Medical Editor: John P. Cunha, DO, FACOEP
Synojoynt (1% sodium hyaluronate) acts as a lubricant and shock absorber for the joints and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics (e.g., acetaminophen). Common side effects of Synojoynt include:
- joint pain,
- upper respiratory tract infections,
- joint swelling,
- joint grinding or creaking,
- runny or stuffy nose,
- injection site pain,
- swelling of extremities,
- urinary tract infection (UTI),
- herpes zoster,
- muscle strain,
- back pain, or
Synojoynt is administered in three weekly intra-articular doses of 2 mL. Synojoynt may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Synojoynt; it is unknown how it would affect a fetus. It is unknown if Synojoynt passes into breast milk. Consult your doctor before breastfeeding.
Our Synojoynt (1% 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.
Adverse event information regarding the use of SYNOJOYNT as a treatment for pain in OA of the knee was available from a 26week multicenter clinical trial conducted in the United States. This study was a threearm prospective, randomized, doubleblind, multicenter study conducted in 33 centers. Table 1 shows the summary of treatment emergent adverse events occurring in ≥1% of patients participating in this trial who received SYNOJOYNT.
Table 1 Summary of Treatment Emergent Adverse Events (TEAEs)* Occurring in ≥ 1% of Patients (Safety Analysis Population)
|System Organ Class||Placebo
|Subjects with Any TEAE(s)||76 (38.6)||82 (41.2)||76 (38.2)||234 (39.3)|
|Diarrhea||0||2 (1.0)||2 (1.0)||4 (0.7)|
|Nausea||1 (0.5)||0||2 (1.0)||3 (0.5)|
|General disorders and administration site conditions|
|Injection site joint pain||12 (6.1)||1 (0.5)||5 (2.5)||18 (3.0)|
|Injection site pain||1 (0.5)||2 (1.0)||2 (1.0)||5 (0.8)|
|Edema peripheral||2 (1.0)||1 (0.5)||2 (1.0)||5 (0.8)|
|Infections and infestations|
|Upper respiratory tract infections||3 (1.5)||7 (3.5)||7 (3.5)||17 (2.9)|
|Nasopharyngitis||8 (4.1)||3 (1.5)||5 (2.5)||16 (2.7)|
|Bronchitis||0||1 (0.5)||5 (2.5)||6 (1.0)|
|Urinary tract infection||2 (1.0)||2 (1.0)||2 (1.0)||6 (1.0)|
|Herpes zoster||0||0||2 (1.0)||2 (0.3)|
|Injury, poisoning and procedural complications|
|Muscle strain||1 (0.5)||1 (0.5)||2 (1.0)||4 (0.7)|
|Musculoskeletal and connective tissue disorders|
|Arthralgia||24 (12.2)||26 (13.1)||19 (9.5)||69 (11.6)|
|Joint swelling||7 (3.6)||3 (1.5)||5 (2.5)||15 (2.5)|
|Joint crepitation||4 (2.0)||3 (1.5)||5 (2.5)||15 (2.5)|
|Joint effusion||4 (2.0)||2 (1.0)||4 (2.0)||10 (1.7)|
|Back pain||3 (1.5)||3 (1.5)||2 (1.0)||8 (1.3)|
|Osteoarthritis||0||1 (0.5)||3 (1.5)||4 (0.7)|
|Nervous system disorders|
|Headache||5 (2.5)||3 (1.5)||3 (1.5)||11 (1.8)|
|Sciatica||0||1 (0.5)||2 (1.0)||3 (0.5)|
|Respiratory, thoracic and mediastinal disorders|
|Cough||0||2 (1.0)||3 (1.5)||5 (0.8)|
|* TEAEs were defined as those adverse events which worsened in severity on or after the date of first administration of study device or with onset date on or after date of first administration of study device.
The incidence of target kneerelated treatment emergent adverse events was comparable with the placebo group [32 (16.1%) subjects in the SYNOJOYNT group versus 45 (22.8%) subjects in the placebo group]. The most common targetknee related treatmentemergent adverse event, by preferred term, was arthralgia [17 (8.5%) subjects in the SYNOJOYNT group versus 21 (10.7%) subjects in the placebo group].
The incidence of devicerelated treatment emergent adverse events was low and comparable with the placebo group [7 (3.5%) subjects in the SYNOJOYNT group versus 11 (5.6%) subjects in the placebo group]. The most common device related TEAE, by preferred term, was injection site joint pain [2 (1.0%) subject in the SYNOJOYNT group versus 5 (2.5%) in the placebo group].
The incidence of injectionrelated treatment emergent adverse events was low and comparable with the placebo group [10 (5.0%) subjects in the SYNOJOYNT group versus 12 (6.1%) subjects in the placebo group]. The most common injectionrelated treatment emergent adverse event, by preferred term was Injection site joint pain [3 (1.5%) subjects in the SYNOJOYNT group versus 7 (3.6%) subjects in the placebo group].
The incidence of serious adverse events (SAEs) in the SYNOJOYNT group was low and comparable with the placebo group [5 (2.5%) subjects in the SYNOJOYNT group versus 3 (1.5%) subjects in the placebo group). None of the SAEs were considered to be targetknee related, devicerelated or injectionrelated. There were no unanticipated adverse device effects in the study. There were no deaths in the study.
The incidence of TEAEs (Targetknee TEAEs, Devicerelated TEAEs and Injectionrelated TEAEs) in SYNOJOYNT was comparable with Euflexxa®.
Potential Adverse Effects Of The Device On Health
Potential adverse effects (e.g., complications) associated with the use of this device and, in general, associated with intra-articular injection devices for the treatment of pain in osteoarthritis of the knee, include:
- Aggravated osteoarthritis
- Injection site reaction
- Arthralgia (knee pain)
- Localized osteoarthritis
- Joint (knee) disorder
- Joint (knee) swelling
- Baker’s cyst
- Joint (knee) effusion
- Joint (knee) stiffness
- Immune response
- Pain in limb
- Injection site erythema
- Injection site edema
- Injection site pain
Incidences of rash, headache, dizziness, chills, hives, nausea, muscle cramps, peripheral edema, and malaise have also been reported in association with intra-articular injections.
A summary of the frequency and rate of adverse events identified in the clinical study for SYNOJOYNT is provided in the “Clinical Studies” section.
Read the entire FDA prescribing information for Synojoynt (1% Sodium Hyaluronate Solution)
© Synojoynt Patient Information is supplied by Cerner Multum, Inc. and Synojoynt Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.