Danantizol

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Danantizol

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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

Overview of Danantizol

Quick Facts

Property Description
Active Ingredient Sodium Metamizole (Dipyrone)
Form Tablets, Solution for Injection, Suppositories
Pharmacological Class Non-opioid Analgesic, Antipyretic, Spasmolytic
Common Purpose Relief of severe pain and high fever
Origin Synthetic, Pyrazolone Derivative

What is Danantizol and Its Primary Active Substance?

Danantizol is a medicine whose active substance is Sodium Metamizole, which is also widely recognized by the chemical synonyms Metamizole or Dipyrone. This compound is a synthetic substance belonging to the pyrazolone derivative chemical group, a structure distinct from that of conventional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). The pyrazolone structure is used for delivering combined pain and fever relief alongside the ability to relax smooth muscles. As a single-ingredient product, Danantizol ensures the therapeutic effects are derived solely from the Metamizole component.

Pharmacological Class and General Purpose

Sodium Metamizole is primarily classified as a potent non-opioid analgesic, an antipyretic, and a powerful spasmolytic. This triple classification establishes its main pharmacological actions: relieving pain, reducing fever, and soothing muscle contractions. This medication is indicated for managing severe pain and fever when they are unresponsive to other available treatments. The mechanism of Metamizole includes its action as a primary spasmolytic agent. This capability allows Danantizol to address intense, cramping pain associated with involuntary muscle contractions, such as biliary or renal spasm.

Available Forms and Administration Routes

Danantizol is available in several versatile dosage forms, including tablets for oral use, suppositories for rectal administration, and sterile solutions for injection intended for rapid parenteral delivery. This variety of forms is a key distinguishing feature, ensuring that the medicine can be administered rapidly via the parenteral route when quick onset is essential for managing severe pain, or when a patient cannot take medication orally.

What side effects are possible with Danantizol?

Possible side effects and safety information

The safety profile of Danantizol, whose active substance is Sodium Metamizole, is defined by specific risks formally documented in regulatory texts. Adverse reactions are classified by frequency and grouped into System-Organ Classes (SOCs).

Official Adverse Reactions and Safety Classifications

Classification Examples of Reactions (SOC)
Rare Agranulocytosis (Blood and Lymphatic System Disorders), Leukopenia, Pancytopenia.
Uncommon Hypersensitivity Reactions (Immune System Disorders, Skin).
Common Hypotensive Reactions (Vascular Disorders), particularly with injection.
Frequency Not Known Severe Cutaneous Adverse Reactions (SJS, TEN, DRESS), Acute renal failure.

Agranulocytosis is a critical, potentially life-threatening reaction characterized by a severe drop in white blood cells. Regulatory documents specify that this serious adverse reaction is not dose-related and can occur at any time during or shortly after treatment exposure. The risk of Anaphylactic Shock is also listed, although classified as Very Rare.

Safety Constraints and Special Populations

Hypotensive Reactions are officially noted to be dose-dependent and more pronounced with the parenteral route of administration, especially following too rapid intravenous injection. For patients with renal or hepatic impairment, official labeling indicates that the elimination rate of Metamizole metabolites is reduced, necessitating caution and advising against the use of multiple high doses. The appearance of a reddish discoloration of the urine is also officially documented as a harmless event caused by a drug metabolite.

Overdose and Emergency Response

A suspected overdose of Danantizol (Sodium Metamizole) is a severe medical event that requires immediate medical attention. The official regulatory profile identifies a cluster of documented manifestations across several physiological systems.

Initial signs often include gastrointestinal disturbances (nausea, vomiting, abdominal pain) and Central Nervous System (CNS) effects such as somnolence, dizziness, and tinnitus, which can progress to seizures or coma in severe cases. Cardiovascular effects like hypotension and tachycardia are also recognized signs of toxicity in regulatory labeling.

The most critical, life-threatening outcomes described in regulatory documentation involve circulatory collapse (shock), severe cardiac arrhythmias, and acute kidney failure (oliguria/anuria). Due to these systemic risks, individuals must contact emergency services or a Poison Control Center immediately upon suspected overdose.

Management is based entirely on symptomatic and supportive treatment, as regulatory labels state that no specific antidote is known. Supportive measures described include gastric lavage, activated charcoal administration, and, in severe cases, accelerated elimination procedures like hemodialysis. Hospital monitoring of vital signs, renal function, and hepatic function is required. Regulatory guidance further notes that patients with pre-existing impaired renal or hepatic function may be at an increased risk of severe toxicity.

Therapeutic Uses of Danantizol

What Danantizol Treats: Main Uses and Benefits

The medication is considered relevant for providing symptomatic support across several key domains marked by heightened patient distress. It is generally applied in contexts where additional support for symptom management is needed, particularly when existing therapeutic measures have not provided sufficient relief.

It is commonly used to help with managing acute severe pain after trauma or surgery, applied for managing symptoms related to colic syndromes (such as renal, biliary, or intestinal colic), applied in situations where additional symptomatic support is needed, and addressing high fever that is unresponsive to conventional therapeutic measures. The comprehensive approach supports patients in coping more steadily with difficult episodes by supporting pain relief, fever reduction, and easing the intensity of muscle spasms.

“It is commonly used across conditions presenting with acute episodes and provides support that helps ease the overall symptom burden.”

Quick Fact: Supportive Management for Severe Pain, Colic, and Refractory High Fever

The medication may assist with managing symptoms that create noticeable physiological strain and assists with maintaining functional stability during periods of heightened discomfort.

Eligibility and Restrictions for Use

Who Can and Cannot Use Danantizol (Danazol) — Official Regulatory Information

Danantizol (Danazol) is a synthetic steroid whose use is strictly governed by a number of official regulatory restrictions, or contraindications.

Populations and Conditions Prohibited from Use

The medicine is officially contraindicated and must not be used in individuals with the following:

  • Pregnancy and Breastfeeding: Use is strictly prohibited during both pregnancy (classified as Category X) and lactation due to the risk of fetal harm. Women of childbearing potential are required to use effective, non-hormonal contraception during therapy.
  • Impaired Organ Function: Patients with markedly impaired function of the liver (hepatic), kidneys (renal), or heart (cardiac) are restricted from use.
  • Thrombotic Disorders: Individuals with active thrombosis or thromboembolic disease, or a history of such events, are restricted.
  • Specific Diseases: Contraindicated in patients with porphyria or an androgen-dependent tumor.
  • Other: Contraindicated for those with undiagnosed abnormal genital bleeding or a known hypersensitivity to the drug.

Groups Requiring Special Consideration

Careful observation and medical supervision are required for patients with certain pre-existing conditions that may be influenced by fluid retention, including epilepsy, migraine headaches, hypertension, or diabetes mellitus.

What should I know about interactions with other medicines?

Danantizol Interactions with other medicines and products

Danantizol (also known as Danazol) can interact with a wide variety of medicines, which may increase the risk of side effects or change the effectiveness of either drug. It is essential to inform your healthcare provider about all prescription and non-prescription medicines, supplements, and herbal products you are currently taking.

Major Drug Interactions (Avoid use)

Concurrent use of Danantizol with certain medications is generally avoided due to the potential for serious adverse effects. These include:

  • Statins: Such as Simvastatin or Lovastatin, which can lead to a significantly increased risk of muscle damage (myopathy/rhabdomyolysis).
  • Calcium Channel Blockers (CCBs): Medications like Diltiazem or Verapamil can increase the risk of serious heart-related events and hyperkalemia when given with intravenous Danantizol.

Other Significant Interactions

Danantizol may also affect the action of the following drug classes, often requiring dose adjustments or closer monitoring:

Drug Class Potential Interaction Monitoring/Action
Anticoagulants (e.g., Warfarin) Increased effect, potentially leading to bleeding. Frequent blood clotting tests (INR).
Medicines for Diabetes May affect blood sugar control, requiring adjustment of diabetes medication doses. Regular monitoring of blood glucose levels.
Immunosuppressants (e.g., Cyclosporine) Increased blood levels of the immunosuppressant, raising the risk of toxicity. Therapeutic drug monitoring (TDM).
Anticonvulsants (e.g., Carbamazepine) Increased blood levels of the anticonvulsant. Monitoring of drug levels and for signs of toxicity.

Alcohol and Other Sedating Products

Danantizol can cause dizziness or drowsiness, and consuming alcohol or taking other medications that cause central nervous system (CNS) depression (such as benzodiazepines or certain pain medications) can enhance these sedative effects, potentially impairing coordination and judgment.

Mechanism of Action

The pharmacological action of Danantizol stems from its active metabolites, which act via a multi-modal mechanism targeting three key mechanistic domains simultaneously. The core effect involves the inhibition of central Cyclooxygenase-3 (COX-3), an enzyme predominantly found in the CNS. By restricting the production of local signaling molecules like Prostaglandin E2, this action modulates nociceptive signaling and resets the elevated set-point of the hypothalamic thermoregulation center. Complementary to this, the metabolites function as modulators at central Cannabinoid Receptor Type 1 (CB1) and engage components of the opioidergic system. This dual interaction reinforces the descending inhibitory pathways, providing a multi-target modulation of afferent signaling. Separately, the spasmolytic mechanism targets involuntary smooth muscle cells in visceral organs. This action interferes with the intracellular signaling required for sustained contraction, specifically by reducing the release of ionic Ca^2+ (calcium). This direct interference promotes the hyper-relaxation of smooth muscle tissue, a key physiological consequence of the cellular mechanism.

Dosage and Administration Information

Administration and Official Dosing Guidelines

Danantizol (Metamizole) is approved for use via multiple routes. These include oral administration (tablets or drops), rectal administration (suppositories), and parenteral delivery (intravenous or intramuscular injection) using a solution. This multi-route availability supports administration across various clinical needs.

The use of Metamizole is guided by the principle of starting with the lowest dose necessary to manage symptoms. For adults (ge 15 years and >53 kg), the standard single oral dose is typically 500 mg to 1,000 mg (1 g). The maximum recommended oral dose should not exceed 4,000 mg (4 g) in a 24-hour period, and doses must be separated by an interval of at least 6 to 8 hours. The total daily parenteral dose (IV/IM) has an official upper limit of 5,000 mg.

Administration Specifics

Dosing for children and adolescents (le 14 years) is calculated strictly based on body weight, with a common single dose ranging from 8–16 mg/kg. Specific procedural requirements are outlined for the injection route: when administered intravenously, the injection must be given very slowly. While Danantizol is primarily used for acute, short-term episodes, use is structured to avoid repeated high doses in patients with existing renal or hepatic impairment.

Recent Clinical Evidence

Danantizol: Recent Clinical Evidence

Research Evidence / Overview of Studies

Early-Phase Investigations

Early research has focused primarily on the initial behavior of the drug components and tolerability profile of the drug combination. Research has explored whether this combination may be associated with pain and inflammation relief. These initial, small-cohort trials typically focused on healthy volunteers and surrogate markers rather than patient-reported outcomes.

One key study evaluated the dual mechanism of action. This early research provided foundational data for further clinical investigation.

Efficacy Trials (Phase 2 & 3)

Chronic Pain

Clinical trials, primarily Phase 2 studies, have focused on the drug’s potential application in chronic musculoskeletal pain. Small-scale trials reported a change in chronic joint pain over a 12-week period. The available data may be reviewed.

Acute Pain Relief

Research has also investigated the agent’s potential in managing acute pain, such as post-operative discomfort. Studies evaluated whether the use of the drug was associated with a change in pain within 30 minutes. Outcomes were measured using patient-reported relief scores and the need for rescue medication. Other studies examined whether the drug performed differently than monotherapy.

Safety and Tolerability Profile

The tolerability of the drug has been evaluated across all clinical phases. Studies reported that the most commonly reported events included mild gastrointestinal upset and headache. Data also suggests long-term use was evaluated in most individuals. Studies evaluated use in individuals with heart conditions. The overall adverse event rate was reported to be comparable to placebo in many Phase 2 trials, though a direct comparison is subject to interpretation.

Conclusion of Evidence

Overall, research continues to evaluate its use as a first-line treatment. The current body of literature indicates the need for larger, longer studies to evaluate long-term findings.

Key Studies & References

  1. Systematic Review on Treatments for Acute Pain (AHRQ Report, supporting Acute Pain efficacy and comparisons)
  2. Long-Term Treatment with Antithyroid Drugs: Efficacy and Safety (Review discussing long-term tolerability/AEs, supporting Safety profile claims)

Frequently Asked Questions (FAQ)

Common questions about Danantizol (FAQ)

Q: How long does it typically take to feel the effects of Danantizol?

A: According to the official product information, the main pain-relieving effect of Danantizol after oral administration can generally be expected to begin within 30 to 60 minutes. The onset of action is understood to vary, reflecting individual physiological differences.

Q: Is Danantizol a type of pain reliever?

A: Yes, Danantizol (Metamizole) is officially classified as a potent non-opioid analgesic, which means it is a type of pain reliever that is not related to opioids. It is also classified as an antipyretic (fever reducer) and a spasmolytic (a medicine that relieves muscle spasms).

Q: Does Danantizol affect your ability to drive or operate machinery?

A: Official labeling indicates that if an individual experiences symptoms that could impair judgment or coordination, such as headache or dizziness, caution is recommended. Due to the potential for impaired coordination, this warning is noted in official documents.

Q: Is Danantizol usage restricted for people with liver problems?

A: Yes, official labeling includes warnings regarding the potential for serious liver injury, including acute hepatitis or acute liver failure. Patients with existing, markedly impaired liver function are restricted from using the medicine. If symptoms of liver problems (like fever, dark urine, or yellowing of the skin) occur, official guidance is to discontinue use and seek immediate medical attention.

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

A: If a dose is missed, official dosing principles advise that it can be taken as soon as it is remembered, provided the necessary time interval before the next scheduled dose is respected. Official documents advise that if the next dose is due shortly, the missed dose should generally be skipped to maintain the proper dosing separation.

Q: What is the general duration of treatment with Danantizol?

A: According to regulatory documents, the treatment duration should be kept as short as possible. This ensures the medicine is only used to manage the severe pain or fever for which it is indicated and minimizes long-term exposure.

Q: Is Danantizol a non-habit-forming medicine?

A: Danantizol (Metamizole) is classified as a non-opioid analgesic. It is not classified as a controlled substance and does not carry the same risk of dependence or habit formation typical of traditional opioid medications.

Q: How is Danantizol different from other medicines that treat similar conditions?

A: Danantizol (Metamizole) is a pyrazolone derivative, distinguishing it chemically from traditional non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol. Its unique pharmacological profile includes potent pain relief, fever reduction, and a strong spasmolytic effect, allowing it to relax smooth muscles.

Q: Is Danantizol considered a high-risk medication?

A: Official regulatory warnings highlight the very rare but potentially life-threatening risk of agranulocytosis (a severe drop in white blood cells), which is not dose-related. The presence of this risk is the basis for its regulatory indication, which specifies use for managing severe pain or high fever when other treatments are ineffective or contraindicated.

Q: Are there any long-term side effects associated with Danantizol use?

A: Official guidance emphasizes that treatment duration should be as short as possible. While the most serious risks, such as agranulocytosis, are not strictly duration-dependent, some reports of liver injury have occurred during more prolonged therapy. The use of the medicine for extended periods is defined in regulatory documents as requiring careful medical supervision.

Q: Can teenagers or children use Danantizol for its approved conditions?

A: Yes, Danantizol can be used in children and adolescents for its approved conditions. The official dose for these populations is based strictly on body weight. However, official documents state that the medicine is contraindicated in infants below the age of 3 months or who weigh less than 5 kg.

Q: Does Danantizol interact with common over-the-counter pain medications?

A: Official product information states that Danantizol has been shown to reduce the effect of acetylsalicylic acid (ASA or Aspirin) when both are taken at the same time. Information on co-administration with other over-the-counter pain relievers is an important consideration for a healthcare provider.

Q: What is the difference between Danantizol and placebo in clinical studies?

A: Clinical trials and systematic reviews indicate that Danantizol provides good short-term relief for pain and fever. Clinical trials confirm that the results achieved with the medicine are statistically superior to the outcomes observed with a placebo in the stated indications.

Q: Is it normal to feel a mild headache when starting Danantizol?

A: Headache is listed as one of the possible adverse effects of Danantizol in regulatory documents. Adverse events are grouped by their frequency, but an exact rate for a mild headache is not universally established in the official labeling.

Q: Do I need to take Danantizol at a specific time of day?

A: Official dosing guidelines establish the necessary time interval between doses, typically 6 to 8 hours, to ensure the maximum daily dose is not exceeded. While consistently maintaining this interval is necessary, taking the medicine at a specific time of day (like morning or night) is not generally required.

Q: Does Danantizol help with sleep problems?

A: Danantizol is not officially indicated for the treatment of sleep problems. However, drowsiness (somnolence) is listed as an adverse effect with an unknown frequency in some official reports.

Q: I heard Danantizol can cause drowsiness; is that a frequent side effect?

A: Drowsiness (somnolence) is listed as an adverse effect of Danantizol. The official labeling classifies the frequency of this specific side effect as 'not known,' meaning that a reliable estimate of its occurrence rate cannot be determined from the available data.

How should Danantizol be stored and disposed of?

How to Store and Dispose of Danantizol (Sodium Metamizole)

Official labeling requires specific conditions to maintain the stability and quality of Danantizol. Storage temperature limits vary by form: tablets must be stored below 30 C, while the solution for injection and suppositories require storage below 25 C.

Storage and Handling

The Solution for Injection must be protected from light and must not be frozen. The medicine must be kept in its original packaging. For stability, any solution remaining in the injection ampoule after opening must be discarded immediately.

Disposal and Safety

All forms must be stored out of the sight and reach of children.

Disposal instructions prohibit discarding unused or expired Danantizol into wastewater or household trash. Instead, the medicine must be returned to a pharmacist or official collection point for proper pharmaceutical waste handling.

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

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