Kitadol

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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 Kitadol

Kitadol is an established, non-prescription (OTC) medication primarily used for the quick relief of mild to moderate pain and fever. It is a brand-name product available mainly in several Latin American countries, including Chile, Peru, and Uruguay, and is manufactured by the Teva pharmaceutical laboratory.

Kitadol's effectiveness is based on its single active ingredient: paracetamol, which is globally recognized as acetaminophen. The medication is typically available as an oral tablet containing a standard 500 mg dose of the active component.

Property Description
Active ingredient Paracetamol (Acetaminophen)
Form Oral tablet (Comprimido)
Pharmacological class Analgesic, Antipyretic
Common use Symptomatic relief of pain and fever
Manufacturer Teva

The pharmacological classification of paracetamol defines it as both an analgesic (a substance that relieves pain) and an antipyretic (a substance that reduces fever). Its role as a key medicine for pain and fever management is clinically established for these purposes.

Paracetamol is one of the most widely utilized OTC analgesic and antipyretic agents globally, employed for various acute painful conditions such as headaches and musculoskeletal discomfort, and is often recommended as a first-line treatment. As a brand, Kitadol provides a consistent and accessible form of this medicine.

Regulatory References

  1. WHO Essential Medicines List for Paracetamol
  2. Acetaminophen StatPearls (NIH)

What side effects are possible with Kitadol?

Possible side effects and safety information

The safety profile of Kitadol, which contains paracetamol (acetaminophen), is defined by regulatory authorities worldwide and is primarily characterized by the risk of hepatotoxicity (liver damage), especially when used at high cumulative doses or in the event of overdose. Adverse reactions are grouped by the affected body systems, which include the Hepatobiliary disorders and the Blood and lymphatic system disorders.


Official Classification of Adverse Reactions

Side effects are categorized based on their officially documented frequency in regulatory summaries:

  • Rare: These effects, which include blood disorders (such as thrombocytopenia and agranulocytosis), general hypersensitivity reactions, and liver function disorders, occur infrequently.
  • Frequency Not Known: This category applies to serious, but rare, events like Severe Cutaneous Adverse Reactions (SCARs), including Stevens-Johnson Syndrome (SJS), and anaphylactic shock, where a precise rate of occurrence cannot be estimated from available data.

Serious Adverse Reactions and Safety Constraints

The most significant serious adverse reaction documented in regulatory labels is Acute Liver Failure, which is strongly associated with toxicity from exceeding the recommended dosage. The product is subject to high-level safety constraints defined in official labeling. Use of Kitadol is contraindicated in individuals with known hypersensitivity to paracetamol or its excipients and in patients with severe hepatocellular insufficiency.

Furthermore, official safety notes identify specific population constraints: individuals with severe renal impairment, pre-existing hepatic impairment, or a history of chronic alcohol consumption have an officially recognized increased risk of adverse effects, requiring specific caution according to regulatory guidelines. The safety profile is also characterized by the crucial constraint that the medicine must not be combined with any other product containing paracetamol.

Overdose and Emergency Response

Overdose with Kitadol, whose active ingredient is paracetamol (acetaminophen), presents a significant and potentially fatal risk due to the potential for severe hepatic damage. Official regulatory guidance mandates that immediate medical attention must be sought for any suspected overdose, even if the person experiences no symptoms initially. This urgent action is required due to the delayed onset of the most serious effects.

The initial signs of overdose, which can occur within 24 hours of ingestion, are often non-specific, including nausea, vomiting, abdominal pain, anorexia, and sweating. These may be followed by a period where the patient feels well before severe toxicity manifests, typically as acute hepatic failure, encephalopathy, and coma.

Official Emergency Response

Classification Regulatory Statements
Primary Risk Hepatic necrosis and life-threatening acute liver failure.
Antidote Status Acetylcysteine (N-acetylcysteine) is documented as the specific antidote and is most effective when administered promptly.
Monitoring Required Hospital observation and serial liver function tests are mandated due to the delayed nature of toxicity.

The profile is structured around the fact that the overdose is a time-critical event. Individuals with chronic alcohol use, malnutrition, or pre-existing liver impairment are officially noted to be at an increased risk of severe outcomes. Contacting a poison control center or emergency services immediately is the mandated regulatory instruction.

Therapeutic Uses of Kitadol

What Kitadol Treats: Main Uses and Benefits

Kitadol, which contains paracetamol (acetaminophen), is commonly used to help with symptoms related to systemic imbalance and symptoms related to physical discomfort. It is generally applied across domains where short-term symptom management is appropriate, primarily focusing on easing symptoms related to physical discomfort and symptoms related to systemic imbalance.


Symptomatic Relief for Acute Discomfort

The medication may assist with easing discomfort in conditions characterized by periods of heightened symptoms, such as headache, toothache, backache, and muscle stiffness. It is applied in addressing symptom clusters that create noticeable physiological strain, helping patients cope more steadily with symptom fluctuations. It is relevant for easing symptoms related to systemic imbalance, such as elevated body temperature, and the general aches associated with colds or flu.

“It is commonly used across conditions presenting with acute episodes, where supportive relief is needed when symptoms intensify.”

Addressing Episodic and Focused Pain

The use of this medicine is applicable within clinical settings that involve recurrent or episodic manifestations, such as the focused discomfort of menstrual cramping (dysmenorrhea). In these scenarios, the benefit contributes to easing the overall symptom load and supports improved day-to-day comfort.

Quick Fact: Symptomatic Support for Acute Episodes
Kitadol is applied in addressing symptoms related to physical discomfort and symptoms related to systemic imbalance in conditions involving temporary physiological imbalance.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

The eligibility profile for Kitadol, typically a fixed-dose combination of Ibuprofen (an NSAID) and Paracetamol (Acetaminophen), is governed by official contraindications associated with both active substances.

Contraindicated Populations (Must Not Use) Conditional/Restricted Use (Caution Required)
Known hypersensitivity to Ibuprofen, Paracetamol, or other NSAIDs (e.g., aspirin-induced asthma) Elderly patients (typically ge 65 years) due to increased organ risk.
Severe hepatic (liver) or renal (kidney) failure Patients with mild to moderate hepatic/renal impairment.
Active or history of recurrent peptic ulceration/haemorrhage or GI perforation Patients with a history of GI disease (e.g., ulcerative colitis).
Severe heart failure (NYHA Class IV), active bleeding, or blood-formation disturbances Patients with uncontrolled hypertension or established cardiovascular disease.
Third trimester of pregnancy (due to Ibuprofen component) Pregnancy during the first and second trimesters and lactation (requires caution).
Concomitant use with other NSAIDs or Paracetamol-containing products Patients with chronic alcoholism or severe dehydration.

Official regulatory documents stipulate that the medicine is generally allowed for adults and adolescents (usually age 12 and older) who do not have any listed exclusions. Eligibility is strictly limited by the presence of severe organ dysfunction, GI bleeding risk, and late-stage pregnancy, which are defined as contraindications in prescribing information.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Category Official Regulatory Statement
Medicinal product categories with documented interactions Anticoagulants (coumarins), Liver Microsomal Enzyme Inducers, Gastric Emptying Modifiers, Antibiotics, Cytotoxic Agents, Reverse Transcriptase Inhibitors.
Specific interacting medicines (if explicitly listed) Warfarin, Carbamazepine, Phenytoin, Rifampicin, Metoclopramide, Domperidone, Cholestyramine, Probenecid, Busulfan, Flucloxacillin, St. John’s Wort.
Mechanistic basis of interactions (only if stated in label) Enzyme Induction increasing the formation of a toxic metabolite; Absorption Rate Modification affecting the speed of uptake; Pharmacodynamic Potentiation leading to enhanced anticoagulant effects; Glutathione Depletion increasing toxicity risk of co-administered agents.
Timing-based interaction rules (if applicable) Co-administration with Cholestyramine must be separated by at least one hour to avoid a reduction in absorption. Busulfan co-administration requires avoidance or limitation in the 72 hours before and during treatment.
Population-specific interaction notes (if applicable) The risk of interaction-related high anion gap metabolic acidosis is noted for patients with risk factors for glutathione deficiency. Interaction toxicity risk is heightened in patients with underlying hepatic impairment.
Interaction-related restrictions Chronic alcohol consumption (three or more drinks per day) is documented to increase the risk of severe liver damage due to enhanced enzyme induction. The interaction with warfarin is specific to prolonged regular daily use.

Resulting Interaction Structure

Official regulatory documents define the interaction structure of Kitadol primarily around pharmacokinetic changes involving enzyme induction and absorption modification, alongside specific pharmacodynamic potentiation with anticoagulant medicines. The profile mandates explicit timing constraints for certain co-administered substances and highlights risks linked to patient-specific conditions like hepatic impairment or glutathione deficiency, all of which reflect officially required label restrictions.

Mechanism of Action

How Kitadol Works: Pharmacodynamic Mechanism

Kitadol's core mechanism operates predominantly within the Central Nervous System (CNS). Its antipyretic effect is mediated by the inhibition of cyclooxygenase (COX) enzymes, specifically limiting the synthesis of prostaglandins within the hypothalamic heat-regulating center. This molecular action directly modulates the central thermal set-point, resulting in the physiological consequence of antipyresis (a decrease in core body temperature).

The analgesic component involves a distinct neurobiological cascade. An active metabolite engages endogenous systems, acting as an agonist for the Transient Receptor Potential Vanilloid 1 (TRPV1) receptor and modulating the endocannabinoid system (CB1). This signaling event stimulates a descending inhibitory pathway in the spinal cord, limiting the propagation of nociceptive signals. This modulation of sensory transmission produces the core physiological effect of analgesia (elevated pain threshold), establishing a central scope of action that minimizes impact on peripheral inflammatory processes.

Dosage and Administration Information

How to Use Kitadol

Kitadol, containing paracetamol (acetaminophen), is used according to specific procedural guidelines for the management of acute symptoms. The instructions detail the administration route, established dosing limits, and required time intervals between doses.

Administration and Dosing Principles

Instruction Official Guidelines for Oral Use
Route of Administration Oral (for tablet formulation)
Standard Single Dose Typically 500 mg to 1,000 mg (1 gram) per dose.
Dosing Frequency Administer a dose every 4 to 6 hours as required for symptom relief.
Maximum Daily Dose The total intake must not exceed 4,000 mg in any 24-hour period.

The official guidelines establish that the medicine is administered in a defined dose range, taken orally with or without food. The schedule is structured as an as-needed (PRN) pattern, but this must always be constrained by the minimum required time interval between doses (4 to 6 hours) and the absolute 24-hour maximum dose. Adherence to the maximum daily dose is a critical procedural constraint for safe use.

Usage Duration and Adjustments

The regulatory framework specifies that paracetamol is for short-term symptomatic relief. Prolonged continuous use is not advised without medical oversight. For specific patient groups, the maximum daily dose must be reduced. Individuals with chronic liver impairment or chronic alcohol use, for instance, are instructed to follow a lower maximum daily limit, often reduced to 2,000 mg or 3,000 mg, as this population requires modified dosing principles.

Recent Clinical Evidence

Research Evidence: Kitadol's Established Uses and Study Landscape

The research on Kitadol, which contains paracetamol (acetaminophen), has been extensive and is primarily based on Randomized Controlled Trials (RCTs) and Systematic Reviews. The source that provides data used by health authorities worldwide to characterize the medicine's approved uses. This summary focuses on describing the structure of this evidence, the study outcomes monitored, and where research remains limited or less certain.


Evidence for Acute Relief of Pain

Research has explored the use of paracetamol in conditions characterized by periods of heightened symptoms. Researchers conducted numerous short-term RCTs that was studied for outcomes related to physical discomfort in adults with episodic tension-type headaches and those recovering from minor surgical procedures. These trials typically monitored pain intensity scores.

Findings describe patterns observed in studies that examined physical discomfort outcomes, with some findings linked to the higher single dose being studied. Across these areas, the follow-up durations were limited, meaning the studies mainly provide insight into the medicine’s immediate effects during an acute episode.


Evidence for Fever Reduction (Antipyresis)

The antipyretic property of paracetamol was evaluated in research focused on outcomes related to systemic or functional imbalance, specifically elevated body temperature. The research included RCTs and Systematic Reviews that monitored the magnitude of body temperature reduction.

Research describes patterns of temperature change following administration in febrile patients. Research focused on the antipyretic properties in otherwise healthy adults is less prevalent. However, the overall certainty remains low regarding the research data when solely assessing temperature reduction in non-distressed children.


Areas of Research Uncertainty and Study Gaps

A core area of uncertainty relates to the evidence for chronic pain. For example, for acute low back pain (LBP), high-quality evidence suggests that studies did not report distinct patterns of pain or disability change compared to placebo. Furthermore, the limited information for long-term outcomes means that the true durability of any measured effect is not fully established by controlled research.

Frequently Asked Questions (FAQ)

Common questions about Kitadol (FAQ)


Q: How fast does Kitadol start to work after you take it?

Official regulatory data on the active ingredient indicate that the onset of action for the oral tablet is typically observed within 37 to 60 minutes of administration. This is the period when the medicine begins to provide symptomatic relief for pain or fever.

Q: How long do the effects of Kitadol usually last?

The effects of this medication generally last for approximately four to six hours. This duration is the basis for the required minimum time interval that is observed between doses.

Q: Does taking Kitadol with food delay its onset of action?

Official pharmacokinetic data notes that taking the medicine after a meal may slow down the rate of absorption by the body. The total amount absorbed generally remains unchanged, but the delay in absorption can influence the time taken to reach peak concentrations (Tmax).

Q: What is the 'active metabolite' of Kitadol mentioned in some studies?

Studies and regulatory literature sometimes reference an active compound in the body that contributes to the pain-relieving effect. The metabolite that is often mentioned in relation to the central nervous system action is called AM404.

Q: Why do people say Kitadol is better than Tylenol/aspirin for certain things?

This medicine's active ingredient is classified by regulatory bodies as an analgesic (pain reliever) and antipyretic (fever reducer). Unlike medicines like aspirin, it acts primarily in the central nervous system and officially lacks the significant anti-inflammatory activity that other classes of pain relievers possess.

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

The guidance for a missed dose of scheduled medicines states that the missed dose should only be considered if the user remains within the required time window before the next scheduled dose. It is a safety constraint that a double dose must not be taken to compensate for a missed dose, as this action carries the risk of exceeding the established safety limits.

Q: What is the maximum number of days Kitadol can be taken continuously?

The official product information specifies that this medicine is intended for short-term use for temporary relief. Regulatory guidance often states that it should not be taken continuously for more than three days, as prolonged use requires professional monitoring.

Q: Why does Kitadol need to be taken with food sometimes?

Regulatory information notes that this medicine is generally well-tolerated whether taken with or without food. However, taking it after a meal may be referenced as an option to help minimize mild nausea or stomach discomfort in sensitive individuals.

Q: Can Kitadol be crushed or split?

Official documents do not generally state that unscored tablets should be altered. Altering the formulation may result in unintended outcomes. Studies show that crushing tablets can sometimes lead to drug loss or potentially alter the absorption of the medicine, which may influence its intended effect.

Q: Can Kitadol be used to help with sleep?

Paracetamol alone is not officially indicated for use as a sleep aid. However, it is an active ingredient in some officially approved products combined with a secondary ingredient (such as an antihistamine) where that second ingredient is included for its sedative properties.

Q: Does Kitadol cause drowsiness or affect driving?

Drowsiness is not typically listed as a common or frequent side effect of paracetamol. However, official safety notes describe the constraint that the user should avoid driving or operating machinery if any side effects are experienced that could impair task performance.

Q: Is it normal to feel a bit dizzy after taking Kitadol?

Official safety documents do not list dizziness as a common side effect of this medicine. However, official safety notes recognize dizziness as a potential symptom that has been reported.

Q: What if I experience a rare or unexpected side effect from Kitadol?

Regulatory bodies have established procedures for reporting all serious or unexpected adverse reactions observed during the use of medications. This process is typically done through a national adverse event reporting program, such as the FDA's MedWatch or the UK's Yellow Card Scheme.

Q: Is Kitadol safe for people who have sensitive stomachs?

Regulatory summaries generally describe paracetamol as having good gastrointestinal tolerability. It is frequently noted for its low risk of causing stomach irritation or bleeding, which is a key distinguishing factor among various pain relievers.

Q: Is Kitadol suitable for children?

Official product information confirms that paracetamol is generally suitable for use in most children, typically starting from 2 to 3 months of age. Safe use in children requires adherence to specific, weight-based dosing and is constrained by the instructions provided in the product's official labeling.

Q: Can older adults use Kitadol safely?

The official product information states that its use in elderly patients is permitted but requires caution. This is due to a potential increased risk of adverse effects linked to age-related changes in organ function, which may necessitate monitoring.

Q: Is Kitadol addictive?

According to regulatory and public health bodies, paracetamol is not classified as an addictive substance. It does not produce physical tolerance or dependence when used appropriately, although all medication use requires adherence to the maximum allowed dosage to avoid health risks.

Q: Can I take Kitadol with coffee or tea?

Official interaction checkers generally find no major interaction between paracetamol and caffeine. However, the official advice is to consider the constraint of overall caffeine intake, particularly when using combination products that contain it.

Q: Does Kitadol interact with alcohol?

Official regulatory labeling includes an explicit and serious warning regarding chronic alcohol consumption. The warning states that the medicine should not be taken if the user consumes three or more alcoholic drinks every day due to a significantly increased risk of severe liver damage.

Q: Can you take Kitadol if you are on blood pressure medication?

Paracetamol is generally not listed with a major interaction with most common blood pressure medications (antihypertensives). However, the relationship between paracetamol and high blood pressure remains an area where some regulatory sources suggest continued observation.

Q: Are there risks to taking Kitadol with other common pain relievers?

Official product information contains a contraindication (a strict warning) against taking this medicine with any other product that contains paracetamol. Official warnings document a requirement for caution when combining it with other non-steroidal anti-inflammatory drugs (NSAIDs) due to a potential for increased risks.

How should Kitadol be stored and disposed of?

Kitadol (Paracetamol 500 mg tablets) must be stored and disposed of according to official regulatory labeling to ensure product quality and public safety.

Store the tablets in the original container at controlled room temperature, generally not exceeding 25 C or 30 C, and protect them from moisture and excessive heat. Do not use the medicine past the expiry date printed on the package.

For safety, the product must always be kept out of the sight and reach of children to prevent accidental exposure.

Disposal of any unused or expired tablets must be done in accordance with local regulations, such as drug take-back programs. You should not throw away medicines via wastewater or household waste unless instructed otherwise by a pharmacist or healthcare provider, as this helps protect the environment.

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

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