Claradol

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Claradol

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 Claradol

Quick Facts

Property Description
Active Ingredient Acetaminophen (Paracetamol)
Forms Tablets, solutions, suppositories, IV infusion
Pharmacological Class Non-opioid analgesic and Antipyretic
General Purpose Symptomatic relief of pain and fever
Origin Synthetic (p-aminophenol derivative)

What Type of Medicine is Claradol and Its Composition?

Claradol is a synthetic, single-component medicinal product classified primarily as a Non-opioid analgesic and an Antipyretic agent. The sole active ingredient is Acetaminophen, formally known as Paracetamol, which is a p-aminophenol derivative. This formal classification places it under the ATC code N02BE01 and defines the drug's core functions: the relief of pain and the reduction of fever.

This substance is a fundamental non-opioid medicine primarily used for pain relief and fever management. Being a monocomponent preparation, its therapeutic effect relies entirely on this single chemical substance, a characteristic clinically recognized for its predictable action profile.


What Forms are Available and What is Claradol's General Purpose?

Claradol is intended for systemic use and is available in multiple pharmaceutical forms to suit various patient needs, including oral solid preparations (tablets and effervescent tablets), oral solutions, rectal suppositories, and preparations for intravenous infusion. This range of routes of administration ensures the active ingredient can be delivered effectively, even when oral administration is not suitable. Its general purpose is to provide symptomatic relief by modulating the body's central pain and fever processes, establishing it as a foundational medicine for common conditions.


How Does Acetaminophen Differ from Other Pain Relievers?

The core difference lies in its method of action, which is predominantly central, targeting the brain and spinal cord to raise the body’s pain threshold. Unlike non-steroidal anti-inflammatory drugs (NSAIDs) like Ibuprofen, which primarily inhibit inflammation throughout the body, Acetaminophen has a negligible effect on peripheral inflammation. This selectivity for the Central Nervous System (CNS) is significant, as it provides effective analgesic and antipyretic effects while minimizing the gastrointestinal irritation risks often associated with broad-spectrum NSAIDs.

Regulatory References

  1. WHO Model List of Essential Medicines

What side effects are possible with Claradol?

Possible Side Effects and Safety Information

The official safety profile for Claradol, which contains Acetaminophen (Paracetamol), is defined by regulatory bodies based on the frequency and nature of adverse reactions observed in clinical data and post-marketing surveillance. This information is organized into specific System-Organ Classes (SOCs).


Key Adverse Reaction Classifications

The most significant documented risks, though rare, relate to serious hepatic injury, including acute liver failure, which has resulted in liver transplantation and death, particularly when recommended dosage limits are exceeded. The other critical safety concern involves rare but potentially fatal Serious Cutaneous Adverse Reactions (SCARs), such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN).

Frequency Classification (Sample) Affected System-Organ Class (SOC) Sample Reactions Officially Listed
Common (e.g., 1/100 to <1/10) Gastrointestinal Disorders Nausea, Vomiting, Constipation
Very Rare (e.g., <1/10,000) Blood and Lymphatic System Disorders Thrombocytopenia, Agranulocytosis
Not Known (Cannot be estimated) Immune System Disorders Anaphylactic shock, Angioedema

Population-Specific Constraints

Official labeling contains specific safety restrictions. The medicine is contraindicated in individuals with severe hepatic impairment or severe active liver disease. Caution is also advised for patients with severe renal impairment, chronic malnutrition, or chronic alcoholism. Furthermore, the product must not be used concurrently with other medicines containing acetaminophen, as this dramatically increases the risk of severe liver damage. Prolonged regular daily use has also been documented to enhance the effect of certain blood thinners, such as warfarin.

Overdose and Emergency Response

Overdose and When to Seek Urgent Medical Help

Claradol contains the active substance paracetamol (acetaminophen). Taking more than the recommended dose constitutes an overdose and carries a serious risk of delayed, severe liver damage (hepatotoxicity), which can be fatal. Prompt medical intervention is essential to prevent irreversible organ damage.

When to Seek Immediate Medical Help

Always seek emergency medical attention straight away if you believe an overdose has occurred, regardless of whether you feel ill or show symptoms. Quick medical assessment is critical, even for children who appear well. Liver damage symptoms may not develop until 12 to 48 hours after ingestion, making early treatment vital.

Documented Overdose Symptoms

Initial symptoms within the first 24 hours can be non-specific, including pallor, nausea, vomiting, abdominal pain, and malaise. These mild signs do not reflect the severity of poisoning. Later signs of liver injury include jaundice (yellowing of the skin or eyes), right upper quadrant tenderness, confusion, and metabolic changes. Acute renal failure and cardiac arrhythmias have also been reported in severe cases.

Risk Factors and Emergency Response

Ingestion of 7.5 grams or more in an adult is generally considered potentially toxic. Liver damage may occur at lower doses ( ge 5 grams) if certain risk factors are present, such as chronic alcohol use, malnutrition, or concomitant use of enzyme-inducing medications. Emergency treatment in a healthcare setting is initiated according to established guidelines and may involve the administration of the antidote N-acetylcysteine to help protect the liver. Do not take Claradol with any other product containing paracetamol to prevent accidental overdose.

Therapeutic Uses of Claradol

What Claradol Treats: Main Uses and Benefits

The medication is generally used in situations involving certain distressing symptoms, applied across domains where additional symptomatic support is needed. The medication is relevant for easing symptoms such as fever, headaches, muscle aches, and menstrual cramps.


Easing Discomfort in Acute Episodes

Claradol may assist with managing pain-related symptom clusters that may become intense or disruptive, such as symptoms related to physical discomfort like headache, toothache, or muscular ache. It is relevant for managing symptoms that interfere with daily comfort. The medication is commonly used across conditions presenting with acute episodes or conditions involving episodic or fluctuating manifestations, including minor injuries, post-procedural discomfort, and during common illnesses like the cold or flu. It contributes to easing the overall symptom load and supports patients during episodes of heightened discomfort.

“The application is relevant when supportive symptom management is appropriate to help maintain day-to-day comfort.”


Symptomatic Focus: Pain and Fever

Symptomatic Focus: Pain and Fever. The medication assists with maintaining comfort and coping during symptomatic periods related to both systemic fever and various non-severe body aches.

Regulatory References

  1. Health Canada overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Claradol? — Official Regulatory Information

The eligibility for Claradol (Acetaminophen/Paracetamol) is strictly governed by regulatory documentation, which outlines absolute prohibitions, conditional restrictions, and age-specific rules.


Populations For Whom Use Is Contraindicated

Use is contraindicated (absolutely prohibited) in patients with known hypersensitivity to the active substance or its excipients. It is also contraindicated in patients with severe hepatic impairment or severe active liver disease.


Eligibility and Restriction Rules

Classification Official Regulatory Statement
Age-Related Rules Generally permitted for use in Adults and Adolescents. Pediatric eligibility is defined by the formulation’s minimum age and/or weight threshold (e.g., specific age/weight for oral forms).
Conditional Restrictions Use requires special caution and restriction in individuals with severe renal impairment, chronic alcoholism, or chronic malnutrition due to elevated risk of hepatotoxicity.
Pregnancy/Lactation Pregnancy: Permitted if clinically needed, but must be at the lowest effective dose for the shortest duration. Lactation: Generally not contraindicated; minimal amounts are excreted in breast milk.

Regulatory Summary

Official regulatory documents define the population eligible by establishing absolute contraindications related to severe liver disease and hypersensitivity. Use is conditionally governed by organ function limitations, particularly renal impairment and conditions that compromise hepatic reserves, requiring special caution. Eligibility is also restricted by age-related thresholds that must be met for specific product formulations.

What should I know about interactions with other medicines?

The official regulatory profile for Claradol (Acetaminophen/Paracetamol) is defined by its metabolic clearance pathways and specific pharmacodynamic risks.

Documented Interaction Patterns

The most significant restriction is the formal prohibition against co-administration with any other medicinal product containing acetaminophen or paracetamol, a measure designed to prevent the risk of severe hepatotoxicity.

Exposure and Metabolism

  • Enzyme-Inducing Medicinal Products: Co-administration with liver enzyme inducers, such as Phenytoin, Carbamazepine, or Rifampicin, accelerates the drug's metabolism. This is documented to worsen the potential for hepatotoxicity due to increased formation of toxic metabolites.
  • Warfarin and Coumarins: Prolonged, regular daily use of Claradol may enhance the anticoagulant effect of coumarin derivatives like Warfarin, increasing the documented risk of bleeding.
  • Clearance Reduction: Probenecid inhibits the drug’s conjugation pathway, which officially results in a 50% reduction in paracetamol clearance.
  • Absorption Rate: Agents like Metoclopramide accelerate absorption, while Cholestyramine reduces it. Cholestyramine requires a mandatory separation of administration by at least one hour.

Substance and Condition Constraints

  • Alcohol: Chronic consumption of three or more alcoholic drinks per day while using Claradol increases the risk of severe liver damage.
  • Population Note: Regulatory documents note that patients with pre-existing hepatic impairment or glutathione deficiency (e.g., in cases of chronic alcoholism or severe malnutrition) are at heightened risk related to these metabolic interactions.

Mechanism of Action

Claradol, whose active substance is paracetamol, exerts its primary pharmacodynamic actions predominantly within the Central Nervous System (CNS). The molecule readily crosses the blood-brain barrier. Its central action is primarily mediated by the inhibition of cyclooxygenase (COX) enzymes, particularly a CNS-expressed variant or a mechanism that is sensitive to low peroxide tone, which is characteristic of the CNS environment. The drug functions as a non-competitive inhibitor by interacting with the peroxidase site of Prostaglandin H2 Synthase (PGHS), also known as COX.

This interaction lessens the availability of the ferryl protoporphyrin IX radical cation, which is essential for the cyclooxygenase activity. The resultant downstream effect is the attenuation of prostaglandin (PG) synthesis, notably Prostaglandin E2 (PGE2), within the spinal cord and hypothalamus. This central reduction in PGE2 concentration modifies the neuronal pathways involved in thermoregulation and nociception. Additionally, a metabolite, AM404, is formed, which acts as a reuptake inhibitor of the endocannabinoid anandamide and may activate the Transient Receptor Potential Vanilloid-1 (TRPV1) receptor and the central cannabinoid receptors, contributing to the systemic physiological modulation.

Dosage and Administration Information

Administration Guidelines for Claradol (Acetaminophen)

Claradol (acetaminophen/paracetamol) is intended for systemic use and is administered via three approved routes: Oral (tablets, solutions), Rectal (suppositories), and Intravenous (IV) infusion, depending on the dosage form. The administration protocol is established to prevent exceeding the total daily dose from all sources.


Dosing and Scheduling

Parameter General Parameters
Standard Single Dose (Adults 50 kg) 500 mg to 1000 mg per dose.
Minimum Dosing Interval 4 to 6 hours between doses.
Maximum Daily Dose Must not exceed 4000 mg (4 g) in any 24-hour period from all acetaminophen-containing products.
Pediatric Dosing Based on body weight (10 to 15 mg/kg per dose), not to exceed 75 mg/kg/day or 4000 mg/day, whichever is less.

Administration Context and Adjustments

Contextual Instructions: Claradol may be administered with or without food; taking it without food may expedite the onset of absorption. The intravenous solution is administered as a 15-minute infusion.

Special Population Adjustments: Dosing adjustments are required for certain conditions, as the standard regimen may lead to accumulation. For severe renal impairment (creatinine clearance leq 30 mL/min), a longer dosing interval (e.g., 6 to 8 hours) and a reduced total daily dose may be warranted. In cases of hepatic impairment, the maximum daily dose is generally reduced (e.g., to 2000 mg), and use is approached with caution.

Prohibition of Concurrent Use: The total 4000 mg daily maximum accounts for all sources of acetaminophen (paracetamol), including combination products and concurrent administration via different routes. This procedural restriction applies to all uses.

Recent Clinical Evidence

Claradol: Recent Clinical Evidence

Evidence for Acute Symptom Management (Pain and Fever)

Clinical research for Claradol primarily consists of Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies explored how symptoms change over time, examining outcomes related to physical discomfort and systemic or functional imbalance, such as acute pain and fever. Researchers monitored various patient-reported outcomes and recorded the time until a measured change in temperature was recorded. Findings describe patterns observed in the studies where short-term symptom changes were recorded. Research provides insight into short-term changes, but the magnitude of the measured difference compared to a placebo was observed to be small in some studies for certain acute pain types. Furthermore, comparative evidence is lacking to fully explore the research base for the intravenous (IV) formulation against the standard oral or rectal forms.


Evidence for Specific Pain Conditions

Research for Episodic Headaches

Claradol was evaluated in studies for conditions characterized by fluctuating or episodic manifestations, such as tension-type headaches (TTH). The studies explored outcomes related to physical discomfort, often measuring the proportion of participants who reported reaching a score indicating absence of pain within a few hours of receiving a single dose. Findings indicate that when studied under specific conditions, patterns related to changes in symptom intensity were monitored. The magnitude of the measured difference was observed in some studies to be small, and certainty remains low for assessing lower single doses due to varying evidence quality.

Research for Chronic Pain (Osteoarthritis)

Claradol was studied for conditions marked by functional limitations, such as Osteoarthritis (OA), in Meta-analyses of RCTs with observation periods up to three months. These studies monitored patient-reported outcomes describing perceived discomfort and outcomes reflecting daily functioning. Research highlights changes measured during the study period, but the reported effect size was characterized as statistically small in magnitude. Comparative evidence is lacking regarding the findings for this medicine against other analgesic medications often studied for chronic conditions, and Findings were mixed when examining patterns against certain other pain reliever classes.


Long-term Follow-up and Durability of Response

Research provides limited insight into sustained effectiveness. For chronic conditions, follow-up durations were limited in key trials, often spanning only up to three months. Because of this, long-term effects are not fully established. Research does not provide insight into the maintenance of initial changes over many months or years of continuous use.


What Research Gaps and Uncertainties Remain

A primary gap is the limited information for long-term outcomes when the medicine was observed in continuous use for chronic pain management. For specific pain conditions, the research describes the measured effect as small. Furthermore, comparative evidence is lacking to fully assess patterns relative to other common over-the-counter pain relievers for every studied indication, meaning research is ongoing to fully contextualize the findings.

Frequently Asked Questions (FAQ)

Common questions about Claradol (FAQ)


Q: Is Claradol the same kind of medicine as Tylenol or Advil?

Regulatory documents define the active ingredient in Claradol as acetaminophen (paracetamol), which is a non-opioid medicine for pain and fever. This is the same active substance found in certain common over-the-counter brands like Tylenol. However, official information highlights that acetaminophen is chemically distinct from non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil).


Q: Does Claradol help with muscle pain?

Official labeling documents indicate that the medicine is used for the temporary relief of common aches and pains. This general use includes the management of muscular aches, according to the official product information.


Q: Can Claradol be taken on an empty stomach?

Administration guidelines state that the medicine may be taken with or without food. Taking it without food may lead to faster absorption of the active ingredient, according to regulatory notes.


Q: Is there a link between Claradol and blood thinning?

Official interaction documents note that prolonged, regular daily use of the medicine may enhance the effect of certain blood thinners, such as coumarin derivatives like Warfarin. This interaction is documented in the product safety information and can increase the risk of bleeding.


Q: What should I do if I feel a side effect from Claradol?

Regulatory guidance for serious reactions, such as severe skin reactions or symptoms consistent with liver damage, advises stopping the use of the medicine. Official guidance also describes immediately seeking medical attention in such instances, as noted in the safety information.


Q: Can Claradol be taken with common cold and flu remedies?

Official procedural restrictions mandate that Claradol must not be used concurrently with any other medicinal product that contains acetaminophen (paracetamol). This restriction is addressed in the official procedural guidelines for use.


Q: Why are there warnings about combining Claradol with certain other drugs?

Warnings are detailed in official documents because co-administration with certain medicinal products, such as specific liver enzyme-inducing drugs, can accelerate the formation of toxic metabolites. The potential risk of liver injury is linked to this interaction, according to regulatory profiles.


Q: Why do some people experience better results from Claradol than others?

Clinical research has examined the measured effectiveness of the medicine against various conditions. Findings have shown that the difference in effect compared to a placebo was observed to be small in some studies for certain types of acute pain, which indicates non-uniformity of measured response patterns among different individuals and pain types.


Q: Is Claradol safe to use before driving?

Official safety profiles for certain formulations have included central nervous system (CNS) effects such as dizziness or somnolence (drowsiness) as documented adverse events. The potential for these effects is a factor that may be considered before engaging in activities that require attention.


Q: How quickly does Claradol start to work?

Pharmacokinetic data cited in regulatory reviews provide insight into the drug's action time. These data suggest that the oral formulation can reach its onset of action (when the effect begins) in under an hour.


Q: How long does the effect of Claradol last?

Regulatory dosing instructions are based on the expected duration of the medicine's effect. Instructions state that the medicine is typically administered every 4 to 6 hours as needed, reflecting the expected span of its analgesic (pain relief) and antipyretic (fever reduction) activity.


Q: Is it normal to feel sleepy after taking Claradol?

The documented side effects for some formulations include somnolence (drowsiness) as an adverse event. Other central nervous system effects, such as dizziness, have also been documented in the safety profiles.


Q: Are there any common side effects people report when using Claradol?

Regulatory safety profiles classify adverse reactions by frequency. Common occurrences listed include gastrointestinal disorders such as nausea, vomiting, and constipation.


Q: What happens if I forget to take Claradol at the usual time?

General regulatory instructions for a missed dose advise taking it as soon as possible, unless it is nearly time for the next scheduled dose. If it is, the missed dose should be skipped, and regulatory guidance advises against doubling the dose.


Q: Does taking Claradol affect lab test results?

Regulatory safety information documents that abnormal liver function tests may occur with the medicine's use, particularly when recommended dosage limits are exceeded. This indicates a measurable effect on certain body chemistry results that may be tested in a lab.


Q: Is Claradol habit-forming or addictive?

Official sources state that the active ingredient, acetaminophen, does not become habit-forming or cause dependence when used as directed. This classification applies when the medicine is used alone.


Q: How is Claradol different from other over-the-counter pain medicines?

Regulatory descriptions note that the medicine's action is predominantly central, targeting pain and fever in the brain and spinal cord. Unlike NSAIDs, the medicine exerts a negligible effect on peripheral inflammation, according to chemical and pharmacological properties.


Q: Are there any foods or drinks that should be avoided when taking Claradol?

Regulatory warnings specifically advise against the chronic consumption of three or more alcoholic drinks per day while using the medicine. This warning is due to an increased risk of severe liver damage associated with the combination.


Q: Can Claradol be used to lower a fever?

The medicine is formally classified as an Antipyretic, which is a category of drug used to reduce fever. Its established general purpose is the symptomatic relief and reduction of fever, according to official documents.


Q: Does Claradol come in different forms, like liquid or capsules?

The medicine is available in multiple pharmaceutical forms, including oral solid preparations (tablets), oral solutions, rectal suppositories, and preparations for intravenous infusion. The active ingredient is also commonly available in capsule forms.


Q: Is Claradol safe for women who are planning to become pregnant?

Regulatory documents define the use of the medicine during pregnancy as permitted if clinically needed, but this must be at the lowest effective dose for the shortest duration. The active substance’s safety profile during pregnancy is a factor for consideration when discussing use with a healthcare professional.


Q: Do studies show long-term effects of using Claradol?

Clinical evidence for chronic conditions often involves follow-up durations limited to a few months in key trials. Because of this, the long-term effects of continuous use over many months or years are not fully established in the current research base.


Q: Can Claradol affect my mental state or mood?

The medicine acts predominantly in the Central Nervous System (CNS), and documented adverse events for some formulations include CNS-related effects such as confusion and dizziness. Official safety profiles should be consulted for details on these effects.


Q: Is Claradol used for chronic pain?

The medicine has been studied for use in chronic conditions, specifically Osteoarthritis, according to clinical research reviews. However, research notes that follow-up durations in key trials for chronic pain were limited, and long-term effects are not fully established.


Q: Are there specific age restrictions for Claradol use?

Eligibility is governed by official age-related rules and weight-based thresholds. These restrictions are specifically defined for different pharmaceutical forms and pediatric populations and must be followed as outlined in regulatory documentation.


Q: Can Claradol be used for pain after a minor injury?

The medicine is formally classified as an analgesic with the general purpose of providing symptomatic relief for common pain. This purpose includes relief for minor aches and pain, according to official regulatory guidance for internal analgesic products.


Q: Are there specific genetic factors that affect how Claradol works?

Regulatory science research has examined the metabolism of the active ingredient. Findings indicate that genetic variations in the enzymes responsible for metabolizing the drug may affect how it is processed and cleared from the body.


Q: What is known about the research on Claradol's effect on sleep?

Documented adverse event reports for certain formulations include somnolence (drowsiness), which is a central nervous system effect. This listing in official safety profiles indicates a known link to sleep-related symptoms.


Q: Are there specific monitoring requirements for Claradol use?

For at-risk individuals or certain administration routes (such as intravenous use), a comprehensive risk management approach is required by regulators. This process includes monitoring for potential adverse events, such as those related to liver function (hepatotoxicity).

How should Claradol be stored and disposed of?

Claradol (Acetaminophen/Paracetamol) must be stored and discarded according to regulatory mandates to maintain its quality and ensure safety.

Storage Requirements Official Mandate
Temperature Store at controlled room temperature (15 C to 25 C); Do not freeze.
Environment Protect from moisture, direct light, and excessive heat; store in a cool, dry place.
Packaging Keep in the original container and keep the container tightly closed.
Child Safety Keep out of the sight and reach of children and pets at all times.
Disposal Dispose of unused or expired product through an official drug take-back program or by following FDA household trash disposal procedures (mix with an undesirable substance, seal, and discard). Do not flush down the toilet or pour down a sink.

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

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