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Фармадол

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Фармадол

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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.

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Overview of Фармадол

What is Фармадол? (Overview)

Property Description
Active Ingredient Metamizole (Dipyrone/Analgin)
Form Typically Tablets or Capsules (Oral)
Pharmacological Class Non-opioid Analgesic, Antipyretic, Antispasmodic
General Purpose Relief of pain, fever, and muscle spasm
Origin Synthetic chemical compound

Фармадол (Pharmadol) is a prescription-only, synthetic combination drug primarily classified as an analgesic (painkiller), antipyretic (fever reducer), and antispasmodic. The core identity of this medication centers on its main component, Metamizole sodium (also known as Dipyrone), which is derived from the pyrazolone chemical group. This formulation is characterized by its fast onset of action in cases of severe acute pain.

The drug is distinguished from common pain relievers by its antispasmodic property and analgesic strength, setting it apart from standard single-ingredient non-steroidal anti-inflammatory drugs (NSAIDs).


Composition and Dual-Action Formulation

Фармадол is defined as a fixed-dose combination medication because it delivers two distinct therapeutic components in a single dosage unit, typically administered orally as a tablet or capsule. The primary substance is Metamizole sodium, responsible for the major pain-relieving and fever-lowering effects. This is combined with a secondary substance, often a stabilizer or auxiliary component (e.g., Triacetonamine).

Metamizole possesses antispasmodic action. This dual action, available from a single oral dose, ensures the medication works to both dull the sensation of pain and relieve the underlying muscular tension.


Why is Фармадол Used for Spasmodic Pain?

This medication is distinguished by its ability to address both the sensation of pain and its muscular cause. The antispasmodic property makes it useful for painful conditions where muscle cramps are a factor, such as various forms of renal or biliary colic, providing relief when the pain involves an element of cramping.

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What side effects are possible with Фармадол?

Possible side effects and safety information

The official safety profile for Фармадол (Metamizole) is defined by regulatory classifications that focus on the potential for rare, serious adverse reactions, as documented in governmental sources.

Key Adverse Reaction Categories

Adverse effects are formally categorized by frequency and affected physiological system in regulatory documentation. The most significant safety considerations relate to potentially life-threatening hematological disorders and severe hypersensitivity reactions.

Category Officially Documented Safety Concerns
System-Organ Classes Blood and Lymphatic System Disorders (e.g., Agranulocytosis, Pancytopenia), Immune System Disorders (e.g., Anaphylaxis), Vascular Disorders (e.g., Hypotension), Renal and Urinary Disorders (e.g., Acute renal failure, Chromaturia).
Serious Adverse Reactions Agranulocytosis, Pancytopenia, Anaphylactic Shock, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN) are explicitly listed as serious concerns in regulatory texts.

Frequency and Time-Related Safety Patterns

The incidence of the most serious effects is classified as Rare or Very Rare in regulatory documents. A critical safety pattern noted in official labeling is that Agranulocytosis can occur at any time during treatment, independent of the dose. Hypotension is noted as being more likely to occur during or shortly after administration.

Population-Specific Safety Notes

Official safety statements require caution in Older Adults and patients with Renal or Hepatic Impairment due to considerations related to drug clearance. Furthermore, regulatory documents define clear constraints, contraindicating use in individuals with pre-existing bone marrow suppression, known hypersensitivity to the drug, or certain metabolic disorders, such as acute intermittent hepatic porphyria.

This information structures the official understanding of the medicine’s risks, emphasizing that the most significant adverse reactions are rare and not predictable by dose or duration, as per government classifications.

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Overdose and Emergency Response

Overdose and When to Seek Help

Overdose of Фармадол (Metamizole) is officially documented to present with severe systemic and organ-specific manifestations. Acute toxicity is primarily characterized by gastrointestinal symptoms, including vomiting, and severe effects on the central nervous system, such as somnolence, vertigo, and convulsions, which may progress to coma. The regulatory labeling also notes critical involvement of the cardiovascular system, potentially resulting in profound hypotension, tachycardia, and life-threatening circulatory collapse (shock).

In addition to these acute effects, regulators have mandated specific actions regarding the potential for severe haematological outcomes. Patients must seek immediate medical attention and discontinue treatment immediately if symptoms suggestive of agranulocytosis appear. These mandated triggers include the sudden onset of fever, chills, sore throat, or painful changes to the mouth or other mucosal regions.

Management of intoxication is strictly symptomatic and supportive, as official regulatory documents confirm that no specific antidote is available for Metamizole sodium. Close medical monitoring is required for patients presenting with overdose. In severe intoxications, procedures such as haemodialysis or haemoperfusion may be required to assist in drug elimination, and immediate blood cell counts are mandated upon suspicion of haematological issues.

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Therapeutic Uses of Фармадол

What Фармадол Treats: Main Uses and Benefits

The therapeutic utility of Фармадол (Metamizole) is used in areas where short-term symptom management is appropriate. Metamizole-based medications are typically indicated for the management of moderate to severe pain and fever.

The medication is commonly used to address symptoms related to physical discomfort that are of moderate-to-severe intensity, such as postoperative pain, post-traumatic pain, and tumor-related pain. It is also applied in acute episodes like renal or biliary colic, and when patients experience high fever that is unresponsive to first-line treatments.

This medication provides supportive relief when symptoms interfere with routine activities, helping to ease the overall burden of discomfort. It helps address symptom clusters that may become intense or disruptive, especially those associated with acute spasmodic discomfort.

Quick Fact: Relief for Intense and Spasmodic Symptoms

A key characteristic of this treatment is that Фармадол may assist with managing symptoms that create noticeable physiological strain, offering symptomatic relief that helps patients cope more steadily with these episodes.

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Eligibility and Restrictions for Use

Who Can and Cannot Use Фармадол (Metamizole)?

Official regulatory guidelines strictly define the populations eligible to use Фармадол (Metamizole), focusing on absolute contraindications and conditional use restrictions.


Populations for Whom Use is Contraindicated

The medicine must not be used by patients with:

  • A history of agranulocytosis caused by Metamizole or any other pyrazolone/pyrazolidine [Source: EMA].
  • Existing diseases of the haematopoietic system or impaired bone marrow function.
  • Known hypersensitivity to the active substance or related compounds.
  • Acute hepatic porphyria or glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
  • Women in the third trimester of pregnancy due to risks of fetal renal impairment and ductus arteriosus constriction [Source: EMA].
  • Infants below 3 months of age or mathbf5 kg body weight.

Conditional Eligibility and Restrictions

Population Regulatory Status / Limitation
Pregnancy (1st & 2nd Trimesters) Not generally recommended; single doses may be acceptable if other analgesics cannot be used.
Breastfeeding Contraindicated for repeated use. For a single dose, breastmilk must be discarded for 48 hours.
Renal/Hepatic Impairment Multiple high doses must be avoided as the elimination of metabolites is reduced.
Elderly Individuals Caution is advised; use may require a lower dose.

Connection to the overall eligibility profile: Regulatory documents establish that use is primarily defined by a set of absolute prohibitions related to a patient’s blood health, metabolic status, and the late stage of pregnancy. Conditional rules place strict limitations, such as avoiding high doses in cases of impaired organ function and setting minimum age thresholds, thereby structuring the official eligibility status.

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What should I know about interactions with other medicines?

The official interaction profile for Фармадол (Metamizole) is defined by pharmacokinetic and pharmacodynamic constraints documented in regulatory labels. This information establishes mandatory co-administration restrictions and specific dose-timing requirements.

Classification Restriction/Requirement
Contraindicated Combinations Methotrexate, Chlorpromazine
Exposure-Altering Enzyme induction (reduced plasma concentration)
Timing-Sensitive Low-Dose Aspirin

Official Interaction Statements

Co-administration is strictly restricted with two medicinal products: Methotrexate, due to the documented risk of increased haematotoxicity, which is specifically relevant in elderly patients; and Chlorpromazine, due to the official risk of severe hypothermia.

Фармадол is documented as a hepatic enzyme inducer. This pharmacokinetic interaction can lead to significantly reduced plasma concentrations and potential loss of therapeutic effect for several co-administered drugs. Medicines affected by this induction include the immunosuppressants Ciclosporin and Tacrolimus, as well as Efavirenz, Bupropion, and Methadone.

A timing-based requirement exists for concomitant use with Low-Dose Aspirin (for cardioprotection). To minimize the potential for Фармадол to interfere with the antiplatelet effect, the doses must be separated by administering Фармадол at least one hour after or two hours before the Aspirin dose. Additionally, the label notes a mutual potentiation of effects when Фармадол is consumed with alcohol.

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Mechanism of Action

Фармадол operates as a selective inhibitor of the enzyme Cyclooxygenase-2 ( COX-2), which is the inducible isoform of cyclooxygenase. The drug's molecular structure grants it a high affinity for a specific hydrophobic sub-pocket within the COX-2 active site, thereby preventing the enzyme's capacity to bind its natural substrate, arachidonic acid.

This molecular interaction directly disrupts the initial and committed step in the eicosanoid biosynthetic pathway. By inhibiting COX-2, the subsequent enzymatic conversion of arachidonic acid to prostaglandin G2 ( PGG2) and then to prostaglandin H2 ( PGH2) is significantly curtailed.

The resultant downstream effect is a dose-dependent reduction in the cellular synthesis of various pro-eicosanoids, particularly prostaglandin E2 ( PGE2), a crucial lipid mediator. The suppression of PGE2 production modulates localized intercellular signaling pathways and ultimately modifies physiological responses at the system level in targeted peripheral and central tissues.

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Dosage and Administration Information

Official Administration Guidelines for Фармадол (Metamizole)

The administration of Фармадол is governed by official prescribing information, which details the specific routes, dose limitations, and procedural conditions for its use. These clinical parameters are established to define the standard therapeutic application of the medication.


Administration Scope

Instruction Detail
Route of administration Oral (tablets, capsules, solution/drops), Intravenous (IV), Intramuscular (IM), and Rectal (suppositories).
Dosing schedule Standard Single Dose: Up to 1,000 mg. Maximum Daily Dose: Not to exceed 4,000 mg for oral use or 5,000 mg for parenteral use.
Timing in relation to meals Can generally be taken with or without food.
Age-group administration rules Pediatric: Dosing is calculated by body weight (e.g., 8–16 mg/kg). Older Adults: A reduced dose may be necessary due to potential for delayed elimination.
Special procedural conditions For IV injection, administration must be performed slowly over a minimum duration of 5 to 10 minutes. Use in patients with renal or hepatic impairment requires a lower dose.

Resulting Procedural Structure

Official use pattern:

  • The dose is determined based on the patient's condition, age, and weight, adhering to a single-dose maximum of 1,000 mg.
  • Dosing frequency is constrained by a minimum interval of 6 to 8 hours between administrations.
  • Intravenous administration involves a mandatory procedural constraint: ensuring the injection is given slowly, over 5 to 10 minutes.

The official instructions mandate a structured approach to administration defined by dose limits and strict time intervals, which govern the maximum drug exposure over a day and the total length of the treatment course.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Фармадол

This overview describes the research that has explored how Фармадол (Metamizole) is studied in clinical settings, focusing on the types of evidence that exist, the populations monitored, and the areas where information is still developing.


Evidence for Acute Moderate-to-Severe Pain

Research was studied for managing outcomes related to physical discomfort that are of moderate to severe intensity, particularly pain occurring after surgical procedures, research exploring short-term symptom changes. The evidence is derived from short-term, randomized controlled trials (RCTs) and meta-analyses that combine the results of multiple studies.

What researchers studied The studies monitored adult populations experiencing acute pain following minor procedures, such as dental or orthopedic surgery. Researchers primarily measured changes in pain intensity using standard rating scales over very short observation periods, typically a few hours after a single dose. Studies also examined the monitored use of rescue analgesia.

What the studies reported (Neutral Summary) The findings describe patterns observed in the studies regarding the monitoring of pain relief compared to treatments like a placebo. Research highlights changes measured during the study period and studies reported patterns related to measured changes in pain intensity among participants. The evidence contributes to understanding symptom patterns over the immediate post-dose period.

What remains uncertain The existing high-quality evidence is primarily focused on single-dose, short-term observation periods. Long-term effects are not fully established by these short-term trials. Also, evidence comparing various dose levels or non-oral routes of administration, beyond the standard oral formulation, remains limited.


Evidence for Spasmodic Pain (Colic)

Фармадол was studied for managing acute, sharp abdominal discomfort, known as renal or biliary colic, which are conditions characterized by fluctuating or episodic manifestations. The research base here includes randomized controlled trials (RCTs) conducted in emergency and acute care settings.

What researchers studied These trials explored how the compound was observed in outcomes related to systemic or functional imbalance during an acute episode. The main outcomes examined were the speed at which the relief was noticed and the overall change in pain intensity shortly after the medicine was observed in administration. The populations were adult patients during episodes where symptoms become more noticeable.

What the studies reported (Neutral Summary) The findings indicate patterns of rapid changes measured during the study period following administration. Research describes measurements of pain relief compared to other medications used for colic. However, much of the evidence that informed the understanding of short time-to-onset was observed in some studies using non-oral doses given in a hospital setting.

What remains uncertain Data are still emerging regarding the relationship between the results seen with non-oral, acute doses and the typical oral tablet form of Фармадол when used in research exploring short-term symptom changes. The follow-up durations were limited to the immediate crisis period, providing little information on the resolution of the underlying condition.

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Frequently Asked Questions (FAQ)

Common questions about Фармадол (FAQ)


Q: What are the signs of the rare blood disorders (Agranulocytosis or Pancytopenia) I need to watch out for?

Regulatory documents state that patients must be aware of the early symptoms of rare but serious blood disorders. If symptoms suggesting a blood disorder occur, such as fever, chills, a sore throat, painful sores in the mouth or throat, or unexpected bleeding or paleness, the use of this medicine must be discontinued, and medical help should be urgently sought.


Q: Is Фармадол metabolized by the CYP450 enzymes, and what are the main byproducts?

Official pharmacokinetic information confirms that Фармадол is converted into several active substances in the body. The main byproducts are 4-methylaminoantipyrine and 4-aminoantipyrine. The drug and its metabolites can also increase the activity of certain liver enzymes, such as CYP3A4 and CYP2B6, which can affect how other medications are processed.


Q: How does Фармадол reduce inflammation and swelling?

Official information classifies Фармадол primarily as a painkiller (analgesic) and fever reducer (antipyretic) with anti-spasm properties. It works by stopping the production of certain body chemicals called prostaglandins, which are involved in pain. However, official labels indicate that its anti-inflammatory properties are modest.


Q: Can I take Фармадол if I have high blood pressure?

Official drug interaction profiles note that Фармадол may reduce the effectiveness of certain medications used to treat high blood pressure, such as ACE inhibitors and beta-blockers. The labels also advise caution in patients with pre-existing circulatory or hypotensive conditions. Patients with high blood pressure are advised to ensure their healthcare provider is aware of all current medications, as interactions may occur.


Q: Is it safe to drive a car or operate machinery while taking Фармадол?

Based on regulatory information, the medicine is not required to carry a warning about impaired ability to drive or use machines when taken at the recommended dosage. The drug is generally considered not to cause drowsiness. However, this assessment is based on typical use, and the user should be mindful of any observed side effects that could affect their attention or coordination.


Q: If I have a history of ulcers or gastritis, is it safe to use Фармадол?

Regulatory labels do not list a history of gastrointestinal ulcers or bleeding as a direct contraindication for this medicine. Official information indicates that its use is not restricted for patients with this history. Its pharmacological profile is different from traditional non-steroidal anti-inflammatory drugs ( NSAIDs).


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How should Фармадол be stored and disposed of?

How to Store and Dispose of Фармадол

The storage and disposal of Фармадол (Metamizole) must adhere strictly to official regulatory guidelines to maintain product quality and ensure safety.

Required Storage Conditions

Condition Type Requirement
Temperature & Environment Store in a dry, cool, and dark place at room temperature (e.g., below 25 C). Certain liquid formulations must not be refrigerated or frozen.
Container & Protection Keep the container tightly closed and store in the original package. The product must be kept away from heat and sources of ignition.
Child Safety Store locked up and out of the sight and reach of children and pets at all times.

Official Disposal Rules

When the product is expired or unused, it must be disposed of as pharmaceutical waste. Contents and containers must be sent to an approved waste disposal plant or special waste collection point in accordance with local regulations ( P501). Avoid release to the environment, and do not allow the product to enter sewers or ground water. Follow national authority guidelines, such as the FDA's instructions for mixing non-flush list medicines with an unappealing substance before disposal in household trash if a take-back program is unavailable.

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

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