Indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

VOLTAREN GEL has not been evaluated for use on the spine, hip, or shoulder.

Do not apply more than 16g daily to any single joint of the lower extremities.

Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.

VOLTAREN GEL is contraindicated in patients with:

• History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients
• In the setting of coronary artery bypass graft (CABG) surgery. Use during the perioperative period in the setting of coronary artery bypass graft (CABG) surgery

Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

Avoid the use of VOLTAREN GEL in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.

Avoid the use of VOLTAREN GEL in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If VOLTAREN GEL is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

Concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse effects including increased GI bleeding.  

NSAIDs, including VOLTAREN GEL, may increase the risk of bleeding events. Comorbid conditions such as coagulation disorders, concomitant use of warfarin, other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk.

NSAIDs, including VOLTAREN GEL, can lead to the onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Fluid retention and edema have been observed in some patients treated with NSAIDs. Use of diclofenac may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning.

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment.

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE-inhibitors or ARBs, and the elderly.

Reports of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

NSAIDs, including diclofenac, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.

Based on the mechanism of action, the use of prostaglandin-mediated NSAIDs, including VOLTAREN GEL, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis.

Patients should minimize or avoid exposure to natural or artificial sunlight on treated areas because studies in animals indicated topical diclofenac treatment resulted in an earlier onset of ultraviolet light induced skin tumors.

Concomitant use of anticoagulants and diclofenac have a risk of serious GI bleeding higher than users of either drug alone.

Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).

Concomitant use of VOLTAREN GEL and pemetrexed may increase the risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.

Instruct patients to avoid concomitant use of VOLTAREN GEL with other topical products, including sunscreens, cosmetics, lotions, moisturizers, and insect repellants. Concomitant use may result in skin reactions or change the absorption of VOLTAREN GEL.

The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.

NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance.

Concomitant use of VOLTAREN GEL and cyclosporine may increase cyclosporine nephrotoxicity.

Concomitant use of VOLTAREN GEL with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects. The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.

Diclofenac may cause premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs, including VOLTAREN GEL, in pregnant women starting at 30 weeks of gestation (third trimester). 

Based on available data, diclofenac may be present in human milk.

GoToSource

• Use in patients under the age of 18. GoToSource 

• Use on the spine, hip, or shoulder. GoToSource

• Dosage greater than 32 g per day over all affected joints. GoToSource 

• Adjunctive therapy for actinic keratosis. GoToSource 

• Reduce acute-phase herpes zoster pain. GoToSource

• Management of periorbital skin malignancy. GoToSource

• Adjunctive therapy for skin cancer. GoToSource 

• Wrist extensor tenosynovitis. GoToSource 

• Soft tissue injuries. GoToSource 

• Acute sprains and tendonitis. GoToSource

• Pityriasis versicolor. GoToSource 

• Acute blunt trauma injuries. GoToSource 

• Noncyclic mastalgia and surgical scar-related breast pain. GoToSource 

• Temporomandibular joint degenerative pain. GoToSource

Upper gastrointestinal hemorrhage. GoToSource

Angina (chest pain caused by reduced blood flow to heart), palpitations (abnormally rapid or irregular beating of the heart), myocardial infarction (heart attack), arrhythmia (irregular heartbeat), venous thrombosis (blood clot that forms in a vein), elevated creatinine (signifies impaired kidney function or kidney disease), elevated LFT (possible inflammation and damage to the liver) and hypertension (high blood pressure). GoToSource

Liver damage and failure, jaundice, and acute and chronic hepatitis (inflammation of the liver). GoToSource 

Stroke. GoToSource  

Worsen congestive heart failure, aseptic meningitis (inflammation of the lining of the brain and spinal cord), psychosis, tinnitus (ringing or buzzing in the ears) and asthma. GoToSource

Inflammation, bleeding, ulceration, and perforation of the stomach or intestines. Elderly patients are at greater risk for serious gastrointestinal events. GoToSource

Clostridium difficile associated disease (colon infection causing severe diarrhea). GoToSource

Thrombocytopenia (low blood platelet count). GoToSource

Increased risk of kidney impairment after laparoscopic radical nephrectomy in elderly patients. GoToSource

Convulsions, disorientation, hallucination and loss of consciousness. GoToSource

Stevens-johnson syndrome (severe skin reaction). GoToSource

Non-gastrointestinal bleeding. GoToSource

Neonatal severe pulmonary hypertension and transient right-sided hypertrophic cardiomyopathy. GoToSource

Pneumonitis ( inflammation of lung tissue). GoToSource

Kidney damage. GoToSource

Hyperkalemic quadriparesis (high potassium level causing muscle weakness). GoToSource

Lawsuits filed for liver damage.