Voltaren Gel Side Effects

Please note - some side effects for Voltaren Gel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Voltaren Gel - for the Consumer

Voltaren Gel

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Voltaren Gel:

Mild irritation at the application site.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent irritation at the application site; severe or persistent stomach pain or nausea; severe vomiting or diarrhea; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; unusual bruising or bleeding; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, yellowing of the skin or eyes); unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Voltaren Gel Side Effects - for the Professional

Voltaren Gel

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical development, 913 patients were exposed to Voltaren® Gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities. Of these, 513 patients received Voltaren® Gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand. Additionally, 583 patients were exposed to Voltaren® Gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee. Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees. Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.

Short-Term Placebo-Controlled Trials:

Adverse reactions observed in at least 1% of patients treated with Voltaren® Gel:

Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing Voltaren® Gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions. These were the only adverse reactions that occurred in > 1% of treated patients with a greater frequency in the Voltaren® Gel group (7%) than the placebo group (2%). 

Table 1 lists the types of application site reactions reported. Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with Voltaren® Gel, compared to 1% of placebo patients.

†Preferred Term according to MedDRA 9.1.

In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with Voltaren® Gel, and 3% for patients in the placebo group. Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation. 

Long-term Open-label Safety Trial:

In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies. In this study, where patients were treated for up to 1 year with Voltaren® Gel up to 32 g per day, application site dermatitis was observed in 11% of patients. Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients. The most common adverse reaction that led to discontinuation of the study was application site dermatitis, which was experienced by 6% of patients.

Side Effects by Body System - for Healthcare Professionals

Local

Local application site reactions have been reported in 75% to 86% of patients and have included rash (35% to 36%), pruritus (31% to 52%), dry skin (25% to 27%), contact dermatitis (19% to 33%), pain (15% to 26%), paresthesia (8% to 20%), exfoliation (6% to 24%), vesiculobullous rash (4%), edema (3% to 4%), hyperesthesia (3%), photosensitivity reaction (3%), acne (1%), alopecia (1% to 2%), erythema (less than 1%), irritation (less than 1%), and papules (less than 1%).

The gel vehicle has also been associated with a high incidence of application site reactions (71% to 86%), including pruritus (45% to 59%), pain (22% to 30%), rash (17% to 20%), dry skin (12% to 17%), exfoliation (4% to 13%), and paresthesia (4% to 20%). Other local reactions have included skin carcinoma, hypertonia, lacrimation disorder, maculopapular rash, purpuric rash, skin hypertrophy, and vasodilation in less than 1% of patients.

Dermatologic

Dermatologic side effects have included pruritus (4%), rash (2% to 4%), dry skin (3%), contact dermatitis (2%), pain (1% to 2%), skin carcinoma (2%), and skin ulcer (1% to 2%). Other dermatologic side effects have included skin hypertrophy, paresthesia, seborrhea, urticaria in less than 1% of patients, and skin discoloration. The gel vehicle has been associated with acne (1% to 2%), herpes simplex (2%), maculopapular rash (2%), and skin nodule (2%).

Cardiovascular

Cardiovascular side effects have included hypertension (1% to 2%), migraine (1%), and palpitation. The gel vehicle has been associated with phlebitis (2%).

Endocrine

Endocrine side effects have included hyperglycemia (greater than 1%).

Gastrointestinal

Gastrointestinal side effects have included dyspepsia (2% to 3%), diarrhea (2%), abdominal pain (1% to 2%), dry mouth, gastroenteritis, mouth ulceration, nausea, rectal hemorrhage, and ulcerative stomatitis. The gel vehicle has been associated with constipation (2%).

Genitourinary

Genitourinary side effects have included hematuria (2%).

Hepatic

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients as well as rare cases of hepatitis, jaundice, and fatal fulminant hepatitis. Liver injury is most likely to occur in older females in the first 6 months of use.

Immunologic

Immunologic side effects have included infection and flu syndrome (greater than 1%).

Metabolic

Metabolic side effects have included increased creatine phosphokinase (4%), increased SGOT (3%), increased SGPT (2%), increased creatinine (2%), hypercholesterolemia (1%), hyperglycemia (1%), and creatinine increased. The gel vehicle has been associated with edema (2%).

Musculoskeletal

Musculoskeletal side effects have included myalgia (2 to 3%), arthralgia (2%), arthrosis (2%), and leg cramps.

Nervous system

Nervous system side effects have included headache (7%), hypokinesia (2%), depression, dizziness, drowsiness, lethargy, paresthesia, and paresthesia at application site. The gel vehicle has been associated with dizziness (4%) and anxiety (1% to 2%).

Ocular

Ocular side effects have included conjunctivitis (2 to 4%) eye pain (2%), blurred or abnormal vision, cataract, and eye disorder.

Respiratory

Respiratory side effects have included asthma, dyspnea, pharyngitis, pneumonia, rhinitis, and sinusitis in 2% of patients.

Renal

Renal side effects have included increased creatinine (2%).

Other

Other side effects have included flu syndrome (1 to 10%), accidental injury (4%), infection (4%), back pain (2 to 4%), asthenia (2%), neck pain (2%), pain (2%), chest pain (1 to 2%), ear pain, and taste perversion.

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