Euflexxa Side Effects

Generic Name: sodium hyaluronate

Note: This page contains information about the side effects of sodium hyaluronate. Some of the dosage forms included on this document may not apply to the brand name Euflexxa.

Not all side effects for Euflexxa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to sodium hyaluronate: injection gel/jelly, injection solution

In addition to its needed effects, some unwanted effects may be caused by sodium hyaluronate (the active ingredient contained in Euflexxa). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking sodium hyaluronate:

Less common
  • Blue color or flushing or redness of skin
  • cough
  • difficulty in swallowing
  • dizziness or feeling faint (severe)
  • fever
  • redness or pain at place of injection
  • skin rash, hives, and/or itching
  • stuffy nose
  • swelling of eyelids, face, or lips
  • tightness in chest, troubled breathing, and/or wheezing

Some of the side effects that can occur with sodium hyaluronate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Diarrhea
  • headache
  • itching of the skin
  • large, nonelevated blue or purplish patches in the skin
  • loss of appetite
  • nausea and/or vomiting
  • stomach pain
  • swelling of the knee

For Healthcare Professionals

Applies to sodium hyaluronate: intra-articular solution

General

Most side effects are related to local reactions such as injection site pain, pain, swelling, effusion, or redness of the joint.

Increased risk, severity, or frequency of side effects does not appear to occur with retreatment of sodium hyaluronate (the active ingredient contained in Euflexxa)

Local

Local side effects for sodium hyaluronate (the active ingredient contained in Euflexxa) in relation to placebo therapy have included injection site pain (23% vs 13%), joint pain and swelling (13% vs 13%), and local skin reactions consisting of ecchymosis and rash (14% vs 10%) and pruritus (7% vs 4%). Warmth and redness have also been reported.

Injection site pain was listed as the reason for premature discontinuation of treatment in 4% (6/164) of the patients treated with sodium hyaluronate as compared to < 1% (1/164) of placebo-treated patients.

Patients with inflammatory arthritis may experience transient increases in inflammation of the injected knee following treatment.

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions and allergic reactions.

Hypersensitivity reactions have included 2 cases of anaphylactoid reactions and 3 cases of allergic reactions, which resolved upon discontinuation of sodium hyaluronate.

Other

Other side effects have included fever and headache.

Seven cases of fever were reported in one pivotal clinical study. Subsequently, 3 of these cases were reported to be associated with local reactions. No association to pyrogenic arthritis was found.

Gastrointestinal

Gastrointestinal side effects for sodium hyaluronate (the active ingredient contained in Euflexxa) in relation to placebo therapy have included unspecified complaints (29% vs 36%).

Non-specific gastrointestinal complaints were severe in both 4% of patients treated with sodium hyaluronate and 4% of patients treated with placebo.

Cardiovascular

There has been one case report of hypotensive crisis or shock, which resolved and did not reoccur with repeated treatment.

Cardiovascular side effects have included hypotensive crisis or shock.

Musculoskeletal

Musculoskeletal side effects have included knee swelling/effusion and pseudosepsis.

Pseudosepsis has been characterized as severe joint inflammation with pain and effusion occurring 24 to 72 hours after injection and it may be more likely to occur after the second or third injection or with repeated courses. Nonsteroidal anti-inflammatory drugs, intra-articular steroids, and/or arthrocentesis are often required to treat pseudosepsis.

In a pivotal clinical study 1.2% (2/164) patients treated with sodium hyaluronate vs. 1.8% (3/164) patients treated with placebo were reported to have a positive bacterial culture of effusion aspirated from the treated knee. Only 1 of the placebo-treated patients required hospitalization for presumptive treatment for septic arthritis. The remaining 4 patients did not show clinical or subsequent signs of infection.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web4)