Hyalgan

Last updated on RxList: 9/10/2019
Hyalgan Side Effects Center

Last reviewed on RxList 9/10/2019

Hyalgan (sodium hyaluronate) is a synovial fluid replacement that works by acting as a lubricant and shock absorber in the joint used to treat knee pain in patients with joint inflammation (osteoarthritis). Hyalgan is usually used in patients who have not responded to other treatments such as acetaminophen, exercise, or physical therapy. Common side effects of Hyalgan include:

  • injection site reactions (pain, swelling, redness, warmth, bruising, stiffness, or puffiness),
  • headache,
  • nausea,
  • stomach pain,
  • back pain,
  • numbness or tingly feeling,
  • cold symptoms (stuffy nose, sneezing, sore throat),
  • tired feeling, or
  • itching or skin irritation around the knee.

Tell your doctor if you have serious side effects of Hyalgan including:

  • severe headache,
  • fast or pounding heartbeat, or
  • fever.

Hyalgan is given by intramuscular (IM) injection. A treatment cycle consists of a dose of five injections, given at weekly intervals. Hyalgan may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Hyalgan should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Hyalgan (sodium hyaluronate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer
Hyalgan Consumer Information

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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:

  • severe pain or swelling around the knee after the injection.

Common side effects may include:

  • warmth, pain, redness, stiffness, bruising, or puffiness where the medicine was injected;
  • nausea, stomach pain;
  • trouble walking;
  • swelling in your hands or feet;
  • back pain, joint pain, muscle pain;
  • numbness or tingly feeling;
  • headache, dizziness; or
  • runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Hyalgan (Hyaluronate)

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
Hyalgan Professional Information

SIDE EFFECTS

Hyalgan® was investigated in a pivotal clinical investigation conducted in the United States in which there were three arms (164 subjects treated with Hyalgan®; 168 with placebo; and 163 with naproxen) (refer to Table 1). Common adverse events reported for the Hyalgan®-treated subjects were gastrointestinal complaints, injection site pain, knee swelling/effusion, local skin reactions (rash, ecchymosis), pruritus, and headache. Swelling and effusion, local skin reactions (ecchymosis and rash), and headache occurred at equal frequency in the Hyalgan®- and placebo-treated groups. Hyalgan® treated subjects had 48/164 (29%) incidents of gastrointestinal complaints that were not statistically different from the placebo-treated group. A statistically significant difference in the occurrence of pain at the injection site was noted in the Hyalgan®-treated subjects: 38/164 (23%) in comparison to 22/168 (13%) in the placebo-treated subjects (p = 0.022). There were 6/164 (4%) premature discontinuations in Hyalgan®-treated subjects due to injection site pain in comparison to 1/168 ( < 1%) in the placebo-treated subjects. These differences were not statistically significant. Two (2/164, 1.2%) Hyalgan®-treated subjects and 3/168 (1.8%) placebo-treated subjects were reported to have positive bacterial cultures of effusion aspirated from the treated knee. The two Hyalgan®-treated subjects and two of the placebo-treated subjects did not exhibit evidence of infection clinically or subsequently and were not treated with antibiotics. One of the placebo-treated subjects was hospitalized and received presumptive treatment for septic arthritis.

Hyalgan® has been in clinical use in Europe since 1987. Analysis of the adverse events that have been reported with the use of Hyalgan® in Europe reveals that most of the events are related to local symptoms such as pain, swelling/effusion, and warmth or redness at the injection site. Usually such symptoms disappear within a few days by resting the affected joint and applying ice locally. Only sporadically have these events been more severe and longer lasting. Very rare cases of intra-articular infection have been reported. Strict aseptic technique must be followed in administering Hyalgan®. Systemic allergic reactions rarely have been recorded. Isolated cases of an anaphylactic or anaphylactic-like reaction have been reported in post-marketing experience and they all resolved. Allergic-type signs and symptoms such as rash, pruritus, and urticaria also are very rare. A few cases of fever were reported. In some instances, they were associated with local reactions, in other cases, no association other than temporal was found with the use of the product.

Adverse experience data from the literature contain no evidence of increased risk relating to retreatment with Hyalgan®. The frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a single treatment cycle. (Carrabba et al., 1995; Carrabba et al., 1991; Kotz and Kolarz, 1999; Scali, 1995).

Read the entire FDA prescribing information for Hyalgan (Hyaluronate)

© Hyalgan Patient Information is supplied by Cerner Multum, Inc. and Hyalgan Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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