Does Voltaren (diclofenac) cause side effects?
- rheumatoid arthritis,
- ankylosing spondylitis,
- 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,
- gastritis, and
- fluid retention.
Serious side effects of Voltaren include
- serious gastrointestinal bleeding,
- liver toxicity, blood clots,
- heart attacks,
- heart failure, and
- impaired kidney function.
Drug interactions of Voltaren include
- ACE Inhibitors,
- angiotensin II receptor blockers (ARBs),
- corticosteroids (prednisone),
- 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.
What are the important side effects of Voltaren (diclofenac)?
The most common side effects of diclofenac involve the gastrointestinal system, such as:
- abdominal burning,
- 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:
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.
Voltaren (diclofenac) side effects list for healthcare professionals
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events
- GI Bleeding, Ulceration and Perforation
- 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,
- gross bleeding/perforation,
- GI ulcers (gastric/duodenal) and
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
What drugs interact with Voltaren (diclofenac)?
See Table 2 for clinically significant drug interactions with diclofenac.
Table 2: Clinically Significant Drug Interactions with Diclofenac
|Drugs That Interfere with Hemostasis|
|Intervention:||Monitor patients with concomitant use of Voltaren with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding.|
|Clinical Impact:||Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone.|
|Intervention:||Concomitant use of Voltaren and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. Voltaren is not a substitute for low dose aspirin for cardiovascular protection.|
|ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers|
|Clinical Impact:||Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Voltaren with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.|
|Clinical Impact:||The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.|
|Intervention:||During concomitant use of Voltaren and digoxin, monitor serum digoxin levels.|
|Clinical Impact:||NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.|
|Intervention:||During concomitant use of Voltaren and lithium, monitor patients for signs of lithium toxicity.|
|Clinical Impact:||Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).|
|Intervention:||During concomitant use of Voltaren and methotrexate, monitor patients for methotrexate toxicity.|
|Clinical Impact:||Concomitant use of Voltaren and cyclosporine may increase cyclosporine’s nephrotoxicity.|
|Intervention:||During concomitant use of Voltaren and cyclosporine, monitor patients for signs of worsening renal function.|
|NSAIDs and Salicylates|
|Clinical Impact:||Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy.|
|Intervention:||The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.|
|Clinical Impact:||Concomitant use of Voltaren and pemetrexed may increase the risk of pemetrexedassociated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).|
During concomitant use of Voltaren and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.
NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.
In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
|CYP2C9 Inhibitors or Inducers:|
|Clinical Impact:||Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac.|
|Intervention:||A dosage adjustment may be warranted when diclofenac is administered with CYP2C9 inhibitors or inducers.|
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Medications & Supplements
- diclofenac - ophthalmic, Voltaren
- diclofenac/misoprostol - oral, Arthrotec
- diclofenac sodium enteric-coated tablet - oral, Voltaren
- diclofenac 3% - topical, Solaraze
- diclofenac - oral, Cataflam, Zipsor
- DICLOFENAC-RECTAL SUPPOSITORY
- Ketorolac vs. diclofenac
- diclofenac, Voltaren, Cataflam, Voltaren-XR, Cambia
- diclofenac and misoprostol (Arthrotec)
- Pennsaid (diclofenac sodium)
- Side Effects of Arthrotec (diclofenac and misoprostol)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.