Hexalgin

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Hexalgin

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 Hexalgin

Quick Facts

Property Description
Active Ingredient Sodium Metamizole (Dipyrone)
Forms Tablets, Oral Drops, Injections, Suppositories
Pharmacological Class Non-opioid Analgesic, Antipyretic, Spasmolytic
General Purpose Pain Relief, Fever Reduction
Origin Synthetic (Pyrazolone derivative)

What is Hexalgin, and What Type of Drug is it?

Hexalgin is the trade name for a pharmaceutical preparation containing the active substance Sodium Metamizole, also known widely as Dipyrone or simply Metamizole. This agent is a synthetic compound classified as a pyrazolone derivative. It is formally categorized as a non-opioid analgesic and a potent antipyretic. The medicine is clinically recognized for its ability to relieve severe discomfort without possessing the addictive properties associated with narcotic agents. Furthermore, Metamizole is distinguished by a marked spasmolytic effect, a property that helps to relax involuntary smooth muscles.

Composition, Forms, and General Therapeutic Purpose

Hexalgin is a single active ingredient product, combining Sodium Metamizole with necessary excipients to create multiple dosage forms, including tablets for oral use, solutions for injection for parenteral administration, and suppositories for rectal delivery. This variety of forms is crucial for use in clinical settings. The drug's general therapeutic purpose is centered on the rapid and reliable control of acute, severe pain and high fever. It is a rapidly acting painkiller suitable for acute severe pain, with its primary value lying in its quick onset of action and reliable efficacy.

What side effects are possible with Hexalgin?

Possible Side Effects and Safety Information

Hexalgin (metamizole) is associated with adverse reactions that are classified by regulatory authorities according to frequency and affected body system. The most critical concerns involve the blood and immune systems, including rare but potentially life-threatening conditions.


Serious Adverse Reactions and Systemic Risks

The most serious risk documented in regulatory sources is Agranulocytosis, a severe decrease in white blood cells that is classified as rare or very rare. This serious adverse reaction is stated to be unpredictable and not related to the dose used, and it may occur at any point during or shortly after treatment. Other severe, officially listed reactions include Anaphylactic Shock, Aplastic Anaemia, and severe skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Adverse effects are documented across various System-Organ Classes. For Vascular Disorders, Hypotension (low blood pressure) is common, and severe hypotensive reactions are noted, particularly with rapid intravenous injection. Cases of Acute Liver Injury and Acute Liver Failure are also listed under Hepatobiliary Disorders.

Population and Contextual Safety Constraints

The official safety profile includes explicit constraints for specific patient groups. Hexalgin is contraindicated during the third trimester of pregnancy due to risks to the fetus. Use is advised against during breastfeeding as metabolites are secreted in milk. Caution and potential dose reduction are advised for the elderly and those with impaired renal or hepatic function due to prolonged drug elimination. Furthermore, the medicine is contraindicated in patients with a history of hypersensitivity to pyrazolones, impaired bone marrow function, or specific genetic conditions like Acute Intermittent Hepatic Porphyria.

Overdose and Emergency Response

Overdose and When to Seek Help

The following information details the officially documented manifestations and required emergency actions for Hexalgin (Metamizole) overdose, based on regulatory prescribing information.

Documented Overdose Manifestations

System Official Regulatory Descriptions
Central Nervous System (CNS) Somnolence, dizziness, generalized convulsions, and progression to coma
Cardiovascular Severe hypotension (low blood pressure) potentially leading to shock and cardiac arrhythmias
Renal Impaired kidney function, including acute kidney injury, oliguria, and anuria
Gastrointestinal Nausea, vomiting, and abdominal pain

Emergency Actions and Required Care

Immediate medical attention is required for any suspected or confirmed overdose. Urgent medical care and hospitalization are mandated for individuals presenting with severe or life-threatening symptoms, such as unmeasurable blood pressure, signs of shock, or profound unconsciousness.

The official management of Hexalgin overdose is symptomatic and supportive. Regulatory documents indicate that measures like gastric lavage, administration of activated charcoal, and forced diuresis may be employed to reduce absorption and enhance elimination of metabolites. It is officially stated that no specific antidote is known for Metamizole overdose.

Therapeutic Uses of Hexalgin

Quick Facts

  • Primary Use: Management of intense pain unresponsive to other agents.
  • Secondary Use: Supportive care for high or persistent fever.
  • Additional Role: May be utilized to help manage pain associated with muscle spasms.

Hexalgin, containing the active substance metamizole, is designated for the supportive management of specific health issues. It is primarily considered for individuals experiencing severe or prolonged pain that has not responded adequately to alternative measures.

This medication is specifically used in clinical practice to address different types of pain, including pain experienced following surgical procedures or injuries, as well as pain related to medical conditions such as colic or tumors. Its established therapeutic function is to provide relief from intense discomfort in these scenarios.

In addition to its role in pain management, Hexalgin is also an option for the temporary reduction of very high fever when other available fever-reducing treatments are deemed insufficient or ineffective. Furthermore, it may be indicated for pain that involves muscle spasms, contributing to comfort during these episodes. Its application is generally reserved for severe pain and fever that cannot be controlled with other available treatments.

Eligibility and Restrictions for Use

Hexalgin (Metamizole) eligibility is strictly defined by regulatory bodies based on the patient's existing health conditions, age, and physiological status. This section summarizes the official rules of use as stated in government-approved drug labeling.


Contraindicated Populations (Absolute Non-Eligibility)

Use is contraindicated and must not occur in:

  • Patients with a history of agranulocytosis or known hypersensitivity to metamizole, pyrazolones, or pyrazolidines.
  • Individuals with impaired bone marrow function or diseases of the haematopoietic system.
  • Individuals with acute intermittent hepatic porphyria or congenital G6PD deficiency.
  • Infants under 3 months of age or weighing less than 5 kg.
  • Pregnant individuals during the third trimester.

Age and Condition-Based Restrictions

Population Category Official Regulatory Status
Pediatric Use Permitted for children (3 months/ge 5 kg) and adolescents; dosage must be based on body weight.
Older Adults Use is permitted, but the total dose should be reduced due to potentially prolonged elimination of metabolites.
Organ Impairment High and repeated doses should be avoided in patients with impaired renal or hepatic function due to reduced metabolite clearance.
Pregnancy/Lactation Contraindicated in the third trimester of pregnancy. Not recommended during breastfeeding; milk must be discarded for 48 hours after a single dose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Metamizole, the active substance in Hexalgin, is formally documented to participate in several clinically relevant drug interactions, primarily through metabolic changes and modifications to co-administered medicines' effects.

Pharmacokinetic (Exposure) Interactions

The official prescribing information classifies Metamizole as a moderate to strong inducer of cytochrome P450 enzymes CYP3A4, CYP2B6, and CYP2C19. This enzymatic induction leads to a reduction in the plasma concentrations of medicines that are substrates of these enzymes. Specifically, co-administration results in decreased exposure of immunosuppressants like Ciclosporin and certain central nervous system agents, including Bupropion and Midazolam. The label advises caution when Metamizole is used with any medicine cleared by these metabolic pathways due to the potential for reduced clinical efficacy.

Pharmacodynamic and Timing-Based Constraints

Metamizole co-administration with low-dose Acetylsalicylic acid (Aspirin) for vascular protection is documented as an antagonistic interaction, interfering with the anti-platelet effect. To mitigate this effect, a mandatory time separation (delay) in administration is officially required. Co-administration with Methotrexate is noted to increase the risk of haematologic toxicity. Furthermore, in patients receiving an Antibiotic, concurrent use of Metamizole is documented to potentially mask the early symptoms of agranulocytosis.

Mechanism of Action

How Hexalgin Works

Hexalgin (Sodium Metamizole) exerts its effects through its active metabolites, which rapidly act across multiple central and peripheral biological pathways. The drug's activity results from a combination of enzymatic inhibition and system activation, primarily within the central nervous system ( CNS).


Central Inhibition and Thermoregulation

The active metabolites rapidly cross the Blood-Brain Barrier ( BBB) and primarily inhibit Cyclooxygenase-3 ( COX-3) activity in the hypothalamus and spinal cord. This molecular action reduces the synthesis of Prostaglandin E2 ( PGE2) in the CNS, which results in the modulation of the elevated thermoregulatory set-point and a reduction in the transmission of nociceptive signals.


Endogenous Pain System Modulation

The mechanism extends beyond COX inhibition by functionally activating key components of the descending inhibitory pain control system. This involves engaging pathways linked to Cannabinoid Receptor type 1 ( CB1) and indirectly modulating the opioidergic system, thereby modulating the descending inhibitory pain pathways that regulate the transmission of nociceptive signals at the spinal cord level.


Visceral Smooth Muscle Spasmolysis

A distinct mechanistic domain targets the involuntary smooth muscles of internal organs, where the drug acts as a modulator of intracellular Calcium ( Ca^2+) dynamics. By inhibiting biochemical processes necessary for Ca^2+ mobilization (such as Inositol phosphate synthesis), the drug results in a decrease in muscular tone and tension within visceral structures.

Dosage and Administration Information

How Hexalgin is Used: Administration Guidelines

Hexalgin, containing metamizole, is administered following established pharmacological principles to ensure standardized use. The medicine is utilized through several routes, including oral (via tablets or drops), intravenous (IV), intramuscular (IM), and rectal administration via suppositories.


Dosing and Frequency Patterns

The fundamental principle of use is to initiate therapy at the lowest effective dose and only increase the amount if clinically necessary. The duration of use is typically for the short-term management of acute episodes.

Instruction Description
Standard Adult Dose Limit Single oral doses should not exceed 1,000 mg.
Maximum Daily Dose The maximum total oral intake is limited to 4,000 mg per day. The maximum total parenteral (IV/IM) dose is 5,000 mg per day.
Dosing Interval Doses must be spaced with a minimum interval of 6 to 8 hours when using the maximum single dose.

Administration Requirements

For pediatric use, dosing is determined based on body weight (typically 8–16 mg per kg) rather than age. Certain fixed-dose tablets are considered unsuitable for children below specific ages due to the non-adjustable strength. When administering Hexalgin intravenously, the injection must be performed slowly (not exceeding 1 mL per minute), and the solution should be warmed to body temperature prior to use. Patients receiving IV doses are often positioned lying down and monitored closely during administration.

In the event of a timing lapse, the protocol is to skip the missed dose and resume the usual schedule; taking a double dose to compensate is not part of the standard usage schedule.

Recent Clinical Evidence

Hexalgin: Recent Clinical Evidence

This overview describes the types of official research that have been conducted on Hexalgin (metamizole) and what the studies monitored. It focuses on how the research base has explored the medicine’s use, while highlighting areas where evidence is still emerging or where questions remain.


Evidence for Acute, Severe Pain

Hexalgin was studied for its use in conditions involving periods of heightened symptoms, such as acute physical discomfort after surgical procedures. Research primarily involved short-term Randomized Controlled Trials (RCTs) and systematic reviews, which monitored outcomes related to physical discomfort, like changes in patient-reported pain intensity scores and rescue medication requirements. Findings describe patterns observed in the research that were associated with measured outcomes comparable to those observed in studies of other non-opioid medications for acute pain. However, follow-up durations were limited to the immediate recovery period.


Evidence for Spasm-Related Pain and Fever

Research explored the use of Hexalgin in conditions associated with acute or disruptive episodes, such as renal colic pain. Studies monitored outcomes describing episodic changes in pain, and data show patterns related to observed smooth muscle response in some research. Similarly, Hexalgin was evaluated in research exploring temporary physiological imbalance, specifically tracking temperature score changes in febrile children and adults. In both cases, evidence relies heavily on short-term observations.


Research Gaps and Limitations

The research base indicates areas where certainty remains low. Long-term effects are not fully established, as most studies focused on acute use. Evidence related to long-term symptom patterns, such as in oncological pain, is limited. Furthermore, data for certain special groups, including older adults or patients with complex comorbidities, remain insufficient. Comparative evidence where Hexalgin was directly compared against certain other non-opioid medications in specific indications sometimes showed mixed or inconsistent findings. The overall research provides insight into short-term observations, but does not determine whether an individual will respond similarly over extended periods of study.

Frequently Asked Questions (FAQ)

Common questions about Hexalgin (FAQ)

Q: Is Hexalgin available without a prescription?

A: The availability of Hexalgin, whose active ingredient is metamizole, varies widely depending on the country. In some jurisdictions, regulatory authorities classify it as a prescription-only medicine that requires authorization from a healthcare professional, while in others, it may be available for over-the-counter purchase.


Q: How quickly does Hexalgin usually start working?

A: Studies on the drug’s pharmacokinetics indicate that Hexalgin is known for its quick onset of action. After being taken orally, the primary active components are rapidly absorbed, leading to a quick start of the pain-relieving effect.


Q: How long does the effect of one dose of Hexalgin last?

A: Official information and research on the drug’s metabolism describe the duration of its pain-relieving and fever-reducing effect. The therapeutic effect of a single dose generally lasts for approximately 4 to 6 hours.


Q: Can Hexalgin be taken for pain that is not on the official list of uses?

A: Official drug documentation, such as the Summary of Product Characteristics from regulatory bodies, defines the specific types of pain and fever for which Hexalgin is formally approved. These documents establish the medicine’s indicated use, which serves as the basis for authorized prescribing.


Q: Is Hexalgin safe to use long-term?

A: Regulatory recommendations state that the use of Hexalgin should be generally limited to short-term treatment, not typically exceeding seven days for most conditions. If treatment is extended beyond this duration, monitoring of blood cell counts is advised in regulatory guidance.


Q: Are there any foods or drinks that should be avoided when taking Hexalgin?

A: Official drug documentation typically warns against taking this medicine alongside alcoholic beverages. This caution is given due to the potential for negative interactions and an increased risk of related adverse effects, particularly those affecting the liver.


Q: Can Hexalgin cause stomach problems?

A: While Hexalgin is noted for a low risk of causing significant gastrointestinal adverse effects compared to some other pain reliever classes, official documentation does list a range of potential side effects. Gastrointestinal issues are generally not emphasized as the most frequent adverse reactions.


Q: Is it normal to feel dizzy or drowsy after taking Hexalgin?

A: The official product information sometimes includes effects on the central nervous system, such as dizziness (vertigo), as a possible adverse reaction. This can also be a consequence of low blood pressure, which is another documented side effect, particularly following rapid administration of the injection form.


Q: Does Hexalgin interact with supplements like vitamins or herbal products?

A: Official guidance issues a standard caution advising patients to inform their healthcare provider or pharmacist about all products being used, including any dietary and herbal supplements. This is important because many supplements can potentially interact with prescription medicines or affect their overall metabolism.


Q: What is the risk of dependence or addiction associated with Hexalgin?

A: Hexalgin is formally classified as a non-opioid analgesic by health authorities like the World Health Organization. It is recognized for its ability to relieve severe discomfort without having the properties associated with narcotic agents, thus limiting the risk of physical dependence.


Q: What happens if Hexalgin is taken with alcohol?

A: Official warnings generally advise against consuming alcohol while taking this medicine. Official warnings advise against this combination due to the possibility of increased risk of adverse effects, particularly concerning liver function.


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

A: The official prescribing information may advise that, especially when using higher doses, there is a potential risk for effects that could impair concentration and reaction capacity. These effects could impact a person's ability to safely drive or operate heavy machinery.


Q: Are generic versions of Hexalgin available?

A: The active substance in Hexalgin is widely known as metamizole or dipyrone. Due to its long history of use, this active ingredient is available globally under numerous brand names and as a generic formulation.


Q: What are the less common, but serious side effects of Hexalgin?

A: Beyond the most critical risks (like agranulocytosis), official documents list other serious adverse effects. These can include reactions such as acute liver injury or serious systemic allergic reactions.


Q: Can Hexalgin be used for muscle cramps?

A: Hexalgin is noted in official contexts for its spasmolytic property, meaning it acts to relax certain involuntary smooth muscles. The medicine is primarily indicated for pain associated with spasms in internal organs, such as those found in the renal tract or the gastrointestinal system.


Q: Can I crush or split Hexalgin tablets?

A: Official labeling advises against altering the tablet unless specific instruction is provided, as crushing, splitting, or chewing the medication can potentially change how the medicine is absorbed and how effectively it works.


Q: Can Hexalgin be taken with blood pressure medication?

A: Official documentation describes that Hexalgin can act as an inducer of certain enzymes in the liver (CYP450). This action may affect medicines that are substrates for these enzymes, potentially leading to reduced plasma concentrations of the co-administered drug.


Q: Does Hexalgin interact with common cold or flu medicines?

A: Official warnings advise caution when combining Hexalgin with other products. Since many common cold and flu preparations contain other pain relievers or anti-inflammatory drugs, official warnings emphasize the potential for interactions or metabolic interference when taken concurrently.


Q: What regulatory bodies have approved Hexalgin?

A: The medicine and its active ingredient, metamizole, have been formally assessed and approved by regulatory bodies across the world. These include various national health authorities and intergovernmental agencies, such as the European Medicines Agency (EMA).


Q: Are there any known genetic factors that affect how a person responds to Hexalgin?

A: Official contraindications for Hexalgin include certain hereditary blood and metabolic conditions, such as congenital G6PD deficiency. Research has also investigated the role of other specific genetic markers in determining an individual’s susceptibility to potential adverse reactions.


Q: What are the major themes or outcomes of the research trials for Hexalgin?

A: The major themes of the official research focus on the medicine's effectiveness in short-term management. Studies have explored its rapid efficacy in controlling acute, severe pain, its use for pain related to spasms, and its reliable function in reducing high fever in adults and children.


Q: Is it possible to take Hexalgin on an empty stomach?

A: Official guidance and supporting research indicate that taking the medicine without food is generally acceptable. Research suggests it may result in a slightly faster absorption compared to taking it with food.


Q: Does Hexalgin affect sleep patterns?

A: Although the medicine is not typically classified as affecting sleep architecture directly, official adverse reaction reports do include potential effects on the central nervous system. These documented effects could potentially influence sleep patterns.


Q: Is Hexalgin effective for headache relief?

A: Official regulatory documents and supporting clinical literature often list the medicine as being indicated for the management of pain. This typically includes its use for the relief of general headache and certain types of acute head pain.


Q: Does taking Hexalgin with food change how well it works?

A: Research indicates that taking the medicine with food can slow the rate of absorption. This change in absorption rate may be associated with a minor delay in the onset of the medicine's effect.


Q: What is the maximum number of days Hexalgin should be used continuously?

A: Regulatory recommendations advise limiting continuous use to short-term treatment, generally not exceeding seven days, as a means to mitigate potential risks. If use is extended, specific monitoring is generally advised in regulatory guidance.

How should Hexalgin be stored and disposed of?

Hexalgin (Metamizole) must be stored and handled according to the official instructions to ensure product stability and safety.

Storage Conditions

Condition Requirement (Regulatory Standard)
Temperature Store generally below 25 C and do not freeze liquid forms.
Protection Keep protected from light and moisture by storing in the original outer carton.
Child Safety Keep out of the sight and reach of children (mandatory across all forms).
Stability Do not use past the expiry date. For oral drops, discard six months after first opening the container.

️ Disposal Requirements

Expired or unused Hexalgin must not be thrown away via wastewater or household waste. This environmental restriction prevents the active ingredient from contaminating water systems. For proper disposal, individuals must ask their pharmacist how to safely discard the medicine, directing it to an authorized pharmaceutical waste collection point.

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

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