Sodium hyaluronate Side Effects

It is possible that some side effects of sodium hyaluronate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

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

As well as its needed effects, sodium hyaluronate may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking sodium hyaluronate, check with your doctor immediately:

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 sodium hyaluronate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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.[Ref]

Local

Local side effects for sodium hyaluronate 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.[Ref]

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.[Ref]

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions and allergic reactions.[Ref]

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

Other

Other side effects have included fever and headache.[Ref]

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.[Ref]

Gastrointestinal

Gastrointestinal side effects for sodium hyaluronate in relation to placebo therapy have included unspecified complaints (29% vs 36%).[Ref]

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

Cardiovascular

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

Cardiovascular side effects have included hypotensive crisis or shock.[Ref]

Musculoskeletal

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

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.[Ref]

References

1. "Product Information. Hyalgan (hyaluronidate sodium)." Sanofi Winthrop Pharmaceuticals, New York, NY.

2. Goldberg VM, Coutts RD "Pseudoseptic reactions to hylan viscosupplementation: diagnosis and treatment." Clin Orthop (2004): 130-7

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