Diclofenac (Oral)

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to treat mild-to-moderate pain and to help relieve symptoms of arthritis (for example, osteoarthritis or rheumatoid arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will only help you as long as you continue to take it.

This medicine is also used to treat ankylosing spondylitis, which is a type of arthritis that affects the joints in the spine, and other painful conditions like menstrual cramps.

Diclofenac is also used to treat acute migraine attacks, with or without aura, in adults. It will not prevent or reduce the number of migraine attacks.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits. This will help your doctor see if the medicine is working well and decide if you should keep taking it. Blood and urine tests may be needed to look for unwanted effects.

This medicine may increase your risk of having a heart attack or stroke. This is more likely in people who already have heart disease or in those who use this medicine for a long time.

This medicine may cause bleeding in your stomach or intestines. These issues can happen without warning signs. This risk is higher if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years old, are in poor health, or are taking certain medicines (for example, steroid medicine, blood thinner).

Contact your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

Serious skin reactions, such as Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS), can happen while using this medicine. Contact your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Some possible warning signs of serious side effects during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting blood or material that looks like coffee grounds, or yellowing of the skin or eyes. Also, signs of serious heart problems could occur, including chest pain or tightness, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurred speech. Contact your doctor right away if you notice any of these warning signs.

Contact your doctor right away if you have bloody urine, a decrease in how often or how much you urinate, increased blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney problem.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Contact your doctor right away if you have stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness in the legs.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and needs immediate medical help. This may happen more often in patients who are allergic to aspirin or other nonsteroidal anti-inflammatory drugs. Call your doctor right away if you have a rash, itching, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Using this medicine in the later part of pregnancy can harm your unborn baby. If you think you might be pregnant while using the medicine, tell your doctor right away.

Taking too much of Cambia® or any other migraine medicines (for example, ergotamine, triptans, opioids, NSAIDs, or a combination treatment for 10 or more days per month) may make your headache worse. Talk to your doctor about this risk. It may also be helpful to note how often your migraine attacks happen and how much medicine you use.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, headache, loss of appetite, nausea, stiff neck or back, or vomiting. These could be signs of meningitis.

Contact your doctor immediately if you have blurred vision, difficulty reading, or any other change in vision during or after your treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may delay ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Before any surgery or medical tests, tell your doctor that you are using this medicine. You may need to stop treatment for a while or switch to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a drug, the chances of using the drug must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform 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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of diclofenac in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of Zipsor® capsules in children 12 to 17 years of age. Safety and efficacy have been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of diclofenac in the elderly. However, elderly patients are more likely to have age-related kidney or stomach issues, which may require caution for patients receiving diclofenac.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this drug during breastfeeding. Weigh the potential benefits against the potential chances prior to using this drug while breastfeeding.

Interactions with Drugs

Although certain drugs 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 clinician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are using 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 this medication with any of the following drugs is not recommended. Your doctor may decide not to treat you with this drug or change some of the other drugs you take.

• Ketorolac

Using this medicine with any of the following medicines is usually not advised, 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.

• Abciximab
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Bemetizide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bivalirudin
• Budesonide
• Bumetanide
• Cangrelor
• Capecitabine
• Ceritinib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Cilostazol
• Citalopram
• Clomipramine
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Cyclothiazide
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deferiprone
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Emtricitabine
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Inotersen
• Ketoprofen
• Lepirudin
• Levoketoconazole
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Mavacamten
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Melphalan
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piretanide
• Piroxicam
• Polythiazide
• Potassium Citrate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Quinethazone
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Selexipag
• Sertraline
• Sibutramine
• Sodium Salicylate
• Sparsentan
• Spironolactone
• Sulfasalazine
• Sulfinpyrazone
• Sulindac
• Sulodexide
• Tacrolimus
• Tenofovir Alafenamide
• Tenofovir Disoproxil Fumarate
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Trazodone
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using this medicine with any of the following medicines may cause an increased chance of certain adverse effects, but using both drugs may be the best therapy for you. If both medications are prescribed together, your clinician may change the dose or how frequently you use one or both of the medications.

• Acebutolol
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cholestyramine
• Ciprofloxacin
• Colestipol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Perindopril
• Pindolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Timolol
• Trandolapril
• Valsartan

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 additionally 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 this medicine. Make sure you inform your physician if you have any other medical issues, especially:

• Allergy to bovine protein—Zipsor® capsule contains gelatin and should not be used in patients with this condition.

• Anemia or
• Bleeding problems or
• Blood clots or
• Congestive heart failure or
• Edema (fluid retention) or
• Heart attack, history of or
• Heart disease or
• Hypertension (high blood pressure) or
• Kidney disease or
• Porphyria (blood disorder) 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, serious—Should not be used in patients with these conditions.

• Dehydration or
• Hypovolemia—Must be corrected first prior to using this medication.

• Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—Should not be used to relieve pain right prior to or following the surgery.

• Liver disease—Use with caution. The effects may be increased because of slower removal of the drug from the body.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Acid or sour stomach
• belching
• bleeding gums
• blood in the urine or stools
• bloody or black, tarry stools
• burning while urinating
• chest pain
• chills
• cough
• clay-colored stools
• cloudy urine
• constipation
• dark urine
• decrease in urine output or ability to concentrate urine
• diarrhea
• dizziness
• feeling of indigestion
• fever
• frequent urge to urinate
• headache
• heartburn
• increased bleeding time
• indigestion
• itching skin or rash
• light-colored stools
• loss of appetite
• nausea and vomiting
• pain in the chest below the breastbone
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• stomach bloating, burning, cramping, discomfort, upset, or pain
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling or inflammation of the mouth
• swollen glands
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting of blood or material that looks like coffee grounds
• weight loss
• yellow eyes and skin

Less common

• Blistering, peeling, loosening of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles," or tingling feelings
• confusion
• change in consciousness
• discouragement
• dizziness, faintness, or lightheadedness when standing up suddenly from a lying or sitting position
• feeling of constant movement of self or surroundings
• feeling sad or empty
• irritability
• joint or muscle pain
• lack of appetite
• lack or loss of strength
• loss of consciousness
• loss of interest or pleasure
• nervousness
• pain or discomfort in the arms, jaw, back, or neck
• pale or blue lips, fingernails, or skin
• red irritated eyes
• red skin lesions, often with a purple center
• redness, soreness, or itching skin
• sensation of spinning
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• stiff neck or back
• trembling or shaking of the hands or feet
• trouble concentrating
• trouble sleeping

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Agitation
• blurred vision
• change in consciousness
• change in ability to see colors, especially blue or yellow
• confusion
• depression
• difficulty or trouble breathing
• hives
• hostility
• irregular, fast or slow, or shallow breathing
• irritability
• loss of consciousness
• muscle twitching
• nervousness
• pain or discomfort in the chest, upper stomach, or throat
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• seizures
• sleepiness
• slow or fast heartbeat
• stupor
• swelling of the face, ankles, or hands
• tightness in the chest
• trouble sleeping
• unusual drowsiness, dullness, or feeling sluggish

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also be able to tell you how 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

• Bloated
• continuous ringing or buzzing or other unexplained noise in the ears
• difficulty in swallowing
• excess air or gas in the stomach or intestines
• hearing loss
• lack or loss of strength
• pain or burning in the throat
• passing gas

Less common

• Burning, dry, or itching eyes
• discharge, excessive tearing
• hair loss, thinning of the hair
• increased sensitivity of the skin to sunlight
• pain in the arms or legs
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• redness or other discoloration of the skin
• severe sunburn

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.

In the U.S.

• Cambia
• Cataflam
• Voltaren
• Voltaren-XR
• Zipsor
• Zorvolex

Available Dosage Forms:

• Capsule
• Tablet, Enteric Coated
• Tablet, Extended Release
• Tablet
• Powder for Solution
• Capsule, Liquid Filled

Therapeutic Class: Central Nervous System Agent

Pharmacologic Class: NSAID

Chemical Class: Acetic Acid (class)

Keep using this medicine for the full time of treatment. However, do not use this medicine more often or for a longer time than your doctor ordered. This medicine is not for long-term use.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

When used for severe or continuing arthritis, this medicine must be taken every day as ordered by your doctor in order for it to help you. This medicine usually begins to work within one week, but in severe cases up to two weeks or longer may pass before you begin to feel better. Several weeks may pass before you feel the full effects of this medicine.

You may take this medicine with or without food. However, diclofenac capsules should be taken on an empty stomach.

To use the oral solution:

• Open the packet of medicine right before you use it.
• Empty the contents of the packet into a cup with 1 to 2 ounces (30 to 60 milliliters [mL]) of water. Do not use any liquid other than water for mixing the medicine.
• Mix well and drink it immediately on an empty stomach.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (Zipsor® capsules):For acute pain: Adults and children 12 years of age and older—25 milligrams (mg) 4 times a day. Children younger than 12 years of age—Use and dose must be determined by your doctor.
• For oral dosage form (Zorvolex® capsules): For acute pain: Adults—18 or 35 milligrams (mg) 3 times a day. Children—Use and dose must be determined by your doctor. For osteoarthritis: Adults—35 milligrams (mg) 3 times a day. Children—Use and dose must be determined by your doctor.
• For oral dosage forms (delayed-release tablets, enteric-coated tablets): For ankylosing spondylitis: Adults—25 milligrams (mg) 4 times a day, with an extra 25 mg dose at bedtime if necessary. Children—Use and dose must be determined by your doctor. For osteoarthritis: Adults—50 milligrams (mg) 2 or 3 times a day, or 75 mg two times a day. Children—Use and dose must be determined by your doctor. For rheumatoid arthritis: Adults—50 milligrams (mg)3 or 4 times a day, or 75 mg two times a day. Children—Use and dose must be determined by your doctor.
• For oral dosage form (immediate-release tablets): For osteoarthritis: Adults—50 milligrams (mg) 2 or 3 times a day. Children—Use and dose must be determined by your doctor. For pain or menstrual cramps: Adults—50 milligrams (mg) 3 times a day. Your doctor may direct you to take 100 mg for the first dose only. Children—Use and dose must be determined by your doctor. For rheumatoid arthritis: Adults—50 milligrams (mg) 3 or 4 times a day. Children—Use and dose must be determined by your doctor.
• For oral dosage form (solution):For migraine headaches: Adults—One packet (50 milligrams) as a single, one time dose. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• Can I take ibuprofen with blood pressure medications?
• Why is diclofenac prescription only but ibuprofen is OTC?
• Can you Double up on Pain Meds? Safe Painkiller Combinations
• Does diclofenac contain narcotics or affect a drug test?
• Which painkiller should you use?
• Can NSAIDs be used to treat a COVID-19 fever?

View more FAQ