Hyalgan 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 Hyalgan.

Not all side effects for Hyalgan 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

Along with its needed effects, sodium hyaluronate (the active ingredient contained in Hyalgan) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while 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 side effects of sodium hyaluronate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 Hyalgan)

Local

Local side effects for sodium hyaluronate (the active ingredient contained in Hyalgan) 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 reactions have included 2 cases of anaphylactoid reactions and 3 cases of allergic reactions, which resolved upon discontinuation of sodium hyaluronate (the active ingredient contained in Hyalgan)

Hypersensitivity side effects have included anaphylactoid reactions and allergic reactions.

Other

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.

Other side effects have included fever and headache.

Gastrointestinal

Gastrointestinal side effects for sodium hyaluronate (the active ingredient contained in Hyalgan) 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

Cardiovascular side effects have included hypotensive crisis or shock.

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

Musculoskeletal

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 (the active ingredient contained in Hyalgan) 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.

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

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