Side Effects of Voltaren (diclofenac)

Voltaren (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat inflammation and pain caused by conditions such as

• rheumatoid arthritis,
• osteoarthritis,
• ankylosing spondylitis,
• tendinitis,
• bursitis, and
• menstrual cramps. 

NSAIDs work by reducing the production of prostaglandins, chemicals that cause pain, fever and inflammation. NSAIDs block the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower production of prostaglandins. 

As a consequence, inflammation, pain and fever are reduced. Since the response to different NSAIDs varies from patient to patient, it is not unusual for a doctor to try different NSAIDs for any given condition. 

Common side effects of Voltaren include

• stomach ulceration and bleeding (black tarry stools, weakness, and dizziness upon standing may be the only signs of internal bleeding),
• abdominal burning,
• pain,
• cramping,
• nausea,
• gastritis, and
• fluid retention.

Serious side effects of Voltaren include

• serious gastrointestinal bleeding,
• liver toxicity, blood clots,
• heart attacks,
• hypertension,
• heart failure, and
• impaired kidney function.

Drug interactions of Voltaren include

• aliskiren,
• ACE Inhibitors,
• angiotensin II receptor blockers (ARBs),
• corticosteroids (prednisone),
• cidofovir,
• cyclosporine,
• lithium,
• methotrexate,
• pemetrexed, and
• other drugs that also may cause bleeding (anti-platelet drugs and "blood thinners"). 

During pregnancy, Voltaren should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. 

It is unknown if Voltaren is excreted in breast milk. Consult your doctor before breastfeeding.

The most common side effects of diclofenac involve the gastrointestinal system, such as:

• ulcerations,
• abdominal burning,
• pain,
• cramping,
• nausea,
• gastritis,
• serious gastrointestinal bleeding, and
• liver toxicity.

Sometimes, stomach ulceration and bleeding can occur without any abdominal pain. Black tarry stools, weakness, and dizziness upon standing may be the only signs of internal bleeding. Rash, kidney impairment, ringing in the ears, and lightheadedness are also seen.

Other important side effects include:

• Fluid retention,
• blood clots,
• heart attacks,
• hypertension, and
• heart failure.

People who are allergic to other NSAIDs should not use diclofenac. NSAIDs reduce the flow of blood to the kidneys and impair function of the kidneys. The impairment is most likely to occur in patients with already reduced kidney function or congestive heart failure, and use of NSAIDs in these patients should be done cautiously. Individuals with asthma are more likely to experience allergic reactions to diclofenac and other NSAIDs.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events
• GI Bleeding, Ulceration and Perforation
• Hepatotoxicity
• Hypertension
• Heart Failure and Edema
• Renal Toxicity and Hyperkalemia
• Anaphylactic Reactions
• Serious Skin Reactions
• Hematologic Toxicity

Clinical Trials 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In patients taking Voltaren (diclofenac sodium enteric-coated tablets), or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are:

Gastrointestinal experiences including:

• abdominal pain,
• constipation,
• diarrhea,
• dyspepsia,
• flatulence,
• gross bleeding/perforation,
• heartburn,
• nausea,
• GI ulcers (gastric/duodenal) and
• vomiting.

Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus.

Additional adverse experiences reported occasionally include:

• Body as a Whole: fever, infection, sepsis
• Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope
• Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice
• Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia
• Metabolic and Nutritional: weight changes
• Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo
• Respiratory System: asthma, dyspnea
• Skin and Appendages: alopecia, photosensitivity, sweating increased
• Special Senses: blurred vision
• Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuriarenal failure
• Other adverse reactions, which occur rarely are:
• Body as a Whole: anaphylactic reactions, appetite changes, death
• Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis
• Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis
• Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
• Metabolic and Nutritional: hyperglycemia
• Nervous System: convulsions, coma, hallucinations, meningitis
• Respiratory System: respiratory depression, pneumonia
• Skin and Appendages: angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
• Special Senses: conjunctivitis, hearing impairment

See Table 2 for clinically significant drug interactions with diclofenac.

Table 2: Clinically Significant Drug Interactions with Diclofenac