In this drug factsheet:
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)
- headache (mild to moderate)
- 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:
- 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
- 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 [severe], 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:
Some people may experience side effects other than those listed.
- 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
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.
HEALTH CANADA ADVISORY
[October 6, 2014]
Health Canada has issued new restrictions concerning the use of diclofenac. To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
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. 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
- heart attack
- heart disease
- high blood pressure
- high cholesterol
- impaired kidney function
- poor circulation
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.
Infection: This medication may hide the signs of an infection, such as a fever or generalized achiness.
Kidney function: 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. Due to the potential for harm to a baby if they are exposed to this medication, breast-feeding must be stopped before starting this medication.
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:
- acetylsalicylic acid (ASA)
- 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)
- "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
- barbiturates (e.g., butalbital, pentobarbital, phenobarbital)
- beta-blockers (e.g., atenolol, metoprolol, propranolol)
- bisphosphonates (e.g., alendronate, etidronate, pamidronate, risedronate, zoledronic acid)
- oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
- diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
- diuretics (water pills; e.g., furosemide, hydrochlorothiazide, spironolactone)
- H2 antagonists (e.g., famotidine, ranitidine)
- herbal medications that affect blood clotting (e.g., ginkgo biloba, garlic, ginger, ginseng, glucosamine)
- low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
- multiple vitamins with minerals
- omega-3 fatty acids
- other NSAIDs (e.g., naproxen, indomethacin)
- other products containing diclofenac
- peginterferon Alfa-2b
- potassium supplements
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- quinolone antibiotics (e.g., ciprofloxacin, norfloxacin, ofloxacin)
- SSRIs (e.g., paroxetine, fluoxetine, citalopram, sertraline)
- sodium phosphates
- tricyclic antidepressants (e.g., amitriptyline, doxepin, imipramine)
- vitamin E
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.