Dipirona Norgreen

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Dipirona Norgreen

Medically reviewed

Laura Arias

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 Dipirona Norgreen

Quick Facts

Property Description
Active Ingredient Dipyrone (Metamizole Sodium)
Form Oral Drops, Tablets, and solutions
Pharmacological Class Pyrazolone Derivative / Non-Opioid Analgesic
General Purpose Relief of moderate-to-severe pain and high fever
Origin Synthetic Compound

What Type of Medicine is Dipirona Norgreen?

Dipirona Norgreen is a specific brand name for a medicine containing the active substance dipyrone, which is also known globally by its International Non-proprietary Name (INN) of metamizole. The medication belongs to the chemical class of pyrazolone derivatives, a group distinct from common Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

As a pyrazolone, metamizole is clinically recognized for its strong dual action as an analgesic (pain-reliever) and an antipyretic (fever-reducer). The drug is an established choice for treating acute pain after surgery or high fever unresponsive to other measures, confirming its role in symptom management. Dipirona Norgreen is typically manufactured in forms such as oral drops and tablets for flexible use by patients.

What is Dipirona Norgreen’s Composition and Origin?

The active pharmaceutical ingredient (API) is metamizole sodium, which is produced as a synthetic organic compound in a controlled manufacturing setting. This laboratory synthesis ensures consistent potency and purity for patient use. The Norgreen designation identifies this product as a generic or equivalent drug, meaning it contains the identical active substance and is required to meet the same quality and efficacy standards as the original reference drug.

What is the General Therapeutic Purpose of Dipirona Norgreen?

The primary purpose of Dipirona Norgreen is to provide effective and rapid control over symptoms of significant pain and elevated body temperature. Its pharmacological function allows it to target the body's central pain and fever response mechanisms. Due to its analgesic properties, the medicine is utilized when a strong, non-opioid agent is required to manage acute, severe symptoms.

What side effects are possible with Dipirona Norgreen?

Possible Side Effects and Safety Information

Dipirona Norgreen (also known as Metamizole) is associated with a range of possible side effects, some of which are rare but potentially serious. Its safety profile is a major point of discussion among global regulatory authorities, resulting in varying availability and restrictions worldwide.

Key Adverse Reactions

The most serious safety risk documented in regulatory literature is agranulocytosis—a rare but life-threatening blood disorder characterized by a severe drop in white blood cell count. This adverse reaction is not related to the dose and can occur at any point during or shortly after treatment. Fatalities resulting from subsequent severe infections (sepsis) have been reported.

Other serious and clinically significant reactions include:

  • Severe Hypersensitivity: Immediate reactions like anaphylaxis (allergic shock) and severe skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).
  • Hepatotoxicity: Cases of acute liver injury, including acute hepatitis and liver failure, have been reported, sometimes requiring liver transplantation.
  • Renal Dysfunction: Interstitial nephritis and other forms of renal impairment.

Common and Less Severe Effects

Adverse events reported to occur more frequently include reactions affecting the digestive, nervous, and general body systems. These may involve nausea, vomiting, abdominal pain, headache, vertigo, rash, and fever.

Safety Restrictions and Monitoring

Due to the documented risk of agranulocytosis, Dipirona Norgreen has been withdrawn or banned from the market in numerous countries, including the United States, United Kingdom, and Australia. It remains available in other regions, typically requiring a prescription and patient awareness of the signs of agranulocytosis (e.g., persistent fever, sore throat, or mucosal ulcers) which necessitate immediate discontinuation and medical evaluation.

Overdose and Emergency Response

Overdose and When to Seek Help

The information below is strictly based on official government regulatory documents detailing the drug’s overdose profile and mandated emergency actions.

Documented Overdose Presentations and Risks

Category Official Regulatory Statement
Documented overdose presentations Gastrointestinal symptoms (nausea, vomiting, abdominal pain), central nervous system effects (somnolence, vertigo, restlessness, convulsions, coma), and cardiovascular compromise like hypotension and tachycardia.
Physiological systems affected Renal function (acute renal failure), Cardiovascular System (shock), Central Nervous System, and Liver (drug-induced liver injury in severe cases).
Severe Outcomes Overdose may result in severe intoxication, potentially leading to acute renal failure and circulatory shock, which are classified as serious or life-threatening events.

Required Emergency Actions

When Immediate Medical Help is Required (Label-Derived Phrasing Only):

  • Acute Overdose: Seek emergency medical services immediately if signs of severe intoxication occur, such as loss of consciousness, convulsions, or circulatory shock.
  • Specific Complications: Regulators mandate that patients stop taking the medicine and seek urgent medical assistance immediately if symptoms suggestive of agranulocytosis (e.g., fever, chills, sore throat, painful mucosal changes) or liver injury (e.g., jaundice, dark urine, upper stomach pain) are observed.

Overdose Management Principles:

  • Antidote Status: No specific antidote for Metamizole overdose is known or documented.
  • Supportive Measures: Management is primarily symptomatic and supportive. Interventions such as gastric lavage or activated charcoal may be considered if ingestion was recent. In severe cases, methods like forced diuresis or haemodialysis are documented procedures to accelerate the elimination of active metabolites.

Therapeutic Uses of Dipirona Norgreen

Medicines containing metamizole are utilized when supportive symptom management is appropriate for pronounced pain and high fever. This supports symptomatic relief across therapeutic domains where symptoms relate to heightened physiological activity.

Dipirona Norgreen is applied across domains where additional symptomatic support is needed to address discomfort that is considered a significant symptomatic burden. This is commonly used to help with symptoms linked to organ-specific functional stress, such as acute colic, and pronounced manifestations like pain related to acute injuries or surgical recovery. It is also relevant for managing symptoms related to systemic imbalance, specifically when high fever is sustained or presents a significant symptomatic burden.

“The benefit of this medication is generally considered to be the support it offers for symptomatic relief, which helps patients cope more steadily with difficult episodes.”

Quick Fact: Support for Key Symptom Types

Therapeutic Focus Conditions/Symptoms
Support for Pain Moderate-to-severe pain, chronic neoplastic pain, post-traumatic discomfort.
Support for Fever High fever, sustained or unresponsive elevated body temperature.
Support for Spasms Acute pain caused by smooth muscle contractions, such as biliary or intestinal colic.

This provides support that helps ease the overall symptom load, assisting with maintaining functional stability during periods of heightened symptoms.

Eligibility and Restrictions for Use

Official Eligibility and Contraindications

Dipirona Norgreen (metamizole) eligibility is strictly defined by regulatory authorities based on a patient’s medical history, age, and physiological status. The medicine is contraindicated and must not be used by specific populations due to the potential for serious, life-threatening reactions.

Absolute Contraindications

Use is prohibited for patients with a documented history of metamizole-induced agranulocytosis or other conditions affecting bone marrow function. Patients with acute intermittent hepatic porphyria, specific enzyme deficiencies (G6PD deficiency), or known hypersensitivity to metamizole or other pyrazolone derivatives are also excluded. Additionally, the drug is contraindicated in the third trimester of pregnancy due to risks to the fetus.

Age and Physiological Restrictions

Dipirona Norgreen is contraindicated for infants below three months of age or those weighing less than 5 kilograms. While allowed in older children, use in patients with renal or hepatic impairment requires caution, and a dose reduction may be necessary. For women who are breastfeeding, repeated use is generally avoided, and official labeling recommends discarding breast milk for 48 hours after a single administration.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Dipirona Norgreen, containing metamizole, has several formally documented interaction patterns based on regulatory labeling, primarily affecting the exposure and function of co-administered medicines.

Pharmacokinetic (PK) Interactions

The medicine is a moderate to strong inducer of several liver enzymes, including CYP3A4 and CYP2B6. This mechanism leads to a reduction in the plasma concentration and potential loss of efficacy for many co-administered drugs. A decrease in exposure is documented for immunosuppressants like Cyclosporine and Tacrolimus, as well as other agents such as Midazolam, Bupropion, and Sertraline.

Pharmacodynamic (PD) Interactions and Restrictions

Constraint / Interacting Substance Official Regulatory Statement
Acetylsalicylic acid (low-dose) To maintain the antiplatelet effect, Aspirin must be taken prior to Metamizole.
Methotrexate The combination should be avoided due to a documented risk of increased blood toxicity.
Phenothiazine Derivatives Concurrent use, such as with Chlorpromazine, carries a documented risk of resulting in severe hypothermia.
Pyrazolone Derivatives Use is contraindicated in patients with a history of agranulocytosis caused by any medicine in this class.
Elimination The elimination rate of metamizole is officially documented as reduced in patients with impaired renal or hepatic function.

Mechanism of Action

Central Pathway Modulation

The mechanism of Dipirona (Metamizole) is distinctively multi-targeted and centered predominantly within the nervous system, resulting in a fast onset of central pathway modulation. The drug's active metabolites, primarily 4-MAA and 4-AA, rapidly target and inhibit the Cyclooxygenase-3 (COX-3) enzyme found within the Central Nervous System (CNS). This enzyme inhibition suppresses the synthesis of Prostaglandin E2 (PGE2), a mediator of the thermal set point, in the hypothalamic thermoregulatory center . Furthermore, the metabolites modulate the descending antinociceptive pathway through the activation of kappa-opioid and CB1 cannabinoid receptors, which promotes the activity of descending inhibitory control over nociceptive signal transmission. These combined actions modulate the hypothalamic thermal set point and attenuate central nociceptive signaling.


Functional Spasmolytic Mechanism

Dipirona possesses a unique mechanism that influences the tone of smooth muscle tissue. This effect is achieved at the cellular level by interfering with the mobilization of intracellular calcium ions (Ca^2+). Specifically, the drug's mechanism leads to a reduction in the synthesis of inositol phosphate, a key messenger required to release Ca^2+ within the cell. The subsequent decrease in available intracellular Ca^2+ produces muscle fiber relaxation and affects smooth muscle tissue.


Mechanistic Specificity and Limitations

The drug exhibits high functional selectivity for these central targets and smooth muscle pathways. Critically, it has only minimal inhibitory activity against the peripheral COX-1 and COX-2 enzymes at the plasma concentrations required for its primary effects. This limited peripheral action means the mechanism is focused on regulating central signaling dynamics but produces minimal peripheral anti-inflammatory consequences. Furthermore, the thermal mechanism is confined to modulating a dysregulated thermal set point and does not decrease body temperature in a physiologically normal state.

Dosage and Administration Information

General Administration Guidelines for Dipirona (Metamizole)

Dipirona, containing the active substance metamizole, is administered orally in the form of tablets, drops, or solution, or via intravenous (IV) injection. Use is generally based on selecting the lowest effective dose for the shortest necessary duration. Dosing frequency typically allows for repeated doses up to four times daily, maintaining a minimum interval of six to eight hours between administrations.

Dosing Rules by Age and Route

Age Group (or Weight) Route Single Dose (Maximum) Maximum Daily Dose
Adults & Adolescents (≥ 15 years or >53 kg) Oral 1000 mg 4000 mg
Adults & Adolescents (≥ 15 years or >53 kg) IV Injection 1000 mg 5000 mg
Children (<15 years) Oral (Drops/Solution) 8 mg/kg to 16 mg/kg Dosing follows weight-based parameters

Note on IV Administration: For intravenous use, the injection is administered very slowly to minimize the risk of a hypotensive reaction, with an administration rate not exceeding 1 mL/minute. If administered as a single dose, the patient should be in a supine position during the injection and for a short time afterward. Oral drops or solution forms should be taken mixed with a small amount of liquid.

There are no explicit instructions regarding administration timing in relation to meals; the medication can typically be taken independently of food. If a dose is missed, it is recommended not to take a double dose; the regular dosing schedule should be resumed with the next planned dose.

Recent Clinical Evidence

Dipirona Norgreen: Recent Clinical Evidence

Overview of Pharmacological Action

Dipirona, also known as metamizole, is a non-opioid analgesic and antipyretic agent. While its precise mechanism of action remains a subject of ongoing scientific investigation, research has explored the role of its active metabolites, such as 4-methylaminoantipyrine (MAA). These metabolites are thought to act centrally by potentially inhibiting cyclooxygenase-3 (COX-3) and modulating the effects of other pain-related systems, including the endogenous opioid and cannabinoid systems. This mechanism differs from the primary actions of traditional non-steroidal anti-inflammatory drugs (NSAIDs).


Efficacy and Study Findings

Clinical studies have evaluated Dipirona in the management of pain and fever. Evidence supports its use for acute severe pain, such as postoperative pain and colic-like abdominal pain. Studies have explored whether Dipirona provides relief comparable to other analgesics in treating various types of headaches, including migraine and tension-type headaches.

Area of Study Key Findings Evaluated
Postoperative Pain The effect on pain scores and opioid consumption in adult and pediatric populations.
Acute Pain (e.g., Colic) Its potential to reduce smooth muscle spasm associated with visceral pain.
Fever (Antipyresis) Its efficacy in lowering high body temperature when first-line treatments are unsuccessful.

Safety Profile and Ongoing Research

The most serious risk associated with Dipirona is a rare blood disorder called agranulocytosis. Epidemiological studies estimate the incidence of this event to be very low, though estimates vary widely across different populations. Regulatory bodies in some regions have conducted extensive reviews of the drug's benefit-to-risk ratio. The use of Dipirona has also been associated with rare cases of liver injury. Due to these potential adverse events, the drug's availability and use are restricted or banned in certain countries, while remaining widely used in others.

Frequently Asked Questions (FAQ)

Common questions about Dipirona Norgreen (FAQ)

Q: How quickly can I expect Dipirona Norgreen to start working?

Regulatory information indicates that a clear effect is described in regulatory documents as potentially occurring within 30 minutes following intravenous administration. The onset for oral forms is generally considered rapid.


Q: How long does the effect of Dipirona Norgreen typically last?

The duration of the pain or fever-relieving effect is reflected in the official guidance for repeat administration. Regulatory documents typically reference an interval of six to eight hours between oral doses.


Q: Is it known to interact with medicines for high blood pressure?

Official product information notes that this medicine can induce (increase the activity of) certain liver enzymes. This mechanism may reduce the concentration of co-administered drugs. The documented interaction with Dihydralazine (an anti-hypertensive agent) illustrates the potential for interaction with medicines in this therapeutic class.


Q: What is the main difference between Dipirona Norgreen and regular painkillers?

Regulatory documents classify this medicine as a pyrazolone derivative, a chemical class distinct from common painkillers like NSAIDs (e.g., ibuprofen) and Paracetamol. The drug's function is centered on providing relief for central pain and fever symptoms, which is achieved with minimal peripheral anti-inflammatory activity.


Q: Why is Dipirona Norgreen restricted or banned in some regions?

The drug's varying availability worldwide is documented to be due to reviews of its benefit-to-risk ratio conducted by regulatory authorities. The primary concern cited in these reviews is the rare but serious risk of a blood disorder called agranulocytosis.


Q: What kind of research has been done on Dipirona Norgreen?

Studies summarized in official documents have investigated its efficacy in managing severe acute pain, such as postoperative pain and colic, and its role as an antipyretic (fever-reducer). Epidemiological studies also examine its safety profile, particularly the risk of rare blood disorders.


Q: Is there a maximum time frame for continuous use of Dipirona Norgreen according to official labels?

Official regulatory documents define the intended duration as the lowest effective dose for the shortest necessary duration. For some specific, severe conditions, official use guidance suggests that continuous use should not exceed seven days.


Q: Can older adults use Dipirona Norgreen safely?

Official guidance states that a dose reduction is typically recommended for older adult patients, as the elimination of its metabolic products may be prolonged in this population.


Q: Are there any known issues with taking Dipirona Norgreen on an empty stomach?

Official administration instructions state that the drug can typically be taken independently of food. There are no explicit instructions or warnings against taking it on an empty stomach.


Q: Can I take Dipirona Norgreen if I am already taking an antidepressant?

Official information indicates that this medicine can induce liver enzymes, such as CYP3A4, which may lower the plasma concentration of many co-administered medicines. This includes the antidepressant Sertraline, suggesting the potential for interaction with medicines in this class.


Q: Can I take Dipirona Norgreen if I have asthma?

Official product information states that the medicine is generally contraindicated (prohibited) in patients with a history of bronchospasm or other hypersensitivity reactions triggered by aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs).


Q: Does Dipirona Norgreen cause drowsiness?

Official documents list certain potential adverse effects, including somnolence (drowsiness) and vertigo (dizziness). These documented effects are important for patient awareness.


Q: Does Dipirona Norgreen affect the ability to drive or operate machinery?

Official labeling states that due to the potential adverse effects, such as somnolence or vertigo (dizziness), a patient's ability to drive or operate complex machinery may be impaired.


Q: Is Dipirona Norgreen considered a habit-forming or controlled substance?

Regulatory and authoritative sources classify the drug as a non-opioid analgesic. It is considered a pyrazolone derivative, and it is not typically listed as a controlled substance.


Q: Does Dipirona Norgreen interact with birth control pills?

Official information documents the drug as an inducer of the liver enzyme CYP3A4. This mechanism can potentially reduce the plasma concentration of many co-administered drugs, which may include oral contraceptives.


Q: Is Dipirona Norgreen available over the counter in some countries?

The drug’s availability is known to range from prescription-only to over-the-counter status, depending on the country. This variation is a result of its differing global regulatory status, where it is withdrawn or banned in some regions but widely used in others.


Q: How is Dipirona Norgreen described by regulatory agencies in terms of effectiveness?

Regulatory documents describe its purpose as a potent non-opioid analgesic and antipyretic. It is indicated for the management of symptoms, specifically moderate to severe pain and high fever.

How should Dipirona Norgreen be stored and disposed of?

How to Store and Dispose of Dipirona Norgreen?

Storage and disposal must strictly adhere to official regulatory requirements to maintain product stability and ensure environmental safety.

Storage Conditions

Requirement Official Instruction
Temperature Store at controlled room temperature (e.g., typically not exceeding 25 C).
Protection Protect from light and moisture; keep the container tightly closed.
Handling Do not refrigerate or freeze.
Child Safety Keep out of the sight and reach of children.

The medicine must remain in its original container to maintain integrity until the stated expiration date.

Disposal Instructions

Unused or expired Dipirona Norgreen must be disposed of according to local regulations for medicinal waste. The preferred method is returning the product to an authorized drug take-back program. It is explicitly required not to throw away the medicine via wastewater (toilet or sink) or household trash.

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

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