What are the side effects of Voltaren (diclofenac)?

From the Guidelines

Voltaren (diclofenac) can cause significant side effects, including increased risk of cardiovascular events, gastrointestinal issues, and kidney problems, and its use should be approached with caution, especially in patients with pre-existing heart disease, high blood pressure, or kidney issues 1. The side effects of Voltaren (diclofenac) can range from common to severe and include:

• Stomach pain, heartburn, nausea, diarrhea, constipation, headache, dizziness, and ringing in the ears
• More serious side effects that require immediate medical attention, such as signs of stomach bleeding, liver problems, kidney problems, high blood pressure, heart problems, and severe skin reactions Diclofenac, like other NSAIDs, works by blocking enzymes that produce inflammatory chemicals in the body, but this same mechanism can affect the protective lining of the stomach and impact kidney and cardiovascular function, as evidenced by studies showing increased cardiovascular risk associated with NSAID use, including diclofenac 1. Key points to consider when using Voltaren (diclofenac) include:
• The risk of side effects increases with higher doses and longer duration of use, so it's best to use the lowest effective dose for the shortest time possible
• People with heart disease, high blood pressure, kidney problems, or a history of stomach ulcers should use Voltaren cautiously and only under medical supervision
• Nonpharmacological approaches and alternative pain management options should be considered before initiating NSAID therapy, especially in high-risk patients 1.

From the FDA Drug Label

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 In patients taking diclofenac potassium 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 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

The side effects of Voltaren (diclofenac) include:

• Cardiovascular events: myocardial infarction, stroke, arrhythmia, hypotension, palpitations, vasculitis
• Gastrointestinal events: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers, vomiting
• Hepatotoxicity: elevated liver enzymes, fulminant hepatitis, liver failure, liver necrosis
• Renal toxicity: abnormal renal function, hyperkalemia
• Hematologic toxicity: anemia, agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
• Nervous system events: headaches, dizziness, convulsions, coma, hallucinations, meningitis
• Skin reactions: rashes, pruritus, angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens Johnson Syndrome, urticaria
• Respiratory events: respiratory depression, pneumonia
• Other events: appetite changes, death, hyperglycemia 2, 2

From the Research

Side Effects of Voltaren (Diclofenac)

The side effects of Voltaren (diclofenac) can be significant and are associated with its use as a non-steroidal anti-inflammatory drug (NSAID). Some of the key side effects include:

• Gastrointestinal (GI) toxicities, such as peptic ulcer disease and gastrointestinal bleeding 3, 4, 5, 6
• Cardiovascular (CV) toxicities, including an increased risk of major CV events 3
• Renal and metabolic complications, although these are not as well-studied in the context of diclofenac use 7

Gastrointestinal Side Effects

The gastrointestinal side effects of diclofenac are a major concern, with up to 25% of patients taking NSAIDs chronically experiencing GI side effects 4. These can include:

• Peptic ulcer disease, which can lead to hospitalization due to bleeding or perforation 4, 5
• Gastrointestinal bleeding, which can be severe and life-threatening 5
• Small bowel enteropathy, which can lead to complications such as bleeding and perforation 6

Cardiovascular Side Effects

The cardiovascular side effects of diclofenac are also significant, with an increased risk of major CV events, including myocardial infarction and stroke 3. The risk of CV events is dose-related, with higher doses of diclofenac associated with a greater risk of CV events 3.

Risk Reduction Strategies

Several strategies can be used to reduce the risk of side effects associated with diclofenac use, including:

• Using the lowest effective dose for the shortest duration necessary 3
• Co-administering proton pump inhibitors (PPIs) to reduce the risk of GI complications 4, 6
• Using selective cyclo-oxygenase (COX)-2 inhibitors, which may be associated with a lower risk of GI complications 6
• Avoiding the use of diclofenac in patients with high cardiovascular risk or those with a history of GI bleeding or perforation 7