NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Diclofenac sodium is contraindicated in the setting of 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 greater risk for serious GI events .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Analgesic
Pharmacologic Class: NSAID
Chemical Class: Acetic Acid (class)
Uses For diclofenac
Diclofenac injection is a nonsteroidal anti-inflammatory drug (NSAID) used to treat adults with mild to moderate pain. It is used alone or given with other opioid (narcotic) pain medicines to treat adults with moderate to severe pain.
diclofenac is to be given only by or under the direct supervision of your doctor.
Before Using diclofenac
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For diclofenac, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to diclofenac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of diclofenac injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac injection in the elderly. However, elderly patients are more likely to have age-related kidney or stomach problems, which may require caution for patients receiving diclofenac injection.
|1st Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|2nd Trimester||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
|3rd Trimester||D||Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving diclofenac, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using diclofenac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using diclofenac with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Amtolmetin Guacil
- Bismuth Subsalicylate
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Dabigatran Etexilate
- Ethacrynic Acid
- Flufenamic Acid
- Magnesium Salicylate
- Mefenamic Acid
- Niflumic Acid
- Nimesulide Beta Cyclodextrin
- Pentosan Polysulfate Sodium
- Phenyl Salicylate
- Protein C
- Salicylic Acid
- Sodium Salicylate
- Tiaprofenic Acid
- Tolfenamic Acid
- Trolamine Salicylate
Using diclofenac with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Azilsartan Medoxomil
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of diclofenac. Make sure you tell your doctor if you have any other medical problems, especially:
- Anemia or
- Bleeding problems or
- Blood clots or
- Congestive heart failure or
- Dehydration or
- Edema (fluid retention) or
- Heart attack, recent or history of or
- Heart disease or
- Hyperkalemia (high potassium in the blood) or
- Hypertension (high blood pressure) or
- Kidney disease or
- Stomach ulcers or bleeding, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Aspirin-sensitive asthma, history of or
- Aspirin (or other NSAIDs) sensitivity, history of or
- Kidney disease, moderate to severe—Should not be used in patients with these conditions.
- Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right before or after the surgery.
Proper Use of diclofenac
A nurse or other trained health professional will give you diclofenac in a hospital. diclofenac is given through a needle placed in one of your veins.
Drink extra fluids so you will pass more urine before receiving diclofenac. This may help prevent kidney problems.
Precautions While Using diclofenac
It is very important that your doctor check you closely while you are receiving diclofenac. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for unwanted effects.
diclofenac may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use diclofenac for a long time might also have a higher risk.
diclofenac may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain medicines (such as a steroid medicine or a blood thinner).
Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellowing of your skin or the whites of your eyes.
If you are rapidly gaining weight, having shortness of breath, chest pain, extreme tiredness or weakness, irregular breathing, irregular heartbeat, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.
diclofenac may cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or nonsteroidal antiinflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swelling of the eyelids or around the eyes. If these effects occur, get emergency help at once.
Serious skin reactions can occur during treatment with diclofenac. Tell your doctor right away if you have any of the following symptoms while using diclofenac: blistering, peeling, loosening of the skin, red skin lesions, sores or ulcers on the skin, or fever or chills.
It is important to tell your doctor if you are pregnant or planning to become pregnant before using diclofenac. Using diclofenac late in pregnancy can harm your unborn baby. Do not use diclofenac during the latter part of a pregnancy unless your doctor tells you to.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
diclofenac Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:Less common
- Abdominal or stomach pain, cramping, or burning
- bloody or black, tarry stools
- bloody urine
- decreased frequency or amount of urine
- heartburn or indigestion
- increased thirst
- loss of appetite
- lower back or side pain
- nausea or vomiting
- severe stomach pain
- swelling of the face, fingers, or lower legs
- trouble breathing
- unusual tiredness or weakness
- vomiting of blood or material that looks like coffee grounds
- weight gain
- Blistering, peeling, or loosening of the skin
- chest pain or discomfort
- difficulty with speaking
- double vision
- fever or chills
- inability to move the arms, legs, or facial muscles
- inability to speak
- pain or discomfort in the arms, jaw, back, or neck
- red skin lesions
- slow speech
- sores or ulcers on the skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
- Difficulty having a bowel movement (stool)
- pain at the injection site
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Side effects (in more detail)
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