Synvisc

Synvisc Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Synvisc (hylan G-F 20) is prescribed for treatment of osteoarthritis of the knee in patients who have failed to respond to simple analgesics. Synvisc is a type of osteoarthritis knee pain treatment called a viscosupplement or hyaluronan injection. Most common side effects are pain, swelling or fluid buildup in or around the knee.

Synvisc is administered in 3 injections in a doctor's office, done one week apart to provide relief of osteoarthritis knee pain for up to 6 months. Tell your doctor if you are allergic to products from birds such as feathers, eggs, or poultry as Synvisc may cause an allergic reaction. Synvisc has not been tested in women who are pregnant or nursing. Tell your doctor if you are pregnant or nursing.

Our Synvisc 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Synvisc in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these 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.

Less serious side effects may include:

  • warmth, pain, stiffness, swelling, or puffiness where the medicine was injected;
  • muscle pain, trouble walking;
  • fever, chills, nausea;
  • numbness or tingly feeling;
  • headache, dizziness;
  • tired feeling; or
  • itching or skin irritation around the knee.

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 Synvisc (Hylan G-F 20) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Synvisc Overview - Patient Information: Side Effects

SIDE EFFECTS: See also How to Use section.

Pain, swelling, redness/warmth/bruising at the injection site, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back pain, severe headache, fast/pounding heartbeat, fever, tingling skin.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Synvisc (Hylan G-F 20)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Synvisc FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Potential Adverse Effects Of The Device On Health

Reported Device-Related Adverse Events

The most commonly reported adverse events associated with SYNVISC (hylan g-f 20) are the following:

  • Pain in the injected knee
  • Swelling in the injected knee
  • Joint effusion
Potential Adverse Events

The following adverse events are among those that may occur in association with intra-articular injections, including SYNVISC (hylan g-f 20) :

A summary of adverse events identified in the clinical studies is provided in the Adverse Event section below.

Post-marketing Experience

SYNVISC® (hylan g-f 20) (3-injection regimen) post-marketing experience has identified the following systemic events to occur rarely with administration: rash, hives, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema, malaise, respiratory difficulties, flushing and facial swelling. There have been rare reports of thrombocytopenia coincident with SYNVISC (hylan g-f 20) (3-injection regimen) injection.

Adverse Events

Adverse Events Involving the Injected Joint

Clinical Trials: A total of 511 patients (559 knees) received 1771 injections in seven clinical trials of SYNVISC (hylan g-f 20) . There were 39 reports in 37 patients (2.2% of injections, 7.2% of patients) of knee pain and/or swelling after these injections. Ten patients (10 knees) were treated with arthrocentesis and removal of joint effusion. Two additional patients (two knees) received treatment with intra-articular steroids. Two patients (two knees) received NSAIDs. One of these patients also received arthrocentesis. One patient was treated with arthroscopy. The remaining patients with adverse events localized to the knee received no treatment or only analgesics.

A total of 157 patients have received 553 injections in the three clinical trials of repeated courses of SYNVISC (hylan g-f 20) treatment. The reports in these trials describe a total of 48 reports of adverse events localized to the injected knee in 35 patients that occurred after injections that patients had received during their second course of treatment. These adverse events accounted for 6.3% of injections in 22.3% of patients as compared to 2.2% of injections in 7.2% of patients in a single course of SYNVISC (hylan g-f 20) injections. In addition, reports of two retrospective studies during the post-marketing period have described adverse events localized to the injected knee that have occurred after 4.4% and 8.5% of injections that patients had received during one or more repeated courses of SYNVISC (hylan g-f 20) treatment.

Postmarket Experience: The most common adverse events reported have been pain, swelling and/or effusion in the injected knee. In some cases the effusion was considerable and caused pronounced pain. In some instances, patients have presented with knees that were tender, warm and red. It is important to rule out infection or crystalline arthropathies in such cases. Synovial fluid aspirates of varying volumes have revealed a range of cell counts, from very few to over 50,000 cells/mm³. Reported treatments included symptomatic therapy (e.g., rest, ice, heat, elevation, simple analgesics and NSAIDs) and/or arthrocentesis. Intra-articular corticosteroids have been used when infection was excluded. Rarely, arthroscopy has been performed. The occurrence of post-injection effusion may be associated with patient history of effusion, advanced stage of disease and/or the number of injections or treatment courses a patient receives. Reactions generally abate within a few days. Clinical benefit from the treatment may still occur after such reactions. The clinical trials described above included 38 patients who received a second course of SYNVISC (hylan g-f 20) injections (132 injections). There were twelve reports in nine patients (9.1% of injections, 23.7% of patients) of knee pain and/or swelling after these injections. Reports of two additional clinical trials in which patients received repeated courses of SYNVISC (hylan g-f 20) treatment have appeared during the post-marketing period. One of these trials included 48 patients who received 210 injections during a second course of SYNVISC (hylan g-f 20) treatment; the other contained 71 patients who received 211 injections during a second course of SYNVISC (hylan g-f 20) treatment.

Intra-articular infections did not occur in any of the clinical trials and have been reported only rarely during clinical use of SYNVISC (hylan g-f 20) .

Other Adverse Events

Clinical Trials: In three concurrently controlled clinical trials with a total of 112 patients who received SYNVISC (hylan g-f 20) and 110 patients who received either saline or arthrocentesis, there were no statistically significant differences in the numbers or types of adverse events between the group of patients that received SYNVISC (hylan g-f 20) and the group that received control treatments.

Systemic adverse events each occurred in 10 (2.0%) of the SYNVISC (hylan g-f 20) treated patients. There was one case each of rash (thorax and back) and itching of the skin following SYNVISC (hylan g-f 20) injections in these studies. These symptoms did not recur when these patients received additional SYNVISC (hylan g-f 20) injections. The remaining generalized adverse events reported were calf cramps, hemorrhoid problems, ankle edema, muscle pain, tonsillitis with nausea, tachyarrythmia, phlebitis with varicosities and low back sprain.

Postmarket Experience: Other adverse events reported include: rash, hives, itching, fever, nausea, headache, dizziness, chills, muscle cramps, paresthesia, peripheral edema, malaise, respiratory difficulties, flushing and facial swelling. There have been rare reports of thrombocytopenia coincident with SYNVISC (hylan g-f 20) injection. These medical events occurred under circumstances where causal relationship to SYNVISC (hylan g-f 20) is uncertain. (Adverse events reported only in worldwide postmarketing experience, not seen in clinical trials, are considered more rare and are italicized.)

Read the entire FDA prescribing information for Synvisc (Hylan G-F 20) »

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Synvisc - User Reviews

Synvisc User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Synvisc sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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