Аркоксия

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Аркоксия

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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

Overview of Аркоксия

Quick Facts

Property Description
Active ingredient Etoricoxib (INN: Etoricoxibum)
Form Film-coated tablets
Pharmacological class Selective Cyclooxygenase-2 (COX-2) Inhibitor
Common use Symptomatic relief of pain and inflammation
Origin Synthetic organic compound

What Type of Medicine is Аркоксия (Etoricoxib)?

Аркоксия (Arcoxia) is a prescription-only pharmacological agent that belongs to the broad group of Non-steroidal anti-inflammatory drugs (NSAIDs). The core of the medicine is its active ingredient, Etoricoxib (INN: Etoricoxibum), which is classified as a Selective Cyclooxygenase-2 (COX-2) Inhibitor. This classification places it within the specialized coxib subgroup. The drug is used for providing symptomatic relief for the pain and inflammation associated with various adult musculoskeletal conditions, a primary differentiating factor from less targeted analgesics.

Etoricoxib: Origin, Form, and General Purpose

Etoricoxib is a synthetic organic compound. It is manufactured as a single active ingredient product, most commonly supplied as film-coated tablets for oral administration, with the basic composition including the active substance and standard solid oral preparation excipients. The general therapeutic goal is to alleviate patient discomfort; this medicine is frequently used in scenarios like managing the pain flare-ups that occur in conditions such as rheumatoid arthritis or ankylosing spondylitis. This medicine is designed to offer relief for the pain and inflammation associated with arthritis and other conditions.

Selective Action: The Key Distinguishing Feature

The selective action of Аркоксия is its most defining characteristic: it achieves its effect by inhibiting the Cyclooxygenase-2 (COX-2) enzyme, which is the key mediator of inflammatory chemical messengers, such as prostaglandins (PGs). This targeted approach is a differentiating factor that separates it from non-selective NSAIDs, which generally affect both the COX-2 and the protective COX-1 enzyme. This selective focus reflects its design as a focused option for managing chronic and acute inflammatory symptoms while mitigating certain side effects linked to broader COX inhibition.

Regulatory References

  1. European Medicines Agency (EMA) documentation

What side effects are possible with Аркоксия?

Official Safety Profile of Etoricoxib

The safety profile of Etoricoxib (Arcoxia) is established by government regulatory bodies and documents such as the European Summary of Product Characteristics (SmPC).

Serious Adverse Reactions and Key Safety Concerns

Regulatory warnings highlight the potential for serious, life-threatening events, primarily involving the cardiovascular and gastrointestinal systems. These serious adverse reactions include:

  • Cardiovascular Events: Myocardial infarction (heart attack), stroke (cerebrovascular accident), worsening of congestive heart failure, and hypertensive crisis.
  • Gastrointestinal Events: Peptic ulceration, gastrointestinal bleeding (haemorrhage), and perforation of the stomach or intestine.
  • Hypersensitivity: Rare but severe allergic reactions such as anaphylaxis, Angioedema, Stevens-Johnson Syndrome (SJS), and Toxic Epidermal Necrolysis (TEN).

Frequency-Classified Adverse Reactions

The most commonly reported side effects classified as Common (affecting up to 1 in 10 people) include hypertension (high blood pressure), oedema/fluid retention, headache, dizziness, abdominal pain, nausea, and elevations in liver enzyme levels (ALT/AST).

Safety Restrictions and Monitoring

The medicine is contraindicated (must not be used) in patients with established heart conditions such as ischaemic heart disease, peripheral arterial disease, active cerebrovascular disease, or severe congestive heart failure (NYHA II-IV). It is also contraindicated in those with active peptic ulceration or severe hepatic dysfunction.

Regulatory documents emphasize that the risk of cardiovascular and gastrointestinal adverse events increases with both dose and duration of treatment. The product label dictates that treatment must use the lowest effective dose for the shortest possible duration. Blood pressure and liver function should be monitored during treatment.

Population-Specific Safety Notes

The medicine is contraindicated during the third trimester of pregnancy, while breastfeeding, and for use in children and adolescents under 16 years of age.

Overdose and Emergency Response

Overdose and When to Seek Help

The information regarding overdose of etoricoxib (the active ingredient in Аркоксия) is derived from official governmental regulatory documents.

In clinical studies, the administration of single doses up to 500 mg and multiple daily doses up to 150 mg for 21 days did not result in significant or unique toxicity. The presentation of an overdose is primarily expected to involve an exacerbation of the drug's known dose-related adverse effects.

These effects potentially involve the primary physiological systems affected by the medication, including the gastrointestinal, renal (kidney), and cardiovascular systems. For instance, signs could include severe abdominal pain, persistent nausea/vomiting, or severe elevation of blood pressure.


Emergency Response and Medical Management

When to Seek Immediate Medical Help:

If an overdose is suspected or if you experience severe symptoms—such as signs of gastrointestinal bleeding (bloody or black, sticky stools), shortness of breath, or a serious skin reaction—immediate medical attention is required.

Overdose Management:

There is no specific antidote for etoricoxib overdose. The official management approach involves standard supportive measures, which may include the removal of any unabsorbed drug from the gastrointestinal tract and clinical monitoring. Due to the high degree of plasma protein binding, hemodialysis is considered an ineffective method for removing the drug from the bloodstream in an overdose situation.

Therapeutic Uses of Аркоксия

What Аркоксия Treats: Main Uses and Benefits

Аркоксия is commonly used to help with symptomatic relief from symptoms related to inflammatory or irritative states associated with various adult conditions. The medication is applied across various therapeutic domains, including the management of persistent symptoms from Osteoarthritis (OA), Rheumatoid Arthritis (RA), and Ankylosing Spondylitis, as well as the short-term treatment of Acute Gouty Arthritis and pain following dental surgery or Primary Dysmenorrhea.

“The goal is generally to help with symptoms that interfere with daily functioning.”

In these contexts, the medication is applied during phases where the symptoms intensify, providing support that assists with maintaining functional stability when they interfere with routine activities. Its use is relevant in contexts involving heightened systemic burden from sudden or persistent pain manifestations.


Summary of Symptom Management

Therapeutic Area Primary Symptom Focus Patient Benefit
Chronic Conditions (RA, OA, AS) Persistent joint pain, stiffness, and swelling. Contributes to easing the overall symptom load.
Acute Episodes (Gout, Post-Surgical) Sudden, intense pain and localized inflammation. Supports the patient during difficult episodes by easing distress.

Eligibility and Restrictions for Use

The eligibility for using Arcoxia (etoricoxib) is strictly defined by regulatory authorities, with numerous absolute restrictions based on a patient's pre-existing conditions and age.

Populations Allowed and Contraindicated

Eligibility Group Regulatory Status
Allowed Population Adults and adolescents ge 16 years of age.
Contraindicated Populations Children and adolescents under 16 years.
Pregnant and breast-feeding women.

Absolute Contraindications

The medicine is strictly prohibited for individuals with specific, high-risk clinical conditions. These absolute contraindications include:

  • Cardiovascular Conditions: Established ischemic heart disease, peripheral arterial disease, cerebrovascular disease, or congestive heart failure (NYHA II–IV).
  • Hypertension: Persistently elevated blood pressure above 140/90 mmHg that has not been adequately controlled.
  • Gastrointestinal Disease: Active peptic ulceration, active gastrointestinal (GI) bleeding, or inflammatory bowel disease (IBD).
  • Organ Function: Severe hepatic dysfunction (Child-Pugh score ge 10) or severe renal impairment (creatinine clearance <30 mL/min).
  • Hypersensitivity: A known allergy to etoricoxib or a history of asthma, acute rhinitis, or urticaria following the use of aspirin or other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs).

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Etoricoxib documents specific interaction patterns with other medicines and substances. Co-administration with other Non-steroidal Anti-inflammatory Drugs (NSAIDs) or high-dose Acetylsalicylic Acid (Aspirin) is not recommended due to an increased risk of gastrointestinal complications.

Pharmacodynamic Interactions

Entity Official Regulatory Description of Interaction
Oral Anticoagulants (e.g., Warfarin) Associated with an approximate 13% increase in International Normalised Ratio (INR), requiring close monitoring.
Antihypertensives (ACE Inhibitors, AIIAs) Etoricoxib may diminish the antihypertensive effect of these medicines.
Immunosuppressants (Cyclosporin, Tacrolimus) Co-administration may increase the nephrotoxic effect of these drugs.

Pharmacokinetic and Exposure Alterations

Substances that significantly alter drug exposure are also documented. Co-administration with Rifampin, a potent inducer of hepatic metabolism, resulted in a 65% decrease in Etoricoxib plasma exposure (AUC). Conversely, Etoricoxib can increase the plasma concentrations of certain co-administered drugs, including Ethinyl Estradiol (a component of oral contraceptives) and Lithium, requiring consideration for appropriate monitoring. Interaction with food or antacids is documented as not being clinically relevant.

Mechanism of Action

Selective Inhibition of the COX-2 Enzyme

The drug operates by performing a selective inhibition of the Cyclooxygenase-2 ( COX-2) enzyme, which is the primary molecular target responsible for generating pro-inflammatory chemical signals. This targeted interaction involves pathways where the enzyme is upregulated in response to biological stress, while largely maintaining the function of the constitutive COX-1 enzyme. This mechanistic difference is the initial molecular step of the drug's action.


Modulation of Prostaglandin Synthesis and Nociceptive Signaling

By blocking COX-2, the drug drastically reduces the biosynthesis of Prostaglandins (PGs), such as PGE2, which are chemical mediators that sensitize pain-receiving neurons (nociceptors). This physiological consequence reduces the activity of mediators that sensitize nociceptors and influence thermoregulation pathways. The resulting physiological adjustment is a reduction in the level of pro-inflammatory mediators within the systemic pathways.


COX-1 Activity and Mechanistic Constraints

The mechanism is defined by both the enzyme it inhibits and the enzyme it does not inhibit. The selectivity for COX-2 leaves the COX-1 enzyme active, meaning the molecule does not inhibit COX-1-dependent functions such as baseline platelet aggregation or gastric prostaglandin synthesis. However, the mechanism inherently involves inhibiting all COX-2-derived mediators, including Prostacyclin (PGI2) in the vasculature, which influences the drug's overall systemic effect profile.

Dosage and Administration Information

Etoricoxib (Arcoxia) is a selective cyclooxygenase-2 (COX-2) inhibitor, a type of non-steroidal anti-inflammatory drug (NSAID), administered orally once daily. The tablets may be taken with or without food; however, taking the tablet without food may result in a faster onset of effect, which should be considered when rapid pain relief is needed.

General Dosage Guidelines

To minimize the potential risk of cardiovascular and gastrointestinal adverse events, etoricoxib should always be used at the lowest effective daily dose and for the shortest duration possible. Treatment needs and patient response should be periodically re-evaluated by a healthcare professional.

Recommended Dosing by Indication

Indication Recommended Daily Dose Maximum Duration
Osteoarthritis (OA) 30 mg or 60 mg once daily Long-term (periodic re-evaluation)
Rheumatoid Arthritis (RA) 60 mg, up to 90 mg once daily Long-term (periodic re-evaluation)
Ankylosing Spondylitis (AS) 60 mg, up to 90 mg once daily Long-term (periodic re-evaluation)
Acute Gouty Arthritis 120 mg once daily Maximum 8 days
Postoperative Dental Surgery Pain 90 mg once daily Maximum 3 days

Note on Acute Pain: For acute symptomatic periods, such as acute gouty arthritis or postoperative pain, etoricoxib should only be used temporarily. Doses exceeding the recommended maximum for each specific indication have not shown additional efficacy.

Special Population Dosing

  • Hepatic Impairment: For patients with mild hepatic dysfunction (Child-Pugh score 5-6), the dose should not exceed 60 mg once daily. For moderate hepatic dysfunction (Child-Pugh score 7-9), the dose should not exceed 30 mg once daily. Use in severe hepatic impairment is contraindicated.
  • Elderly Patients: No dose adjustment is generally necessary; however, caution is advised due to increased risk factors in the elderly population.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Arcoxia (Etoricoxib)

Evidence for Use in Osteoarthritis (OA) Research

Research into Arcoxia included large-scale Randomized Controlled Trials (RCTs) involving adult patients with osteoarthritis of the knee or hip. Studies monitored outcomes related to physical discomfort and daily functioning using the WOMAC Index, which monitors patient-reported outcomes describing perceived discomfort. Findings describe patterns observed in the studies where outcomes related to physical discomfort research highlights changes measured during the study period across short-term and intermediate-term trial periods.

Evidence for Use in Rheumatoid Arthritis (RA) Research

Research explored the use of Arcoxia in conditions involving periods of heightened symptoms in adult patients diagnosed with active Rheumatoid Arthritis (RA). Studies examined outcomes reflecting daily functioning, such as the ACR response criteria and the DAS28-CRP score, which are ways of measuring how systemic or functional imbalance changes over time. Outcomes related to joint tenderness and swelling were reported by patients and assessed by investigators. Research data show patterns related to changes in disease activity metrics during the intermediate-term follow-up (e.g., 12–52 weeks).

What is Still Uncertain About Arcoxia Research

Key limitations persist in the evidence landscape. Long-term effects are not fully established, particularly concerning the persistence of changes in functional measures. Data for certain groups remain insufficient, especially for those with complex or severe pre-existing illnesses like poorly controlled heart disease or advanced kidney impairment, where subgroup findings are uncertain.

Additionally, while comparative evidence was evaluated in many trials, comparative evidence is lacking for all possible competing medications or combinations. Findings describe group patterns, not personal outcomes, and research does not determine whether an individual will respond similarly.

Key Studies & References

  1. A multinational randomized, controlled, clinical trial of etoricoxib in the treatment of rheumatoid arthritis [ISRCTN25142273] (Etoricoxib vs. Naproxen in RA)
  2. A Randomized, Clinical Trial to Assess the Relative Efficacy and Tolerability of Two Doses of Etoricoxib in Patients with Ankylosing Spondylitis (Etoricoxib in AS study)

Frequently Asked Questions (FAQ)

Common questions about Аркоксия (FAQ)


Q: How quickly can a person expect to feel the effect of Аркоксия?

Official information states that the onset of the medicine's effect may be faster when the tablet is taken without food. This consideration is noted for times when rapid symptomatic relief is desired, such as for acute pain. However, there is no official guarantee of a precise time frame for when an individual will feel relief.


Q: What is the typical length of time Аркоксия stays active in the body?

Regulatory data on how the body processes the drug indicates that the elimination half-life of etoricoxib is approximately 22 hours. This time frame describes how long it takes for half of the drug to be removed from the bloodstream. This property supports the drug's once-daily oral administration.


Q: Are there any known issues with combining Аркоксия with alcohol?

Specific warnings about moderate alcohol consumption are often not detailed in the official product information. However, safety advice for this class of medicine (NSAIDs) generally suggests exercising caution or abstaining from alcohol. This is often noted in clinical studies to maintain consistency and monitor for side effects.


Q: Can patients with heart conditions or high blood pressure use Аркоксия?

The medicine is strictly contraindicated for patients with established, high-risk heart conditions, such as a history of heart attack or stroke, or severe congestive heart failure. It is also prohibited for those with persistently uncontrolled high blood pressure (hypertension). For other patients, regulatory documents emphasize the need for caution and require that blood pressure be monitored during treatment.


Q: Does Аркоксия require any special dietary considerations?

Official regulatory documents indicate that the tablets may be taken with or without food. Taking the dose with a high-fat meal does not affect the total amount of drug absorbed by the body. Furthermore, the interaction between this medicine and common antacids is not considered clinically important.


Q: Is it important to monitor any specific symptoms while taking Аркоксия?

Yes, official safety documents specify that blood pressure should be checked within two weeks of starting treatment and periodically thereafter. Monitoring is recommended for patients who show signs of liver dysfunction or persistently abnormal liver function test results, in line with official safety guidance.


Q: What is the typical time frame patients use Аркоксия for conditions like acute gout?

Official regulatory dosing guidance for acute pain, such as the pain associated with acute gouty arthritis, specifies a short-term use. The maximum recommended duration for this specific indication is 8 days.


Q: Are there any specific organs that the safety warnings for Аркоксия focus on?

Official safety warnings particularly focus on key body systems. These include the cardiovascular system (concerning events like heart attack and stroke), the gastrointestinal system (concerning events like bleeding and ulceration), and monitoring of both liver and kidney function.


Q: Is there a possibility of becoming dependent on Аркоксия?

The medicine is classified as a Non-steroidal Anti-inflammatory Drug (NSAID) and is not an opioid or narcotic. Dependence on the drug is not listed as an expected adverse event in the official product information.


Q: What is the meaning of the specific dosage strengths that Аркоксия comes in?

The various strengths of the tablet (such as 30 mg, 60 mg, 90 mg, and 120 mg) are intended to treat different approved conditions and symptom levels. For long-term conditions like Osteoarthritis, the strengths provide flexibility to allow a healthcare professional to adjust the dose if the initial response is not sufficient.


Q: Is there a generic version of Аркоксия available?

The active ingredient in Arcoxia is etoricoxib. Official drug registers in many countries list generic versions of etoricoxib that have been approved by regulatory bodies.


Q: Can someone who is lactose intolerant use Аркоксия tablets?

The official composition details indicate that the film-coated tablets contain lactose as one of the excipients (inactive ingredients). The presence of lactose is specified for patients who have intolerance considerations.


Q: What is meant by the 'selective' action of Аркоксия?

The drug is officially described as a selective cyclo-oxygenase-2 ( COX-2) inhibitor. This means its mechanism is targeted to inhibit the COX-2 enzyme, which is the primary source of chemical signals for pain and inflammation, while mostly preserving the protective COX-1 enzyme.


Q: Is there an official patient information leaflet (PIL) available for Аркоксия?

Yes, regulatory bodies and government agencies in the regions where the drug is approved are required to make a Patient Information Leaflet (PIL) or a similar Patient Information document publicly available for etoricoxib.


Q: Can Аркоксия be taken with cold and flu medications?

Official documents advise that the co-administration of other Non-steroidal Anti-inflammatory Drugs (NSAIDs) is not recommended due to a documented increased risk of gastrointestinal complications. Since many common cold and flu relief products contain NSAIDs or similar-acting ingredients, caution is advised.


Q: What are the main research findings related to the long-term use of Аркоксия?

Research has examined the use of the drug in large clinical trials for chronic conditions such as Osteoarthritis and Rheumatoid Arthritis. These studies monitored patient outcomes related to changes in physical discomfort and daily functioning over intermediate periods, typically ranging from 12 to 52 weeks.


Q: Does Аркоксия have any known effects on fertility?

Official information advises that, as with other medicines that inhibit COX synthesis, etoricoxib may temporarily impair fertility in women. For this reason, it is not recommended for use by women who are actively attempting to conceive.


Q: Are there any common mental or mood-related side effects linked to Аркоксия?

Official product information lists a range of nervous system and psychiatric disorders among the possible side effects. These include less common events such as anxiety, depression, confusion, and hallucinations, and very rare events like restlessness.


Q: What should a patient do if they notice a skin reaction after starting Аркоксия?

The medicine is associated with a risk of severe, life-threatening skin reactions, such as Stevens-Johnson Syndrome (SJS). Official regulatory guidance states that the medicine should be discontinued immediately at the first sign of a skin rash or any sign of hypersensitivity, emphasizing the seriousness of these reactions.


Q: Can using Аркоксия affect the results of certain medical tests?

Official regulatory documents list abnormal results for specific laboratory tests as undesirable effects. Most commonly, these involve documented elevations in liver enzyme levels ( ALT/AST), which are classified as a common side effect.


Q: Is it possible to be allergic to Аркоксия?

Yes, hypersensitivity (allergy) to the active substance (etoricoxib) or to any of the inactive ingredients is listed as a contraindication. Severe allergic reactions, including anaphylaxis and angioedema, have been reported in official documents.


Q: How do regulatory agencies generally view the overall benefit-risk profile of Аркоксия?

Official documentation notes that the decision to use a selective COX-2 inhibitor should be based on an assessment of the individual patient's overall risk factors. The medicine is approved because the therapeutic benefits for the indicated uses are considered to outweigh the risks when it is used strictly according to the official safety constraints and warnings.


Q: Is it normal to feel dizzy or drowsy when first starting Аркоксия?

According to official product information, dizziness is classified as a Common side effect (affecting up to 1 in 10 people). Drowsiness (somnolence) is listed as an Uncommon side effect (affecting up to 1 in 100 people).


Q: Are there any interactions between Аркоксия and herbal supplements?

While specific herbal products may not be listed individually in official documents, general regulatory safety advice suggests that caution is necessary with supplements that affect key systems. This applies particularly to supplements that can affect blood clotting, blood pressure, or liver function.


Q: Why is Аркоксия used to treat pain from dental surgery?

The medicine is officially indicated for the short-term treatment of moderate pain following dental surgery. It is selected for this use based on its combined analgesic (pain-relieving) and anti-inflammatory properties.


Q: What is the official classification of Аркоксия (e.g., analgesic, anti-inflammatory)?

Etoricoxib is officially classified as a Selective Cyclooxygenase-2 ( COX-2) inhibitor and belongs to the broad group of Non-steroidal Anti-inflammatory Drugs (NSAIDs). It is used for the symptomatic relief of pain and inflammation.


Q: Are there any official restrictions on driving or operating machinery while taking Аркоксия?

Official information advises caution regarding driving or operating machinery for patients who experience side effects like dizziness, vertigo, or somnolence (drowsiness), as these can affect attention and coordination.


Q: What are some of the less common but officially listed serious side effects of Аркоксия?

The official product label lists serious adverse events that have been reported, though they are not common. These include severe allergic reactions (anaphylaxis), severe skin reactions (like SJS/TEN), heart attack, stroke, and gastrointestinal bleeding or perforation.

How should Аркоксия be stored and disposed of?

The official regulatory documents specify strict conditions for the storage and disposal of Arcoxia (etoricoxib) to ensure product quality and safety.

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store below 25 C or 30 C (varies by region).
Protection Store in the original package in order to protect from moisture.
Safety Keep out of the sight and reach of children.

Disposal Instructions

There are no special requirements for disposal beyond following local regulatory guidelines. Any unused medicinal product or waste material must be disposed of in accordance with local requirements.

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

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