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Hyaluronan Side Effects

In Summary

Commonly reported side effects of hyaluronan include: arthralgia and headache. Other side effects include: back pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to hyaluronan: intra-articular gel, intra-articular solution

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • bleeding;

  • increased knee pain; or

  • signs of infection (warmth, swelling, redness) around your knee.

Common side effects may include:

  • joint pain, stiffness, or swelling;

  • itching, numbness, or tingling;

  • headache, dizziness;

  • back pain;

  • swelling, pain, redness, or mild discomfort where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to hyaluronan: intra-articular gel, intra-articular solution

Local

Local side effects have included erythema, edema, pain, and other injection site reactions in 0.2% to 2.5% of patients.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia, arthritis, arthropathy, Baker's cyst, bursitis, joint disorder, joint effusion, joint stiffness, joint swelling, pseudosepsis, localized osteoarthritis, aggravated osteoarthritis, ecchymosis, and knee arthroplasty.[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 double-blind, controlled trial involving 226 patients with knee osteoarthritis the most frequent cause of discontinuation of sodium hyaluronate therapy was worsening of knee pain (11% vs. 13% with saline).[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea, diarrhea, dyspepsia, and abdominal pain.[Ref]

Other

The most common side effects have included arthralgia (12.6% vs 17.2% with saline and 0.8% with arthrocentesis), back pain (6.9% vs 12.2% with saline and 4.9% with arthrocentesis), headache (12.1% vs 16.6% with saline and 17.9% with arthrocentesis).[Ref]

Other side effects have included general fatigue and pain.[Ref]

References

1. Adams ME, Lussier AJ, Peyron JG "A risk-benefit assessment of injections of hyaluronan and its derivatives in the treatment of osteoarthritis of the knee." Drug Saf 23 (2000): 115-30

2. "Product Information. Orthovisc (hyaluronan)." Ortho Biotech Inc, Bridgewater, NJ.

3. Brandt KD, Block JA, Michalski JP, Moreland LW, Caldwell JR, Lavin PT "Efficacy and safety of intraarticular sodium hyaluronate in knee osteoarthritis. ORTHOVISC Study Group." Clin Orthop (2001): 130-43

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

Some side effects of hyaluronan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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