Durolane

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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

Overview of Durolane

Quick Facts

Property Description
Active Ingredient Sodium Hyaluronate
Form Sterile gel (Viscous solution in a pre-filled syringe)
Pharmacological Class Viscosupplementation Agent
Common Use Symptomatic treatment of Osteoarthritis (OA) pain
Origin Non-animal (Biosynthesized via bacterial fermentation)

Identity and Classification

Durolane is a registered brand name for a sterile, high molecular weight injectable viscosupplementation agent. It is classified as a Medical Device, based on its primary mechanical function within the joint cavity rather than a chemical or metabolic effect. This product belongs to the broader pharmacological class of Viscosupplementation Agents, a category clinically recognized for its role in improving the physical properties of joint fluid.

Composition and Purpose

The sole active component is Sodium Hyaluronate (INN), a specific, high molecular weight form of hyaluronan (Hyaluronic Acid). The formulation is distinctive because it utilizes cross-linked hyaluronan, which contributes to its long persistence within the joint. This non-animal origin Sodium Hyaluronate is produced through controlled bacterial fermentation, ensuring high purity and biocompatibility. The product is administered exclusively as a single intra-articular injection directly into the joint space.

By introducing this stable, highly viscous gel, the general purpose is to mitigate friction and reduce the mechanical stress placed on the remaining articular cartilage. This action supports the joint's natural function and provides symptomatic relief from discomfort and stiffness, particularly for individuals with mild to moderate Osteoarthritis pain.

What side effects are possible with Durolane?

Possible Side Effects and Safety Information

The safety profile of Durolane, a viscosupplementation agent, is primarily characterized by localized and transient adverse reactions at the injection site, as documented in official regulatory materials.

Adverse Reaction Scope

Category Details (As documented in Regulatory Labels)
Frequency Classification Common (may affect up to 1 in 10 patients); Uncommon (may affect up to 1 in 100 patients).
Key Adverse Reactions Local, temporary pain, swelling, warmth, redness, and stiffness in the injected joint. The occurrence of joint effusion (fluid buildup) is also classified as common.
System-Organ Classes Adverse events are classified within Musculoskeletal and Connective Tissue Disorders and General Disorders at the Administration Site, reflecting the product's localized effect.
Serious Adverse Reactions Infrequent but serious adverse events documented include septic arthritis (joint infection) and severe systemic reactions like anaphylaxis (hypersensitivity).

Official Safety Constraints

Use is contraindicated in patients with a known hypersensitivity to hyaluronate preparations. Furthermore, the product should not be administered to individuals who have a pre-existing infection or severe inflammation in or around the intended injection site, or a known joint infection or disease in the target joint. Local joint reactions are typically described as transient and mild to moderate, resolving spontaneously. A specific safety note advises against co-administration with disinfectants containing quaternary ammonium salts, which can lead to the chemical precipitation of the hyaluronan component.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory documentation for Durolane, which is classified as an injectable viscosupplementation medical device, does not contain a conventional section on systemic pharmacological overdose. The official overdose profile is strictly constrained to the potential local effects and resulting clinical manifestations arising from the physical administration of an excessive volume into the intra-articular joint space.

Overdose Scope

Domain Official Regulatory Statement
Documented Manifestations Clinical signs that may indicate an over-administration include increased local pain and joint swelling (effusion) specifically within the injected joint, consistent with volume-related pressure or local inflammation.
Antidote Status The official labeling confirms that no specific antidote is known or documented as necessary for the active component, Sodium Hyaluronate, reflecting its non-systemic classification.
Management Management of an over-administration or severe local event is formally stated to be based on symptomatic and supportive treatment alone.
Population Notes No population-specific overdose severity or considerations (e.g., in geriatric patients or those with hepatic/renal impairment) are explicitly addressed in the official prescribing information.

When to Seek Immediate Medical Help

The official instructions mandate that patients must seek immediate medical attention for the management of any severe or unexpected local adverse reactions or for symptoms that may indicate over-administration. This requirement defines the urgent response trigger for pronounced, persistent pain or significant swelling that follows the administration.

Connection to the Overall Overdose Profile

The regulatory profile defines the overdose situation by focusing exclusively on localized physical effects within the joint. This requires patients to seek immediate medical attention for severe local symptoms, and it confirms that management relies entirely on symptomatic and supportive care.

Therapeutic Uses of Durolane

What Durolane Treats: Main Uses and Benefits

Durolane is a single-injection hyaluronic acid treatment designed to manage symptoms associated with joint degeneration. It belongs to a class of therapies known as viscosupplementation, which aims to restore the natural lubricating properties of joint fluid.

Primary Indications

The most common application for Durolane is the treatment of mild to moderate osteoarthritis. It is primarily used for patients who have not achieved sufficient relief from conservative measures such as physical therapy, weight management, or simple analgesics.

While frequently associated with the knee, Durolane is also indicated for the treatment of osteoarthritis in other synovial joints, including:

  • Hip joints
  • Ankle, shoulder, and elbow joints
  • Small joints, such as those in the fingers or toes

Mechanism of Action

In a healthy joint, synovial fluid contains high concentrations of hyaluronic acid, which acts as both a lubricant and a shock absorber. Osteoarthritis reduces the quality and concentration of this natural substance, leading to increased friction and joint wear.

Durolane utilizes a stabilized form of hyaluronic acid that resists rapid breakdown. When injected into the joint space, it serves to:

  • Supplement the synovial fluid: Restoring the viscoelasticity of the joint environment.
  • Reduce friction: Helping the joint surfaces glide more smoothly over one another.
  • Provide cushioning: Improving the joint's ability to absorb impact during physical activity.

Anticipated Benefits

The goal of treatment is to improve the overall functional environment of the affected joint. Patients may observe several clinical benefits following the procedure:

  • Reduction in Joint Pain: By improving lubrication, the treatment can decrease the mechanical pain associated with movement.
  • Improved Mobility: Reduced discomfort and stiffness often allow for a greater range of motion and an easier return to daily activities.
  • Long-Lasting Effect: Due to its stabilized formulation, a single application is designed to provide symptomatic relief that can persist for several months.
  • Delay of More Invasive Procedures: By managing symptoms effectively, viscosupplementation may help patients maintain their quality of life before considering surgical interventions.

Regulatory References

  1. FDA Instructions for Use

Eligibility and Restrictions for Use

Durolane eligibility is strictly defined by regulatory authorities based on the patient's condition and established safety data. It is officially indicated for adult patients suffering from osteoarthritis (OA) knee pain who have not responded adequately to conservative non-pharmacological treatment or simple analgesics.


Prohibited Use (Contraindications)

Use of Durolane is strictly contraindicated for patients with:

  • A knee joint infection or any infection or skin disease present at the intended injection site.
  • A known hypersensitivity or allergy to Sodium Hyaluronate (HA) preparations.

Restricted Populations and Conditions

Safety and effectiveness have not been established for several key groups, which restricts use:

  • Pediatric patients (21 years of age or younger).
  • Pregnant women or nursing mothers (excretion in human milk is not known).
  • Use in joints other than the knee is not established.

The product should be used with caution in patients with pre-existing chondrocalcinosis due to the risk of an acute attack of the condition. These eligibility statements define the official boundaries for use according to government regulatory documents.

What should I know about interactions with other medicines?

Durolane Interactions with other medicines and products

The official regulatory profile for Durolane, which is an intra-articular viscosupplementation agent, focuses the documented interaction information on a single, critical constraint involving a physico-chemical incompatibility at the intended injection site. This narrow interaction scope is consistent with the product's classification as a medical device intended for local, non-systemic use, as noted in the product's regulatory labeling.


Documented Interaction Restriction

Category Official Statement
Interacting Substance Category Disinfectants containing quaternary ammonium salts are officially documented to interact with the product.
Mechanistic Basis The documented interaction is a physico-chemical reaction where the high molecular weight Sodium Hyaluronate material precipitates upon direct contact with these salts, compromising the intended physical function of the solution.
Mandatory Restriction These disinfectants are prohibited for use in skin preparation at the injection site. This restriction constitutes a mandatory administration-timing rule requiring non-concomitant use during the procedure.

Systemic Interaction Profile

The overall interaction structure is defined by an absence of documented systemic interactions. Official regulatory labeling contains no information regarding drug-drug interactions mediated by metabolic enzymes such as the Cytochrome P450 system or by drug transporters. Likewise, no clinically significant interactions with food, alcohol, or herbal products are documented in regulatory sources for this locally acting product.

Mechanism of Action

How Durolane Works

Durolane's mechanism of action is multifaceted, combining physical action with local biological modulation. The primary action is viscosupplementation, achieved by the physical introduction of highly cross-linked, high molecular weight hyaluronan to restore the essential viscoelasticity of the pathological synovial fluid. This mechanism establishes a protective, load-bearing layer that dramatically reduces friction and mechanical stress on the articular cartilage surfaces, which contributes to the functional restoration of the joint's load-bearing properties.

Simultaneously, the molecule acts as a modulator by signaling through cell surface receptors like CD44 on synoviocytes and chondrocytes. This interaction downregulates key pro-inflammatory mediators and catabolic enzymes, such as Matrix Metalloproteinases (MMPs), contributing to the stabilization of the joint's biochemical environment and stimulating the endogenous production of natural joint fluid components. Furthermore, the highly viscous substance exerts a local neurophysiological effect by physically coating and shielding the sensory nerve endings and nociceptors in the synovial membrane, thereby inhibiting the afferent signal transduction from mechanical stimuli within the joint.

Dosage and Administration Information

Durolane is a viscosupplementation agent used via a standardized protocol based on its classification as a medical device. Its use is defined by a precise administration route, a fixed dose, and a specified frequency pattern.


Administration Route and Dose

The route of administration for Durolane is exclusively a single intra-articular injection, meaning it is delivered directly into the synovial space of the affected joint, most commonly the knee. The product is supplied as a sterile gel in a pre-filled syringe containing a fixed amount of 60 mg of Sodium Hyaluronate in 3 mL. The standard dosing regimen is a single injection that constitutes the entire treatment course.

Frequency and Procedural Conditions

Because Durolane is designed for a sustained local effect, re-treatment is specified to occur not sooner than 6 months after the initial administration. This single-course regimen establishes its use as an intermittent, specialized intervention.

Administration must be performed by a trained physician in a clinical setting, utilizing strict aseptic technique to maintain sterility. Before the injection, any existing joint effusion (excess fluid) is typically removed by aspiration. Durolane is intended for single use only. There are no specified systemic dose adjustments for older adults or patients with renal or hepatic impairment, consistent with its local and mechanical action.

Recent Clinical Evidence

Overview of Clinical Research

Clinical evidence for Durolane, a single-injection viscosupplementation treatment containing Non-Animal Stabilized Hyaluronic Acid (NASHA), primarily focuses on the management of pain associated with knee osteoarthritis (OA). Research has investigated the safety and efficacy of the single-dose regimen compared to both saline (placebo) and multi-injection hyaluronic acid products or corticosteroids.

Efficacy and Comparator Trials

Studies have assessed outcomes using standard measures, such as the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function subscales. While some initial trials showed no significant difference compared to saline in the overall patient population, subsequent analyses focusing on specific subgroups (ee.g., those without joint effusion or only knee OA) did report statistically significant improvements in pain relief over the saline control at certain time points.

Key non-inferiority trials have evaluated the compound against other established treatments:

  • Versus Corticosteroid: One randomized, controlled trial demonstrated that Durolane was non-inferior to a single injection of methylprednisolone acetate (MPA) at 12 weeks. The study noted that the observed benefit of the NASHA product was maintained up to 26 weeks, whereas the observed benefit of MPA declined.
  • Versus Multi-Injection HA: A comparative trial demonstrated that a single injection of Durolane was non-inferior to a five-injection regimen of another hyaluronic acid product (Artz) across measures of pain, physical function, and stiffness over 18 and 26 weeks.

Safety and Repeat Use

In clinical trials, the product was generally documented to be well tolerated. The most commonly reported adverse events were transient, localized reactions at the injection site, such as mild pain or swelling. Safety data from open-label extension studies support that repeated courses of the injection over time do not appear to increase the incidence of adverse events.

Frequently Asked Questions (FAQ)

Common questions about Durolane (FAQ)


Q: What is the main difference between Durolane and other hyaluronic acid injections?

According to official product information, Durolane is distinguished by its use of highly stabilized, cross-linked sodium hyaluronate. This composition is described in the product labeling as contributing to the longevity of the substance within the joint. Clinical studies have indicated that this single-injection treatment course is comparable to the effectiveness achieved with some hyaluronic acid products that require multiple injections.


Q: How long does Durolane typically stay in the knee joint?

Information from clinical data indicates that the product remains in the joint for an extended period. The reported half-life of the product within the joint cavity is approximately 30 days or four weeks.


Q: Is Durolane available without a prescription in some countries?

Regulatory bodies classify Durolane as a prescription medical device. This means it is restricted to sale by or on the order of a licensed healthcare practitioner. It is therefore not available as an over-the-counter (OTC) product.


Q: Is there a limit to how many times a joint can be treated with Durolane?

Official regulatory documents state that the safety and effectiveness of repeated cycles of Durolane treatment have not been established in clinical studies. The standard procedure specifies that a subsequent treatment should be administered no sooner than 6 months after the initial injection.


Q: Does Durolane interact with common supplements like glucosamine or chondroitin?

Official labeling focuses on a single local incompatibility involving specific disinfectants at the injection site. For systemic substances like oral supplements, no documented systemic interactions are noted in regulatory sources for this locally acting product.


Q: What are the typical ingredients listed on the Durolane label?

The product is a viscous gel that contains the single active ingredient, sodium hyaluronate. The sodium hyaluronate is suspended in phosphate-buffered saline, which serves as the primary inactive component of the gel.


Q: Why are people with known joint infections excluded from using Durolane?

The use of Durolane is strictly prohibited (contraindicated) if a patient has an infection in the joint or a skin infection at the intended injection site. This is a mandatory safety constraint intended to avoid the risk of serious adverse events, such as a severe joint infection (septic arthritis).


Q: How quickly can a person expect to notice something after getting the injection?

Clinical studies generally evaluate the full effect of the product at longer time points, such as 12 or 26 weeks. However, initial assessments of safety and efficacy were sometimes recorded in early patient visits, such as those occurring around 2 weeks after the injection.


Q: Are there specific activities I should avoid immediately following the procedure?

Official documents advise that specific restrictions on activity apply for the first 48 hours following the procedure. During this time, strenuous activities, such as jogging or heavy lifting, and prolonged weight-bearing activities (like standing for more than an hour) are advised to be avoided.


Q: Why do doctors recommend resting the joint after the Durolane injection?

The advice to avoid heavy activity for 48 hours is a post-injection instruction noted in the official regulatory documents. This temporary restriction is intended to allow the injected joint to recover immediately following the procedure.


Q: How does Durolane compare to physical therapy alone?

Official indications state that Durolane is for adult patients with osteoarthritis knee pain who have not responded adequately to conservative non-pharmacological therapies. This patient population includes those who did not experience sufficient relief from interventions such as physical therapy or simple pain relievers alone.


Q: What happens if I accidentally put too much pressure on the joint after the injection?

Regulatory documents advise against strenuous activity or putting excessive pressure on the joint for 48 hours after the injection. Failure to follow this instruction may be associated with an increase in transient local adverse reactions, such as temporary pain, swelling, or fluid buildup in the joint.


Q: Does Durolane contain preservatives?

Official information states that the product is a sterile, single-use gel that must be used immediately after the sealed package is opened. These conditions are consistent with a formulation that does not contain multi-dose preservatives.


Q: Can I drive immediately after having a Durolane injection?

Regulatory documents do not contain a specific prohibition on driving. However, because common adverse reactions include transient pain and stiffness at the injection site, these symptoms may affect activities that require full and comfortable joint mobility.


Q: How long after the treatment can a person usually return to intense exercise?

The required restriction period for intense activity is mandated for the first 48 hours following the injection. Patients are advised by regulatory documents to avoid strenuous or prolonged weight-bearing activities during this time.

How should Durolane be stored and disposed of?

How to Store and Dispose of Durolane

Durolane (sodium hyaluronate) must be stored in its original packaging within a temperature range of 0°C to 30°C (32°F to 86°F). It is mandatory to protect the product from freezing; refrigeration is not required for storage. Do not use the product after the expiration date printed on the package.

Handling and Waste Disposal

The product is designated for single use only. Since the contents are sterile, the syringe must be used immediately once the sealed blister packaging is opened. The pre-filled syringe and any unused Durolane must be discarded after the injection, and the product must not be re-sterilized. The medicine should be stored out of the sight and reach of children, and all medical waste disposal must comply with local regulations.

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

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