Виокс

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Виокс

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Medically reviewed

Laura Arias

Last updated on 22/12/2025

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

Overview of Виокс

What is Виокс? (Rofecoxib)

Property Description
Active ingredient Rofecoxib (C17H14O4S)
Form Tablets and Oral Suspension
Pharmacological class Nonsteroidal Anti-inflammatory Drug (NSAID)
Common use Relief of pain, inflammation, and fever
Origin Synthetic

What Type of Medicine is Виокс?

Виокс (Vioxx) is a synthetic prescription medicine classified as a Nonsteroidal Anti-inflammatory Drug (NSAID) that belongs to the sub-class of Coxibs. Its sole active ingredient is the chemical compound Rofecoxib. Rofecoxib is categorized as a highly specific Cyclooxygenase-2 (COX-2) selective inhibitor, meaning it was engineered to target the COX-2 enzyme preferentially to minimize certain effects associated with nonselective NSAIDs. This specialized structure was designed to provide potent anti-inflammatory action.

How is Rofecoxib Classified and What are its Forms?

Rofecoxib is primarily classified by its mechanism of action: the selective inhibition of the cyclooxygenase-2 (COX-2) isoenzyme, which mediates inflammation. This unique selectivity is a key feature that distinguishes it within the broader NSAID class. The drug was supplied in two distinct dosage forms for oral administration: solid tablets and an oral suspension, offering different consumption options for the patient group. The existence of both the solid and aqueous formats ensured the orally active substance, Rofecoxib, could be administered appropriately.

What General Symptoms is Виокс Designed to Relieve?

The general purpose of Виокс is to provide effective relief from the symptoms of pain, inflammation, and fever. This combined anti-inflammatory, analgesic, and antipyretic effect results from Rofecoxib’s ability to prevent the COX-2 enzyme from producing prostaglandins. As prostaglandins are the biological messengers that drive inflammatory responses, inhibiting their synthesis is the core mechanism by which the drug controls symptoms associated with inflammatory processes.

What side effects are possible with Виокс?

Possible Side Effects and Safety Information

The regulatory documentation for rofecoxib (Виокс) details an established profile of potential adverse effects, including risks that are classified as common and others that are considered serious adverse reactions across multiple organ systems. The text below is consistent only with official prescribing information issued by government health authorities.

Documented Adverse Reactions

Adverse reactions are formally categorized by the affected body system (System-Organ Class) and frequency. Common effects, reported frequently in clinical trials, include Gastrointestinal symptoms such as dyspepsia, nausea, and diarrhea, as well as systemic effects like headache, dizziness, fatigue, and lower extremity edema (swelling). Less common effects noted in official labeling include insomnia and urinary tract infection.

Serious Adverse Reactions and Systemic Risks

Official regulatory texts highlight several serious adverse reactions:

  • Cardiovascular Thrombotic Events: The drug is associated with an increased risk of serious events, including myocardial infarction (heart attack) and stroke, which can be fatal. This risk is noted to potentially occur early in treatment and increase with the duration of use.
  • Gastrointestinal Toxicity: Serious bleeding, ulceration, and perforation of the stomach or intestines are documented risks that can occur at any time during treatment and may present without warning symptoms.
  • Other Risks: Severe reactions affecting the liver (including fatal fulminant hepatitis) and the kidneys (acute kidney failure) have been reported, particularly in susceptible patients. Severe allergic reactions, such as anaphylactoid reactions and Stevens-Johnson syndrome, are also officially documented.

Safety Considerations

Specific safety considerations are noted for certain patient groups. Older adults are documented to be at a greater risk for serious gastrointestinal events. Patients with pre-existing conditions, such as impaired renal function, are recognized as being at increased risk for renal toxicity. Official labeling restricts use in the late stages of pregnancy and in patients with aspirin-sensitive asthma.

Overdose and Emergency Response

Overdose and When to Seek Help

Documented Overdose Presentation

Official regulatory documentation states that acute massive over-ingestion of Rofecoxib may result in clinical manifestations generally limited to symptoms such as lethargy, drowsiness, nausea, vomiting, and epigastric pain. The profile of a severe overdose, however, officially includes the potential for serious outcomes affecting the gastrointestinal system (e.g., bleeding) and the renal system (e.g., acute failure). Rare but severe neurological and cardiovascular effects, such as coma and hypertension, are also noted as potential documented manifestations.

Required Emergency Actions and Management

If an overdose is suspected, immediate medical attention is required as a mandated regulatory action, and contacting a Poison Control Center is officially specified. Management is confined to symptomatic treatment and supportive care, as regulatory information confirms that no specific antidote is known. Procedural steps such as gastric lavage or administration of activated charcoal may be considered if the ingestion is recent. Monitoring of the patient's clinical status is necessary during the management period.

Therapeutic Uses of Виокс

What Виокс Treats: Main Uses and Benefits

Vioxx (rofecoxib) is considered relevant in conditions presenting with systemic or localized discomfort, serving in therapeutic domains where short-term symptomatic assistance was needed prior to its voluntary withdrawal. Its primary domains were used in situations involving certain distressing symptoms, such as those associated with chronic conditions like osteoarthritis and rheumatoid arthritis.

The medication was also approved for the management of acute pain in adults and for the relief of painful menstrual cycles (primary dysmenorrhea). This medication was applied in addressing symptoms related to physical discomfort and symptoms related to inflammatory or irritative states.

Its use may assist with easing the overall symptom burden, which contributes to improved comfort during periods of heightened symptoms. It supports patients in maintaining functional stability when symptoms interfere with routine activities.


Quick Fact: Relief for Symptoms that Create Noticeable Physiological Strain

Eligibility and Restrictions for Use

Who can and cannot use Виокс? (Rofecoxib)

Official regulatory documents define strict eligibility criteria, prohibitions, and limitations for Rofecoxib use across different populations and clinical states.


Populations for whom use is contraindicated (Must Not Use):

  • Patients with known hypersensitivity to Rofecoxib or a history of allergic reactions (e.g., asthma, urticaria) after taking Aspirin or other NSAIDs.
  • Patients in the setting of Coronary Artery Bypass Graft (CABG) surgery.
  • Use during the third trimester of pregnancy.

Age- and Organ-Function Eligibility Rules:

Population Group Eligibility Status (Regulatory)
Adults (18+ years) Approved for use for all labeled indications.
Pediatric (2–17 years) Approved only for Juvenile Rheumatoid Arthritis (JRA). Use below age 2 is not established.
Advanced Renal Disease Use is not recommended (creatinine clearance <30 mL/min).
Severe Hepatic Insufficiency Use is not studied and should not be used.
Older Adults (over 65) Use permitted; therapy must be initiated at the lowest recommended dose.

The regulatory profile clearly establishes patient suitability based on age, cardiac history, and organ function, explicitly excluding or restricting use for specific populations to define the conditions of the drug's approved eligibility.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Rofecoxib documents specific interaction patterns concerning pharmacodynamic reinforcement and pharmacokinetic alterations of plasma concentrations.


Interaction-Related Restrictions and Contraindications

Rofecoxib is contraindicated for the management of peri-operative pain following Coronary Artery Bypass Graft ( CABG) surgery. Co-administration with other non-aspirin Nonsteroidal Anti-inflammatory Drugs ( NSAIDs) is advised against due to the potential for additive adverse effects. Concomitant use with Aspirin is associated with an increased risk of gastrointestinal issues.


Pharmacodynamic Effects

Co-administration with anticoagulants like Warfarin creates a synergistic effect on bleeding risk and may increase the International Normalized Ratio ( INR). Like other NSAIDs, Rofecoxib may diminish the anti-hypertensive activities of ACE Inhibitors and reduce the efficacy of diuretics. The combination with Serotonin Reuptake Inhibitors ( SSRIs) also carries a documented potential to increase bleeding risk.


Exposure-Modifying Interactions

Co-administration with Rifampin, a strong hepatic metabolic inducer, is documented to cause a 50% decrease in Rofecoxib plasma concentrations. Conversely, Rofecoxib can increase the plasma concentrations of certain co-administered drugs, including Theophylline and Lithium. Rofecoxib can also reduce the exposure ( AUC) of the CYP3A4 substrate Midazolam, suggesting induction of intestinal metabolism. Antacids caused a slight decrease in Rofecoxib exposure, a finding specifically noted in elderly subjects. The exposure of Rofecoxib is also noted to be higher in patients with Moderate Hepatic Insufficiency.

Mechanism of Action

Виокс (Rofecoxib) functions as a selective non-steroidal anti-inflammatory drug (NSAID) by targeting the Cyclooxygenase-2 (COX-2) enzyme. It acts as a competitive inhibitor at the active site of the COX-2 enzyme, effectively preventing its catalytic function within cells and tissues. This selective mechanism differentiates it from non-selective NSAIDs which also inhibit the constitutive COX-1 enzyme.

The primary role of the COX-2 enzyme is the conversion of arachidonic acid—a lipid substrate released from cell membranes—into unstable intermediates, which are then rapidly synthesized into a class of signaling molecules known as prostanoids (including various prostaglandins and thromboxanes).

By blocking the COX-2 active site, Rofecoxib modulates the inflammatory pathway by decreasing the local cellular synthesis of these pro-inflammatory prostanoids. This reduction in the concentration of local signaling mediators results in a system-level physiological consequence—a diminished signal transmission that is associated with processes like nociception and thermoregulation. The mechanism is strictly confined to the inhibition of COX-2-mediated prostanoid synthesis.

Dosage and Administration Information

How to Use Виокс (Rofecoxib)

The administration of Rofecoxib is strictly defined by regulatory guidelines, focusing on specific dosage strengths, frequency, and duration patterns. The medicine is designated solely for the oral route of administration and is available in two forms: tablets and an oral suspension.

Official Administration and Dosing Patterns

The standard frequency for Rofecoxib across all approved uses is once daily. Official instructions state that the tablets may be taken without regard to meals, allowing flexibility in the timing of intake.

Indication Standard Daily Dose Range Maximum Chronic Daily Dose
Osteoarthritis 12.5 mg to 25 mg 25 mg
Rheumatoid Arthritis 25 mg 25 mg
Acute Pain / Dysmenorrhea 50 mg 50 mg (short-term use only)

Duration and Population-Specific Guidelines

Official prescribing information distinguishes between chronic and acute use. The higher 50 mg dose is restricted to short-term acute treatment (such as acute pain or dysmenorrhea), typically limited to no more than five days. This dose is not recommended for chronic use.

For older adults, the official instruction recommends initiating treatment at the lowest effective dose (12.5 mg). Specific dosage adjustments are required for patients with moderate hepatic impairment, where the maximum recommended chronic dose is reduced to 12.5 mg daily. For the pediatric population (2–11 years, over 10 kg), the oral suspension is often recommended to ensure accurate, weight-based dosing of 0.6 mg/kg up to a maximum of 25 mg once daily.

Recent Clinical Evidence

Recent Clinical Evidence

Rofecoxib (formerly marketed as Vioxx) was a selective nonsteroidal anti-inflammatory drug (NSAID) studied for use in conditions such as osteoarthritis, rheumatoid arthritis, and acute pain. Key findings from its clinical evaluation, particularly regarding cardiovascular safety, became central to understanding its overall risk profile.

Cardiovascular Safety Findings

The drug was subject to several large-scale clinical trials and post-market analyses, which identified a potential link to cardiovascular events.

  • VIGOR Trial: The Vioxx Gastrointestinal Outcomes Research (VIGOR) trial, designed to evaluate gastrointestinal safety compared to the NSAID naproxen, indicated an elevated rate of cardiovascular events, including myocardial infarction (heart attack), in the rofecoxib group.
  • APPROVe Trial: The Adenomatous Polyp Prevention on VIOXX (APPROVe) trial, which studied the drug's effect on colon polyps, was halted early due to findings that subjects taking rofecoxib for more than 18 months had an increased risk of stroke and myocardial infarction compared to the placebo group.
  • Pooled Analyses: Cumulative pooled analyses of randomized, placebo-controlled trials later demonstrated a trend toward increased risk of cardiovascular thromboembolic events associated with rofecoxib use, particularly at higher doses and with longer durations of treatment.

Efficacy in Pain and Inflammation

Studies generally reported a difference in symptom relief compared to placebo in patients with osteoarthritis and rheumatoid arthritis. For example, trials comparing rofecoxib to placebo in rheumatoid arthritis found that a greater percentage of patients reported improvement in symptoms and physical function. In clinical trials for osteoarthritis, the drug was associated with a reduction in measures of pain and stiffness.

Frequently Asked Questions (FAQ)

Common questions about Виокс (FAQ)

Q: How quickly can a person expect Виокс to start relieving pain?

A: Official information indicates that the active substance reaches its highest concentration in the bloodstream approximately two to three hours after taking a dose. Pain reduction was reported as early as two hours in some studies, while other reports observed consistent relief within the first one or two weeks of daily treatment.


Q: Is Виокс meant for short-term acute pain or for long-term chronic conditions?

A: According to official regulatory documents, Виокс was approved for both short-term use and long-term use. It was used to manage short-term acute pain, such as menstrual pain, and for the chronic treatment of conditions like osteoarthritis and rheumatoid arthritis. It was prescribed in different dosage patterns depending on whether the treatment was for acute or chronic conditions.


Q: Can Виокс be taken with a low-dose aspirin regimen?

A: The official product information notes that taking Виокс together with aspirin is associated with an increased risk of problems in the stomach or intestines. Although it was sometimes studied in patients already taking low-dose aspirin, the decision to combine these must be discussed with a healthcare professional due to the documented increase in gastrointestinal risk.


Q: Is it safe to use Виокс if I have high blood pressure?

A: Official warnings indicate that Виокс can cause fluid retention and may worsen existing high blood pressure (hypertension). It can also make certain blood pressure-lowering medications less effective. Regulatory guidance recommends that blood pressure should be carefully monitored after starting treatment. Patients with concerns about blood pressure are advised to consult their healthcare provider.


Q: Can patients with a history of stomach ulcers use Виокс?

A: Official labeling advises caution for patients with a history of gastrointestinal conditions, as they are at a higher risk of serious adverse events. Виокс is associated with risks of serious bleeding, ulceration, and perforation of the stomach or intestines. Patients with a history of gastrointestinal conditions should consult their healthcare provider.


Q: What should I do if I think I am experiencing a severe side effect?

A: Official patient information states that immediate medical attention is necessary if symptoms of a severe allergic reaction occur, such as swelling of the face or difficulty breathing. Immediate attention is also necessary if you notice symptoms such as chest pain, sudden weakness, or signs of stomach bleeding, like passing black, tarry stools.


Q: Was Виокс ever studied for preventing conditions other than pain?

A: Yes, in addition to its approved uses for pain and inflammation, the drug was studied in a large clinical trial called the APPROVe trial. The purpose of this study was to investigate the drug’s potential effect on preventing the recurrence of certain growths in the colon, known as adenomatous polyps.


Q: How is Виокс different from other common over-the-counter pain relievers?

A: Виокс is a prescription non-steroidal anti-inflammatory drug (NSAID) known as a COX-2 selective inhibitor. This classification means it was specifically developed to block the COX-2 enzyme, which is involved in inflammation and pain. This mechanism is different from some common over-the-counter pain relievers that block both the COX-1 and COX-2 enzymes.


Q: What is the general expectation for how long the pain relief from Виокс lasts?

A: The medicine is generally prescribed for once-daily dosing. This is based on the fact that the time required for the body to eliminate half of the drug's concentration is approximately 17 hours. This prescribing pattern suggests the treatment is intended to provide relief over a full 24-hour period.


Q: If I miss a dose of Виокс, what is the usual recommendation?

A: Official instructions state that if a dose is missed, it should be taken as soon as it is remembered. However, if the next scheduled dose is due soon, the missed dose should be skipped entirely. Patients are instructed not to take two doses at the same time to make up for a missed dose.


Q: Does Виокс cause anxiety or changes in mood?

A: Official documentation lists both anxiety and depression as adverse events that were reported during clinical trials or after the drug was marketed. If mood changes are experienced, reviewing them with a healthcare provider is recommended.


Q: Are there any specific dietary restrictions to consider while on Виокс?

A: The tablets can be taken without regard to meals. Official regulatory labeling does not list any specific food or beverage restrictions that must be followed while taking the medicine. However, one study noted that antacids caused a slight decrease in the drug's absorption.


Q: Why is it important to continue taking low-dose aspirin, even when on Виокс?

A: NSAIDs like Виокс do not prevent heart attack or stroke. Low-dose aspirin is often taken to protect against these cardiovascular events. Since Виокс does not replace this function, the decision on whether to continue aspirin is determined by a healthcare professional based on individual cardiovascular needs.


Q: Can I take Виокс for migraines or just for arthritis pain?

A: According to the official Indications for Use, Виокс was approved for the acute treatment of migraine attacks in adults, with or without aura. This was an approved indication, alongside its use for chronic conditions like osteoarthritis and rheumatoid arthritis, and for general acute pain.


Q: Is there a generic version of Виокс (rofecoxib) available?

A: The active ingredient in Виокс is rofecoxib, which is the generic name for the drug. However, the manufacturer voluntarily withdrew the product from the global market in 2004. As a result, neither the brand-name product nor any potential generic versions are currently available for use or prescription.


Q: How is the long-term safety profile of Виокс described in official sources?

A: Official regulatory warnings describe a risk of serious cardiovascular events, such as heart attack and stroke. This risk was noted to potentially occur early in treatment and to increase with the duration of use, particularly in patients who used the drug continuously for periods longer than 18 months.


Q: Do other COX-2 inhibitors carry the same risks as Виокс?

A: Regulatory bodies have issued communications stating that all non-aspirin NSAIDs, including COX-2 inhibitors, carry an increased risk of serious cardiovascular events. Regulatory bodies generally maintain a warning for the entire drug class, although the specific risk may vary slightly among different drugs.


Q: Is Виокс still available in all countries?

A: No. The manufacturer voluntarily withdrew the drug from the global market in October 2004 following the results of a clinical trial (APPROVe) that indicated an increased risk of heart attack and stroke with long-term use. Therefore, it is generally no longer available anywhere in the world.


Q: Does stopping Виокс suddenly cause any withdrawal symptoms?

A: Official drug documentation does not report or list any specific withdrawal symptoms that are known to occur when the medicine is stopped suddenly.


Q: Can a patient with asthma safely take Виокс?

A: Official labeling advises restrictions on the use of Виокс for patients who have aspirin-sensitive asthma due to the risk of severe allergic reactions. For patients with other forms of asthma, use is not formally restricted, but regulatory documents generally advise careful consideration with all medications in the NSAID class.


Q: Does the drug have a known effect on blood pressure?

A: Yes, official documentation lists the aggravation of high blood pressure (hypertension) as a serious adverse reaction that has been reported. Виокс can also cause fluid retention, which may lead to an increase in blood pressure.

How should Виокс be stored and disposed of?

Official Storage and Handling Requirements

Official regulatory labeling dictates specific conditions for storing VIOXX (rofecoxib) tablets and oral suspension to maintain stability:

  • Temperature: Store at 25 C (77 F), which is Controlled Room Temperature. Temperature excursions are permitted between 15 C and 30 C (59 F and 86 F).
  • Child Safety: The product must be kept out of the reach of children.

Disposal Instructions

  • Market Status: VIOXX was voluntarily withdrawn from the market by the manufacturer in 2004.
  • Discarding: Because the product is no longer commercially distributed, individuals with unused or expired medicine must consult their pharmacist or local waste management authorities for the proper method of disposal.

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

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