Пропифеназон

Quick links to important sections

Пропифеназон

Treatment option:

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 Пропифеназон

What is Propyphenazone?

Propyphenazone is a medication belonging to the pyrazolone class of drugs. It is primarily used for its analgesic (pain-relieving) and antipyretic (fever-reducing) properties. Developed as a derivative of phenazone, it was designed to provide therapeutic effects similar to other non-steroidal anti-inflammatory drugs (NSAIDs).

Chemical Nature and Classification

As a pyrazolone derivative, propyphenazone shares a chemical lineage with substances like metamizole and phenazone. It functions by inhibiting the synthesis of prostaglandins—compounds in the body that signal pain and trigger inflammatory responses. Unlike some other medications in this class, propyphenazone is noted for its relatively rapid onset of action.

Common Uses

Propyphenazone is rarely used as a standalone treatment. Instead, it is frequently found as a component in fixed-dose combination medications. These combinations often include other active ingredients such as:

  • Paracetamol: To enhance pain relief through a different mechanism.
  • Caffeine: To potentially accelerate the absorption and effectiveness of the analgesic components.
  • Codeine: Included in some formulations for more severe pain management.

These combinations are typically utilized to address various types of mild to moderate discomfort, including headaches, toothaches, menstrual pain, and feverish conditions associated with the common cold or flu.

Historical Context

Propyphenazone has been available in several international markets for many decades. While it remains a common ingredient in over-the-counter and prescription pain relievers in various regions, its use has become less frequent in some countries as newer analgesic alternatives with different safety profiles have been developed.

What side effects are possible with Пропифеназон?

Possible side effects and safety information

Propyphenazone's official safety profile is formally structured in regulatory documents to detail adverse reactions by their physiological group and frequency of occurrence. As a pyrazolone derivative, the documented safety profile is characterized by specific risks, primarily concerning the blood and immune systems.

Safety Characteristics and Regulatory Classifications

Regulatory agencies classify adverse reactions using standardized frequency categories, such as Rare and Uncommon. The most critical safety considerations documented in official product information involve haematological effects and hypersensitivity responses.

System-Organ Class Key Documented Adverse Reactions
Blood and Lymphatic System Agranulocytosis (a severe reduction in white blood cells) and leucopenia are documented as rare but serious risks.
Immune System Disorders Reactions range from Uncommon dermatological issues (rash, urticaria) to Rare but serious events such as Anaphylactic Shock.
Gastrointestinal Disorders Non-serious effects such as nausea, vomiting, and abdominal discomfort are commonly listed in product information.

Population-Specific Safety Notes

The official label imposes specific limitations, reflecting an increased risk in certain patient groups. The medicine is formally contraindicated in individuals with pre-existing conditions such as severe bone marrow depression and those with severe hepatic or renal impairment. Furthermore, specific safety notes are included for individuals with Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency due to the associated risk of haemolysis.

This structured safety profile establishes the formal constraints and the defined, though rare, serious risks associated with the medicine's use.

Overdose and Emergency Response

Overdose and when to seek help

The information below is based on documented regulatory and governmental sources defining the overdose profile and mandated emergency actions for Propyphenazone, often in combination formulations.

Documented Overdose Manifestations

Overdose presentations typically begin with nausea, vomiting, abdominal pain, and pallor. Severe toxicity can progress to affecting major organ systems and the central nervous system. Documented serious manifestations include acute liver injury progressing to hepatic coma, acute renal failure, and CNS effects such as seizures and coma.

Physiological systems noted as being affected include the Hepatobiliary (liver), Renal (kidneys), and Cardiovascular (leading to cardiac arrhythmias or circulatory collapse).

Required Emergency Actions

The official guidance mandates that individuals seek medical assistance immediately in the event of suspected or confirmed overdosage, even if the patient feels well.

Management Procedure Regulatory Status
Symptomatic and supportive treatment Primary management approach
Gastric decontamination Recommended within one hour post-ingestion
Specific Antidote No specific antidote is known for Propyphenazone toxicity

Hospital monitoring is required for continuous observation of vital signs and laboratory function due to the risk of delayed organ damage. Patients with pre-existing conditions, such as hepatic or renal impairment, are noted to be at increased risk for severe outcomes following an overdose.

Therapeutic Uses of Пропифеназон

Propyphenazone is relevant for symptomatic management, typically addressing symptoms related to physical discomfort and systemic imbalance in various acute conditions. The medication's relevance is generally focused on supporting comfort and contributing to easing the overall symptom burden during short-term episodes.

The medication is commonly used to help manage the intensity of sudden, non-chronic mild to moderate pain. This includes common symptomatic episodes like headaches, dental pain, general musculoskeletal aches, and discomfort associated with primary dysmenorrhea (menstrual cramps). It also supports easing the physical strain of elevated body temperature and associated systemic symptoms of colds and influenza.

“The medication is applied when acute discomfort creates noticeable functional strain.”

Applied in scenarios where additional management of discomfort is required, the medication contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability.

Quick Fact: Relief for Acute Episodic Pain

Propyphenazone is commonly used in conditions presenting with acute episodes where short-term symptomatic assistance for pain and fever is appropriate. It plays a role in managing symptoms that become more noticeable during flare-ups.

Regulatory References

  1. Philippine FDA approved label for Propyphenazone combination

Eligibility and Restrictions for Use

Eligibility for Propyphenazone: Official Regulatory Information

The eligibility for Propyphenazone is strictly defined by regulatory documents, largely based on its classification as a pyrazolone derivative and the potential risks associated with this chemical group.

Population Group Eligibility Status (Regulatory Wording)
Adults Allowed under standard labeled conditions.
Adolescents (12+ Years) Use generally established.
Children Under 12 Years Contraindicated/Not Recommended.

Absolute Contraindications

The medicine is absolutely contraindicated for specific populations where the risk is highest, as stated in official labeling:

  • Individuals with a known hypersensitivity to Propyphenazone or other pyrazolone derivatives.
  • Patients with severe kidney failure or severe liver failure.
  • Individuals with pre-existing conditions affecting bone marrow hematopoiesis (e.g., leukopenia) or G6PD deficiency.
  • Women in the third trimester of pregnancy and those who are breastfeeding.

Restricted or Conditional Use

Caution is required for elderly patients and individuals with moderate hepatic impairment or moderate renal impairment.


The official eligibility statements define who can and cannot use the drug by formally classifying specific organ dysfunctions, chemical allergies, and physiological states (such as late-stage pregnancy) as absolute contraindications. Use is therefore restricted to adults and adolescents (12 years and older) who do not possess these documented risk factors.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Propyphenazone has the potential for clinically important interactions with several medicinal product classes and specific substances. Co-administration may result in altered drug levels, reduced therapeutic efficacy, or an increased risk of adverse effects.

The most significant interaction concerns are:

  • Increased Risk of Bleeding: Combining Propyphenazone with Anticoagulants (such as Acenocoumarol or Apixaban) or other agents that affect blood coagulation may increase the risk and severity of bleeding or hemorrhage.
  • Alcohol: Concomitant use with Alcohol is generally restricted due to the potential for clinically hazardous interaction.
  • Reduced Efficacy: Propyphenazone may decrease the blood pressure-lowering effects of certain Antihypertensives (e.g., Acebutolol, Amlodipine).
  • Altered Drug Levels: The drug may decrease the elimination rate of many other medicines, including certain Antiepileptics, Chloramphenicol, and Sedatives, potentially leading to higher systemic exposure and increased risk of toxicity for the co-administered drug (e.g., Alprazolam, Abacavir).

Other agents cited in interaction monitoring lists include Ergotamine, Metoclopramide, and Rifampicin. Patients should consult a healthcare professional regarding all current medications and products to assess interaction risks.

Mechanism of Action

u1F52C Enzyme Inhibition and Pathway Modulation

Propyphenazone acts within domains involving enzyme-mediated signaling by binding to and inhibiting the cyclooxygenase (COX) enzymes, specifically both COX-1 and COX-2 isoforms. This action modifies early molecular steps by preventing the conversion of arachidonic acid into prostaglandin H2. This suppression initiates a signaling sequence that reduces the overall synthesis of prostaglandins and other pro-inflammatory mediators. The reduction in prostaglandin synthesis modifies downstream signaling relevant to the regulation of physiological response thresholds.


u1F321️ Regulation of Thermoregulatory Processes

The reduction in prostaglandin synthesis is relevant in systems where these mediators dominate the regulation of body temperature. Prostaglandins, particularly PGE2, play a key role in resetting the hypothalamic thermostat. By suppressing the synthesis of these pyretic mediators, Propyphenazone engages mechanisms that regulate dysregulated processes in the central nervous system. The pathway adjustment shifts the hypothalamic set point, resulting in a regulated decrease in core body temperature.


u1F9E0 Influence on Nociceptive Signaling

Propyphenazone also modulates key pathways associated with the modulation of nociceptive signaling. Beyond the reduction of peripheral prostaglandins, the compound is observed to influence central mechanisms. This engages mechanisms that regulate dysregulated processes in the nervous system, with a proposed effect involving the antagonism of receptors like TRPA1 in certain contexts. This mechanism modulates the transmission of nociceptive signals, influencing the systemic response governed by mediator activity.

Dosage and Administration Information

How to Use Propyphenazone: Administration Guidelines

Propyphenazone is primarily utilized as a component within fixed-dose combination products alongside other analgesic and antipyretic agents. Its use is defined by specific parameters concerning the route of intake, dosing thresholds, and treatment duration.


Administration and Dosage Rules

The standard route of administration is Oral for tablets and capsules, although the Rectal route (suppositories) may be used in specific regions.

Usage Constraint Requirement
Standard Single Dose Typically 1 to 2 tablets, corresponding to a Propyphenazone equivalent of 150 mg to 300 mg.
Maximum Daily Limit The total Propyphenazone intake must not exceed 1050 mg within a 24-hour period.
Dosing Frequency Administration is limited to a maximum of three single doses per 24 hours.
Administration Context Oral tablets should be consumed with ample water or other fluid.

Procedural Structure and Duration

Prescribing information outlines a usage pattern for acute, non-chronic symptomatic episodes. Treatment is defined as short-term; use is generally constrained to not exceed one week.

Combination products often include specific procedural rules for age groups. For example, the single dose for adolescents (aged 12–16 years) is often set at 1 tablet (150 mg Propyphenazone equivalent), differentiating it from the adult range. Subsequent doses are taken only as required, adhering to the maximum daily threshold.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Propyphenazone

Evidence for Use in Acute Pain Relief

Research has extensively explored Propyphenazone as a component in fixed-dose combination products (FDCs) relevant in trials assessing short-term or episodic symptom patterns. The majority of data comes from pooled analyses of randomized controlled trials (RCTs) used in research exploring how symptoms change over time. These studies were generally conducted in generally healthy adult populations, and researchers monitored patient-reported outcomes describing perceived discomfort over defined, short-term time intervals, typically lasting 4 to 6 hours after a single administration. The findings describe patterns observed in the studies where pain measurements evolved in the observed populations during the short study period. The overall evidence base for acute pain contributes to the broader evidence landscape through the repeated examination of these FDCs.

Evidence for Use in Managing Elevated Body Temperature

Propyphenazone was studied for its role in managing outcomes related to systemic or functional imbalance, such as fever. The evidence base here is limited for single-agent use and is derived from its pharmacological classification, with research on this indication often included as a secondary outcome in analgesic trials. Studies explored how symptoms evolved in the observed populations by monitoring the change in body temperature from baseline. Dedicated modern RCTs focusing solely on this function are less common.

Long-Term Studies and Observation Periods

The clinical trials establishing the efficacy framework for its use are focused on short-term symptom patterns. The typical observation period in these acute-use trials is only a matter of hours. Data for long-term outcomes remains insufficient for chronic condition management, and long-term effects are not fully established by the existing research structure.

Research in Specific Patient Groups and Subpopulations

The main clinical trials were largely confined to generally healthy adults. Data for certain groups remain insufficient. For instance, data for certain groups remain insufficient for older adults, children, or individuals with pre-existing, complex health conditions. Consequently, the results apply only to the populations studied in the primary clinical evaluations.

Understanding Research Gaps and Uncertainty

A significant limitation is that the evidence is overwhelmingly derived from studies of fixed-dose combination products, making it challenging to isolate the specific contribution of Propyphenazone as a single agent. Evidence quality varies across studies, and the research provides context but not individual predictions of outcome. The final evidence highlights what is known—and what is still uncertain—about this medicine's research base.

Frequently Asked Questions (FAQ)

Common questions about Пропифеназон (FAQ)

Q: How is Propyphenazone different from common pain relievers like paracetamol?

Official regulatory documents classify Propyphenazone as a pyrazolone derivative (N02BB04). This places it in a different chemical class than common medications like paracetamol (acetaminophen).

It is frequently included in fixed-dose combination products alongside paracetamol and caffeine to achieve a synergistic effect for pain and fever relief.


Q: Does Propyphenazone help with migraine or only with common headache?

Therapeutic indications in official sources define the use of Propyphenazone for general headache and mild-to-moderate pain.

While some fixed-dose combination products may be specifically indicated for the relief of migraine, the regulatory labeling generally addresses acute, non-specific headache relief.


Q: What signs of side effects require attention?

Regulatory information indicates that prompt medical evaluation should be sought if signs of severe hypersensitivity, such as swelling or difficulty breathing, occur. Attention is also required for symptoms potentially indicating blood disorders (like agranulocytosis), which may include an unexplained fever, persistent sore throat, or unusual bruising and bleeding.


Q: What is agranulocytosis associated with Propyphenazone?

Agranulocytosis is a documented adverse reaction that is considered rare but serious.

According to official product information, this condition involves a sharp reduction in the white blood cells (neutrophils) necessary for fighting infection.


Q: Does food affect the action of Propyphenazone?

Official administration guidelines recommend taking oral forms of the medication with ample water or other fluid.

Some regulatory recommendations note that taking the drug with food may be permissible to help reduce the potential for gastrointestinal discomfort, although this does not necessarily address changes in effectiveness.


Q: How long does the effect of Propyphenazone last?

The duration of the therapeutic effect is typically based on the drug's dosing schedule.

Official documents suggest that the analgesic and antipyretic effect generally lasts for approximately 4 to 6 hours, which aligns with the intervals monitored in acute pain studies.


Q: What is the main difference in the mechanism of action between Propyphenazone and aspirin?

Both medications operate by inhibiting cyclooxygenase (COX) enzymes to reduce the synthesis of prostaglandins (chemical mediators of pain and fever).

But, aspirin is chemically distinct, however, due to its irreversible inhibition of platelet COX, an effect that is not associated with Propyphenazone.


Q: What is the INN (international nonproprietary name) for Propyphenazone?

The international nonproprietary name (INN) is officially designated as Propyphenazone.

Official nomenclature documents from regulatory bodies also frequently list the chemical synonym, Isopropylantipyrine.


Q: Does Propyphenazone cause drowsiness?

Official safety labels for the medication indicate that central nervous system (CNS) side effects are possible.

Drowsiness or dizziness may be listed as uncommon or rare adverse reactions. Patients should be aware of these potential effects.


Q: Is Propyphenazone addictive?

Propyphenazone is not classified by regulatory bodies as a controlled substance.

Official data indicates that this medication is not associated with the potential for physical dependence or addiction.


Q: How does Propyphenazone interact with other pain relievers, such as ibuprofen?

Regulatory documents advise caution against taking Propyphenazone simultaneously with other pyrazolone derivatives or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), which includes ibuprofen.

This restriction is generally in place due to the potential for an increased risk of adverse effects, such as those affecting the gastrointestinal system or blood.


Q: How quickly does Propyphenazone start working?

Pharmacokinetic data detailed in official regulatory documents show that the medication is quickly absorbed after oral intake. The highest concentration of the drug in the blood plasma is typically reached within 30 to 60 minutes.


Q: Why might the effect of Propyphenazone be weaker than expected?

Regulatory documents explain that the drug’s effectiveness can be subject to individual metabolic differences among patients.

Furthermore, co-administration with certain medications that accelerate the drug's breakdown (metabolic inducers) is noted to potentially lead to a reduced therapeutic effect.


Q: Can I take Propyphenazone if I have asthma?

Official regulatory information may list asthma or a history of known hypersensitivity to NSAIDs as a condition where taking Propyphenazone is either contraindicated or requires extreme caution.

This warning exists due to the potential for hypersensitivity reactions.


Q: Is Propyphenazone approved in the US (FDA)?

The regulatory status of Propyphenazone varies globally.

Official records generally indicate that Propyphenazone, whether as a single agent or a widely marketed combination product, is not approved or routinely marketed for use in the United States by the FDA.


Q: What official information about Propyphenazone is available for patients?

Official patient information, such as safety summaries and package leaflets, is made available through government health authorities.

These resources can often be found on the websites of the relevant national drug agency (like the EMA) or reputable government-backed patient resources such as the NIH MedlinePlus.


Q: Are Propyphenazone and Analgin the same thing?

Propyphenazone and Analgin (Metamizole) are both classified in the same chemical group, the pyrazolone derivatives.

However, official regulatory and nomenclature documents confirm that they are distinct chemical compounds with differing safety profiles and regulatory restrictions in various countries.


Q: Can I take Propyphenazone if I need to drive a car?

Official safety warnings advise caution regarding activities like driving or operating machinery. This is because the medication carries the potential for rare side effects such as dizziness or impaired reaction time, which may affect the ability to operate machinery or drive.


Q: What types of pain can Propyphenazone not relieve?

Official therapeutic indications limit the use of Propyphenazone to acute, mild-to-moderate pain, such as headache or toothache.

The medication is not indicated or intended for the management of chronic pain or severe pain syndromes.


Q: Is there a risk of medication-overuse headache from frequent Propyphenazone intake?

Regulatory documents for acute pain relievers often include warnings about frequent use.

They state that the prolonged or habitual intake of such medication may lead to the development of a medication-overuse headache (MOH), also known as a rebound headache.


Q: Does Propyphenazone affect laboratory test results?

Official product information sometimes contains warnings regarding interference with laboratory assays.

Propyphenazone may potentially affect the measurement of certain substances in the blood, such as creatinine or uric acid, which could lead to potentially misleading test results.

How should Пропифеназон be stored and disposed of?

How to Store and Dispose of Propyphenazone

Propyphenazone must be stored according to official regulatory specifications to ensure product integrity and safety. The medication should be kept at room temperature, generally between 15 C and 30 C.


Storage Requirements

  • Protection: Store the product in its original container and keep it tightly closed to protect it from light and moisture.
  • Child Safety: It is a mandatory requirement that the medicine be stored out of the sight and reach of children.

Disposal Instructions

Unused or expired Propyphenazone must not be disposed of in household waste or wastewater. Regulatory documents require that disposal be completed through an approved drug take-back program or at an appropriate pharmaceutical waste disposal facility.

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

Available in countries:

Equivalent of Пропифеназон found in:

A-Z Index: