Orthovisc Side Effects

Generic name: hyaluronan

Note: This document contains side effect information about hyaluronan. Some of the dosage forms listed on this page may not apply to the brand name Orthovisc.

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

For the Consumer

Applies to hyaluronan: intra-articular solution

Notify your doctor immediately if you experience a rare but serious allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives) to hyaluronan (the active ingredient contained in Orthovisc)

Other less serious side effects may also occur. Talk to your doctor if you experience

• temporary pain or swelling of the affected joint;

• rash or bruising at the injection site; or

• an overall achy feeling.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

For Healthcare Professionals

Applies to hyaluronan: 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.

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.

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).

Gastrointestinal

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

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).

Other side effects have included general fatigue and pain.

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