Synojoynt

Last updated on RxList: 12/20/2018
Synojoynt Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 12/20/2018

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:

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.

SLIDESHOW

Rheumatoid Arthritis Exercises: Joint-Friendly Workouts See Slideshow
Synojoynt Professional Information

SIDE EFFECTS

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
N=197
n (%)
Euflexxa®
N=199 n
(%)
SYNOJOYNT
N=199 n
(%)
Total
N=595
n (%)
Subjects with Any TEAE(s) 76 (38.6) 82 (41.2) 76 (38.2) 234 (39.3)
Gastrointestinal disorders
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.
  • N/n=number of subjects
  • Euflexxa® is a registered trademark of Ferring BV.

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
  • Arthropathy
  • Joint (knee) disorder
  • Arthrosis
  • Joint (knee) swelling
  • Baker’s cyst
  • Joint (knee) effusion
  • Bursitis
  • Joint (knee) stiffness
  • Immune response
  • Pain in limb
  • Infection
  • Paraesthesia
  • Injection site erythema
  • Phlebitis
  • Injection site edema
  • Pruritis
  • Injection site pain
  • Tendonitis

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)

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer

© 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.

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