Diclofenac sodium 500 mg

Contents

Diclofenac Potassium 50 mg Tablets

General

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2 Posology and method of administration and GI and cardiovascular risks below).

The concomitant use of diclofenac with systemic NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the absence of any evidence demonstrating synergistic benefits and the potential for additive undesirable effects (see section 4.5 Interactions with other medicaments and other forms of interaction).

Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight (see section 4.2 Posology and Method of administration).

As with other nonsteroidal anti-inflammatory drugs including diclofenac, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug (see section 4.8 Undesirable effects). Hypersensitivity reactions can also progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Presenting symptoms of such reactions can include chest pain occurring in association with an allergic reaction to diclofenac.

Like other NSAIDs, diclofenac may mask the signs and symptoms of the infection due to its pharmacodynamic properties.

Gastrointestinal effects:

Gastrointestinal bleeding (haematemesis, melaena) ulceration or perforation which can be fatal has been reported with all NSAIDs including diclofenac and may occur at any time during treatment, with or without warning symptoms or a previous history of serious GI events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving diclofenac, the drug should be withdrawn.

As with all NSAIDs, including diclofenac, close medical surveillance is imperative and particular caution should be exercised when prescribing diclofenac in patients with symptoms indicative of gastrointestinal disorders, or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation(see section 4.8 Undesirable effects).The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses including diclofenac, and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation.

The elderly have increased frequency of adverse reactions to NSAIDs especially gastro intestinal bleeding and perforation which may be fatal (see section 4.2 Posology and method of administration).

To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.

Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant use of medicinal products containing low dose acetylsalicylic acid (ASA/aspirin or medicinal products likely to increase gastrointestinal risk. (See section 4.5 Interactions with other medicaments and other forms of interaction).

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms (especially GI bleeding).

Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as systemic corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors (SSRIs) or anti-platelet agents such as acetylsalicylic acid (see section 4.5 Interaction with other medicaments and other forms of interaction).

Close medical surveillance and caution should be exercised in patients with ulcerative colitis, or with Crohn’s disease as these conditions may be exacerbated (see section 4.8 Undesirable effects).

NSAIDs, including diclofenac, may be associated with increased risk of gastro-intestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastro-intestinal surgery.

Hepatic effects:

Close medical surveillance is required when prescribing diclofenac to patients with impairment of hepatic function as their condition may be exacerbated.

As with other NSAIDs, including diclofenac, values of one or more liver enzymes may increase. During prolonged treatment with Diclofenac, regular monitoring of hepatic function is indicated as a precautionary measure.

If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), diclofenac should be discontinued.

Hepatitis may occur with diclofenac without prodromal symptoms.

Caution is called for when using diclofenac in patients with hepatic porphyria, since it may trigger an attack.

Renal effects:

As fluid retention and oedema have been reported in association with NSAIDs therapy, including diclofenac, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function, and those patients with substantial extracellular volume depletion from any cause, e.g. before or after major surgery (see section 4.3 Contraindications). Monitoring of renal function is recommended as a precautionary measure when using diclofenac in such cases. Discontinuation therapy is usually followed by recovery to the pre-treatment state.

Skin effects:

Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including diclofenac (see section 4.8 Undesirable effects). Patients appear to be at the highest risk of these reactions early in the course of therapy: the onset of the reaction occurring in the majority of cases within the first month of treatment. Diclofenac should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity.

SLE and mixed connective tissue disease:

In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis (see section 4.8 Undesirable effects).

Cardiovascular and cerebrovascular effects:

Patients with congestive heart failure (NYHA-I) or patients with significant risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking) should only be treated with diclofenac after careful consideration.

As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. The patient’s need for symptomatic relief and response to therapy should be re-evaluated periodically.

Appropriate monitoring and advice are required for patients with a history of hypertension and congestive heart failure (NYHA-I) as fluid retention and oedema have been reported in association with NSAID therapy, including diclofenac.

Clinical trial and epidemiological data consistently point towards increased risk of arterial thrombotic events (for example myocardial infarction or stroke) associated with the use of diclofenac, particularly at high dose (150mg daily) and in long term treatment.

Patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a physician immediately in case of such an event.

Haematological effects:

Use of diclofenac are recommended only for short term treatment.

During prolonged treatment with diclofenac, as with other NSAIDs, monitoring of the blood count is recommended.

Diclofenac may reversibly inhibit platelet aggregation (see anticoagulants in section 4.5 Interaction with other medicaments and other forms of interactions). Patients with defects of haemostasis, bleeding diathesis or haematological abnormalities should be carefully monitored.

Pre-existing asthma:

In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (i.e. nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so called intolerance to analgesics / analgesics asthma), Quincke’s oedema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances, e.g. with skin reactions, pruritus or urticaria.

Like other drugs that inhibit prostaglandin synthetase activity, diclofenac sodium and other NSAIDs can precipitate bronchospasm if administered to patients suffering from, or with a previous history of bronchial asthma.

Female fertility:

The use of diclofenac may impair female fertility and is not recommended in women attempting to conceive. In women who may have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of diclofenac should be considered (see section 4.6 Pregnancy and Lactation).

Cataflam

SIDE EFFECTS

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

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

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 718 patients treated for shorter periods, i.e., 2 weeks or less, with CATAFLAM® (diclofenac potassium immediate-release tablets), adverse reactions were reported one-half to one-tenth as frequently as by patients treated for longer periods. In a 6-month, double-blind trial comparing CATAFLAM (N=196) versus Voltaren® (diclofenac sodium delayed-release tablets) (N=197) versus ibuprofen (N=197), adverse reactions were similar in nature and frequency.

In patients taking CATAFLAM 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, proteinuria, renal 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

Read the entire FDA prescribing information for Cataflam (Diclofenac Potassium Immediate-Release Tablets)

About diclofenac

Type of medicine Non-steroidal anti-inflammatory drug (NSAID)
Used for Pain and inflammation
Also called Voltarol®; Dicloflex®; Diclomax®; Volsaid®; Arthrotec® (contains diclofenac with misoprostol)
Available as Tablets and dispersible tablets, gastro-resistant tablets, prolonged-release tablets and capsules, suppositories, mouthwash

Diclofenac side-effects

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with diclofenac. You will find a full list in the manufacturer’s information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Common diclofenac side-effects What can I do if I experience this?
Indigestion, heartburn, stomach pain Try taking your dose after a meal if you are not already doing so. If the discomfort continues, speak with your doctor
Feeling sick Stick to simple meals – avoid rich or spicy foods
Diarrhoea Drink plenty of water to replace the lost fluids

Important: if you experience any of the following less common but more serious symptoms, stop taking diclofenac and contact your doctor for advice straightaway:

  • If you have any breathing difficulties such as wheeze or breathlessness.
  • If you have any signs of an allergic reaction such as swelling around your mouth or face, or a severe itchy skin rash.
  • If you pass blood or black stools, bring up (vomit) blood, or have severe tummy (abdominal) pains.

If you experience any other symptoms which you think may be due to diclofenac, speak with your doctor or pharmacist for further advice.

Diclofenac interactions and warnings

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking your diclofenac dosage, it is important that your doctor knows:

  • If you have asthma or any other allergic disorder.
  • If you have ever had a stomach or duodenal ulcer, or if you have an inflammatory bowel disorder such as Crohn’s disease or ulcerative colitis.
  • If you have a heart condition, or a problem with your blood vessels or circulation.
  • If you are pregnant or breastfeeding.
  • If you have high blood pressure.
  • If you have any blood clotting problems.
  • If you have a connective tissue disorder, such as a condition called systemic lupus erythematosus (SLE).
  • If you have problems with the way your liver works, or problems with the way your kidneys work.
  • If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, as well as herbal and complementary medicines.
  • If you have ever had an allergic reaction to any other NSAID (such as aspirin, naproxen, indometacin, and ibuprofen), or to any other medicine.

Dosage and formulations

  • Before you start taking diclofenac, read the manufacturer’s printed information leaflet from inside the pack. It will give you more information about diclofenac and will provide you with a full list of the side-effects which you may experience from taking it.
  • Take diclofenac exactly as your doctor tells you to. Your doctor or pharmacist will tell you how much to take and how often to take it. You may be asked to take just one dose a day, or several doses each day. This information will also be printed on the label of the pack to remind you.
  • As a general rule, taking diclofenac with a glass of milk or after eating some food can help to reduce side-effects such as indigestion.
  • There are a number of different formulations of diclofenac, such as standard tablets, dispersible tablets, gastro-resistant tablets, and prolonged-release tablets/capsules. On the label of your pack there will be instructions to tell you how to take the type you have been given. For example, dispersible tablets should be taken mixed into a small amount of water, and prolonged-release tablets/capsules must be swallowed whole without chewing. Read and follow the directions on the label carefully.
  • If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next dose. In which case, take your next dose when it is due and leave out the missed dose. Do not take two doses together to make up for a forgotten dose.
  • If you have been prescribed diclofenac mouthwash, gargle or rinse 15 ml of mouthwash two or three times a day. You can use the mouthwash for up to seven days after dental treatment or six weeks after radiotherapy.

How diclofenac works

Diclofenac is given to treat painful conditions such as arthritis, sprains and strains, gout, migraine, dental pain, and pain after surgical operations. It eases pain and reduces inflammation. Diclofenac is available on prescription.

Diclofenac works by blocking the effect of chemicals in your body, called cyclo-oxygenase (COX) enzymes. These enzymes help to make other chemicals in the body, called prostaglandins. Prostaglandins are produced at sites of injury or damage, and cause pain and inflammation. By blocking the effect of COX enzymes, fewer prostaglandins are produced, which means pain and inflammation are eased.

There are two forms of diclofenac – diclofenac sodium and diclofenac potassium. The main difference between the two is that diclofenac potassium is absorbed into the body more quickly than diclofenac sodium. A quick action is useful where immediate pain relief is required, and a prolonged action is more useful in reducing inflammation. Some brands of diclofenac also contain a medicine called misoprostol. The brands are called Arthrotec® and Misofen®, and are prescribed for arthritis. Misoprostol helps to protect the stomach against irritation which can be caused by taking diclofenac over a period of time.

Diclofenac is not a suitable medicine for people who have heart disease (such as heart failure), or who have circulatory problems, or who have had a heart attack or a stroke. This is because it has been found that there is a small increased risk of heart attack and stroke in this group of people. Other anti-inflammatory medicines are more suitable for people with these conditions – ask your doctor or pharmacist for advice about an alternative medicine.

Diclofenac is also formulated as skin gels, patches and as eye drops. There is more information about these formulations in the separate medicine leaflets called Diclofenac gel/patch for pain and inflammation, Diclofenac gel for sun damage and Diclofenac eye drops.

Voltaren

Generic Name: diclofenac sodium Brand Name: Voltaren, Voltaren-XR, also Cambia, Cataflam, Zipsor, Zorvolex, Dyloject

Medically reviewed by Kaci Durbin, MD Last updated on Feb 14, 2019.

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What is Voltaren?

Voltaren (diclofenac) is a nonsteroidal anti-inflammatory drug (NSAID). Voltaren works by reducing substances in the body that cause pain and inflammation.

Voltaren oral tablets are used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis. Voltaren is also used to treat ankylosing spondylitis.

Voltaren ophthalmic eyedrops are used to treat pain, inflammation, and light sensitivity after eye surgery or for certain eye conditions.

Voltaren gel is used to treat osteoarthritis of the knees and hands.

Voltaren may also be used for purposes not listed in this medication guide.

Important information

You should not use Voltaren if you have a history of allergic reaction to aspirin or NSAIDs (non-steroidal anti-inflammatory drugs).

Voltaren can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Voltaren may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using Voltaren, especially in older adults.

Before taking this medicine

Voltaren can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine.

Do not use Voltaren just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

You should not use Voltaren if you are allergic to diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Voltaren is safe for you, tell your doctor if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;

  • a history of heart attack, stroke, or blood clot;

  • a history of stomach ulcers or bleeding;

  • asthma;

  • liver or kidney disease;

  • fluid retention.

Taking Voltaren during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether Voltaren passes into breast milk or if it could harm a nursing baby. Talk to your doctor before breast-feeding while using this medicine.

Voltaren is not approved for use by anyone younger than 18 years old.

How should I take Voltaren?

Take Voltaren exactly as prescribed by your doctor. Follow your doctor’s instructions about how much medicine to take.

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not take Voltaren in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Do not crush, chew, or break a Voltaren XR extended-release tablet. Swallow the tablet whole.

If you use Voltaren long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Voltaren?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs while you are taking Voltaren.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or other NSAID drugs.

Voltaren side effects

Get emergency medical help if you have signs of an allergic reaction to Voltaren: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Voltaren and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • signs of stomach bleeding – bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • signs of liver problems – nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of kidney problems – little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • signs of high blood pressure – severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;

  • signs of low red blood cells (anemia) – pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction – fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling; or

  • blurred vision or difficulty seeing (Voltaren ophthalmic eyedrops)

Common Voltaren side effects may include:

  • indigestion, gas, stomach pain, nausea, vomiting;

  • diarrhea, constipation;

  • headache, dizziness, drowsiness;

  • stuffy nose;

  • itching, increased sweating;

  • increased blood pressure; or

  • swelling or pain in your arms or legs; or

  • burning or stinging in eyes (Voltaren ophthalmic eyedrops)

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Voltaren?

Ask your doctor before using Voltaren if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your current medicines and any you start or stop using, especially:

This list is not complete. Other drugs may interact with Voltaren, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Voltaren only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2020 Cerner Multum, Inc. Version: 15.01.

Related questions

  • Does the drug diclofenac have narcotics in it?
  • Why is diclofenac only available on prescription but ibuprofen can be bought over the counter?

Medical Disclaimer

More about Voltaren (diclofenac)

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  • Drug class: Nonsteroidal anti-inflammatory drugs
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Consumer resources

  • Voltaren (Advanced Reading)

Other brands: Cataflam, Cambia, Zipsor, Zorvolex, Dyloject

Professional resources

  • Voltaren (FDA)
  • … +1 more

Other Formulations

  • Voltaren Gel
  • Voltaren-XR
  • Voltaren Ophthalmic

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How does this medication work? What will it do for me?

Diclofenac belongs to the class of medications known as non-steroidal anti-inflammatories (NSAIDs). It is used to reduce pain, swelling, and inflammation.

The diclofenac sodium tablet and suppository are used to relieve pain for people with rheumatoid arthritis, osteoarthritis, and degenerative joint diseases of the hip. The diclofenac potassium tablets are used for short-term relief of pain and inflammation, such as pain caused by sprains, surgery, dental work or menstrual cramps.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Tablets

Voltaren Rapide
Each reddish-brown, round, biconvex, sugar-coated tablet contains 50 mg of diclofenac potassium. Nonmedicinal ingredients: cellulose, colloidal silicon dioxide, corn starch, ferric oxide, magnesium stearate, polyethylene glycol, povidone, sodium carboxymethyl starch, sucrose, talc, titanium dioxide, and tribasic calcium phosphate.

Delayed-release tablet

50 mg
Each light brown, round, slightly biconvex, enteric-coated, tablet, printed “VOLTAREN” on one side and “50” on the other, contains 50 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, castor oil derivatives, colloidal silicon dioxide, corn starch, hypromellose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, talc, and titanium dioxide.

Extended-release tablet

75 mg
Each light pink, triangular, biconvex, film-coated tablet, printed “VOLTAREN SR” on one side and “75” on the other, contains 75 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, carnauba wax, cellulose compounds, cetyl alcohol, colloidal silicon dioxide, hypromellose, magnesium stearate, polysorbate 80, povidone, red iron oxide, sucrose, talc, and titanium dioxide.

100 mg
Each pink, round, biconvex, film-coated tablet, printed “VOLTAREN SR” on one side and “100” on the other, contains 100 mg of diclofenac sodium. Nonmedicinal ingredients: black ink, carnauba wax, cellulose compounds, cetyl alcohol, colloidal silicon dioxide, hypromellose, magnesium stearate, polysorbate 80, povidone, red iron oxide, sucrose, talc, and titanium dioxide.

Suppositories

50 mg rectal suppository
Each bullet-shaped suppository, white to yellowish-white in colour, with a smooth surface and a fat-like odour, contains 50 mg of diclofenac sodium. Nonmedicinal ingredients: semi-synthetic glycerides.

100 mg rectal suppository
Each bullet-shaped suppository, white to yellowish-white in colour, with a smooth surface and a fat-like odour, contains 100 mg of diclofenac sodium. Nonmedicinal ingredients: semi-synthetic glycerides.

How should I use this medication?

Tablets: The usual adult dosage ranges from 50 mg to 100 mg daily. The enteric-coated diclofenac sodium tablets are taken twice daily with food. Diclofenac potassium tablets are taken every 6 to 8 hours as needed with food. The long-acting (sustained-release, or SR) tablets are taken once daily with food or milk. The maximum recommended daily dose of diclofenac is 100 mg. The lowest effective dose of diclofenac for the shortest duration possible should be used.

Tablets should be swallowed whole with some fluid. Do not crush or chew the tablets as this can change the way the medication is absorbed into your body. It may increase the risk of side effects, such as stomach irritation or bleeding.

Suppositories: The suppositories are usually used as a substitute for the last daily dose in a 50 mg or 100 mg strength, to a maximum total daily dose of 100 mg of diclofenac.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to diclofenac or any ingredients of the medication
  • are breast-feeding
  • are in the third trimester of pregnancy (after 28 weeks)
  • are planning to have or have recently had heart bypass surgery
  • currently have or have recently had inflammatory diseases of the stomach and intestines, such as stomach or intestinal ulcer or ulcerative colitis
  • have bleeding in the brain or a bleeding disorder
  • have had an allergic reaction to ASA or other anti-inflammatory medications
  • have high levels of potassium in the blood
  • have severe uncontrolled heart failure
  • have severely impaired or deteriorating kidney function
  • have significant liver impairment or liver disease

Do not use diclofenac suppositories if you:

  • have any inflammatory lesions of the rectum or anus
  • have recently had rectal or anal bleeding

Do not give this medication to children or adolescents less than 16 years of age.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abdominal or stomach cramps, pain, or discomfort (mild to moderate)
  • dizziness
  • drowsiness
  • headache (mild to moderate)
  • heartburn
  • nausea
  • sun sensitivity

Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • confusion
  • decreased hearing, any other change in hearing, or ringing or buzzing in ears
  • difficulty swallowing
  • discoloration of the skin
  • “flu-like” symptoms (malaise, fatigue, loss of appetite)
  • increased blood pressure
  • persistent indigestion, nausea, stomach pain, or diarrhea
  • rectal itching or bleeding
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of heart failure (e.g., shortness of breath, fatigue, swelling in legs, ankles, feet)
  • signs of kidney problems (e.g., increased urination at night, decreased urine production, blood in the urine)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of meningitis not caused by infection (e.g., headache , throbbing, or with stiff neck or back)
  • swelling of face, feet, or lower legs
  • symptoms of urinary tract problems (e.g., bladder pain, pain when urinating, increased need to urinate, change in urine colour or odour)
  • unexplained, unexpected, or unusually heavy vaginal bleeding
  • vision changes

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • large hive-like swellings on face, eyelids, mouth, lips, or tongue
  • severe and continuing nausea, heartburn, vomiting
  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Some people who are allergic to other anti-inflammatory medications also experience allergic reactions to diclofenac. Before you take diclofenac, inform your doctor about any previous adverse reactions you have had to medications, especially ketorolac or ibuprofen. Contact your doctor at once if you experience signs of an allergic reaction, such as skin rash, itching, difficulty breathing, or swelling of the face and throat.

Breathing problems: People who have asthma, long term breathing problems, or allergic conditions such as hay fever or nasal polyps are more likely to experience difficulty breathing and allergic reactions, caused by NSAIDs. If you have a history of allergic reactions to other substances, or respiratory illness, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Drowsiness/reduced awareness: Some people have reported headache, dizziness, lightheadedness, and confusion while taking this medication. Avoid operating motor vehicles and doing other potentially hazardous activities until you have determined how this medication affects you.

Fertility: As with other NSAIDs, this medication may make it more difficult for a couple to conceive if the woman is taking diclofenac. Stopping the medication allows the body’s chemistry to return to normal which often resolves this issue.

Fluid retention: Diclofenac may cause fluid retention and swelling, possibly worsening high blood pressure, congestive heart failure, or decreased heart function. If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you develop shortness of breath; fatigue; excessive weight gain; chest pain; or swelling of the legs, feet, or ankles while taking this medication, consult your doctor immediately.

Heart problems: Like other NSAID medications, diclofenac may increase the risk of heart attacks, strokes, and blood clots, which may be fatal. The risk is greater with higher total daily doses and taking the medication for a long period of time. Due to this increased risk, people with the following conditions or risk factors should be closely monitored by their doctor if they use diclofenac:

  • congestive heart failure
  • diabetes
  • heart attack
  • heart disease
  • high blood pressure
  • high cholesterol
  • impaired kidney function
  • poor circulation
  • smoking
  • stroke

If you have any of these conditions, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Contact your doctor as soon as possible if you experience signs of decreasing heart function, such as swelling in the hands and feet, difficulty breathing when lying down, or easily becoming short of breath.

Seek medical help immediately if you experience signs of heart attack while taking this medication. Signs of heart attack may include a crushing sensation or pain in the chest, difficulty breathing, becoming pale and sweating, or sudden development of nausea and vomiting.

Infection: This medication may hide the signs of an infection, such as a fever or generalized achiness.

Kidney function: Decreased kidney function and kidney disease may cause diclofenac to build up in the body, causing side effects. If you have decreased kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Long-term use of diclofenac may lead to a higher risk of reduced kidney function. This is most common for people who already have kidney disease, liver disease, or heart failure; for people who are take diuretics (water pills); and for seniors. If you experience signs of decreasing kidney function, such as increased fluid retention or decreased amounts of urine being produced, see your doctor as soon as possible.

Liver function: This medication may cause liver problems. If you have a liver condition, you may need more frequent checkups with your doctor. If you develop signs of a liver problem (such as yellow skin or eyes, dark urine, pale stools, abdominal pain, or itchy skin), stop taking the medication and see your doctor as soon as possible.

Potassium levels: Diclofenac may increase the risk of high potassium levels in the blood, especially for seniors, people who have conditions such as diabetes or kidney failure, or those taking certain other types of medications. Your doctor may order blood tests periodically during long-term treatment to monitor the amount of potassium in your blood. People who have been diagnosed with having high potassium levels in their blood should not take this medication.

Stomach problems: Stomach ulcers, perforation, and bleeding from the stomach have been known to occur during treatment with diclofenac. These complications can occur at any time, and are sometimes severe enough to require immediate medical attention. The risk of ulcers and bleeding are increased for people taking higher doses of NSAIDs for longer periods of time.

Diclofenac should be taken under close medical supervision by people prone to irritation of the stomach and intestines, particularly those who have had a stomach ulcer, bloody stools, or diverticulosis or other inflammatory disease of the stomach or intestines (such as ulcerative colitis or Crohn’s disease). In these cases, your doctor must weigh the benefits of treatment against the possible risks.

Stop taking the medication and contact your doctor immediately if you experience symptoms or signs suggestive of stomach ulcers or bleeding in the stomach (black, tarry stools). These reactions can occur at any time during treatment without warning.

Sun sensitivity: This medication may make your skin more sensitive to the sun. While you are using this medication, avoid excessive sun exposure, including tanning beds and sun lamps. If you experience sunburn with itching, swelling, and blistering, stop using this medication and contact your doctor.

Pregnancy: When diclofenac is taken during the last 3 months of pregnancy, there is an increased risk of the child developing heart problems and the mother having a longer labour to deliver the baby. If diclofenac is taken during the earlier stages of pregnancy, there is an increased risk of miscarriage. For these reasons, this medication is not recommended for use during pregnancy.

Breast-feeding: It is not known if diclofenac passes into breast milk. If you are a breast-feeding mother and are taking diclofenac, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: Diclofenac is not recommended for children under 16 years of age. The safety, effectiveness, and dosage of this medication for this age group have not been established.

Seniors: Seniors appear to have a higher risk of side effects with this medication. The lowest effective dosage should be used under close medical supervision.

What other drugs could interact with this medication?

There may be an interaction between diclofenac and any of the following:

  • acetaminophen
  • acetylsalicylic acid (ASA)
  • aliskiren
  • alcohol
  • aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
  • angiotensin II receptor blockers (ARBs; e.g., candesartan, irbesartan)
  • angiotensin converting enzyme (ACE) inhibitors (e.g., ramipril)
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • apixaban
  • aprepitant
  • aripiprazole
  • “azole” antifungals (e.g., fluconazole, itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
  • beta-blockers (e.g., atenolol, metoprolol, propranolol)
  • bimatoprost
  • bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate, zoledronic acid)
  • bosentan
  • capecitabine
  • carbamazepine
  • celecoxib
  • cholestyramine
  • clopidogrel
  • colestipol
  • oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
  • cyclosporine
  • dabigatran
  • dasatinib
  • deferasirox
  • delavirdine
  • desmopressin
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, rosiglitazone)
  • digoxin
  • dipyridamole
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, spironolactone)
  • dofetilide
  • drospirenone
  • edoxaban
  • eplerenone
  • luorouracil
  • gemfibrozil
  • glucosamine
  • H2 antagonists (e.g., famotidine, ranitidine)
  • haloperidol
  • heparin
  • herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
  • hydralazine
  • latanoprost
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • mesalamine
  • methotrexate
  • multiple vitamins with minerals
  • obinutuzumaab
  • omega-3 fatty acids
  • other NSAIDs (e.g., naproxen, indomethacin)
  • pemetrexed
  • pentoxifylline
  • phenytoin
  • pimozide
  • porfimer
  • potassium supplements
  • prasugrel
  • primidone
  • quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
  • rifampin
  • rivaroxaban
  • serotonin-norepinephrine reuptake inhibitors (SNRIs; desvenlafaxine, duloxetine, venlafaxine)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., paroxetine, fluoxetine, citalopram, sertraline)
  • sodium phosphates
  • sulfasalazine
  • sulfinpyrazone
  • sulfonamide antibiotics (“sulfas”; e.g., sulfisoxazole, sulfamethoxazole)
  • tacrolimus
  • tenofovir
  • ticagrelor
  • ticlopidine
  • tipranavir
  • tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine)
  • vancomycin
  • vitamin E
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Voltaren

Diclofenac Dosage

Medically reviewed by Drugs.com. Last updated on Mar 13, 2019.

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  • Dosage
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Usual Adult Dose for:

  • Osteoarthritis
  • Ankylosing Spondylitis
  • Dysmenorrhea
  • Rheumatoid Arthritis
  • Migraine
  • Pain

Additional dosage information:

  • Renal Dose Adjustments
  • Liver Dose Adjustments
  • Dose Adjustments
  • Precautions
  • Dialysis
  • Other Comments

Usual Adult Dose for Osteoarthritis

Diclofenac free acid capsules: 35 mg orally 3 times a day
Diclofenac potassium immediate-release tablets: 50 mg orally 2 or 3 times a day
Diclofenac sodium enteric-coated tablets: 50 mg orally 2 or 3 times a day or 75 mg orally 2 times a day
Maximum dose: 150 mg daily
Diclofenac sodium extended-release tablets: 100 mg orally once a day
Use: For the relief of signs and symptoms of osteoarthritis.

Usual Adult Dose for Ankylosing Spondylitis

Diclofenac sodium enteric-coated and delayed-release tablets: 25 mg orally 4 times a day. An additional 25 mg dose may be administered at bedtime, if necessary
Maximum dose: 125 mg per day
Use: For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis.

Usual Adult Dose for Dysmenorrhea

Diclofenac potassium immediate-release tablets: 50 mg orally 3 times a day
Comments: An initial dose of 100 mg orally followed by 50 mg oral doses may provide better relief for some patients; initiate treatment upon appearance of the first symptoms and continue for a few days.
Use: For the relief of signs and symptoms of primary dysmenorrhea.

Usual Adult Dose for Rheumatoid Arthritis

Diclofenac potassium immediate-release tablets: 50 mg orally 3 or 4 times a day
Diclofenac sodium enteric-coated and delayed-release tablets: 50 mg orally 3 to 4 times a day or 75 mg orally twice a day
Maximum dose: 225 mg daily
Diclofenac sodium extended-release tablets: 100 mg orally once a day
Maximum dose: 100 mg orally 2 times a day; this would be for the rare patient in whom the benefits outweigh the clinical risks.
For the relief of signs and symptoms of rheumatoid arthritis

Usual Adult Dose for Migraine

Diclofenac potassium for oral solution packets: 50 mg (1 packet) orally once
Comments: This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches; the safety and efficacy of a second dose has not been established.
Use: For acute treatment of migraine with or without aura.

Usual Adult Dose for Pain

Oral:
Diclofenac potassium liquid-filled capsules: 25 mg orally 4 times a day
Diclofenac free acid capsules: 18 mg or 35 mg orally 3 times a day
Diclofenac potassium immediate-release tablets: 50 mg orally 3 times a day; an initial dose of 100 mg orally followed by 50 mg oral doses may provide better relief in some patients.
Comment: Neither the diclofenac potassium liquid filled capsules nor the diclofenac free acid capsules are interchangeable with each other or with other diclofenac products containing the sodium or potassium salt.
Parenteral:
37.5 mg IV bolus over 15 seconds every 6 hours as needed for pain
Maximum Dose: 150 mg per day
Comment: Patients should be well hydrated prior to IV administration of this drug in order to reduce the risk of adverse renal reactions.
Uses: For the management of mild to moderate acute pain (oral, IV) and moderate to severe pain alone or in combination with opioid analgesics (IV).

Renal Dose Adjustments

Oral:
Use with caution in patients with advanced renal disease; if treatment is initiated, close monitoring of renal function is recommended.
Parenteral:
Moderate to severe renal insufficiency in the perioperative period and at risk for volume depletion: Use is contraindicated
Moderate to severe renal impairment: Use is not recommended

Liver Dose Adjustments

Oral:
Use with caution; patients with hepatic disease may require reduced doses; start at the lowest dose, if efficacy is not achieved, consider drug discontinuation.
Parenteral:
Mild hepatic impairment: No dosage adjustment recommended
Moderate to severe hepatic impairment: Use is not recommended

Dose Adjustments

-Use the lowest effective dose for the shortest possible duration.
-No dose adjustments are recommended based on body weight.

Precautions

US BOXED WARNINGS: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS:
-Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
-This drug is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
-NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.

Dialysis

Diclofenac is not expected to be removed by dialysis due to its high degree of protein binding.

Other Comments

Administration advice:
Oral:
-Enteric coated: Swallow whole with liquid, preferably before meals
-Immediate-release, extended or modified-release tablets: Swallow whole with liquid preferably with or after meals
-Liquid-filled capsules and Powder for Oral Solution: Take on empty stomach;
-Powder for Oral Solution: Empty contents of a single 50 mg packet into 1 to 2 ounces of water, mix well and drink immediately; taking with food may reduce efficacy.
Parenteral:
-For IV administration only; give by IV bolus over 15 seconds
-Patients should be well hydrated prior to administration
Storage:
Injection for IV use: Protect from light; Do not freeze; Store at controlled room temperature 20C to 25C (68F to 77F)
General:
-Formulations of diclofenac are not bioequivalent or interchangeable.
-This drug is not indicated for the prophylactic therapy of migraine or for use in cluster headaches.
-Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Monitoring:
-Blood pressure should be monitored closely during initiation and throughout course of therapy.
-Monitor for signs/symptoms of gastrointestinal bleeding.
-Monitor renal status, especially in patients with conditions where renal prostaglandins have a supportive role in the maintenance of renal perfusion.
-Monitor blood counts, renal, and hepatic function periodically for patients receiving long-term therapy.
Patient advice:
-Patients should seek medical advice for signs and symptoms of cardiovascular events, gastrointestinal events, adverse skin reactions, allergic reactions, hepatotoxicity, or unexplained weight gain or edema.
-Patients should talk to their health care provider if they are pregnant, planning to become pregnant, or breastfeeding.
-Patients should talk to their health care provider before they use over the counter analgesics.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

  • Does the drug diclofenac have narcotics in it?
  • Why is diclofenac only available on prescription but ibuprofen can be bought over the counter?

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More about diclofenac

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  • Drug class: Nonsteroidal anti-inflammatory drugs
  • FDA Alerts (9)
  • Diclofenac
  • Diclofenac Capsules
  • Diclofenac Delayed-Release Tablets
  • Diclofenac Extended-Release Tablets
  • Diclofenac Immediate-Release Tablets
  • … +4 more

Other brands: Voltaren, Cataflam, Cambia, Zipsor, … +3 more

  • Diclofenac Potassium (AHFS Monograph)
  • … +9 more
  • Back Pain
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  • Frozen Shoulder
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  • … +8 more

Brand Names: Cambia, Cataflam, Voltaren, Voltaren-XR, Zipsor, Zorvolex

Generic Name: diclofenac

  • What is diclofenac?
  • What are the possible side effects of diclofenac?
  • What is the most important information I should know about diclofenac?
  • What should I discuss with my healthcare provider before taking diclofenac?
  • How should I take diclofenac?
  • What happens if I miss a dose?
  • What happens if I overdose?
  • What should I avoid while taking diclofenac?
  • What other drugs will affect diclofenac?
  • Where can I get more information?

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). This medicine works by reducing substances in the body that cause pain and inflammation.

Diclofenac is used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis. The Cataflam brand of this medicine is also used to treat menstrual cramps.

Diclofenac powder (Cambia) is used to treat a migraine headache attack. Cambia will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Diclofenac may also be used for purposes not listed in this medication guide.

What are the possible side effects of diclofenac?

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using diclofenac and call your doctor at once if you have:

  • the first sign of any skin rash, no matter how mild;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • signs of stomach bleeding–bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems–nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems–little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • high blood pressure–severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;
  • low red blood cells (anemia)–pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction–fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • indigestion, gas, stomach pain, nausea, vomiting;
  • diarrhea, constipation;
  • headache, dizziness, drowsiness;
  • stuffy nose;
  • itching, increased sweating;
  • increased blood pressure; or
  • swelling or pain in your arms or legs.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about diclofenac?

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults.

Diclofenac, a popular painkiller sold as Voltaren and other brand names, is as risky as Vioxx and should be taken off the market, Canadian researchers warn.

However, in the absence of action from Health Canada, researchers are taking the unusual step of asking patients to stop taking the drug and turn to safer alternatives, such as naproxen.

” is symptom relieving. You can buy alternatives over the counter without a prescription,” said David Henry, chief executive officer of Toronto’s Institute for Clinical Evaluative Sciences and professor of medicine at the University of Toronto. “Don’t wait for your doctor to take you off it. Take yourself off it.”

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Henry is the co-author of a study published this week in the journal PLos Medicine that found certain non-steroidal anti-inflammatory drugs (NSAIDs) increase the risk of heart attack and stroke in people with diabetes, high cholesterol, previous heart attack or other factors that put them at high risk for cardiovascular problems. NSAIDs are widely prescribed to relieve pain associated with arthritis, muscle injuries and other conditions.

Diclofenac is believed to be the most commonly prescribed NSAID in the world. Although it’s not the most popular in Canada, it is among the more commonly prescribed NSAIDs in this country. About 1.3 million prescriptions for diclofenac were dispensed from Canadian retail pharmacies in 2009.

The study published this week analyzed data from previously published studies of NSAIDs. The researchers concluded that diclofenac comes with substantial risks and should not be taken by people in danger of heart problems.

Another drug, etoricoxib, which isn’t available in Canada, is also singled out as risky. The study highlights research that found people taking etorixocib faced double the cardiovascular risks compared with people not on the drug. However, the heart risks linked to etoricoxib have not been as well established as that of diclofenac.

Vioxx is an infamous member of the NSAID class. In 2004, it became a cautionary tale for regulators when it was pulled in the market after studies confirmed that it increases the risk of heart attack and stroke. After that controversy, researchers began taking a closer look at other NSAIDs and found that some also carry a high-risk profile.

Henry, as well as other researchers around the world, have since concluded that diclofenac poses serious risks and should be removed from the marketplace.

Despite repeated calls over several years to stop the use of diclofenac, he said, he does not have much hope that Health Canada or other regulators will take decisive action. Part of the problem is that diclofenac is off-patent, which means it is produced by a number of manufacturers. This makes it harder to single out one company and apply pressure for the removal of the drug.

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Health Canada was unable to respond to questions about the status of diclofenac and whether it is conducting any safety reviews.

At the same time, diclofenac has been around for so long and is so widely used that it may simply be hard to break the habit. “That familiarity breeds a certain complacency about the drug,” Henry said.

Now, he and his colleagues plan to lobby the World Health Organization to have naproxen listed on “essential medicines” lists around the world instead of diclofenac. Countries use these lists to prioritize which medicines they need to satisfy the health-care priorities of the population. Last October, the European Medicines Agency launched a review of the cardiovascular safety of diclofenac.

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