Andolor

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Andolor

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 Andolor

Property Description
Active ingredient Sodium Metamizole (Dipyrone)
Form Tablets, Oral drops, Solution for injection/infusion, Suppositories
Pharmacological class Non-Opioid Analgesic, Pyrazolone Derivative
General purpose Pain relief, Fever reduction, Spasm relief
Origin Synthetic organic compound

Andolor: Identity, Differentiation, and Pharmacological Class

Andolor is a medication containing the active ingredient Sodium Metamizole, which is internationally recognized under the non-proprietary name Dipyrone. It is classified as a powerful Non-Opioid Analgesic and belongs to the chemical group of Pyrazolone Derivatives. This classification differentiates its mechanism of action from traditional NSAIDs like Ibuprofen, positioning it for moderate to severe symptoms. The substance is a synthetic organic compound that functions as a prodrug; it transforms into pharmacologically active compounds, such as 4-methyl-amino-antipyrine (MAA), soon after it is administered. The distinct Pyrazolone structure is clinically recognized for contributing to its potent pain-relieving effects, primarily by influencing pain processing within the Central Nervous System.

Composition, Forms, and General Therapeutic Purpose

Andolor is supplied as a monopreparation, utilizing only Sodium Metamizole as its core therapeutic agent. It is available in various dosage forms, including tablets, oral drops, and solutions for both intravenous and intramuscular injection, allowing for flexible oral, rectal, or parenteral routes of administration. The general therapeutic purpose of the medicine is defined by its triple functional capacity: providing strong pain relief (analgesia), acting as an effective fever reducer (antipyretic action), and inducing a direct spasmolytic effect by relaxing the smooth muscles of internal organs. This unique combination of effects is utilized in many countries for treating severe pain and fever that are not adequately addressed by other treatments.

What side effects are possible with Andolor?

Possible Side Effects and Safety Information

The safety profile of Andolor (Sodium Metamizole) is primarily characterized by the officially documented risk of rare but serious adverse reactions, particularly those affecting the blood and immune systems. All statements are based strictly on regulatory classifications.

Adverse Reaction Scope

The most significant and consistently noted safety concern in regulatory documents is Agranulocytosis (a severe reduction in white blood cells), which is classified as a Very Rare event. Other serious, potentially life-threatening reactions classified as Rare or Very Rare include Anaphylactic Shock, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

Adverse effects are documented across several System-Organ Classes, including Blood and Lymphatic System Disorders, Immune System Disorders, Skin and Subcutaneous Tissue Disorders, and Vascular Disorders. Uncommon documented reactions include Hypotensive Reactions (a drop in blood pressure) and Fixed Drug Eruption.

Safety Considerations and Constraints

The official labeling notes that serious hematological events like Agranulocytosis are explicitly not dose-dependent and may occur at any time during treatment. In contrast, Hypotensive Reactions are often noted as being dose-dependent and more frequent when the medication is administered by injection.

Specific Safety Constraints are documented for patient populations with reduced drug clearance. Caution is advised for older adults and individuals with impaired renal or hepatic function due to the potential for product metabolite accumulation. The medicine is formally Contraindicated in individuals with pre-existing severe bone marrow dysfunction or a history of agranulocytosis caused by Metamizole or other pyrazolone derivatives.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Profile

Official regulatory documents define the overdose profile of Andolor (Metamizole/Dipyrone) by listing specific systemic risks and mandated emergency actions. All overdose events require prompt medical attention.

Feature Official Regulatory Documentation Summary
Documented Overdose Manifestations Nausea, vomiting, abdominal pain, salivation, vertigo, headache, somnolence, and convulsions.
Severe or Life-Threatening Outcomes Circulatory collapse, shock, coma, respiratory paralysis, and acute renal or liver failure are reported as severe potential complications.
Antidote Information A specific antidote for Metamizole is not available.

When Urgent Medical Help is Required

The most critical instruction from regulatory bodies is to seek urgent medical assistance immediately if an overdose is suspected or if symptoms of certain severe adverse effects, such as a blood disorder (e.g., fever, chills, sore throat), appear. The medicine must be stopped immediately in these cases.

Management and Considerations

Overdose management is restricted to symptomatic treatment and supportive measures due to the lack of an antidote. Procedures such as gastrointestinal decontamination (e.g., gastric lavage, activated charcoal) or forced diuresis may be considered as part of the supportive strategy. The official label also notes a reduced elimination rate in patients with impaired renal or hepatic function, which may increase the risk and severity following high-dose exposure.

Therapeutic Uses of Andolor

What Andolor Treats: Main Uses and Benefits

Andolor (Sodium Metamizole/Dipyrone) is generally applied across domains where additional symptomatic support is needed, relevant in clinical settings marked by heightened patient distress. The medication is relevant for easing symptoms within therapeutic domains involving heightened responses, especially severe pain and fever. It is used in contexts where temporary symptomatic assistance is appropriate to help patients cope more steadily with difficult episodes.


Therapeutic Areas of Use

The medication is commonly used to help manage symptoms related to severe acute pain, such as pronounced discomfort following surgical procedures (postoperative pain) or physical injuries, and the intense, spasmodic cramping pain characteristic of renal or biliary colic. It is also applied in situations where patients experience high-grade fever (hyperthermia) where additional symptomatic support is required. The supportive effect helps patients during difficult episodes by easing distress and helping to maintain a sense of stability when symptoms are more noticeable.

“It provides support that helps ease the overall symptom burden, contributing to improved comfort during periods of heightened symptoms.”


Quick Fact: Support for Acute Pain and Spasms

Andolor is generally applied when symptoms intensify, and supportive relief is needed to address symptom clusters that may appear suddenly and interfere with daily comfort. The medication is considered relevant for managing conditions characterized by heightened, acute manifestations.

Eligibility and Restrictions for Use

Andolor (Sodium Metamizole) eligibility is strictly defined by regulatory contraindications and restrictions. Absolute prohibition applies to patients with a history of agranulocytosis induced by Metamizole or similar pyrazolone-based medicines, as well as those with impaired bone marrow function or known analgesic-induced asthma syndrome. The medicine is also contraindicated in patients diagnosed with acute intermittent hepatic porphyria or congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Age and Physiological Status

Adults and Adolescents aged 15 years or older (or with a body weight over 53 kg) are generally considered the standard approved population. Pediatric use is allowed for children from 3 months of age provided their weight is over 5 kg. Use is contraindicated in infants below this age/weight threshold.

Use is strictly prohibited during the third trimester of pregnancy due to documented risks of fetal renal impairment and ductus arteriosus constriction. For breastfeeding women, repeated use is not recommended; regulatory guidance advises discarding breastmilk for 48 hours following a single administration.

Condition-Based Restrictions

Conditional eligibility applies to patients with compromised organ function. Those with impaired renal or hepatic function must avoid multiple high doses due to reduced elimination rates, and use in severe impairment is not established. Caution is also required for patients with pre-existing arterial hypotension or unstable circulation.

What should I know about interactions with other medicines?

Official Interaction Patterns

The interaction profile for Andolor (Sodium Metamizole) is primarily defined by documented effects on drug metabolism and specific pharmacodynamic risks, based strictly on government regulatory documents.

Pharmacokinetic Interactions (Enzyme Induction)

Metamizole's active metabolites are officially documented as moderate to strong inducers of Cytochrome P450 (CYP) enzymes, specifically CYP3A4, CYP2B6, and CYP2C19. This induction pattern leads to a pharmacokinetic interaction that causes a reduction in the plasma concentrations (exposure) of co-administered medicines that are substrates for these enzymes. This exposure modification is noted with drugs such as the immunosuppressants Ciclosporin and Tacrolimus, as well as Bupropion. Monitoring of plasma levels is required when combining these sensitive medications.

Pharmacodynamic Effects and Timing Rules

Regulatory labels identify specific pharmacodynamic interactions. Co-administration with Methotrexate carries an additive risk of enhanced haematologic toxicity. A documented interference occurs with low-dose Acetylsalicylic acid (ASA), where Metamizole reduces ASA's antiplatelet effect. To mitigate this, mandatory timing separation is noted in prescribing information, such as administering Metamizole 30 minutes after or 8 hours before antiplatelet ASA. Furthermore, co-use with Chlorpromazine is associated with an official risk of additive hypothermia. Use in populations with a history of agranulocytosis linked to similar pyrazolone medicines is restricted due to the potential for cross-hypersensitivity.

Mechanism of Action

Andolor is a pro-drug that undergoes rapid hydrolysis to its active metabolites, primarily 4-methyl-amino-antipyrine (MAA). The mechanism involves multiple targets, distinguishing it from conventional non-steroidal anti-inflammatory drugs (NSAIDs).

MAA functions as an inhibitor of central cyclooxygenase-3 (COX-3), leading to the localized reduction of prostaglandin E2 synthesis within the central nervous system. This molecular activity modulates signal transduction in the spinal cord and brain. Simultaneously, the metabolites are thought to exert influence by interacting with components of the opioidergic and cannabinoid systems, specifically via CB1 receptors, thereby activating descending inhibitory pathways. A separate physiological consequence includes the reduced release of intracellular Ca^2+ through the modulation of inositol phosphate synthesis, which influences smooth muscle cell tone at a systemic level. The net effect is the direct modulation of central nociceptive signal propagation and cellular contractility.

Dosage and Administration Information

Official Administration Protocols

Andolor (Sodium Metamizole) is administered through several officially approved pathways, allowing for flexible use based on clinical necessity. These routes include oral administration (via tablets, capsules, or drops), rectal use (via suppositories), and parenteral routes such as intravenous (IV) injection/infusion and intramuscular (IM) injection.

Standard oral dosing for adults typically ranges from a single dose of 500 mg up to 1,000 mg (1 g). Administration is generally scheduled up to four times daily, but a minimum interval of 6 to 8 hours must be observed between oral doses. The maximum daily intake is officially established at 4,000 mg for oral use. In all cases, the protocol requires adherence to the lowest possible dose necessary for the administration.

Intravenous administration involves specific procedural conditions: the solution must be injected very slowly to comply with regulatory constraints. The injectable solution may be diluted only with approved solutions, such as saline or glucose 5%, and must be administered immediately after preparation.

Dosage modifications are required for specific patient groups. For older adults and those with hepatic or renal impairment, a reduced dose must be used due to potential delays in metabolite elimination. Pediatric dosing (children under 15) is weight-dependent, typically based on a single dose of 8–16 mg/kg body weight.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Andolor

Evidence for use in Severe Acute Pain

Andolor was studied in research exploring outcomes related to physical discomfort in conditions characterized by acute, intense discomfort, such as the period following surgery or acute low back pain. The primary research applied involves short-term, randomized controlled trials (RCTs) and systematic reviews that monitored outcomes related to symptom axes over defined time intervals. Researchers examined changes in pain intensity scores and noted the need for supplemental pain medication. The findings describe short-term patterns observed during the immediate defined observation period. However, follow-up durations were limited, and data for certain groups remain insufficient, as the results apply only to the populations studied in the trials.

Evidence for use in Spasmodic Cramping Pain

Research has explored the use of Andolor in conditions associated with acute or disruptive episodes, such as renal colic or biliary colic. The evidence is derived mainly from short-duration RCTs conducted in settings with heightened symptom activity. Studies monitored rapid symptom patterns, focusing on outcomes capturing phases of heightened symptom activity. Findings describe patterns related to rapid changes measured shortly after administration. What remains less clear is the long-term impact on these conditions characterized by fluctuating or episodic manifestations.

Evidence for use in High-Grade Fever

Andolor was evaluated in studies that examined outcomes related to systemic or functional imbalance, specifically the management of high-grade fever. Trials were designed to monitor physiological strain by measuring the rate and total magnitude of body temperature decrease. Findings describe patterns observed, especially in research scenarios where alternative antipyretic options were not used or where the observed response was below a specific threshold. Evidence quality varies across studies, and comparative evidence is lacking for its use as a primary, first-line treatment.

What the Research Shows is Still Uncertain

While studies help show what has been observed so far, the overall certainty remains low in several key areas. Evidence quality varies across studies, and findings were mixed in some specific contexts. There is a need for more research, particularly concerning long-term effects and in populations not well-represented in existing trials. The research describes group patterns and helps contextualize the evidence landscape.

Frequently Asked Questions (FAQ)

Common questions about Andolor (FAQ)


Q: How does the action of Andolor compare to similar over-the-counter treatments?

Regulatory information indicates that Andolor is a Pyrazolone derivative, which means its mechanism of action is distinct from traditional over-the-counter pain relievers like NSAIDs. The difference is primarily that Andolor's active compounds affect pain processing more directly within the Central Nervous System.

Q: Is Andolor considered a short-term or a long-term medication?

According to official product information, Andolor is generally intended for short-term use. Long-term use is not typically recommended in regulatory guidance because the risk of certain side effects may potentially increase over time.

Q: Why is Andolor only available with a prescription?

The medicine is available by prescription only due to the potential for rare but serious adverse reactions, such as agranulocytosis (a blood disorder). This potential risk requires the ongoing supervision and specific safety constraints provided by a medical professional.

Q: What are the most common reported side effects of Andolor?

Official product safety information reports that common side effects can include dizziness, drowsiness, nausea, headache, stomach pain, and general skin reactions like rash or itching. It is important to know that regulatory documents often focus on listing serious or severe side effects (which are rare) rather than a complete list of all mild, common occurrences.

Q: Is a change in sleep pattern a known side effect of Andolor?

Yes, official safety information indicates that drowsiness is a potential side effect of Andolor. Since the drug acts within the Central Nervous System, this effect may lead to changes in a person's sleep pattern or general alertness.

Q: What symptoms indicate a possible allergic reaction to Andolor?

Official documents note that rare but severe hypersensitivity reactions, like anaphylactic shock or severe skin reactions (SJS/TEN), are possible. Warning signs for a severe allergic reaction can include sudden swelling of the face, lips, or throat, difficulty breathing, or the development of a severe, blistering rash.

Q: Does Andolor carry a warning about the risk of dependence or addiction?

Andolor is classified as a non-opioid analgesic. According to regulatory documents, there are no official warnings about the risk of dependence or addiction associated with its use.

Q: What happens if I forget to take a scheduled dose of Andolor?

Official regulatory guidance concerning a missed dose is to take it as soon as remembered, unless it is almost time for the next scheduled dose. If it is almost time for the next dose, the missed dose should be skipped entirely to avoid taking too much medication too close together.

Q: Does Andolor interact with alcohol consumption?

Official guidance notes that co-administration with alcohol may increase the risk of severe adverse effects. Therefore, avoidance of alcohol is typically advised in the product information.

Q: Are there any common over-the-counter medicines that should be avoided with Andolor?

A specific warning exists for low-dose Aspirin (Acetylsalicylic acid), which requires a timing separation when taking Andolor. Caution is advised when combining Andolor with any other pain reliever or medication that could increase the risk of toxicity.

Q: Does Andolor interact with common dietary or herbal supplements?

Official documents state that the drug's active compounds induce certain liver enzymes, such as CYP3A4 and CYP2C19. Dietary or herbal supplements that are metabolized by these same enzymes may have their effects or concentration in the body reduced, so caution is required.

Q: Does taking Andolor affect the effectiveness of birth control pills?

Since Andolor is documented to induce the enzyme CYP3A4, which is responsible for breaking down many hormonal birth control pills, this is a factor to consider. This enzyme induction may lead to reduced concentrations of the birth control medication in the body, which could potentially affect its effectiveness.

Q: Is Andolor suitable for use by older adults?

Andolor can be used by older adults, but regulatory caution is strongly advised. A reduced dose is often required because the elimination of the product's active compounds may be delayed in this population.

Q: Can people with pre-existing liver conditions safely use Andolor?

Official protocols state that for patients with impaired liver function, use of a reduced dose is necessary. Furthermore, use in cases of severe liver impairment is generally restricted as it has not been established in regulatory documents.

Q: Are there any safety concerns regarding Andolor and patients with heart disease?

Official safety constraints advise caution for patients with pre-existing arterial hypotension or unstable circulation. This is due to the risk of hypotensive reactions (a significant drop in blood pressure) that have been documented with the medication.

Q: Does using Andolor affect blood pressure or blood sugar levels?

Hypotensive Reactions (a drop in blood pressure) are documented as a potential uncommon side effect of Andolor. However, there is no explicit information in regulatory safety documents that blood sugar levels are generally affected by the medicine.

Q: Where can I access the full patient information leaflet (PIL) or medication guide for Andolor?

Official patient information, such as the Patient Information Leaflet or Medication Guide, is made available online. This information can typically be accessed on the website of the national regulatory body that approved the medicine, such as the FDA or EMA.

Q: Is it okay to store Andolor in the bathroom medicine cabinet?

Official storage requirements state that the medication should be kept in its original container, protected from both light and moisture. Because bathroom cabinets are often exposed to high humidity and significant temperature fluctuations, they may not consistently meet these conditions.

Q: What is the purpose of the non-active ingredients (fillers) in the Andolor tablet?

Non-active ingredients, also known as excipients, are added to the formulation for specific pharmaceutical purposes. Their purpose is to provide the required physical form (like a tablet), ensure the drug's stability over time, or help control the rate at which the active drug is released in the body.

Q: Can the medication be crushed or opened if a person has trouble swallowing pills?

Regulatory instructions typically advise that tablets should be swallowed whole and not crushed or chewed. Altering the medication’s form in this way can negatively affect how the medicine is absorbed and change its intended action in the body.

Q: Is there any data on how Andolor affects a person's ability to drive or operate machinery?

Official product information notes that the medication may cause dizziness or drowsiness in some patients. If these symptoms occur, regulatory guidance suggests caution and advises against activities requiring high mental alertness, such as driving a vehicle or operating machinery.

Q: Why do official documents advise caution when combining Andolor with other sedating medications?

Caution is advised when combining Andolor with sedating medicines because of the drug's documented activity in the Central Nervous System (CNS). Taking it with other CNS depressants may lead to additive effects, such as increased sedation.

Q: Is it normal to feel a change in appetite after starting Andolor?

Change in appetite is not typically listed as a common side effect of the medication. However, other gastrointestinal issues, such as nausea and stomach pain, are reported as potential side effects in the safety information.

Q: Do the benefits of Andolor generally outweigh the potential risks, as described in regulatory reviews?

Regulatory approval is granted when the official bodies determine that the benefits of the medicine for its specified uses are considered to outweigh the potential risks. This balance is contingent upon strictly following all official contraindications and warnings.

Q: Can a person take Andolor at a different time of day than prescribed if needed?

Regulatory administration protocols specify that a minimum interval of 6 to 8 hours must be observed between oral doses. Dosing must comply with this required interval regardless of the time of day the medication is taken.

Q: What are the different strengths or dosages Andolor is typically available in?

Andolor is supplied in various forms, including tablets, oral drops, and solutions for injection. The single-dose strengths typically range from 500 mg up to 1,000 mg (1 g) for standard adult oral administration, depending on the specific product formulation.

How should Andolor be stored and disposed of?

Storage and Disposal Requirements

Official regulatory labeling dictates specific conditions for storing and discarding Andolor (Sodium Metamizole) to maintain quality and safety.

Storage Conditions

The medicine must be stored below a specified maximum temperature, typically 25 C or 30 C depending on the formulation. It is mandatory to store the product in its original container, protected from both light and moisture. For child safety, the medicine must be kept out of the sight and reach of children, in line with requirements to store it securely.

Stability and Disposal

For multi-dose liquid forms, a strict in-use shelf life is specified (e.g., 28 days) after the initial opening, and the product must be discarded afterward. Unused or expired Andolor must not be placed in household trash or flushed down the toilet. Disposal must follow regulatory guidance, requiring the product to be taken to a national collection scheme or approved waste disposal plant.

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

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