Dipirona

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Dipirona

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Dipirona

What is Dipirona? (Sodium Metamizole)

Property Description
Active Ingredient Sodium Metamizole (Metamizole)
Common Forms Tablets, Oral solution, Solution for injection
Pharmacological Class Non-opioid analgesic, Antipyretic, Spasmolytic
Origin Synthetic organic compound (Pyrazolone derivative)
Primary Actions Pain relief, Fever reduction, Muscle spasm relaxation

Identity, Composition, and Origin of Sodium Metamizole

Dipirona is a recognized name for the medication containing the active ingredient Sodium Metamizole, which is also scientifically known as Dipyrone. This substance is a potent synthetic organic compound originating from the pyrazolone chemical group. It is typically prepared as a single-agent product, meaning the formulation contains only the active ingredient, Sodium Metamizole, combined with essential, inert excipients to create stable forms, such as solid tablets or a sterile solution for injection.

Pharmacological Class: Non-Opioid Analgesic and Triple Action

Sodium Metamizole is classified as a powerful non-opioid analgesic and antipyretic, serving to relieve pain and reduce fever without engaging the narcotic pathways of typical opioid drugs. Its official classification by the WHO designates it under the ATC code N02BB02. This drug is uniquely characterized as an atypical NSAID due to its central mechanism of action, distinguishing it from peripheral-acting agents. The medicine is supplied in multiple forms, including oral solution and drops, often intended for use in both adults and children where regulatory guidelines permit.

General Purpose and Unique Differentiation

The primary purpose of Dipirona is to provide effective relief from discomfort when a rapid and powerful response is needed for pain or fever. The pharmacological profile is clinically recognized for its defining triple action: providing strong analgesia, reducing fever (antipyresis), and offering a significant spasmolytic effect. This unique spasmolytic capacity is a key differentiating factor, making it a common choice for pain that involves involuntary muscle contractions, such as that associated with gastrointestinal or urinary tract distress. The compound functions as a prodrug, ensuring quick conversion into its active metabolites upon administration.

What side effects are possible with Dipirona?

Possible Side Effects and Safety Information

The official safety profile for Sodium Metamizole (Dipirona) is defined by the potential for adverse reactions that are classified by regulatory authorities based on the body systems affected. The most serious concerns involve the blood and immune systems, though these severe effects are generally classified as rare or very rare in official product labeling.


Officially Documented Adverse Reactions

Adverse effects are primarily grouped into the following System-Organ Classes (SOCs):

System-Organ Class Key Adverse Reactions Listed (by severity)
Blood and Lymphatic System Disorders Agranulocytosis (severe reduction in granulocytes) and Neutropenia
Immune System and Skin Disorders Anaphylactic shock, Anaphylaxis, Urticaria, and severe cutaneous reactions (e.g., Stevens-Johnson syndrome)
Hepatobiliary Disorders Acute hepatitis and Acute Liver Failure
Vascular Disorders Hypotension (a drop in blood pressure, noted particularly with rapid intravenous administration)

Key Safety Constraints and Patterns

The most serious reaction, agranulocytosis, is officially noted to be dose-independent and can occur at any time during treatment or even shortly after the medicine is stopped. The risk may increase with the duration of intake. Because of this risk, the medicine is restricted and generally should not be used in individuals with a history of Metamizole-induced agranulocytosis or pre-existing severe bone marrow disorders.

Furthermore, regulatory documents state that the medicine is contraindicated during the third trimester of pregnancy due to specific risks to the developing fetal circulatory system. The official safety data focuses on outlining these specific, label-documented adverse outcomes.

Overdose and Emergency Response

Overdose and When to Seek Help: Official Regulatory Information

Overdosage with Dipirona (Sodium Metamizole) is documented in regulatory sources to affect multiple physiological systems, ranging from mild to life-threatening severity. Immediate medical attention is required for any suspected overdosage.

Documented Overdose Manifestations

Overdose presentations may include initial signs of Gastrointestinal Toxicity, such as nausea, vomiting, and abdominal pain. Central Nervous System symptoms are also documented, encompassing somnolence, vertigo, and agitation, potentially progressing to convulsions and coma. Severe toxicity also includes cardiovascular and renal effects.

Severe Outcomes and Emergency Actions

The regulatory profile identifies life-threatening outcomes, including severe blood pressure decrease (Shock) and Acute Renal Failure. If severe or life-threatening symptoms manifest, contact emergency services immediately.

The established management approach is restricted to Symptomatic and supportive treatment, as no specific antidote is known. Procedures to limit absorption, such as gastrointestinal decontamination, and measures to accelerate elimination, like haemodialysis, are described as necessary management steps that require hospital monitoring.

Therapeutic Uses of Dipirona

What Dipirona Treats: Main Uses and Benefits

Dipirona (Sodium Metamizole) is commonly used to provide symptomatic assistance across key domains of discomfort, particularly in clinical settings marked by heightened distress. This includes addressing symptoms related to physical discomfort and symptoms that interfere with daily functioning. It is considered relevant for managing severe pain and fever where additional symptomatic support is needed.

The medicine is applied in contexts where short-term symptomatic assistance is needed for moderate to severe acute pain, such as post-surgical discomfort, severe headache episodes, and chronic tumor-related pain. It is also generally used to help with conditions involving episodic or fluctuating manifestations of pain driven by smooth muscle contractions, including the intense, cramp-like discomfort of renal colic and biliary colic.

The therapeutic benefit contributes to easing the overall symptom load and supports the patient during difficult episodes. The therapeutic benefit supports the patient's comfort when pain is coupled with spasms.

“The medication may be applied to support the patient during episodes of heightened discomfort by easing distress.”

Quick Fact: Symptomatic Support for Colic Pain

Quick Fact: Addressing Cramp-like Spasms Dipirona may assist with maintaining functional stability and contributes to improved comfort by addressing the specific symptom clusters of pain associated with involuntary smooth muscle contractions.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Dipirona — Official Regulatory Information

The eligibility profile for using Dipirona (metamizole) is strictly defined by regulatory bodies and depends heavily on the country of authorization, as the medicine is banned for human use in some jurisdictions (e.g., the United States) but authorized in others (e.g., Brazil and many European nations).

Official Eligibility Constraints

Use is contraindicated and explicitly prohibited for specific populations due to the potential for severe adverse reactions, particularly affecting the blood-forming system. You must not use Dipirona if you have:

  • A history of agranulocytosis (a severe reduction in white blood cells) caused by metamizole or other pyrazolone derivatives.
  • Impaired bone marrow function or a pre-existing disease of the hematopoietic system.
  • Acute intermittent hepatic porphyria or congenital glucose-6-phosphate dehydrogenase (G6PD) deficiency.
  • Known hypersensitivity to metamizole or its related compounds.

Restrictions Based on Age and Physiological State

The medicine is also contraindicated for infants under three months of age or those weighing less than 5 kg.

Furthermore, use is contraindicated during the third trimester of pregnancy due to potential risks to the fetus and while breastfeeding (unless the period is strictly managed according to the product label).

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official interaction profile for Dipirona (Sodium Metamizole) is largely defined by its metabolic effects. The medicine is documented as a moderate to strong inducer of several Cytochrome P450 enzymes, specifically CYP2B6, CYP3A4, and CYP2C19. This enzyme induction leads to a pharmacokinetic interaction that results in the reduction in plasma concentrations of sensitive co-administered substrates, which includes immunosuppressants like Ciclosporin and Tacrolimus, the antidepressant Bupropion, and certain Direct Oral Anticoagulants (DOACs).


Co-administration is not recommended or should be avoided with several agents. This includes Methotrexate due to the officially documented risk of increasing its blood toxicity (myelosuppression), and other NSAIDs due to the risk of cumulative renal and hepatic injury. A pharmacodynamic interaction exists with low-dose Acetylsalicylic acid (Aspirin), where co-administration may reduce the antiplatelet effect; this is a time-sensitive interaction requiring consideration of the sequence of administration. In elderly patients and those with reduced creatinine clearance, the elimination of metabolic products may be prolonged, carrying an accumulation risk. Furthermore, co-use with Alcohol may potentiate the effects of both agents.

Mechanism of Action

Dipirona (metamizole) functions as a pro-drug, rapidly metabolized into active compounds, including 4-Methylaminoantipyrine (MAA), which exhibit a multi-target pharmacodynamic profile. These lipophilic metabolites readily cross the blood-brain barrier to act within the central nervous system (CNS).

Central Modulation of Nociceptive and Thermoregulatory Pathways

The primary mechanism involves the inhibition of the Cyclooxygenase-3 ( COX-3) enzyme within the CNS. This enzyme interaction blocks the synthesis of Prostaglandin E2 ( PGE2), influencing signal transduction in pathways associated with nociception and regulating thermoregulatory set-points.

Smooth Muscle Ca^2+ Dynamics Adjustment

Further mechanistic activity involves the modulation of intracellular calcium ion ( Ca^2+) dynamics in smooth muscle cells. This interference with Ca^2+ availability results in the adjustment of smooth muscle tension. Separately, the metabolites potentially interact with endogenous systems that regulate descending inhibitory pathways, influencing the overall profile of central signal modulation.

Dosage and Administration Information

Administration and Official Usage Patterns

Dipirona (Sodium Metamizole) is approved for administration through multiple official routes, including Oral (as tablets or solution), Intravenous (IV), Intramuscular (IM), and Rectal (as suppositories). The administration route is selected based on the clinical context and the required speed of effect, though the medicine is intended for short-term symptomatic use only.


Dosage and Frequency

For adults (age 15 and above or >53 kg), the standard single oral dose ranges up to 1,000 mg. The medication is generally taken intermittently, with a maximum frequency of 4 times per day. A minimum interval of 6 to 8 hours must be maintained between doses, and the total daily oral dose should not exceed 4,000 mg. The lowest effective dose should always be selected to manage the symptoms.


Procedural and Population Requirements

Specific procedural instructions govern the parenteral administration technique. Intravenous injection must be administered slowly, over a defined period of at least 5 minutes, as a procedural requirement documented in regulatory information.

Dosing is further structured for specific populations: the dosage for children and adolescents (up to 14 years of age) is primarily based on body weight (e.g., 10–16 mg/kg per dose). Additionally, a dose reduction is generally necessary for older adults and patients with known impaired renal or hepatic function, based on caution in drug elimination capacity.

Recent Clinical Evidence

Dipirona: Recent Clinical Evidence

Clinical evidence for dipirona (also known as metamizole) centers on its use as a non-opioid analgesic (pain reliever) and antipyretic (fever reducer). It is widely available in many countries but is banned or restricted in others, including the United States and the United Kingdom, due to concerns over rare but potentially life-threatening blood disorders.

Efficacy and Indications

Dipirona is principally studied for the management of moderate to severe acute pain and fever. Systematic reviews, including those from Cochrane, have examined its effectiveness:

  • Acute Postoperative Pain: Single doses of 500 mg to 1000 mg have been compared with placebo in randomized controlled trials (RCTs). Studies indicate that a 500 mg dose provides pain relief for a significant proportion of patients with moderate to severe pain over a four- to six-hour period.
  • Fever: Research has investigated its use as an antipyretic, showing it to be effective at reducing high-temperature levels. Comparative studies in children have suggested an antipyretic effect similar to that of ibuprofen.
  • Other Pain Types: Dipirona is also studied for use in conditions involving pain, such as renal colic and cancer-related pain.

Safety and Tolerability

While considered relatively safe for short-term use in hospital settings in regions where it is available, the drug's tolerability profile remains a subject of debate due to reports of rare, serious adverse events.

Adverse Event Concern Clinical Research Findings
Agranulocytosis (severe drop in white blood cells) A rare but critical risk; incidence estimates vary widely (e.g., 1 in 10,000 to 1 in 1,000,000 exposed). This is the primary reason for market withdrawal in some countries.
Gastrointestinal Risk Studies suggest a favorable gastrointestinal tolerability profile compared to classic non-steroidal anti-inflammatory drugs (NSAIDs).

High-quality, long-term trials assessing the intermediate and long-term safety of dipirona are still needed.

Frequently Asked Questions (FAQ)

Common questions about Dipirona (FAQ)


Q: Does Dipirona cause dependence or withdrawal symptoms?

Dipirona (metamizole) is classified as a non-opioid analgesic, which means it works differently than narcotic pain relievers. Official product information and regulatory documents generally do not list physical dependence or withdrawal symptoms as a recognized risk or adverse effect associated with this medication.


Q: How quickly does Dipirona start working after I take a tablet?

According to official product information, when Dipirona is taken orally (as a tablet or solution), the medication typically begins to show its analgesic or fever-reducing effect approximately 30 to 60 minutes after intake. The drug is known for a relatively quick onset of effect due to how it is processed by the body.


Q: Can I use Dipirona for long-term chronic pain management?

Official regulatory documents indicate that Dipirona is intended primarily for the short-term treatment of acute pain and fever. Due to the rare but serious risk of agranulocytosis (a severe blood disorder), official warnings stress that the duration of treatment should be kept as brief as possible. The risk of rare side effects, such as agranulocytosis, may be associated with increased duration of use.


Q: Is it safe to take Dipirona with my oral contraceptive pill?

Regulatory documents advise caution when combining Dipirona with certain hormonal contraceptives. Dipirona is documented as a moderate inducer of specific liver enzymes (like CYP3A4), which may potentially reduce the plasma concentration of the contraceptive. Due to this potential interaction, regulatory information suggests discussing the need for alternative or additional non-hormonal contraception.


Q: Can I take this medication with food, or does it have to be on an empty stomach?

Official instructions state that oral forms of Dipirona, such as tablets or solutions, can be taken with or without food. Taking the medication immediately after a meal may cause a slight delay in the onset of its effects. The effect on overall absorption or effectiveness is typically considered negligible when taken with meals.


Q: Are there any specific lifestyle changes recommended while taking Dipirona (e.g., avoiding sun exposure)?

Official safety information does not generally contain warnings about sun avoidance. However, regulatory documents indicate that the ability to concentrate and react may be impaired, particularly if high doses are taken or if alcohol is consumed, which should be considered before driving or operating machinery.


Q: What happens if I accidentally take two doses too close together?

Accidentally taking doses closer than the minimum recommended time interval exceeds the intended limits, which may increase the risk of side effects. Regulatory documents mention that potential overdose can cause symptoms like a drop in blood pressure (hypotension). If symptoms of a potential overdose are experienced, prompt medical attention is advised.


Q: What is the standard liquid dose for a child who weighs 35 kg?

Official drug labels contain detailed weight-based dosing charts for children. These charts specify the appropriate single oral volume of the liquid solution for specific weight ranges (such as 31-45 kg) and establish strict limits on the maximum total daily dose. The required dose must be determined by a healthcare professional based on the specific product label.

How should Dipirona be stored and disposed of?

The storage and disposal of Dipirona (Sodium Metamizole) must strictly follow the conditions specified in the medicine's official regulatory labeling.

Storage Requirements

Condition Requirement
Temperature Store below 30 C or 25 C, as specified on the package.
Protection Store in the original package, protected from light and moisture.
Handling Keep the container tightly closed. Do not freeze formulations unless explicitly directed.
Child Safety Keep out of the sight and reach of children.
Stability Observe the product's limited in-use stability period after first opening liquid forms.

Disposal Instructions

Official instructions mandate that expired or unused Dipirona must not be disposed of via wastewater or household waste. The medicine should be returned to a pharmacist or a designated collection point, ensuring proper pharmaceutical waste handling according to local regulations.

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

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