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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Voltaren Gel - for the Consumer

Voltaren Gel Gel

All medicines can 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 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; dark urine; 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; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Voltaren Gel Side Effects - for the Professional

Voltaren Gel

Most common adverse reactions (incidence >2% of patients treated with Voltaren® Gel and greater than placebo) are application site reactions, including dermatitis. (6.1)

Side Effects by Body System

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's 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. The gel's 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%) and migraine (1%). The gel's 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%), and abdominal pain (1% to 2%). The gel's vehicle has been associated with constipation (2%).

Genitourinary

Genitourinary side effects have included hematuria (2%).

Hepatic

Hepatic side effects have included increased SGOT and SGPT (greater than 1%).

Immunologic

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

Metabolic

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

Musculoskeletal

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

Nervous system

Nervous system side effects have included headache (7%), and hypokinesia (2%). The gel's vehicle has been associated with dizziness (4%) and anxiety (1% to 2%).

Ocular

Ocular side effects have included conjunctivitis (2% to 4%) and eye pain (2%).

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%), and chest pain (1% to 2%).

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