Arcoxia

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Arcoxia

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Arcoxia

Quick Facts

Property Description
Active ingredient Etoricoxib
Form Film-coated tablets
Pharmacological class Selective COX-2 Inhibitor (NSAID)
General purpose Relief from pain and inflammation
Origin Synthetic compound

Defining Arcoxia: Active Ingredient and Pharmacological Class

Arcoxia is the trade name for the prescription medicine containing the single, synthetic active compound Etoricoxib (INN), which belongs to the class of Non-steroidal Anti-inflammatory Drugs (NSAIDs). Etoricoxib is specifically classified as a selective cyclooxygenase-2 (COX-2) inhibitor. This selectivity differentiates it from traditional NSAIDs by its targeted mechanism. The medicine is typically indicated for adult patients and is supplied as a prescription-only medicine, underscoring its status as a controlled pharmaceutical agent.

Form and Structure: Understanding the Preparation

The medicine is manufactured exclusively as film-coated tablets designed for oral ingestion, representing the only route of administration for this drug entity. As a single-ingredient product, the tablets contain the active substance Etoricoxib precisely formulated with pharmaceutical excipients—the inert base materials necessary for tablet compression, stability, and systemic delivery. The preparation allows for consistent and rapid absorption of Etoricoxib following oral intake, which is essential for achieving a uniform therapeutic effect.

General Function: The Purpose of a Selective NSAID

The general function of Etoricoxib is to provide relief from pain and combat associated inflammation by selectively interrupting the body's inflammatory cascade. This mechanism ensures that the drug's core benefit is realized through its analgesic and anti-inflammatory properties. The drug is clinically recognized for its effectiveness in managing discomfort associated with inflammatory processes. By intervening specifically at the COX-2 enzyme, the selective NSAID action minimizes the production of the chemical signals (prostaglandins) responsible for triggering and sustaining discomfort and swelling, thereby offering its principal therapeutic effect.

Regulatory References

  1. World Health Organization (WHO)
  2. European Medicines Agency (EMA)

What side effects are possible with Arcoxia?

Possible side effects and safety information

This section describes the officially documented adverse reactions and safety characteristics of Etoricoxib (Arcoxia), as classified in government regulatory documents like the Summary of Product Characteristics (SmPC) and FDA Prescribing Information.

The official safety profile is structured by System-Organ Classes (SOC) and frequency classification.

Frequency Category Examples of Adverse Reactions (Official Classification)
Very Common (1/10) Abdominal pain
Common (1/100 to <1/10) Hypertension, oedema/fluid retention, headache, dizziness, palpitation, arrhythmia, dyspepsia, increased liver enzymes (ALT/AST)

Serious adverse reactions listed in regulatory texts primarily involve cardiovascular thrombotic events (such as myocardial infarction or stroke) and gastrointestinal complications (including perforations, ulcers, or bleedings (PUBs)). Serious skin reactions like Stevens-Johnson syndrome (SJS) and hepatic failure are also documented as rare events.

Safety Constraints and Patterns

The official label notes that the risk of serious cardiovascular thrombotic events may increase with the dose and duration of exposure. The regulatory guidance advises that the lowest effective daily dose should be used for the shortest duration possible.

Specific population-based safety constraints are established: Etoricoxib is contraindicated in individuals with established ischaemic heart disease, specific severe stages of congestive heart failure, severe hepatic dysfunction, and significant renal impairment (creatinine clearance <30 ml/min). Furthermore, the medicine may mask signs of fever and inflammation, a key consideration documented in the prescribing information.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory guidance for Etoricoxib emphasizes that any suspected overexposure requires immediate medical attention. While clinical trials have reported no significant toxicity following single doses up to 500 mg, the risk of severe complications associated with the NSAID pharmacological class necessitates prompt assessment.

Documented Overdose Manifestations

Domain Regulatory Documentation Statement
Clinical Presentation Overexposure has been associated with typically mild gastrointestinal symptoms [Source: Regulatory SmPC/PIL guidance].
Severe Outcome Potential Potential for systemic effects including acute renal failure, exacerbated hypertension, and serious gastrointestinal events (e.g., bleeding/perforation) [Source: Regulatory Data Sheet].
Help Seeking Mandate If a patient takes too many tablets, they must seek medical attention immediately [Source: Regulatory Guidance].

Official Overdose Management

Domain Regulatory Management Procedure
Antidote Status No specific antidote is known for Etoricoxib overexposure [Source: Regulatory SmPC/PIL guidance].
Supportive Measures Treatment should employ the usual supportive measures and institute symptomatic and supportive therapy, including efforts to remove unabsorbed material [Source: Regulatory SmPC/PIL guidance].
Monitoring Note Clinical monitoring is required, and the drug is not dialysable by haemodialysis [Source: Regulatory SmPC/PIL guidance].

This structure ensures that patients are aware of the regulator-mandated action (seek immediate medical attention) and the procedural facts about management, including the absence of a specific antidote, without providing unauthorized medical advice.

Therapeutic Uses of Arcoxia

Arcoxia (Etoricoxib) is commonly used across conditions characterized by periods of heightened symptoms related to inflammatory or irritative states. The medication is applied across domains where additional symptomatic support is needed to help manage discomfort and functional strain, which may intensify temporarily.

It is primarily used to address symptom clusters that may become intense or disruptive in conditions such as Osteoarthritis (OA), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), and for the short-term relief of acute gouty arthritis and certain acute pain following dental surgeries. The medicine helps maintain a sense of stability when symptoms are more noticeable and provides support that helps ease the overall symptom burden. This supportive action assists with maintaining functional stability and contributes to improved comfort during symptomatic phases.


Quick Fact: Relief for Inflammatory Pain

Symptom Domain Application Context Key Benefit
Joint Pain & Stiffness Long-term management of chronic arthritis (OA, RA, AS) Contributes to easing the overall symptom load
Acute Inflammation Short-term support for severe episodes (Gout, Acute Pain) Assists with maintaining functional stability

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Arcoxia (Etoricoxib) — Official Regulatory Information

Eligibility Scope

Category Official Regulatory Status
Populations for whom use is allowed Adults and adolescents 16 years of age and older who do not have any listed contraindications or specific co-existing conditions.
Populations for whom use is not recommended Women who are attempting to conceive, and patients with advanced renal disease (creatinine clearance < 30 ml/min) due to limited clinical experience.
Populations for whom use is contraindicated Patients with hypersensitivity to Etoricoxib, aspirin, or any NSAID. Patients with active peptic ulceration or GI bleeding. Patients with uncontrolled hypertension. Patients with established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease (including stroke). Patients with congestive heart failure (NYHA Class II–IV). Patients with severe hepatic dysfunction (Child-Pugh score 10). Children and adolescents under 16 years of age. Pregnant women. Breastfeeding mothers.

Eligibility Classifications (High-Level)

Category Official Regulatory Status
Eligibility severity classification Contraindicated (absolute exclusion), Restricted Dose (conditional use in mild/moderate hepatic impairment), Not Recommended (conditional exclusion).
Eligibility-context constraints Exclusion is based on Established Cardiovascular/Cerebrovascular Disease, Active GI Pathology, Severe Organ Impairment, and Age/Reproductive Status.

Resulting Eligibility Structure

Official eligibility statements:

  • The medicine is contraindicated in patients with established ischaemic heart disease, peripheral arterial disease, or cerebrovascular disease.
  • Use is contraindicated in patients with uncontrolled hypertension, heart failure (NYHA Class II–IV), active peptic ulceration, or active gastrointestinal bleeding.
  • Severe hepatic dysfunction (Child-Pugh score 10) is an absolute contraindication. Mild or moderate hepatic dysfunction requires strict, lower maximum dose limits.
  • The medicine is contraindicated for use in individuals under 16 years of age, and during pregnancy or lactation.

Connection to the overall eligibility profile:

Regulatory documents define the eligibility profile of Arcoxia primarily through a series of absolute contraindications related to pre-existing conditions affecting the cardiovascular system, gastrointestinal tract, and liver/kidney function. These official statements identify the specific patient populations, including those under 16, pregnant, or breastfeeding, who must not use the medicine under any circumstance as defined by governmental labeling. The profile permits use only in adults and adolescents aged 16 or older who do not present with any of the formally restricted or contraindicated clinical states.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Etoricoxib (Arcoxia) defines specific drug–drug interactions that require close attention or are formally prohibited.


Contraindicated Combinations

Combination Regulatory Restriction
Non-selective NSAIDs (e.g., Ibuprofen) Co-administration is contraindicated due to the absence of demonstrated benefits and the potential for additive gastrointestinal (GI) adverse reactions.
High-dose Acetylsalicylic acid Contraindicated due to a significantly increased risk of GI ulceration and complications.

Exposure-Modifying and Pharmacodynamic Interactions

Etoricoxib has documented pharmacokinetic interactions that alter the plasma exposure of co-administered medicines, and pharmacodynamic interactions that affect efficacy and safety profiles.

  • Co-administration with Warfarin is associated with an approximate 13% increase in the International Normalized Ratio (INR), necessitating standard monitoring, particularly in the first days of co-treatment.
  • Etoricoxib increases the plasma exposure (AUC) of Ethinyl Estradiol (in oral contraceptives) by 50% to 60%; this elevation must be considered when selecting a contraceptive.
  • The potent enzyme inducer Rifampin decreases Etoricoxib plasma AUC by 65%.
  • The combination with Diuretics, ACE Inhibitors, or Angiotensin II Antagonists may diminish their antihypertensive effect and carries a documented caution for further renal function deterioration in patients with compromised renal function, including the elderly.

Mechanism of Action

Selective Inhibition of the COX-2 Enzyme

The mechanism of Etoricoxib is defined by its highly effective and selective inhibition of the Cyclooxygenase-2 (COX-2) enzyme. By preferentially binding to the active site of COX-2—the inducible enzyme responsible for synthesizing inflammatory mediators—the drug blocks the conversion of arachidonic acid into pro-inflammatory prostaglandins. This defining feature of the modulation of the inflammatory cascade results from its minimal inhibition of the constitutive COX-1 enzyme.


Decoupling of Peripheral Signaling in Inflammatory Processes

The molecular blockade of COX-2 results in a rapid and sustained reduction in the local concentration of pathway mediators, such as PGE2. Physiologically, this reduces the chemical sensitization of peripheral nociceptors (pain-sensing nerves), which in turn dampens the transmission of sensory signals and limits the localized vascular changes that promote fluid accumulation and tissue response.


Homeostatic Pathway Constraint

The mechanism of COX-2 inhibition extends to the COX-2 enzymes involved in renal homeostasis. Since this COX-2 activity is essential for producing prostaglandins that help regulate renal blood flow and fluid balance, its inhibition can lead to an intrinsic alteration of homeostatic cardiorenal function.

Dosage and Administration Information

The use of Etoricoxib (Arcoxia) involves fixed maximum daily doses and specific treatment durations for the administration of the film-coated tablets. The core administration principle is to use the lowest effective daily dose for the shortest duration possible. The medicine is administered orally and all regimens are taken once daily.


Condition Recommended Daily Dose Maximum Daily Dose Duration Rule
Osteoarthritis (OA) 30 mg to 60 mg 60 mg Re-evaluate periodically
Rheumatoid Arthritis (RA) / Ankylosing Spondylitis (AS) 60 mg (may be titrated to 90 mg) 90 mg Re-evaluate periodically
Acute Gouty Arthritis 120 mg 120 mg Limited to 8 days
Postoperative Dental Pain 90 mg 90 mg Limited to 3 days

The tablet can be administered with or without food. Taking the medicine without food may result in a faster onset of action, which is a consideration when rapid symptomatic relief is sought. No dosage adjustment is necessary for older adults.

Dose adjustments are required for patients with reduced liver function. For mild hepatic impairment (Child-Pugh 5–6), the daily dose must not exceed 60 mg. For moderate hepatic impairment (Child-Pugh 7–9), the maximum daily dose is 30 mg. If a dose is missed, patients must not take a double dose to compensate; the regimen should be resumed with the next scheduled dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Arcoxia (Etoricoxib)

Evidence Overview for Chronic Arthritis Conditions

This section summarizes the structure of the clinical research, including Randomized Controlled Trials (RCTs) and long-term extension studies, that was evaluated in the use of Etoricoxib for chronic conditions like Osteoarthritis, Rheumatoid Arthritis, and Ankylosing Spondylitis. This evidence contributes to the broader research base for these conditions.

Studies in Osteoarthritis (OA) and Joint Function

Research for Osteoarthritis (OA) was studied for conditions characterized by fluctuating or episodic manifestations of joint discomfort. The studies were largely Randomized Controlled Trials (RCTs) conducted during periods of increased symptom activity. These trials included adult patients with symptomatic OA and used comparative designs using either inactive substances or other established medications.

The studies primarily focused on outcomes related to physical discomfort and outcomes reflecting daily functioning or activity level. Specifically, researchers used scales to measure pain intensity and evaluated changes in physical function over the study periods. Findings describe patterns observed in the studies regarding these patient-reported outcomes.

Studies in Rheumatoid Arthritis (RA) and Disease Activity

For Rheumatoid Arthritis (RA), the research was evaluated in adult patients with active disease, focusing on conditions involving periods of heightened symptoms. The studies were designed to explore short-term symptom changes using active-comparator trials and placebo-controlled methods.

The outcomes related to systemic or functional imbalance were the primary focus, specifically using composite measures to assess changes in disease activity. Studies report how symptoms evolved in the observed populations, and findings describe the patterns observed in the studies when Etoricoxib was observed in comparison to the comparator medications.

Evidence Overview for Acute Pain Episodes

This section summarizes the structure of the rapid-response, short-term symptom changes that were evaluated in trials for acute, disruptive episodes of pain and inflammation.

Studies in Acute Gouty Arthritis

In Acute Gouty Arthritis, research was evaluated in conditions associated with acute or disruptive episodes of joint inflammation. The studies were designed as Randomized Controlled Trials (RCTs), often comparing the agent against other established treatments for acute gout. Research describes the measured changes in physical discomfort outcomes over a treatment period of around eight days.

Studies in Acute Pain Following Surgery

For pain following dental surgery, the research was studied for conditions involving periods of heightened symptoms using highly standardized Randomized Controlled Trials (RCTs). Studies explored short-term symptom changes and focused on outcomes describing episodic or acute changes, such as the total pain assessment scores measured over the first few hours post-dose.

Understanding Research Gaps and Uncertainty

Research highlights what is known, but evidence also indicates areas where certainty remains low or data are still emerging. The overall follow-up durations were limited in some trials, and data for long-term outcomes beyond one year are not fully established. Therefore, research is still needed to fully establish long-term patterns, particularly in areas like cardiovascular outcomes. Study results reflect the specific conditions under which they were conducted and research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Arcoxia (FAQ)


Q: Is it normal to feel a bit nauseous when taking Arcoxia?

According to official product information, nausea is a documented side effect of this medicine. It is typically classified as a common event, meaning it has been reported in a higher percentage of patients during clinical trials.


Q: Can Arcoxia affect sleep patterns?

Official regulatory texts indicate that effects on the central nervous system may occur. Both difficulty sleeping (insomnia) and feeling overly sleepy or drowsy (somnolence) are listed as uncommon side effects in the product information.


Q: Has there been much research on the long-term safety of Arcoxia?

The research base for this medicine includes large clinical programs, such as the MEDAL study, which was specifically designed to evaluate the long-term cardiovascular and gastrointestinal tolerability profiles. Official documents summarize the data collected during these evaluations.


Q: Can Arcoxia be crushed or split if it's hard to swallow?

Official product instructions state that Arcoxia is manufactured as a film-coated tablet for oral use, and these tablets are intended to be swallowed whole. Modifying the tablet by breaking or crushing is generally not recommended as per the regulatory information.


Q: What are the signs that Arcoxia might be causing a problem with my liver?

Regulatory documents advise that if signs of hepatic (liver) insufficiency occur, discontinuation of the medication must be considered by a healthcare professional. These signs may include persistently abnormal results on liver function tests, such as elevated liver enzymes (ALT/AST).


Q: Do I need special monitoring while on Arcoxia?

Official guidelines recommend that for patients on long-term treatment, the need for the medicine and the therapeutic response are periodically reviewed by a healthcare professional. Additionally, blood pressure should be checked from time to time, particularly in those with pre-existing high blood pressure.


Q: What happens if you accidentally take too much Arcoxia?

Official regulatory information states that a suspected overdose requires immediate attention from emergency medical services or a healthcare professional. In such an event, general supportive measures are typically instituted by healthcare providers, such as clinical monitoring.


Q: How is Arcoxia cleared from the body?

The body processes the active ingredient, Etoricoxib, into other substances. Regulatory documents indicate that these processed substances are then primarily eliminated from the body through the urine, and some are also passed through the faeces.


Q: Does alcohol interact negatively with Arcoxia?

Regulatory patient information often includes a caution regarding alcohol intake. This caution is typically advised because alcohol consumption may potentially increase the risk of adverse effects when taken concurrently with the medication.


Q: How quickly does Arcoxia start working after you take it?

The official label notes that the speed at which the medicine begins to work may be faster when it is taken on an empty stomach. However, a specific time frame for the onset of effect is not always detailed in the core regulatory texts.


Q: Can Arcoxia be used for back pain relief?

Arcoxia is indicated for the symptomatic relief of signs and symptoms of various inflammatory conditions. Official regulatory documents list indications that may include conditions such as chronic low back pain.


Q: Can Arcoxia be used for period pain (menstrual cramps)?

Official therapeutic indications for Arcoxia include the relief of acute pain associated with primary dysmenorrhoea, which refers to common menstrual cramps.

How should Arcoxia be stored and disposed of?

Arcoxia (etoricoxib) must be stored and handled according to specific regulatory requirements to ensure product stability and safety.

Storage Requirements

  • Temperature: The medicinal product must be stored at a temperature not exceeding 25 C or 30 C, depending on the regional label, in a cool dry place.
  • Protection: Tablets must be kept in the original blister pack or container in order to protect from moisture.
  • Integrity: The medicine must not be used after the expiry date shown on the package has passed.
  • Child Safety: Arcoxia must be stored out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired tablets must be done in compliance with environmental regulations. Any unused medicinal product or waste material must be disposed of in accordance with local requirements, typically via a pharmacist or designated collection point, and should not be discarded through household waste or wastewater.

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

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