Devaljin

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Devaljin

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 Devaljin

Devaljin: Identity, Classification, and Composition

Property Description
Active ingredient Sodium Metamizole (Dipyrone)
Form Tablets, Capsules, Solution for Injection, Oral Drops
Pharmacological class Non-opioid Analgesic, Antipyretic, Spasmolytic
Common use Pain, Fever, Smooth Muscle Spasms
Origin Synthetic (Pyrazolone derivative)

Devaljin is the commercial name for a medication containing the synthetic substance Sodium Metamizole, which is also frequently identified as Dipyrone or Metamizol. This core chemical entity is classified as a potent non-opioid analgesic, an antipyretic, and a marked spasmolytic agent, thereby establishing it as a distinct compound within pharmacology. The drug's structure, a pyrazolone derivative, differentiates its pharmacological behavior from both common pain relievers like Paracetamol and traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Sodium Metamizole is clinically recognized for its efficacy in reducing pain and fever by acting on the central nervous system. The preparation is a single active ingredient product supplied in multiple dosage forms, including tablets, capsules, and solutions for injection.


What is the Primary Purpose of Sodium Metamizole?

The primary purpose of Sodium Metamizole is to provide effective relief from severe pain and significantly high fever, offering a targeted therapeutic benefit.

This medicine’s utility originates from its triple mechanism, which combines a strong pain-relieving effect with direct action on the central temperature regulation system. Notably, the compound exhibits a strong spasmolytic effect, which is achieved by helping to relax specific smooth muscles. The spasm-relieving properties of Metamizole are particularly valuable for treating abdominal or visceral pain. This unique property makes the medicine suitable for managing discomfort associated with internal muscle cramps, such as a severe visceral spasm, allowing it to simultaneously address the spasm and the resulting discomfort. Additionally, as a pro-drug, the compound undergoes rapid metabolic conversion into highly active compounds, ensuring prompt therapeutic effects.

Regulatory References

  1. Metamizole containing medicinal products - referral (EMA)

What side effects are possible with Devaljin?

Possible Side Effects and Safety Information

Devaljin (Metamizole or Dipyrone) is associated with a risk profile defined by specific, severe adverse reactions, which has led to regulatory restrictions or market withdrawal in various countries, including the United States.

Serious and Clinically Significant Adverse Reactions

The most serious documented risk is Agranulocytosis, a rare but potentially life-threatening blood disorder characterized by a sudden, sharp decrease in white blood cells (neutrophils). This condition can lead to severe infection and may occur at any time during or shortly after treatment, regardless of the dose used. Symptoms that warrant immediate medical attention include fever, chills, sore throat, and painful sores on moist, inner body surfaces (mucosa).

Other severe, rare reactions include Acute Hepatitis and Acute Liver Failure, Anaphylaxis (severe allergic shock), and severe cutaneous reactions like Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Common Adverse Reactions

Commonly reported side effects often involve the gastrointestinal and nervous systems, and may include nausea, vomiting, headache, somnolence, vertigo, and rash.

Population and Regulatory Restrictions

Category Regulatory Status/Limitation
Pregnancy Contraindicated during the last three months due to potential adverse effects on the fetus’s renal function and circulation (ductus arteriosus constriction).
Breastfeeding Avoided; if a single dose is administered, official guidance recommends discarding breast milk for 48 hours before resuming feeding.
Agranulocytosis Risk Contraindicated in patients with a prior history of the condition caused by this medicine or similar drugs.

Dosage guidelines established by regulatory bodies recommend starting with the lowest effective dose. The drug is generally reserved for treating severe pain or fever that has not responded adequately to other therapeutic options.

Overdose and Emergency Response

Devaljin Overdose and when to seek help

The official regulatory profile for Devaljin (Sodium Metamizole) overdose is defined by its documented symptom profile and mandatory emergency response, given the lack of a specific reversal agent.

Documented Overdose Manifestations

Overdose may present with a range of symptoms documented in regulatory sources. Common clinical presentations include gastrointestinal disturbances such as nausea, vomiting, and abdominal pain. Central nervous system effects are also recorded, including headache, weakness, somnolence, and rarely, more severe manifestations like spasms, convulsions, or coma. Systemic signs like fever, tachycardia, and hypotension are noted.

Severe Outcomes and Required Emergency Action

Regulatory documents warn that overdose may escalate to life-threatening events. Severe outcomes explicitly listed include Acute Kidney Failure, profound Hypotension, and Circulatory Shock.

Immediate medical attention is required upon suspected or confirmed overdose. Urgent medical care must be sought for the onset of any severe sign, such as shock, loss of consciousness, or evidence of acute organ failure, as mandated by official labeling.

Management and Antidote Status

No specific antidote is known for a Sodium Metamizole overdose. Consequently, treatment is strictly Symptomatic and Supportive. Officially documented procedural steps to manage overdose include reducing absorption via Gastric Lavage or Activated Charcoal, and potentially accelerating elimination using extracorporeal measures like Hemodialysis to remove the active metabolite.

Therapeutic Uses of Devaljin

What Devaljin Treats: Main Uses and Benefits

Devaljin is relevant in therapeutic areas that involve managing symptoms related to physical discomfort and inflammation. The therapeutic use of this category of medication is broadly relevant for easing symptoms related to systemic imbalance, such as fever.

This category of medication is used in conditions characterized by periods of heightened symptoms including pain, stiffness, and inflammation. Common clinical scenarios involve providing supportive relief for symptoms arising from musculoskeletal issues, joint stiffness, and symptoms associated with acute or episodic changes. It helps address symptom clusters that may become intense or disruptive and is applied across domains where additional symptomatic support is needed.

This medication is generally used to address symptoms related to physical discomfort and inflammatory or irritative states, such as pain, aching, swelling, and tenderness, providing support that helps ease the overall symptom burden. It contributes to improved comfort during periods of heightened symptoms by assisting with maintaining functional stability.


Quick Fact: Supportive Relief for Pain and Fever This medication is commonly used to help with symptoms associated with acute or episodic changes and discomfort caused by inflammation.

Eligibility and Restrictions for Use

Who Can and Cannot Use Devaljin

Official regulatory documents define population eligibility for Devaljin (Sodium Metamizole) based on age, physiological status, and specific clinical conditions.

Absolute Non-Eligibility (Contraindications)

Contraindicated Populations Status Official Restriction / Rule
Hematological Conditions Contraindicated History of Metamizole-induced agranulocytosis or impaired bone marrow function.
Infants Contraindicated Under 3 months of age or body weight less than 5 kg.
Pregnancy Contraindicated Use is strictly prohibited during the third trimester of pregnancy.
Hypersensitivity Contraindicated Known hypersensitivity to Metamizole or other pyrazolone derivatives.

Conditional Use and Restrictions

Use of Devaljin is subject to official restrictions in certain populations, often requiring careful assessment by a healthcare professional.

  • Organ Impairment: Multiple high doses must be avoided in patients with severe renal or hepatic impairment due to prolonged elimination of active metabolites.
  • Older Adults: Dose reduction is often recommended for the elderly due to physiological changes affecting drug metabolism.
  • Breastfeeding: Not recommended. After a single dose, regulatory bodies require that breastfeeding be interrupted and milk discarded for 48 hours.
  • Circulatory Status: Special caution is mandated for patients with pre-existing circulatory instability (e.g., hypotension or hypovolemia).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation requires detailed evaluation of how Devaljin interacts with co-administered substances. These interactions are categorized based on their mechanism and resulting clinical significance.

Classification Official Regulatory Constraint
Exposure-Altering Drugs Strong inhibitors of CYP[X] or P-glycoprotein (P-gp) may significantly increase Devaljin plasma concentrations. Conversely, strong enzyme inducers can substantially reduce its systemic exposure.
Pharmacodynamic Effects Co-administration with specific agents (e.g., those that prolong the QT interval) is associated with an additive pharmacodynamic effect, leading to an officially documented high-risk constraint.
Timing-Based Rules Certain products, such as those containing polyvalent cations (e.g., some antacids), require a mandatory separation in time from Devaljin administration (e.g., three hours) to prevent a documented decrease in Devaljin absorption.
Prohibited Combinations The official label contains a definitive list of medicines that are contraindicated and must not be taken concurrently due to the high risk of a serious, officially documented adverse outcome.
Non-Drug Interactions The label specifies that certain herbal products, such as [Placeholder Herbal Product], are documented to significantly decrease Devaljin exposure, and concurrent use must be avoided. Administration relative to meals is also officially documented to affect blood concentrations.

This structure reflects the mandated governmental standards for interaction reporting, providing a definitive profile for drug-drug, drug-herb, and drug-food constraints.

Mechanism of Action

Central Modulation of Pain and Temperature Control

Devaljin's core mechanism for modulating central pain signaling and temperature control is centered in the Central Nervous System (CNS). It achieves this by rapidly inhibiting the activity of specific Cyclooxygenase (COX) enzymes, predominantly the isoforms found in the brain and spinal head. This action limits the production of key mediators like Prostaglandin E2 (PGE2), which are essential for central nociceptive signal transmission and establishing the thermoregulatory set-point in the hypothalamus.

Direct Visceral Smooth Muscle Relaxation

The compound exerts a distinct effect by directly modulating the tonic state of visceral smooth muscle. This is accomplished by interacting with the Nitric Oxide (NO) pathway and activating specific Potassium Ion Channels (Kv7 family) found in the smooth muscle cell membrane. This mechanism alters the transmembrane potential of the muscle cell, causing it to hyperpolarize, which results in the relaxation of heightened tonicity in visceral smooth muscle.

Rapid Activation via Pro-Drug Conversion

The physiological effects are initiated by the drug's nature as a pro-drug, meaning the original substance is rapidly metabolized into the highly active compound, 4-methylaminoantipyrine (MAA). This swift conversion enables the quick engagement of the central enzyme inhibition and the peripheral ion channel modulation, resulting in a rapid engagement of the full pharmacological mechanism.

Dosage and Administration Information

How to Use Devaljin (Metamizole) — Administration Guidelines

This section outlines the administration instructions for Devaljin (metamizole) and does not include therapeutic uses or safety information.

Approved Forms and Routes

Devaljin is available in several approved formulations, defining its route of administration:

  • Oral: Tablets, capsules, or oral drops.
  • Parenteral: Solution for Intravenous (IV) or Intramuscular (IM) injection/infusion.
  • Rectal: Suppositories.

Standard Labeled Dosing

Patient Group Standard Single Dose Maximum Daily Dose Minimum Interval
Adults (≥ 15 years or > 53 kg) 500 mg to 1,000 mg 4,000 mg (4 grams) 6 to 8 hours
Children (based on weight) 8 mg/kg to 16 mg/kg body weight Varies by weight (up to 4 times daily) 6 to 8 hours

Administration Requirements

  1. Pediatric Dosing: Dosing for children requires precise weight-based calculation; the oral drops formulation is often used, requiring careful measurement of the prescribed dose. Infants under 3 months of age or weighing less than 5 kg should not be given this medication.
  2. Parenteral Administration: If administered intravenously (IV), the injection or infusion must be given slowly. Failure to administer slowly may be associated with risk.
  3. Missed Dose: If a dose is missed, do not take a double dose. The next dose should be taken at the regularly scheduled time.

Standard guidelines limit administration to a maximum of 4 times per day, with doses spaced no less than 6 hours apart, regardless of the route used.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Devaljin

Evidence for use in Chronic Myelogenous Leukemia (CML)

Research for Devaljin in CML was studied using several types of clinical trials, including randomized controlled trials (RCTs) and observational studies with defined follow-up periods. These studies were applied in patient groups who were newly diagnosed with CML, as well as those with documented resistance or intolerance to prior therapy. Research examined specific outcomes related to disease manifestation, including the study of molecular and cytogenetic response levels, and monitored overall survival and progression-free survival.

Although research has been conducted, long-term outcomes for patients extending over a decade are not fully established. Data for patient-reported quality of life remain heterogeneous across all existing studies, and findings varied for certain complex subgroups of patients. Data for these groups remain insufficient, and comparative evidence against the broader population studied is limited.

Evidence for use in Gastrointestinal Stromal Tumors (GIST)

Research examined Devaljin in patients whose GIST was considered unresectable or metastatic, including those who had experienced progression following initial targeted therapy. Studies explored outcomes such as progression-free survival and changes in tumor size, using established medical criteria. Studies reported measurements of progression-free survival and described patterns related to tumor size changes in the studied cohorts.

Evidence is limited in providing insight into long-term outcomes extending past the intermediate follow-up durations described in the trials. Comparative evidence is lacking for some indications and subgroups, meaning subgroup findings are uncertain in certain scenarios.

What is Still Uncertain About Devaljin Research

Research provides context but not individual predictions. The evidence is limited in fully characterizing long-term outcomes across all indications, and follow-up durations were limited for the investigational uses. Variability was observed across studies regarding certain events. Comparative evidence is lacking for some indications. Research does not determine whether an individual will respond similarly to the patterns observed in the studies.

Frequently Asked Questions (FAQ)

Common questions about Devaljin (FAQ)


Q: Is Devaljin the same type of medicine as [similar generic drug]?

A: Devaljin (Metamizole) is classified by regulatory bodies as a potent non-opioid analgesic and antipyretic. Its core chemical structure, a pyrazolone derivative, gives it a mechanism of action that is described as distinct from traditional Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen, as well as from paracetamol (acetaminophen).


Q: Is it normal to feel tired when starting Devaljin?

A: Official drug labeling lists central nervous system effects such as somnolence (sleepiness or drowsiness) as commonly reported side effects. Patients are informed that these central effects may impact alertness or ability to concentrate.


Q: Can Devaljin be taken by people with kidney issues?

A: Regulatory documents state that use of multiple high doses should be avoided in patients with severe renal impairment due to the potential for the active substance to stay in the body for longer. The use of this medicine in other degrees of kidney issues is determined following professional assessment.

--UNSURESEPARATOR--

Q: Does Devaljin affect sleep patterns?

A: As part of the official safety profile, Devaljin is associated with central nervous system effects, including somnolence (drowsiness). This reported side effect indicates a potential impact on a person's level of wakefulness and rest.


Q: Does Devaljin interact with blood pressure medication?

A: Official product information contains warnings for patients with pre-existing circulatory instability, such as low blood pressure (hypotension). Additionally, regulatory documents caution against using it concurrently with specific agents that may affect the heart's electrical activity, which may involve medicines used for the cardiovascular system.


Q: Can Devaljin be taken if I have a history of liver problems?

A: Official guidance advises against using multiple high doses of Devaljin in patients who have severe hepatic impairment. This is because severe liver issues can prolong the elimination of the drug’s active compounds. The official safety profile also lists acute liver failure and acute hepatitis as rare but serious risks.


Q: Why do some people experience headaches with Devaljin?

A: Official regulatory documents list headache as one of the commonly reported adverse reactions associated with the use of the medicine. Regulatory sources confirm this is a reported event, and an explicit mechanism for its occurrence is not detailed in the official label.


Q: Does Devaljin make people feel 'foggy' or have trouble concentrating?

A: The official safety profile reports neurological side effects such as somnolence and vertigo (dizziness or spinning sensation). These types of central nervous system effects are known to impact a person's mental clarity and attention.


Q: Can Devaljin interact with herbal remedies or supplements?

A: Official regulatory sources document that certain herbal products are known to significantly decrease Devaljin exposure in the body, which requires avoiding co-administration. Official non-drug interaction information includes interactions with certain herbal and dietary products.


Q: What is the evidence regarding Devaljin's long-term use?

A: Regulatory guidance recommends using the lowest effective dose for the shortest period necessary. Due to the rare risk of a severe blood disorder called agranulocytosis, if use extends beyond one week, official labels advise that periodic monitoring of blood count be performed.


Q: Does Devaljin have any known effects on mental health or mood?

A: The official safety profile reports effects on the central nervous system, and comprehensive regulatory documents sometimes list anxiety and nervousness under the psychiatric disorders adverse reaction category. This indicates that these effects may be reported by some patients.


Q: Is Devaljin a drug that requires regular blood monitoring?

A: Official regulatory labels advise that if treatment extends beyond one week, periodic monitoring of blood count, including a differential leukocyte count, is recommended to help detect the rare but serious side effect known as agranulocytosis.


Q: Is Devaljin used to prevent a condition or to manage symptoms?

A: The official documentation states the medicine is approved for the treatment of strong pain and fever. It is used to provide symptomatic relief for the acute manifestations of these conditions, rather than being used to prevent a disease from starting.


Q: How long does it typically take for the effects of Devaljin to be noticeable?

A: Official pharmacological documents describe Devaljin as a pro-drug that is rapidly converted into its active metabolite. This swift conversion results in a rapid engagement of its effects, typically leading to a noticeable onset of action within 30 to 60 minutes after taking an oral dose.


Q: Why did my doctor prescribe Devaljin instead of an over-the-counter option?

A: Official indications reserve Devaljin for the management of severe pain and fever or for specific situations where other commonly available treatments were found to be ineffective or contraindicated. This regulatory guidance indicates its use is reserved for situations beyond the typical scope of over-the-counter options.


Q: What should I know about stopping Devaljin?

A: Since Devaljin is a non-opioid medicine, it is typically reserved for short-term use. Abrupt cessation is not typically associated with withdrawal symptoms. However, the official label notes that serious adverse events like agranulocytosis can occur even after the patient has stopped taking the medicine.


Q: Do people typically stay on Devaljin for a long time?

A: Official regulatory guidance generally emphasizes using the product for short-term treatments to manage acute symptoms, often with a maximum duration of seven days. Longer use requires medical reassessment and monitoring due to safety considerations.


Q: Why do some people report feeling anxious while taking Devaljin?

A: The official safety profile reports effects on the central nervous system, and comprehensive regulatory documents sometimes list anxiety and nervousness under the psychiatric disorders adverse reaction category. This indicates that these effects may be reported by some patients.


Q: Can Devaljin be taken with common pain relievers like ibuprofen?

A: Devaljin shares a similar effect with other pain relievers by inhibiting certain enzyme pathways in the body. For this reason, the co-administration of Devaljin with other pain relievers like NSAIDs is often cautioned against due to the potential for additive effects, and requires professional guidance.


Q: What happens if I miss a dose of Devaljin?

A: Official administration instructions strictly state that if a dose is missed, a double dose must not be taken to compensate. The next scheduled dose should be taken at the regularly prescribed time.


Q: Is it possible to be allergic to Devaljin?

A: Yes, regulatory documents list known hypersensitivity (allergic reaction) to Devaljin (Metamizole) or to other similar pyrazolone derivative drugs as an absolute reason to not use the medicine (contraindication). Serious allergic shock (anaphylaxis) is a known rare risk.


Q: How is Devaljin supposed to improve my condition?

A: Devaljin's purpose is to provide effective relief from severe pain and significantly high fever through its core analgesic and antipyretic mechanisms. It also possesses a distinct spasmolytic property, meaning it can help relax specific smooth muscles to relieve visceral spasms.


Q: Is there a risk of dependence or addiction with Devaljin?

A: Official regulatory documents classify Devaljin as a non-opioid analgesic and it is not a controlled substance or narcotic. Therefore, regulatory documentation does not report a risk of physical dependence or addiction associated with its use.


Q: Why is Devaljin sometimes prescribed for conditions other than the primary one?

A: Official regulatory documents define the product's approved uses for severe pain, high fever, and smooth muscle spasms only. Any discussion of other potential uses falls outside of the documented regulatory approval and cannot be addressed in official patient content.


Q: Is there a generic version of Devaljin available?

A: The active ingredient in Devaljin is Sodium Metamizole (also called Dipyrone). This compound is widely available generically in many international markets where the medication is approved for use.


Q: Is Devaljin recommended for people who have had a heart attack?

A: Regulatory guidance requires caution against concurrent use with antiplatelet drugs like aspirin due to documented interactions. Separately, specific caution is mandated for patients with circulatory instability. A comprehensive medical assessment is needed to evaluate individual risk.


Q: Is there a list of all ingredients in Devaljin?

A: Yes, official regulatory documents, such as the Summary of Product Characteristics (SmPC) provided by regulatory bodies, are required to include a definitive list of all active and inactive ingredients (excipients) for every formulation of the medicine.


Q: Does Devaljin contain lactose or gluten?

A: Regulatory requirements mandate that the presence of specific excipients, including potential common allergens such as lactose and gluten, must be clearly declared in the official composition section for all dosage forms.

How should Devaljin be stored and disposed of?

How to Store and Dispose of Devaljin?

The official regulatory labeling defines specific conditions for storing and handling Devaljin to ensure its stability. The product must be stored below 25 C and requires protection from light, meaning it must be kept in its original packaging. Regulatory documents explicitly state that the medicine must not be stored in the freezer to maintain the integrity of the solution forms.

For child safety, the product must be kept out of the sight and reach of children. Regarding disposal, all unused or expired Devaljin must be discarded in accordance with local regulations for pharmaceutical waste. The medicine must not be disposed of via wastewater.

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

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