Темпалгин

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Темпалгин

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Темпалгин

Quick Facts

Property Description
Active ingredients Sodium Metamizole, Triacetonamino-4-toluenesulfonate
Form Film-coated tablets
Pharmacological class Non-opioid analgesic, Antipyretic, Anxiolytic
Common use Symptomatic relief of mild to moderate pain and fever
Origin Synthetic combination product

What Type of Medicine is Темпалгин?

Темпалгин (Tempalgin) is a synthetic combination drug delivered as film-coated tablets for oral administration, classified primarily as a non-opioid analgesic and antipyretic. Its principal active component, Sodium Metamizole (also known as Dipyrone), belongs to the chemical group of pyrazolone derivatives. Its most differentiating factor is its designation as a combination product, signifying that it contains two distinct active substances designed to address both the physical pain and the associated emotional components. This formulation is typically available as a prescription-only (Rx) medication in many regions where it is sold, distinguishing its controlled use from many over-the-counter (OTC) single-ingredient analgesics.


Composition and General Purpose

The medication's effectiveness stems from its two active ingredients: Sodium Metamizole and Triacetonamino-4-toluenesulfonate. Sodium Metamizole is responsible for the potent central pain relief and fever reduction effects, with its efficacy in relieving acute pain clinically recognized by established health bodies. The secondary component, Triacetonamino-4-toluenesulfonate (Tempidone), provides a mild anxiolytic or sedative effect. This inclusion helps to alleviate nervous tension or anxiety that can often heighten the perception of discomfort, a common factor in many pain syndromes. This dual composition ensures the medication is purposed for the symptomatic relief of mild to moderate pain syndrome and fever, including pain accompanied by spasms or emotional distress, such as certain types of visceral pain.

What side effects are possible with Темпалгин?

Possible Side Effects and Safety Information

The safety profile of Темпалгин is primarily defined by the risks associated with its main active ingredient, Sodium Metamizole. Official regulatory documents classify potential adverse reactions based on system-organ classes and frequency.

Serious Adverse Reactions

The most critical documented risk is Agranulocytosis, a severe reduction in white blood cells. Regulatory sources classify this as a Rare hematological disorder (ge 1/10,000 to <1/1,000) that is not related to dose or duration of use and can occur at any time during or shortly after treatment. Other serious adverse reactions, often classified as Very Rare (<1/10,000) or of Not Known frequency, include Anaphylactic Shock, Drug-Induced Liver Injury (DILI), Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN), affecting the immune system, liver, and skin, respectively.

System-Organ Class Key Adverse Reactions (Regulatory Listing)
Blood and Lymphatic Agranulocytosis, Aplastic Anaemia, Pancytopenia
Immune System Anaphylactic Reactions, Hypersensitivity Reactions
Hepatobiliary Drug-Induced Liver Injury (DILI), Acute Liver Failure

Safety Considerations for Specific Populations

Official safety information places constraints on use for certain populations. Older adults may require a reduced dose due to altered elimination of metabolites. Caution and dose reduction are advised for patients with pre-existing impaired renal or hepatic function. Furthermore, the medication is generally advised against for women who are pregnant in the third trimester or are breastfeeding. Use is strictly restricted for individuals with a prior history of Metamizole-induced agranulocytosis or pre-existing conditions like impaired bone marrow function.

Overdose and Emergency Response

The official regulatory description of Темпалгин overdose, primarily related to its active component Sodium Metamizole, documents a serious acute systemic toxicity profile. Manifestations can include symptoms affecting the Central Nervous System (CNS), such as vertigo, somnolence, and convulsions, potentially leading to unconsciousness. Gastrointestinal signs like nausea and vomiting are also commonly documented.

More severe presentations involve the Cardiovascular System, including hypotension and tachycardia, which can progress to life-threatening shock and coma. Immediate medical assistance is required upon the occurrence of any severe acute symptoms.

Regulators mandate that the medicine must be stopped, and urgent medical help must be sought if any symptoms indicative of potential Metamizole-Induced Agranulocytosis are noted, such as an unexplained fever, chills, or a sore throat. The officially documented management of overdose involves symptomatic and supportive treatment, potentially including decontamination procedures like Activated Charcoal or methods such as Haemodialysis to accelerate elimination.

It is officially stated that no specific antidote is known for Metamizole intoxication. Monitoring is required until blood counts return to normal, especially for patients with underlying conditions like G6PD Deficiency.

Therapeutic Uses of Темпалгин

What Темпалгин Treats: Main Uses and Benefits

Tempalgin is commonly used for symptomatic relief, managing physical discomfort, reducing fever, and supporting the easing of associated tension, primarily for pain ranging from mild to moderate intensity. The medication is relevant for addressing symptom clusters that may appear suddenly or fluctuate.

Easing Acute Pain Syndromes and Febrile Symptoms

Tempalgin is applied in clinical settings that involve acute or unstable symptom patterns, being relevant for managing symptoms related to physical discomfort that may become intense or disruptive. It is used to address pronounced symptoms associated with conditions involving headache, toothache, and various forms of musculoskeletal or nerve pain. It is also commonly used to manage elevated body temperature associated with febrile states. This support contributes to easing the overall symptom load, supporting general well-being during symptomatic phases.

Relief of Pain Accompanied by Spasm or Tension

The medication is relevant in contexts marked by increased discomfort or tension, including symptoms related to heightened muscular activity. This includes conditions involving episodic or fluctuating manifestations like colic (renal or biliary) and pain syndromes where symptoms of nervous tension are present. This combination supports the patient during difficult episodes by easing distress and assists with maintaining functional stability.


Quick Fact: Relief for Key Symptom Clusters
Pain Intensity Mild to moderate pain syndrome
Associated Symptoms Spasm, nervous tension, high fever
Usage Context Acute episodes, post-traumatic discomfort, colic

Regulatory References

  1. NIH MedlinePlus overview of Pain Relievers

Eligibility and Restrictions for Use

Who Can and Cannot Use Темпалгин?

Eligibility for Tempalgin (Metamizole/Triacetonamino-4-toluenesulfonate) is defined strictly by official governmental regulatory documentation, establishing populations who are absolutely contraindicated and those for whom use is restricted.

Absolute Non-Eligibility (Contraindications)

Use is prohibited for patients with a history of Metamizole-induced agranulocytosis or impaired bone marrow function. The medicine is also contraindicated if there is a known hypersensitivity to any of its components or other pyrazolone derivatives. Specific physiological states that prohibit use include the third trimester of pregnancy, breastfeeding (lactation), and the presence of acute intermittent hepatic porphyria.

Age and Conditional Restrictions

Official labeling generally permits use in adults and adolescents aged 15 years or older. The solid oral form is not recommended for children younger than 15 years. Use requires caution and conditional assessment in older adults, patients with pre-existing renal or hepatic impairment, and individuals with conditions leading to circulatory instability or hypotension.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe several interactions that constrain the co-administration of Tempalgin (containing Metamizole) with other medicinal products. These interactions are categorized by their mechanism and resulting clinical concern.


Documented Interaction Domains

Domain Practical Implication based on Official Documentation
Drugs Affecting CYP Enzymes Reduces plasma concentrations of co-administered substrates, such as Ciclosporin, by inducing metabolic enzymes (CYP3A4, CYP2B6, CYP2C19).
Antiplatelet Agents May reduce the antiplatelet effect of low-dose Acetylsalicylic acid (Aspirin) by competitively inhibiting its irreversible binding to COX-1. This is of particular concern for patients with vascular risk.
Anticoagulants and Diuretics May alter the effects of Warfarin, Heparin, and diuretics like Furosemide; monitoring of treatment effects is advised.
Myelosuppressive and Cytostatic Agents Concomitant use with Methotrexate increases the risk for serious haematological toxicity (e.g., bone marrow aplasia).

Interaction Constraints

Co-administration with other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) should be avoided due to the additive risk of severe toxicities, including renal and hepatic injury. The drug also increases the risk of hypothermia when combined with phenothiazines like Chlorpromazine. Official information suggests that the pharmacokinetic interactions due to enzyme induction become relevant with high dosages prescribed for more than one day, necessitating dosage adjustments for affected co-administered drugs.

Mechanism of Action

Central Modulation of Pain and Fever Pathways

The active metabolites of Metamizole principally target the Central Nervous System (CNS) by inhibiting Cyclooxygenase-3 ( COX-3) and PGE2 synthesis in the brain and spinal cord, while also activating the body's own descending pain inhibitory systems (Opioidergic and Endocannabinoid). This combined central action leads to a reduction in nociceptive signal transmission and the resetting of the hypothalamic thermoregulatory set-point, initiating heat dissipation.


Visceral Spasmolysis and Smooth Muscle Relaxation

This distinct mechanism involves Metamizole's direct action on smooth muscle cells outside of the CNS. It achieves relaxation (spasmolysis) by interfering with intracellular Ca^2+ release, which is necessary for muscle contraction. This modification of Ca^2+ signaling reduces tension and involuntary contraction in structures like the gastrointestinal and urinary tracts.


Adjunctive Modulation of Emotional State

Triacetonamine, the second active ingredient, acts as a CNS modulator with anxiolytic properties. By operating on central pathways related to emotional state, it modulates central pathways influencing emotional state and psychological tension, thereby contributing to a combined central nervous system effect with the primary analgesic mechanism.

Dosage and Administration Information

How to use Темпалгин: Official Administration Guidelines

Темпалгин is officially designated for short-term symptomatic use and is administered via the oral route as a fixed-dose film-coated tablet containing Metamizole and Triacetonamino-4-toluenesulfonate. The tablets must be swallowed whole with water, and administration is conventionally advised after meals.

This medication is procedurally constrained, with the overall course of treatment typically restricted to a maximum of three to five consecutive days. This temporal restriction defines its role in managing acute episodes rather than sustained, chronic conditions.

The standard dosing regimen for adults and adolescents aged 15 years and older is one tablet per single dose. This single dose may be repeated up to a maximum of three times daily (TID). A mandatory minimum interval of four hours must be observed between doses, and the official maximum daily intake is restricted to six tablets.

Dosing principles require procedural adjustment for specific patient groups to account for altered drug elimination. In patients with renal or hepatic impairment, the dosage must be reduced, and the interval between doses extended. A lower dose is also utilized for older adults. Due to the fixed combination and strength, the product is officially not recommended for pediatric patients younger than 15 years of age.

Recent Clinical Evidence

Evidence for Use in Acute Pain Syndromes

Research has explored the medication component’s role in conditions characterized by fluctuating or episodic manifestations of physical discomfort, such as pain after dental procedures or surgery. Studies primarily utilized rigorous designs, including Randomized Controlled Trials (RCTs), monitoring patient groups to assess outcomes related to physical discomfort. The research reports how symptoms evolved in observed populations, concentrating on short-term outcomes measured over defined time intervals. Available research provides limited information for long-term outcomes regarding functional activity; most high-quality trials focus on outcomes measured after a single dose over 24 hours.


Evidence for Use in Visceral Pain and Pain with Spasm

Studies have also explored patient-reported experiences in conditions involving periods of heightened symptoms linked to spasm, such as renal or biliary colic. Research examined this usage through controlled trials, monitoring outcomes related to spasm-associated pain and related functional measures. Studies reported patterns observed in patients experiencing these conditions. A key limitation is that comparative evidence is lacking for the specific combination product that includes Triacetonamino-4-toluenesulfonate (the component studied for nervous tension), as research relies heavily on evidence related to the main pain-relieving ingredient.


Evidence for Use in Elevated Body Temperature (Fever)

The medication component was evaluated in research exploring outcomes related to systemic or functional imbalance, such as elevated body temperature. This evidence base includes RCTs and comparative trials. Studies consistently reported measurements of the change in body temperature following administration, describing patterns of rapid onset and time to peak measured change. The research is largely constrained to short-term research scenarios related to fever, with follow-up often limited to 24 hours.


Limitations and Future Research Gaps

Research exploring symptom changes associated with Темпалгин has focused predominantly on short-term data (14 days or less), meaning long-term effects are not fully established. While adults and children were studied for fever, data for certain groups remain insufficient, including older adults with complex comorbidities. Research exploring the unique benefit of the combination product is not fully established across all indications. The available findings describe group patterns, and research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Темпалгин (FAQ)


Q: How quickly should I expect Темпалгин to start working?

Regulatory documents indicate that the active ingredient, Metamizole, has a relatively rapid onset of action. A noticeable effect on symptoms is typically expected about 30 to 60 minutes after the drug is administered orally. The speed of the drug's effect is a characteristic mentioned in official pharmacological summaries.

Q: How long does the pain relief from Темпалгин typically last?

The minimum interval between doses is stated in administration guidelines as 6 to 8 hours (or 4 to 6 hours depending on the specific product formulation). This interval indicates the required minimum time between doses, which is related to the drug's expected functional duration.

Q: Can Темпалгин be used for menstrual cramps?

The primary active ingredient is officially indicated for treating acute, severe pain linked to muscle spasm, such as colic. Menstrual cramps involve smooth muscle contraction. Therefore, this indication for spasm-associated pain provides context for the drug's potential use in such conditions.

Q: Is the sedation (drowsiness) from Темпалгин a common side effect?

The secondary ingredient is a CNS modulator with anxiolytic properties, which means it may cause sedation or drowsiness. Official documents list somnolence (drowsiness) as a potential adverse event of the primary ingredient. However, its exact frequency is often classified as uncommon or 'not known' in regulatory listings.

Q: Is there a risk of dependency or addiction with Темпалгин?

The medication is consistently classified in regulatory documents as a non-opioid analgesic. According to this classification, the drug is not associated with the same risks of dependency or addiction as narcotic or opioid pain relievers.

Q: What are the signs of an allergic reaction to Темпалгин?

Official safety information advises vigilance for symptoms of severe hypersensitivity reactions, which may include systemic symptoms like fever and chills. Patients should also be aware of the sudden development of a widespread skin rash or painful sores in the mouth, throat, or genital region.

Q: What general safety classifications does the main ingredient in Темпалгин hold (e.g., NSAID class)?

Official pharmacological classification defines the main active component (Metamizole) as a pyrazolone derivative. It is classified as an atypical analgesic that is not considered a traditional Non-Steroidal Anti-Inflammatory Drug (NSAID), despite sharing some general mechanisms of action.

Q: Can I drive or operate machinery after taking Темпалгин?

Official labeling typically includes a warning that no adverse effect on the ability to drive or operate heavy machinery can be excluded. This warning is based on the drug's secondary component, which has sedative properties that may cause drowsiness, particularly when taken at higher doses. The warning is based on the drug's sedative properties and potential for impairment.

Q: What is the general level of evidence for using Темпалгин for migraines?

While the drug is officially indicated for general acute pain, some international medical summaries note its use for pain conditions including migraine headache. However, this may not be listed as a primary indication in all regulatory documents, and the evidence base may be constrained.

Q: Why is Темпалгин sold in some countries but not others, and is it banned anywhere?

The drug's regulatory status varies significantly across the globe. It has been withdrawn or is not authorized for sale in certain countries, including the United States, the United Kingdom, and Canada. This decision is primarily based on concerns regarding the rare but serious risk of the blood disorder agranulocytosis.

Q: Does Темпалгин treat inflammation or just pain?

Official pharmacological information states that the main ingredient primarily provides analgesic (pain relief), antipyretic (fever reduction), and spasmolytic (smooth muscle relaxation) effects. It is described as having weak or no clinically relevant anti-inflammatory properties at standard therapeutic doses.

Q: Is it normal to feel a mild stomach upset after taking the drug?

Official regulatory listings include gastrointestinal issues among the common side effects reported for the main active ingredient. Nausea and general upset stomach are therefore noted as non-serious adverse events that may be reported.

Q: Can I use Темпалгин if I have asthma?

The drug is generally contraindicated for use in individuals with asthma. Official documents advise against its use or require extreme caution for anyone with a history of hypersensitivity reactions, especially to other analgesic medications like Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

Q: Are there different forms of Темпалгин (e.g., liquid, injectable, tablet)?

While the specific combination product is most commonly supplied as film-coated tablets for oral use, the primary active component (Metamizole) is available in several forms worldwide. These include tablets, suppositories for rectal use, and solutions for injection, depending on the local market and regulatory status.

Q: What happens if you take more than the recommended amount (focus on general toxicity, not personal advice)?

Official safety information describes that exceeding the recommended amount can result in general toxicity, with symptoms including nausea, vomiting, and abdominal pain. Central nervous system effects, such as somnolence and convulsions, and potential deterioration of kidney function are also noted.

Q: Does Темпалгин interact with common antibiotics?

Official drug interaction guides indicate that the main ingredient may interact with certain antibiotics, such as ampicillin and penicillin G. The primary concern is that the drug’s fever-reducing effect could potentially mask a fever, which is a vital early symptom of severe side effects like agranulocytosis.

How should Темпалгин be stored and disposed of?

How to Store and Dispose of Темпалгин?

Official regulatory documents define specific, mandatory conditions for the storage and disposal of Tempalgin (Metamizole sodium/Triacetonamine-4-toluenesulfonate) tablets.

Required Storage and Protection

Tempalgin must be stored at a temperature that does not exceed 25 C. The medication requires protection from both light and moisture and must be kept in its original packaging to maintain stability. For safety, the product must be stored out of the sight and reach of children.

Official Disposal Rules

Unused or expired Tempalgin must not be disposed of in household waste or flushed into wastewater. Regulatory instructions require that the product be discarded through a formal pharmaceutical collection system, such as those provided by pharmacies, for the proper management of medicinal waste.

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

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