralgin for chronic pain management?

A: The primary official uses for Piralgin are the treatment of severe acute pain and high fever. While the medication has been examined in clinical trials for some specific chronic pain conditions, its established and general official use is predominantly focused on acute pain relief.


Q: Why are there different maximum daily dose recommendations for Piralgin in different regions?

A: Differences in regulatory oversight and national history have resulted in varying official recommendations for Piralgin (Metamizole) across the world. Regulatory bodies, such as the European Medicines Agency (EMA), have acknowledged and initiated efforts to harmonize the maximum daily dose and other recommendations across member states due to these initial, substantial differences in national labeling.


Q: Is it considered safe to take Piralgin for more than a few days?

A: Official regulatory instructions include procedural constraints that typically restrict the use of Piralgin to a short duration, such as up to 3 to 5 consecutive days. Regulatory documents note that the risk of a severe blood disorder (agranulocytosis) has been reported with both short and prolonged use, supporting the regulatory constraint for short-term consumption.


Q: Can taking Piralgin cause a false positive result on any medical tests?

A: Official literature and laboratory documents state that the medicine's metabolites may interfere with the measurement of certain compounds during medical testing. This interference has been documented, specifically with the measurement of serum creatinine when tested using the enzymatic method.


Q: Does Piralgin need to be taken with food, or can it be taken on an empty stomach?

A: Official advice in some regions suggests taking analgesics with food to potentially reduce the risk of stomach upset. Studies also indicate that taking the medication on an empty stomach may affect the speed and peak concentration of the effect.


Q: Why do some people experience low blood pressure after taking Piralgin?

A: The potential for arterial hypotension (low blood pressure) is noted in regulatory documents, particularly requiring caution for those with unstable circulation. Studies suggest that Metamizole can cause a significant decrease in mean arterial pressure, and this effect may also have an additive hypotensive effect when co-administered with other blood pressure medicines.


Q: What types of pain is Piralgin considered most effective for, based on clinical evidence?

A: Clinical evidence, as summarized in regulatory reviews, primarily supports the use of Piralgin for severe acute pain. Specific types of pain studied include postoperative pain, acute low back pain, and discomfort associated with smooth muscle spasm (colic). This reflects the conditions where its efficacy has been most clearly demonstrated.


Q: Do genetic factors influence how a person responds to Piralgin?

A: Research has examined possible genetic factors that may be associated with the risk of agranulocytosis from Piralgin. While specific genetic markers have been reported, current official evidence indicates that there is insufficient data to justify changes to regulatory frameworks or to predict individual risk based on genetic factors alone.


Q: How does Piralgin affect the body's natural defense system?

A: The most serious, though rare, documented effect of Piralgin on the body's defense system is agranulocytosis. This condition is a severe reduction in white blood cells (a component of the immune system) and is explicitly listed in regulatory documents as a life-threatening risk due to its impact on the body's ability to fight infection.


Q: What is the history of Piralgin's use in medicine?

A: Piralgin's active component, Metamizole, was first developed in Germany in the 1920s. Its subsequent history involved significant changes in regulatory status globally in the 1980s. This was due to the documented risk of agranulocytosis, which led to the drug being withdrawn from the market or restricted to prescription-only status in various regions.


Q: Are there any special warnings about Piralgin for people with asthma or allergies?

A: Official regulations list the presence of analgesic-induced asthma syndrome as a contraindication, meaning the medicine should not be used in such cases. Furthermore, the known potential for severe hypersensitivity reactions, including anaphylaxis, requires specific caution for all persons with a history of allergies.

How should Piralgin be stored and disposed of?

The storage and disposal of Piralgin (Metamizole sodium) must adhere strictly to official regulatory labeling to ensure product integrity and public safety.

Official Storage and Disposal Requirements

Requirement Area Labeled Condition
Temperature Range Store at a temperature not exceeding 25 C or 30 C (varies by formulation/region).
Handling/Protection Protect from light and moisture; do not freeze the product.
Packaging Keep the medicine in the original package until use.
Child Safety Must be stored out of the sight and reach of children.
Disposal Rule Do not dispose of unused or expired product in household trash or via wastewater; return to a pharmacy or collection system.

These official rules define the mandatory environment for the product, preventing degradation caused by light, humidity, or temperature extremes, and ensure environmentally responsible pharmaceutical waste management.

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

Available in countries:

Equivalent of Piralgin found in:

A-Z Index: