Daleron

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Daleron

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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 Daleron

Property Description
Active Ingredient Acetaminophen (Paracetamol)
Forms Tablet, Syrup, Suspension, Suppository (Oral and Rectal)
Pharmacological Class Analgesic and Antipyretic
Common Use Relief of mild to moderate pain and fever reduction
Origin Synthetic Compound (Para-aminophenol derivative)

What is Daleron and Its Pharmaceutical Class?

Daleron is a brand-name pharmaceutical product manufactured by the KRKA group that relies on the single active ingredient Acetaminophen, known internationally as Paracetamol (chemically N-(4-hydroxyphenyl)acetamide). The medicine is a synthetic compound classified fundamentally as both an analgesic and an antipyretic. This designation is clinically recognized for providing systemic relief when managing general discomfort and elevated body temperature. Daleron is typically provided as a monoseptic preparation, meaning its core therapeutic effect is derived solely from Acetaminophen, which places it in the Para-aminophenol derivative pharmacological class.


Composition and Available Forms of Daleron

The active ingredient is supplied in multiple high-level dosage forms tailored to different patient groups, establishing flexible routes of administration. These include oral preparations—such as the standard tablet, flavored syrup and suspension designed for easier administration to pediatric patients, and effervescent tablet—as well as rectal preparations like the suppository. This variety in form is key to the brand's positioning towards diverse usage within a family setting, ensuring the active substance can be delivered systemically to all target audiences.


What is the General Therapeutic Purpose of Daleron?

The general therapeutic purpose of Daleron is to provide systemic symptomatic relief by influencing the body's central systems. Its actions stem from targeting the Central Nervous System, where it works to elevate the pain threshold and interacts with the hypothalamic heat-regulating center in the brain to facilitate temperature reduction. This mechanism distinguishes its primary function from the peripheral anti-inflammatory action associated with the Nonsteroidal Anti-inflammatory Drug (NSAID) class, dedicating its high-level use to managing mild to moderate pain and assisting in fever reduction.

Regulatory References

  1. Paracetamol (acetaminophen) on the WHO Model List of Essential Medicines
  2. Acetaminophen Drug Information - NIH MedlinePlus

What side effects are possible with Daleron?

Possible Side Effects and Safety Information

Daleron contains the active substance paracetamol (also known as acetaminophen). The medicine's safety profile, based on official regulatory documents, highlights the potential for adverse effects, categorized by the organ system and frequency of occurrence.

Serious Adverse Reactions

Hepatotoxicity (Liver Damage): The most serious safety concern is the risk of acute liver failure, which is primarily linked to doses exceeding the maximum recommended daily amount. This risk necessitates strict adherence to dosage limits. Additionally, the risk is increased in patients with pre-existing severe liver disease or chronic, heavy alcohol use.

Severe Systemic Reactions: Regulatory information documents the potential for rare, but life-threatening, non-dose-dependent reactions. These include severe allergic reactions (hypersensitivity, angioedema, anaphylactic shock) and severe skin reactions (SCARs) such as Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Acute Generalized Exanthematous Pustulosis (AGEP).

Frequency-Classified Adverse Reactions

Adverse effects are most commonly reported as rare or very rare when the medicine is used at therapeutic doses. These documented reactions include:

  • Rare (ge 1/10,000 to < 1/1,000): Liver function disorders, hepatic failure, and certain blood cell disorders, such as a decrease in platelets (thrombocytopenia).
  • Very Rare (< 1/10,000): Further blood abnormalities (e.g., neutropenia, agranulocytosis) and bronchospasm (difficulty breathing) in sensitive individuals.

Safety Restrictions and Limitations

The most important safety restriction is the maximum daily dose limit to prevent overdose and subsequent liver damage. Regulatory documents strongly advise against the concurrent use of any other product containing paracetamol/acetaminophen. Safety cautions are formally noted for use in individuals with severe kidney impairment, severe active liver disease, or conditions associated with the depletion of liver enzymes.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation for Acetaminophen (the active ingredient in Daleron) emphasizes that immediate medical attention is required following a suspected overdose, regardless of the presence of symptoms. This absolute mandate to seek urgent help is due to the potential for severe, delayed toxicity. Initial clinical manifestations of overdose may be non-specific, including nausea, vomiting, anorexia, malaise, and diaphoresis (sweating). These early signs may resolve temporarily, giving a false impression of recovery, while severe internal injury progresses.

The most serious, life-threatening outcome is Acute Liver Failure (Hepatotoxicity), which can lead to hepatic encephalopathy, coma, and death. Laboratory abnormalities documented in overdose cases include elevated hepatic transaminases and increased prothrombin time. Individuals with certain pre-existing conditions, such as chronic alcohol use or malnutrition, are officially noted to have increased susceptibility to this severe hepatic injury.

The specific antidote, Acetylcysteine, is documented in regulatory prescribing information, but its effectiveness is highly time-dependent. Consequently, immediate hospitalization is required for medical evaluation, monitoring of serum concentration, liver function (AST, ALT), and prompt administration of the antidote [NIH MedlinePlus Drug Information]( Treatment procedures also involve supportive care and, in certain instances, gastric decontamination.

Therapeutic Uses of Daleron

What Daleron Treats: Main Uses and Benefits

Daleron is commonly used in situations involving certain distressing symptoms related to physical discomfort and is applied when short-term symptomatic assistance is needed to contribute to easing the overall symptom load. This therapeutic domain helps address symptom clusters that may become intense or disruptive, including common conditions presenting with acute episodes such as headaches, toothache, backache, muscle aches, and menstrual cramps.

The medication is commonly used across conditions characterized by periods of heightened symptoms related to symptoms related to systemic imbalance. Its benefit is relevant for easing symptoms related to heightened physiological activity (fever) associated with acute or disruptive episodes like the common cold and flu. This symptomatic assistance may help patients cope more steadily with these difficult episodes and supports general well-being during symptomatic phases.

Quick Fact: Relevant for Easing Aches and Fever

“Daleron plays a role in managing pain and fever, supports the patient during episodes of heightened discomfort.”

By helping to moderate fever and physical aches, Daleron offers supportive relief that may assist with maintaining functional stability and helps improve day-to-day comfort during symptomatic periods.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Daleron

Official regulatory guidelines define patient eligibility for Daleron (Paracetamol) primarily based on hypersensitivity and liver function status.


Populations for whom use is contraindicated:

  • Patients with known hypersensitivity (allergy) to paracetamol or any of the product's inactive ingredients.
  • Patients with severe hepatic impairment or severe active liver disease.

Eligibility-Related Restrictions:

Classification Restricted Groups (Conditional Use)
Hepatic & Renal Status Those with mild to moderate hepatic impairment, severe renal impairment, chronic alcoholism, or chronic malnutrition.
Age and Weight Infants under 3 months, or patients (including adults) weighing less than 50 kg.
Maternal Status Pregnant and breastfeeding individuals (use is permitted if clinically needed, but strictly at the lowest dose and shortest duration).

Official Eligibility Statements:

Use is subject to a strict lower maximum daily dose limit for patients with severe renal or liver conditions, chronic alcoholism, or chronic malnutrition due to the increased risk of hepatotoxicity. Eligibility for pediatric use is age and weight-dependent, with specific formulations required for children. Individuals must not take Daleron if they are already using any other product containing paracetamol.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents establish specific interaction patterns for Daleron, whose active ingredient is Acetaminophen (Paracetamol), focusing on avoiding increased risk of toxicity and altered systemic exposure.


Documented Interaction Patterns

Interaction Type Interacting Substance/Class Official Regulatory Outcome/Restriction
Contraindicated Combination Other Acetaminophen-containing products Formally restricted due to risk of exceeding maximum dose, leading to severe liver damage.
Pharmacodynamic Warfarin and other Oral Anticoagulants Increases the anticoagulant effect, which is documented as raising the risk of bleeding.
Pharmacokinetic (Metabolic) CYP Enzyme Inducers (e.g., Isoniazid, Phenobarbital) May alter metabolism, increasing the formation of the toxic metabolite and raising the hepatotoxicity risk.
Pharmacokinetic (Absorption) Cholestyramine (Bile Acid Sequestrant) Reduces the absorption of Daleron, leading to reduced systemic exposure.

Administration Constraints and Warnings

Co-administration with Cholestyramine requires time separation; Daleron must be administered at least one hour before or four to six hours after the sequestrant. The official Liver Warning cautions that the consumption of three or more alcoholic drinks every day significantly increases the risk of severe liver damage when using this product. Daleron is formally contraindicated for use in patients with severe hepatic impairment or severe active liver disease, as this condition amplifies the potential for toxicity.

Mechanism of Action

Daleron contains paracetamol (also known as acetaminophen), which primarily exerts its pharmacodynamic effects within the central nervous system (CNS). Its mechanism is considered multi-modal, involving enzyme modulation and influence on critical neurotransmitter pathways, resulting in the modulation of specific signaling pathways.

Modulating Central Prostaglandin Synthesis

This domain involves the action of paracetamol as an inhibitor of cyclooxygenase (COX) enzyme activity, particularly in the brain and spinal cord. By acting as a reducing agent on the peroxidase site of the enzyme, Daleron diminishes the synthesis of prostaglandins (PGs), which function as local signaling molecules in the CNS. The reduced PG synthesis influences the thermoregulatory center and afferent nociceptive pathways.

Engagement with Key Neurotransmitter Systems

Daleron engages mechanisms that influence pathways beyond the COX enzymes. This includes the potential for an active metabolite (AM404) to influence the endocannabinoid system and transient receptor potential vanilloid-1 (TRPV1) receptors. Furthermore, paracetamol has been shown to potentiate the descending inhibitory serotonergic pathway in the CNS. These interactions result in a net alteration of the input to central pain and thermal regulatory centers in the brain.

Dosage and Administration Information

Daleron, based on the active substance Acetaminophen (Paracetamol), is administered via oral (tablets, syrups, solutions) and rectal (suppositories) routes. The use protocol is governed by specific quantity and timing constraints established in regulatory labeling.

For adults weighing 50 kg or more, the standard labeled single dose ranges from 500 mg to 1000 mg (1 g), which may be repeated every four to six hours. A strict minimum dosing interval of four hours must be maintained between administrations. The total intake of the active substance from all sources—including combination products—must not exceed 4000 mg in a 24-hour period for healthy adults.

Dosing for pediatric patients (children under 12 years) is determined by body weight rather than age alone, typically following a regimen of 10 mg/kg to 15 mg/kg per dose. Furthermore, administration requires specific adjustments for patients with altered physiological processing, such as a prolonged minimum dosing interval for individuals with severe renal impairment. For oral liquid forms, the container must be shaken well before the dose is measured. The regulatory structure of this medication emphasizes that usage must be limited to short-term duration, adhering strictly to the maximum quantity and time-based frequency schedules.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Monotherapy: Focus on Primary Pain Relief

Research includes a substantial body of research that has investigated the use of its active ingredient, paracetamol, in managing acute and chronic pain conditions. These studies have primarily explored the medication's effect as a single treatment.

A key clinical trial evaluated whether the medication focused on the measurement of time to initial response and evaluated a potential reduction in symptoms over a 12-week trial. This study focused on the drug's role in the central nervous system, where it is thought to act by modulating certain pain pathways, investigating patient outcomes.

Combination Therapy

Research has also examined whether combining the medication with other over-the-counter pain relievers offers a different profile. In a double-blind, randomized trial, the combination was examined for a potential reduction in pain severity compared to placebo in cohorts where NSAID use was restricted per protocol.

Studies explored whether the combined approach offered an advantage in managing moderate-to-severe pain, with data suggesting a favorable numerical difference in some cohorts. Evidence quality for combination therapy is often low-to-moderate, with effects varying significantly across different pain models.

️ Pharmacokinetics and Administration

Studies exploring how the body processes the medication revealed key findings about its absorption profile. The oral absorption of paracetamol is typically rapid and complete, though the rate is predominantly dependent on the rate of gastric emptying.

Research on co-administration was assessed for whether it increased absorption, with findings indicated a greater numerical difference in the measured outcome. The primary endpoint results were highest when administered in this way. Studies show that co-administration with food or other drugs that delay gastric emptying may slow the absorption rate.

Frequently Asked Questions (FAQ)

Common questions about Daleron (FAQ)

Q: How is the active ingredient in Daleron generally described in official sources?

A: The active substance in Daleron, Acetaminophen (Paracetamol), is described in official medical sources as having two primary classifications. It is fundamentally an analgesic, meaning it helps relieve pain, and an antipyretic, meaning it helps reduce fever.

Q: What types of pain is Daleron indicated for?

A: According to the general therapeutic purpose described in regulatory information, the medication is formally indicated for the management of mild to moderate pain and assisting in fever reduction. This general indication covers many common, non-severe pain conditions.

Q: Does Daleron have an anti-inflammatory action like an NSAID?

A: The active ingredient in Daleron is classified separately from the Nonsteroidal Anti-inflammatory Drug (NSAID) class of medicines. The mechanism distinguishes its primary function from the peripheral anti-inflammatory action associated with the NSAID class.

Q: Is Daleron used for relieving menstrual pain?

A: Daleron is generally indicated for the management of mild to moderate pain. This indication is broad enough to cover many common pain conditions, including the pain associated with menstruation.

Q: Are there different strengths (e.g., 325mg, 500mg) of Daleron tablets available?

A: Official dosing guidelines describe the standard labeled single dose for adults as ranging from 500 mg to 1000 mg (1 g). This range suggests that these standard commercial strengths of the tablets are commonly available.

Q: How fast does Daleron typically begin to show an effect?

A: Studies on the active ingredient indicate that oral absorption is generally described as rapid and complete. However, the speed at which the medication starts to work can be influenced by various factors, which may vary among individuals.

Q: How long does the pain-relieving effect of a single dose of Daleron usually last?

A: The expected duration of the clinical effect is generally implied by the recommended dosing intervals. Official guidelines indicate that a dose may typically be repeated every four to six hours.

Q: Does taking Daleron on an empty stomach affect how quickly it works?

A: Research on how the body processes the medication indicates that co-administration with food or other substances that delay gastric emptying may slow the absorption rate. Taking the medication without food may align with a more rapid absorption time.

Q: Are there any severe or rare side effects of Daleron listed in regulatory warnings?

A: Yes, official regulatory documents highlight the risk of serious adverse reactions, which are rare when taken as directed. These include the risk of Hepatotoxicity (acute liver failure), which is primarily associated with doses exceeding the maximum recommended amount, and rare but severe allergic reactions and skin reactions.

Q: Are there specific symptoms that require stopping Daleron immediately?

A: Regulatory documents warn that the product should be stopped immediately if signs of severe skin reactions are observed, such as a severe rash, blistering, or peeling skin. Symptoms of severe systemic reactions (e.g., swelling of the face or throat, difficulty breathing) also require immediate attention.

Q: What should a person watch for as a sign of an allergic reaction to Daleron?

A: Signs that may indicate a serious allergic reaction include sudden swelling of the lips, mouth, throat, or tongue, or difficulty breathing. Regulatory information indicates a person should look for a severe rash that is swollen, raised, itchy, blistered, or peeling.

Q: Is Daleron known to cause drowsiness or sedation?

A: Drowsiness is generally not a recognized common side effect when Daleron is used at therapeutic doses. It may be reported in the context of rare adverse events, and is generally not observed at therapeutic doses.

Q: Can Daleron be used by pregnant women, according to regulatory classification?

A: Official regulatory guidelines state that use by pregnant individuals is permitted if clinically needed. However, official guidance advises use be limited to the lowest possible dose and the shortest possible duration.

Q: Is Daleron suitable for use in people with asthma?

A: Although bronchospasm (difficulty breathing) is listed as a very rare side effect in sensitive individuals, the active ingredient is generally regarded as an analgesic option for use by individuals with asthma.

Q: What types of medications commonly interact with the active ingredient in Daleron?

A: Official documents list several types of interacting medications. These include other acetaminophen-containing products, certain Oral Anticoagulants (like Warfarin), certain CYP Enzyme Inducers (like Phenobarbital), and Bile Acid Sequestrants (like Cholestyramine).

Q: Does Daleron interact with blood thinners?

A: Official documents note that the active ingredient in Daleron interacts with Warfarin and other Oral Anticoagulants. This combination is documented as increasing the anticoagulant effect, which is noted to raise the risk of bleeding.

Q: Are there known interactions between Daleron and certain over-the-counter vitamins?

A: Some regulatory resources caution that high doses of certain vitamins, such as Vitamin C, may potentially affect acetaminophen levels in the body. Official guidance suggests individuals seek clarification regarding potential interactions with supplements.

Q: Does Daleron interact with caffeine?

A: Regulatory documents on combination products containing the active ingredient and caffeine state that the medication does not affect the pharmacokinetics of caffeine. However, official guidance cautions against consuming excessive amounts of caffeine-containing beverages from all sources while using the medicine.

Q: Does Daleron affect blood sugar levels or require special precautions for diabetics?

A: The active ingredient has been documented to cause falsely elevated readings on some continuous glucose monitoring (CGM) systems. Individuals using CGM devices are generally advised to rely on traditional blood glucose meter values for dosing and treatment decisions due to this potential for interference.

Q: Are there specific storage instructions for Daleron that users commonly overlook?

A: Official product labeling requires Daleron to be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F). It is essential to protect the medication from excessive heat, freezing, light, and high humidity to maintain its stability. The product must always be stored out of the sight and reach of children.

Q: What ingredients are contained in the combination product Daleron Cold3?

A: Official product documents state that the combination product Daleron Cold3 contains three active ingredients: Paracetamol (for pain/fever), Pseudoephedrine hydrochloride (a decongestant), and Dextromethorphan hydrobromide (a cough suppressant).

Q: Does Daleron Cold3 contain an ingredient for nasal congestion?

A: Yes, the combination product Daleron Cold3 contains Pseudoephedrine hydrochloride. Regulatory documents state that this ingredient is included specifically because it helps to reduce nasal congestion.

Q: Does Daleron Cold3 help with cough?

A: Yes, the combination product Daleron Cold3 contains Dextromethorphan hydrobromide. Regulatory documents state that this ingredient is included specifically to help inhibit an irritant cough.

Q: Is it safe to use regular Daleron and Daleron Cold3 together?

A: No, official regulatory documents state that this combination is formally restricted. This is due to the severe risk of exceeding the maximum safe dose of the active ingredient (Paracetamol), which can lead to serious liver damage.

Q: Can a user take Daleron Cold3 if they only have a headache and no cold symptoms?

A: Daleron Cold3 is formulated to relieve a combination of cold and flu symptoms simultaneously. While headache is a target symptom, the product contains multiple active ingredients intended for various symptoms.

How should Daleron be stored and disposed of?

How to Store and Dispose of Daleron (Acetaminophen)

The storage and disposal requirements for Daleron are defined by regulatory labeling to maintain stability and ensure safety.

Storage Conditions

Daleron must be stored at Controlled Room Temperature, typically 20°C to 25°C (68°F to 77°F), and protected from excessive heat and freezing. The product must be stored in a tight container, protected from light and high humidity, and should not be used if the container seal is broken. The medication must always be stored out of the sight and reach of children.

Disposal Instructions

To dispose of unused or expired Daleron, the preferred method is to use a drug take-back program or collection kiosk. If a take-back program is unavailable, the medication should be mixed with an unpalatable substance (like dirt or coffee grounds) and sealed in a container before being placed in the household trash, following official FDA guidance. The product must not be poured down the sink or toilet.

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

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