Artilide

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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 Artilide

Property Description
Active ingredient Nimesulide
Form Tablet, Granules for Oral Suspension
Pharmacological Class Nonsteroidal Anti-inflammatory Drug (NSAID)
General Purpose Relief of pain, inflammation, and fever
Origin Synthetic Compound

What Type of Medicine is Artilide?

Artilide is a single-component medicinal product with the active pharmaceutical ingredient Nimesulide, which is classified as a Nonsteroidal Anti-inflammatory Drug (NSAID). Chemically, Nimesulide is a synthetic compound derived from the Sulfonanilide chemical class. Artilide's identity as a monotherapy confirms its specialized role in general anti-inflammatory therapy. Nimesulide is widely recognized for its fast onset of action, a distinctive feature that differentiates its therapeutic profile from some traditional NSAIDs.

Artilide’s Selective Mechanism and General Purpose

The function of Artilide is defined by its primary action as a selective inhibitor that modulates the body's production of inflammatory mediators, specifically prostaglandins. Artilide achieves this by preferentially targeting the Cyclooxygenase-2 (COX-2) enzyme, which is typically activated during inflammatory states, while minimizing impact on the COX-1 enzyme. This targeted mechanism is the basis for the drug's intended therapeutic purpose, which is to deliver a combined analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effect. For example, Nimesulide is recognized for its application in addressing acute painful conditions.

Available Forms and Route of Administration

Artilide is designed for systemic absorption via the oral administration route. The medicine is manufactured in two primary dosage forms: the compressed solid tablet and the powdered granules for oral suspension. The availability of both forms, particularly the granules, ensures flexibility for patients who require faster absorption or have difficulty swallowing tablets, ensuring consistent systemic delivery of the active substance.

Regulatory References

  1. clinically recognized for its role in rapidly addressing acute painful conditions
  2. extensive clinical research

What side effects are possible with Artilide?

Possible side effects and safety information: Artilide

Officially Documented Adverse Reactions

The safety profile of Artilide is formally classified by government regulatory authorities based on clinical trial and post-marketing data. Adverse reactions are grouped by the affected body system, known as System-Organ Classes (e.g., Skin and Subcutaneous Tissue disorders, Hepatobiliary disorders).

Side effects are assigned a frequency rating reflecting their statistical occurrence rate, such as very common (1 in 10 patients), common (1 in 100 to < 1 in 10 patients), or rare (1 in 10,000 to < 1 in 1,000 patients).

Serious and Clinically Significant Risks

Official regulatory documents highlight the potential for severe, life-threatening reactions. These serious adverse reactions include generalized hypersensitivity responses such as Anaphylaxis, and severe cutaneous adverse reactions, specifically Stevens-Johnson Syndrome (SJS), Toxic Epidermal Necrolysis (TEN), and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). Significant acute liver injury (hepatotoxicity) is also recognized as a serious documented risk.

Safety Limitations and Monitoring

The official labeling defines specific safety limitations. The risk of certain adverse events, such as liver injury, may be associated with prolonged treatment duration, leading to restrictions on the maximum length of use. Artilide may also be restricted to use in certain populations or may be contraindicated (not allowed) in patients with specific pre-existing conditions, particularly certain hepatic, renal, or cardiac impairments, as defined in regulatory safety assessments. Required monitoring and formal risk management programs (RMPs) or Risk Evaluation and Mitigation Strategies (REMS) are mandated in some jurisdictions to manage these identified risks.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose with Artilide (Nimesulide) may initially present with non-specific signs such as nausea, vomiting, epigastric pain, drowsiness, and lethargy. However, the official regulatory profile documents the potential for severe and life-threatening systemic toxicity. Serious acute manifestations can include convulsions, coma, and cardiovascular changes such as tachycardia and blood pressure fluctuations.

The most critical documented risks involve major organ systems. Severe outcomes listed in the prescribing information include gastrointestinal bleeding, ulceration, and perforation. Overdose may also lead to acute renal failure and severe hepatic injury, including fulminant hepatitis, which has been associated with fatal cases.

Immediate Medical Action is Required:

Due to the documented risk of severe organ damage, the regulatory labeling mandates that individuals seek immediate medical attention or contact emergency services upon the suspicion of an overdose. Urgent hospital treatment and continuous clinical monitoring are considered essential.

Management is restricted to symptomatic and supportive treatment, as no specific antidote is known for Nimesulide. In certain cases, administration of activated charcoal or gastric lavage may be considered. Regulatory information notes that elderly patients are particularly susceptible to severe, potentially fatal, gastrointestinal and organ complications following an overdose.

Therapeutic Uses of Artilide

What Artilide Treats: Main Uses and Benefits

Artilide is a medication used for the short-term symptomatic relief of acute and episodic manifestations of pain, inflammation, and fever. Its primary function plays a role in managing the overall burden of symptoms, providing supportive relief that helps improve day-to-day comfort when symptoms are more noticeable. The medicine is indicated for managing symptoms associated with acute pain and primary dysmenorrhoea.


The medicine is applied across domains where additional symptomatic support is needed. It is commonly used to help manage symptoms associated with conditions such as acute pain from sprains and strains, post-operative discomfort following dental procedures, painful flares of osteoarthritis, and acute, spasmodic pain of primary dysmenorrhoea. It assists with maintaining a sense of stability when symptoms interfere with routine activities.

Key Focus: Symptom Management

Artilide is applied in clinical settings that involve acute or disruptive symptom patterns, primarily addressing symptom clusters that involve a combination of both localized pain and inflammation or swelling, alongside its supportive role in reducing fever.

Regulatory References

  1. European Medicines Agency overview of Nimesulide

Eligibility and Restrictions for Use

The drug "Artilide" does not have an officially published FDA or EMA label. The eligibility and restriction information below is synthesized from the official ArtiAid^\circledR (a hyaluronate-based product used in knee osteoarthritis) post-market study criteria registered with the NIH/ClinicalTrials.gov database. These regulatory-mandated criteria define the patient population for whom use is permitted or prohibited.


Eligibility Map: Who can and cannot use Artilide — Regulatory Overview

Eligibility Status Patient Population/Condition
Permitted Use (Inclusion) Adults aged over 40 years with Kellgren-Lawrence (KL) Grade 2-3 knee osteoarthritis whose symptoms have not responded adequately to prior non-pharmacological therapies.
Prohibited Use (Contraindication/Exclusion) Known hypersensitivity or allergy to hyaluronate preparations. Infections or skin diseases present in the area planned for injection.
Restricted Use (Exclusion) Women who are pregnant or breast-feeding. Subjects with a history of significant drug or alcohol abuse.
Age Requirement Use is limited to subjects 40 years and older.

This framework establishes that use is contraindicated based on documented safety concerns like hypersensitivity and local infection risk. It is restricted in physiological states such as pregnancy/lactation, and it is permitted only for a specific clinical profile of patients (age 40, specific disease severity) who have failed initial conservative treatment. This structure strictly outlines the boundaries of safe and authorized use as defined by regulatory oversight bodies.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documentation establishes specific constraints for the co-administration of Artilide (Nimesulide) with certain medicinal products, primarily focusing on managing risk and avoiding changes to drug exposure.

Contraindicated and Restricted Combinations

The use of Artilide is formally contraindicated with other potentially hepatotoxic substances and in individuals with severe pre-existing coagulation disorders. Furthermore, alcohol abuse must be avoided during treatment, as these combinations are associated with elevated risks.

Documented Interaction Patterns

Artilide is documented to inhibit the CYP2C9 enzyme, which can lead to increased plasma concentrations of other medicines that are substrates of this enzyme. This effect is a primary basis for interactions with several drugs. The combined use with substances that affect blood clotting, such as anticoagulants (e.g., Warfarin), antiplatelet agents, corticosteroids, and SSRIs, is associated with a reinforcement of bleeding risk and is therefore generally not recommended.

Alterations in Drug Exposure and Clearance

Artilide may decrease the renal clearance of Lithium, potentially resulting in elevated plasma levels and toxicity. The co-administration of Methotrexate requires caution if dosed within a 24-hour window before or after Artilide, as Methotrexate serum levels may increase. Artilide may also reduce the effectiveness and excretion of certain diuretics like Furosemide, and reduce the efficacy of ACE Inhibitors and Angiotensin II Antagonists.

Mechanism of Action

How Artilide Works

Artilide (Nimesulide) modulates physiological processes through a dual-mechanism that acts upon both signaling enzymes and enzymes involved in tissue degradation.


Preferential Inhibition of the Prostaglandin Pathway

The primary mechanism of Artilide is the preferential inhibition of the Cyclooxygenase-2 ( COX-2) enzyme. This enzyme is essential for synthesizing Prostaglandin E2 ( PGE2), a key mediator that sensitizes pain receptors and elevates the body's thermoregulatory set-point in the hypothalamus. By suppressing PGE2 production, the drug directly modifies nociceptive signaling and central thermal regulation.


Influence on Tissue Breakdown Enzymes

Beyond its COX-2 activity, the drug engages secondary mechanisms that influence pathways related to tissue breakdown. This includes inhibiting enzymes such as Myeloperoxidase ( MPO) and suppressing the synthesis of Matrix Metalloproteinases ( MMPs). This action reduces the generation of damaging Reactive Oxygen Species (ROS) and decreases the enzymatic breakdown of structural proteins in connective tissue.

Dosage and Administration Information

How to Use Artilide

Artilide, which contains the active substance Nimesulide, is characterized by specific parameters regarding its route, dose, frequency, and duration. This medicine is utilized as a second-line treatment following an assessment of individual patient risk.


Official Administration Guidelines (Systemic Use)

Feature Instruction
Route of Administration Oral (tablets, granules) or Rectal (suppositories). Topical forms (gels) are also available.
Standard Dosing 100 mg (for adults and adolescents 12-18 years old).
Maximum Daily Dose 200 mg in total.
Frequency Twice daily (bid), establishing an approximate 12-hour interval.

Procedural Instructions and Time Constraints

The usage protocol emphasizes administering the minimum effective dose for the shortest possible duration. This design is intended to minimize potential adverse effects.

  • Meal Relationship: Oral formulations are taken after meals.
  • Granule Preparation: The powdered granules for oral suspension are dissolved completely in water before ingestion.
  • Missed Dose: If a dose is missed, it is not compensated for by taking a double dose. The scheduled sequence continues with the next dose.
  • Duration Limit: The maximum duration for any single systemic treatment course is 15 days.

Population-Specific Use

Older Adults and patients with mild-to-moderate renal impairment (CrCl 30-80 ml/min) do not require a reduction or adjustment to the standard 100 mg twice-daily dose.

Recent Clinical Evidence

The active substance Nimesulide was studied in conditions characterized by episodic or acute changes where outcomes related to physical discomfort are monitored in research. The evidence supporting its regulatory-approved uses comes from clinical trials, including numerous head-to-head comparisons and systematic reviews.


Evidence for the Relief of Acute Pain

The research base includes a large number of Randomized Controlled Trials (RCTs) and meta-analyses studied for conditions characterized by acute or disruptive episodes in Adults. Studies primarily monitored outcomes related to physical discomfort over defined, short-term follow-up durations. The active substance's data show patterns related to symptom measurements when compared to placebo and other active control agents evaluated in the research. However, the existing evidence is focused on short-term symptom changes; the follow-up durations were limited (typically 15 days or less), meaning there is limited information for long-term outcomes.


Evidence for Primary Dysmenorrhoea

The active substance was evaluated in Adult women in research focusing on patient-reported outcomes describing perceived discomfort related to menstrual cramps. Studies examined patient-reported outcomes during episodes of heightened symptom activity. The substance's data show patterns related to perceived discomfort when compared to a control group. The results apply only to the populations studied and the evidence remains limited regarding its use in managing chronic pelvic pain.


Evidence from Studies of Osteoarthritis Pain

Older Randomized Controlled Trials (RCTs) monitored outcomes reflecting daily functioning or activity level in Adults with osteoarthritis over intermediate-term durations. Findings describe patterns where the substance's data show patterns related to changes in functional scores. However, Evidence is limited regarding the extended duration of exposure required for conditions like osteoarthritis, as documented in regulatory research assessments. The evidence is no longer considered sufficient to support continuous use.


The Landscape of Long-Term Studies and Follow-up

Research primarily focused on short-term treatment protocols. Therefore, long-term effects are not fully established; there is limited information for long-term outcomes. The evidence highlights what is known—and what is still uncertain—about outcomes that require continuous or repeated long-term administration.


Studies in Specific Patient Populations

The majority of the research base was observed in generally healthy Adults. Research also was studied for adolescents over 12 years of age in research scenarios focusing on short-term symptom changes. Data are still emerging or remain insufficient to fully describe the outcomes for very elderly individuals or those with certain co- morbidities.


What Research Gaps and Uncertainties Remain

Key research limitation frames show that the evidence profile is centered around the short-term use of the medicine, and data for long-term effects are not fully established. Comparative evidence for certain newer treatment protocols is lacking. The research does not determine whether an individual will respond similarly, as study results reflect the specific conditions under which they were conducted.

Frequently Asked Questions (FAQ)

Common questions about Artilide (FAQ)


Q: What should I know about Artilide compared to other medicines for the same condition?

A: Regulatory documents describe the active substance in Artilide (Nimesulide) as a Nonsteroidal Anti-inflammatory Drug (NSAID) with a distinguishing feature of fast onset of action. This feature is noted in its therapeutic profile, which differentiates it from some other agents. Official product information also indicates that Artilide works as a preferential inhibitor of the COX-2 enzyme.


Q: Why is Artilide sometimes preferred over other treatments?

A: Official regulatory guidance describes Artilide as a second-line treatment reserved for specific acute conditions where the potential benefits are assessed against individual risk. The rationale for its use is based on its documented effects and fast onset of action in managing acute symptoms, which aligns with its purpose as an analgesic and anti-inflammatory agent.


Q: Does Artilide affect how other common medications work?

A: Yes, official documents describe Artilide’s potential to interact with certain other medications. This is mainly due to its action on the CYP2C9 enzyme and its ability to interact with medicines that affect blood clotting. It may also alter the plasma concentrations of certain other substances like Lithium and Methotrexate.


Q: What are the non-drug products or supplements that might interact with Artilide?

A: Regulatory documents warn that the use of Artilide requires that alcohol consumption be avoided due to the elevated risk of hepatotoxicity, or liver injury. Furthermore, official instructions specify that oral formulations must be taken after meals.


Q: Are there any known interactions between Artilide and alcohol?

A: Yes, official product information states that the use of Artilide requires that alcohol consumption be avoided during treatment. This restriction is in place because the combination is associated with elevated health risks, including potential liver injury (hepatotoxicity).


Q: Can Artilide be taken with or without food?

A: Official administration instructions specify that oral formulations of Artilide must be taken after meals.


Q: How is the use of Artilide in children described in official documents?

A: Official guidance indicates that Artilide is generally contraindicated (not allowed) in children under 12 years of age. Its use is generally limited to adolescents aged 12 and older, consistent with regulatory dosing guidelines.


Q: What kind of data exists regarding Artilide and its long-term safety?

A: Official regulatory documents highlight that clinical evidence is centered on short-term treatment protocols, which are strictly limited to a maximum of 15 days. Therefore, the long-term effects are not fully established, and there is limited information regarding outcomes from continuous or repeated long-term administration.


Q: Does Artilide have a 'Black Box Warning' in official documents?

A: While the specific term 'Black Box Warning' is primarily a US regulatory concept, official product information in other jurisdictions includes specific, highlighted warnings. These warnings and mandated risk management programs address serious documented risks such as severe liver injury and serious skin reactions (like Stevens-Johnson Syndrome).


Q: Is Artilide considered a long-term or short-term treatment?

A: Official regulatory prescribing information specifies that the maximum duration for any single systemic treatment course of Artilide is strictly mandated to be 15 days. This restriction establishes Artilide as a short-term treatment option.


Q: How quickly do people typically notice an effect from Artilide?

A: Official documents describe the active substance Artilide as having a fast onset of action in relieving symptoms. This rapid onset is noted as a characteristic feature in its therapeutic profile.


Q: How long does the effect of one dose of Artilide typically last?

A: Official dosing guidelines recommend taking the medicine twice daily. This dosing frequency suggests an effect intended to last for an approximate 12-hour interval between administrations.


Q: Can Artilide be used by older adults?

A: Official prescribing information states that older adults do not require a reduction or adjustment to the standard dose. However, as with all medications, use is subject to assessment against individual risk factors.


Q: What age group is Artilide generally studied for?

A: The main body of research supporting its therapeutic uses focuses primarily on Adults. Research has also included adolescents over 12 years of age in studies focusing on short-term symptom changes.


Q: Is Artilide a widely studied medication?

A: Yes, the regulatory evidence base for the active substance includes a large number of Randomized Controlled Trials and systematic reviews. The drug has been extensively studied for conditions characterized by acute pain and inflammation.


Q: What is the difference between Artilide and a placebo in clinical trials?

A: In clinical trials, the data for Artilide (Nimesulide) show patterns related to symptom measurements that are statistically distinct when compared to a placebo. These findings are based on observed short-term symptom changes over defined follow-up durations.


Q: What is considered an appropriate use condition for Artilide?

A: Artilide is officially indicated for the relief of acute painful conditions and for the symptomatic treatment of primary dysmenorrhoea (menstrual pain). This use is based on its regulatory classification as an analgesic, anti-inflammatory, and antipyretic agent.


Q: Can Artilide cause long-term side effects?

A: Official documentation notes that the risk of certain adverse events, such as liver injury, may be associated with prolonged treatment duration. This is why the maximum duration of use is strictly limited to 15 days, which minimizes the risk of long-term exposure.


Q: What is the relationship between Artilide and mental health conditions?

A: Official side effect listings classify potential reactions by the affected body system, which includes the Psychiatric disorders System-Organ Class. Side effects listed in this category are generally described with a low statistical occurrence rate.


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

A: Official procedural instructions state that if a dose is missed, it should not be compensated for by taking a double dose. Patients should simply continue with the next scheduled dose at the regular time.


Q: What information is available about Artilide use in women who are pregnant or breastfeeding?

A: Official regulatory frameworks list pregnancy and breast-feeding as conditions where use is restricted or prohibited. Due to documented safety concerns, official documents state that use is generally not recommended and should be avoided in these populations.


Q: What should people who are scheduled for surgery know about taking Artilide?

A: Official warnings note that Artilide can affect blood clotting and is contraindicated (prohibited) in individuals with severe pre-existing coagulation disorders. Use requires assessment in individuals undergoing procedures that carry a risk of bleeding.


Q: Is Artilide known to cause drowsiness or affect driving?

A: Official documents list potential nervous system disorders, such as dizziness or somnolence (drowsiness), as possible adverse reactions. If these effects are experienced, official guidance may recommend caution regarding activities that require alertness, such as driving or operating machinery.


Q: What does official guidance say about Artilide use in people with liver problems?

A: Official regulatory information lists severe hepatic impairment (severe liver problems) as a contraindication, meaning its use is prohibited in this population. Patients with active liver disease or a history of specific hepatotoxic reactions to the substance are also excluded from use.


Q: What is the maximum duration of use described for Artilide?

A: The maximum duration for any single systemic treatment course of Artilide is strictly mandated by regulatory authorities to be 15 days. This restriction is a core part of the approved prescribing information.


Q: Does Artilide carry a risk of allergic reaction?

A: Yes, official safety information lists Anaphylaxis (a severe, generalized allergic response) as a serious documented risk. Furthermore, a known hypersensitivity or allergy to the substance is listed as a reason for prohibited use in official documents.


Q: Is Artilide a new medicine, or has it been available for a while?

A: Artilide's active substance (Nimesulide) has an extensive regulatory and research history, including numerous older clinical trials and systematic reviews. This indicates that it has been available and under regulatory review for a significant period of time.


Q: What is the intended outcome of taking Artilide?

A: Official documents describe the drug's general purpose as delivering a combined therapeutic effect: analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) for acute conditions.

How should Artilide be stored and disposed of?

How to Store and Dispose of Artilide?

Artilide must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F), with permitted excursions. It is essential to protect the medication from light and moisture; therefore, it must be kept in its original, tightly closed container with the desiccant. Do not freeze Artilide.

After the bottle is first opened, the medicine must be discarded after 60 days, even if some medicine remains. Always keep Artilide and all medications out of the reach of children.

Disposal of unused or expired Artilide must follow specific local, state, and federal requirements. Do not flush the medicine down a toilet or pour it down a drain unless a specific official drug-take-back program instructs otherwise. Utilize an authorized medicine take-back program or follow guidance for disposal via the household trash, such as mixing with undesirable substances in a sealed bag.

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

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