Diclofenac

Diclofenac is the generic name for a prescription drug that’s available under a number of brand names, such as Voltaren, Pennsaid, Solaraze, Zipsor, Cataflam, and Zorvolex.

Diclofenac is normally taken to relieve pain, swelling, or inflammation caused by injuries and conditions such as osteoarthritis, rheumatoid arthritis, painful menstruation periods, migraines, and ankylosing splondylitis.

Diclofenac belongs to group of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs). They work by inhibiting a specific type of prostaglandin that causes inflammation.

Diclofenac was first approved in 1998 by the Food and Drug Administration (FDA) under the brand name Voltaren. It was originally manufactured by Novartis.

Diclofenac Warnings

Diclofenac has two black-box warnings:

• Diclofenac can increase the risk of heart trouble and has been linked to heart attacks, strokes, and blood clots — all of which can be deadly. Get emergency medical help right away if you experience signs of stroke or heart problems, such as chest pain, shortness of breath, changes in speech, or other unusual symptoms.
• Diclofenac can damage the lining of your stomach, putting you at risk for stomach ulcers and heartburn. Tell your doctor if you have stomach pain, nausea, or black or tarry stools.

If you are about to have heart surgery, especially a procedure called coronary artery bypass graft (CABG), you should not take diclofenac.

If you suffer from a condition known as the “aspirin triad,” where you have allergic reactions to aspirin or other NSAIDs and develop polyps or growths in the nose, you should not take diclofenac.

You should also be careful taking diclofenac and first speak to your doctor if you:

• Have ever had asthma or a strong allergic reaction, such as hives, to aspirin or other NSAIDs
• Congestive heart failure (CHF), recent heart attack, or high blood pressure
• Have a tendency to retain fluid
• Have a bleeding ulcer
• Smoke or are a heavy drinker
• Kidney or liver problems
• Any condition that includes abnormal activity of the bone marrow
• Any bleeding disorders, including poor clotting or blood cell abnormalities

Do not take diclofenac if you are allergic to it or any of its inactive ingredients.

Diclofenac and the Elderly

If you are older, you should be careful taking diclofenac. Diclofenac tends to have very strong effects when taken by people who are older. It can put you at risk for falls and other dangerous events.

In general, NSAIDs — whether purchased over-the-counter (OTC) or via prescription — can cause extreme sleepiness, confusion, dizziness, loss of balance, and severe stomach problems in the elderly.

Pregnancy and Diclofenac

Because risk of damage to the unborn child varies during pregnancy, diclofenac falls under two FDA pregnancy categories:

• In the first 29 weeks of pregnancy, diclofenac has a category C rating: There is a risk of harm to the fetus, but it has not yet been confirmed in humans.
• During or after the 30th week of pregnancy, diclofenac has a category D rating: In this case, the drug can cause a birth defect by causing a major artery to close that nourishes the baby’s heart. So you should only take diclofenac if there are no other safer options available.

Regardless, you should tell your doctor if you are pregnant or plan to become pregnant before taking this medication.

You should also alert your physician if you are breastfeeding or plan to breastfeed. Diclofenac is found in breast milk, and mothers should avoid taking this drug while nursing.

Common Side Effects of Diclofenac:

Although these side effects of diclofenac are more common, they may be very serious. Stop taking diclofenac and tell your doctor right away if you have any of the following symptoms:

• Stomach problems, including gas, bloating, pain, cramping, constipation, and diarrhea
• Upset stomach and/or bleeding in your stomach, esophagus, or intestines
• Headache and ringing in the ears
• Rash

Serious Side Effects

Stop taking diclofenac and get immediate medical attention if you experience any of the following:

• Nosebleeds
• Liver damage or inflammation of the liver (watch for yellowing or graying of the skin or eyes, swelling of the abdomen or lower extremities)
• Low blood pressure (one sign of low blood pressure is dizziness when getting up to stand)
• Blood disorders, such as low platelet count, decreased hemoglobin, and decreased bone marrow activity
• Congestive heart failure (watch for swelling in your lower limbs, shortness of breath, trouble walking normal distances’, extra tiredness)
• Bruising
• Severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis (tell your doctor about any skin abnormalities; get emergency medical help right away if you have any dramatic or severe skin reactions)

Rare Side Effects

In severe cases, diclofenac may cause a deadly liver condition known as fatal fulminant hepatitis.

Get medical help if you have any yellowing or graying of the skin or eyes, if your lower extremities or abdomen is swelling, if you are extra sleepy, or become confused.

Diclofenac may be found in some form under the following brand names:

• Arthrotec

• Cambia

• Cataflam

• Dyloject

• Flector

• Pennsaid

• Solaraze

• Surpass Anti-Inflammatory

• Voltaren

• Voltarol

• Zipsor

The most common side effects of diclofenac include the following:

Oral:

• swelling
• nausea
• headache
• dizziness
• vomiting
• constipation
• pruritus
• pain in extremity
• upset stomach

Topical:

• itching
• redness
• irritation
• rash
• dryness
• scaling or peeling

This is not a complete list of diclofenac side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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

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

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

diclofenac is available only with your doctor's prescription.

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:

Allergies

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.

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of diclofenac 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.

Pregnancy

Breast Feeding

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 taking 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.

• Ketorolac

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.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Ceritinib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deferiprone
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• 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
• Piroxicam
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

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.

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

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
• 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, 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.

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

Mechanism of Action

Diclofenac has analgesic, anti-inflammatory, and antipyretic properties.

The mechanism of action of Diclofenac, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2).

Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because Diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.

Pharmacokinetics

Diclofenac is 100% absorbed after oral administration compared to IV administration as measured by urine recovery. However, due to first-pass metabolism, only about 50% of the absorbed dose is systemically available (see Table 1). Food has no significant effect on the extent of Diclofenac absorption. However, there is usually a delay in the onset of absorption of 1 to 4.5 hours and a reduction in peak plasma levels of <20%.

The apparent volume of distribution (V/F) of Diclofenac sodium is 1.4 L/kg.

Diclofenac is more than 99% bound to human serum proteins, primarily to albumin. Serum protein binding is constant over the concentration range (0.15-105 mcg/ml) achieved with recommended doses.

Diclofenac diffuses into and out of the synovial fluid. Diffusion into the joint occurs when plasma levels are higher than those in the synovial fluid, after which the process reverses and synovial fluid levels are higher than plasma levels. It is not known whether diffusion into the joint plays a role in the effectiveness of Diclofenac.

Metabolism

Five Diclofenac metabolites have been identified in human plasma and urine. The metabolites include 4'-hydroxy-, 5-hydroxy-, 3'-hydroxy-, 4',5-dihydroxy- and 3'-hydroxy-4'-methoxy-Diclofenac. The major Diclofenac metabolite, 4'-hydroxy-Diclofenac, has very weak pharmacologic activity. The formation of 4'-hydroxy- Diclofenac is primarily mediated by CYP2C9.

Both Diclofenac and its oxidative metabolites undergo glucuronidation or sulfation followed by biliary excretion. Acylglucuronidation mediated by UGT2B7 and oxidation mediated by CYP2C8 may also play a role in Diclofenac metabolism. CYP3A4 is responsible for the formation of minor metabolites, 5-hydroxy- and 3'-hydroxy-Diclofenac. In patients with renal dysfunction, peak concentrations of metabolites 4'-hydroxy- and 5-hydroxyDiclofenac were approximately 50% and 4% of the parent compound after single oral dosing compared to 27% and 1% in normal healthy subjects.

Excretion

Diclofenac is eliminated through metabolism and subsequent urinary and biliary excretion of the glucuronide and the sulfate conjugates of the metabolites. Little or no free unchanged Diclofenac is excreted in the urine. Approximately 65% of the dose is excreted in the urine and approximately 35% in the bile as conjugates of unchanged Diclofenac plus metabolites. Because renal elimination is not a significant pathway of elimination for unchanged Diclofenac, dosing adjustment in patients with mild to moderate renal dysfunction is not necessary. The terminal half-life of unchanged Diclofenac is approximately 2 hours.

Special Populations

Pediatric: The pharmacokinetics of Diclofenac has not been investigated in pediatric patients.

Race: Pharmacokinetic differences due to race have not been identified.

Hepatic Impairment: Hepatic metabolism accounts for almost 100% of Diclofenac elimination, so patients with hepatic disease may require reduced doses of Diclofenac compared to patients with normal hepatic function.

Renal Impairment: Diclofenac pharmacokinetics has been investigated in subjects with renal insufficiency. No differences in the pharmacokinetics of Diclofenac have been detected in studies of patients with renal impairment. In patients with renal impairment (inulin clearance 60-90, 30-60, and <30 mL/min; N=6 in each group), AUC values and elimination rate were comparable to those in healthy subjects.

Voriconazole: When co-administered with voriconazole (inhibitor of CYP2C9, 2C19 and 3A4 enzyme), the C max and AUC of Diclofenac increased by 114% and 78%, respectively ( see PRECAUTIONS; Drug Interactions).

Aspirin: When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. The clinical significance of this interaction is not known. See Table 2 for clinically significant drug interactions of NSAIDs with aspirin ( see PRECAUTIONS; Drug Interactions).

Different brands of diclofenac contain different amounts of this medicine, and may have different uses. If you switch brands, your dose needs may change. Follow your doctor's instructions about how much medicine to take. Ask your pharmacist if you have any questions about the brand you receive at the pharmacy.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Take Zorvolex on an empty stomach, at least 1 hour before or 2 hours after a meal.

Do not crush, chew, or break an extended-release tablet or delayed-release tablet. Swallow it whole.

Dissolve Cambia powder in to 2 ounces of water. Do not use any other type of liquid. Stir this mixture and drink all of it right away. Cambia works best if you take it on an empty stomach.

Call your doctor if your headache does not completely go away after taking Cambia. Do not take a second dose of diclofenac powder without your doctor's advice. Overuse of migraine headache medicine can make headaches worse. Tell your doctor if the medicine seems to stop working as well in treating your migraine attacks.

If you use diclofenac 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.

Applies to diclofenac: compounding powder, intravenous solution, oral capsule, oral delayed release tablet, oral powder for reconstitution, oral tablet, oral tablet extended release

Gastrointestinal

Very common (10% or more): Nausea (up to 24%), constipation (up to 13%)
Common (1% to 10%): Abdominal pain, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, gastric and duodenal ulcers, vomiting
Rare (less than 0.1%): Colitis, eructation, pancreatitis
Frequency not reported: Dry mouth, esophagitis, gastritis, glossitis, hematemesis, stomatitis[Ref]

NSAIDs including this drug, can cause serious gastrointestinal (GI) events which can occur at any time, with or without warning. For patients who develop a serious upper GI event, only about 20% were symptomatic. Upper GI ulcers, gross bleeding, or perforation occurred in approximately 1% of patients treated with NSAIDs for 3 to 6 months and 2% to 4% of patients treated for 1 year. Patients with a prior history of peptic ulcer disease and/or GI bleeding had a greater than 10-fold increased risk for developing a GI bleed than patients with neither of these risk factors.[Ref]

Hepatic

Borderline elevations of 1 or more liver tests to less than 3 times the upper limit of the normal (3 x ULN) or greater elevations in transaminases occurred in about 15% of patients treated with this drug. Elevations to greater than 3 x ULN of AST occurred in about 2% (n=5700) of patients at some point during treatment. In an open-labeled trial among patients receiving NSAIDs, a higher incidence of transaminase elevations were observed in patients receiving diclofenac compared with other NSAIDs.[Ref]

Common (1% to 10%): Elevated liver enzymes
Rare (less than 0.1%): Hepatitis, jaundice, liver disorder
Very rare (less than 0.01%): Fulminant hepatitis, hepatic necrosis, hepatic failure
Postmarketing reports: Drug-induced hepatotoxicity[Ref]

Renal

Common (1% to 10%): Abnormal renal function, increased serum creatinine
Rare (less than 0.1%): Nephrotic syndrome, interstitial nephritis, renal papillary necrosis, acute renal failure, urinary frequency, nocturia, proteinuria, and hematuria[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rashes
Rare (less than 0.1%): Angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, urticaria
Very rare (less than 0.01%): Bullous eruptions, eczema, erythema, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome), dermatitis exfoliative, loss of hair, photosensitivity reaction
Frequency not reported: Increased sweating[Ref]

Hematologic

NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, the NSAID effect on platelet function is quantitatively less, of shorter duration, and reversible.[Ref]

Common (1% to 10%): Anemia, increased bleeding time
Rare (less than 0.1%): Agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia
Very rare (less than 0.01%): Thrombocytopenia, leukopenia, positive Coombs' test
Frequency not reported: Ecchymosis, eosinophilia, melena, purpura, rectal bleeding[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Urticaria, rash, angioedema, bronchospasm
Rare (less than 0.1%): Anaphylactic reactions
Very rare (less than 0.01%): Angioneurotic edema (including facial edema)[Ref]

Metabolic

Rare (less than 0.1%): Changes in appetite, hyperglycemia
Frequency not reported: Weight changes[Ref]

Nervous system

Common (1% to 10%): Dizziness, headaches
Rare (less than 0.1%): Meningitis
Very rare (less than 0.01%): Memory impairment
Frequency not reported: Confusion, drowsiness, insomnia, paresthesia, tremors[Ref]

Cardiovascular

Clinical trials of several cyclooxygenase (COX)-2 selective and nonselective NSAIDs of up to 3 years duration have shown an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. All NSAIDs appear to have a similar risk. There is no consistent evidence that concurrent use of aspirin mitigates this increased risk and may be associated with an increased risk of serious gastrointestinal events.

Pharmacoepidemiological data reveal an increased risk of arteriothrombotic events associated with diclofenac use, particularly at a high dose and during long-term treatment. In a meta-analysis of long-term treatment with diclofenac 150 mg/day, compared with placebo use of this drug resulted in approximately 3 additional major vascular events per 1000 participants.[Ref]

Common (1% to 10%): Edema
Uncommon (0.1% to 1%): Cardiac failure, chest pain
Rare (less than 0.1%): Arrhythmia, hypotension, myocardial infarction, palpitations
Very rare (less than 0.01%): Vasculitis
Frequency not reported: Congestive heart failure, tachycardia, syncope, hypertension[Ref]

Psychiatric

Rare (less than 0.1%): Hallucinations
Very rare (less than 0.01%): Disorientation, depression, nightmare, irritability, psychotic disorder
Frequency not reported: Anxiety, nervousness[Ref]

Other

Common (1% to 10%): Tinnitus,
Rare (less than 0.1%): Hearing impairment
Frequency not reported: Fever, asthenia, vertigo[Ref]

Ocular

Rare (less than 0.1%): Conjunctivitis
Very rare (less than 0.01%): Blurred vision, visual disturbance, diplopia
Frequency not reported: Optic neuritis

General

The most common adverse reactions among patients treated with this drug included; gastrointestinal events of abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding,/perforation, heartburn, nausea, gastric and duodenal ulcers, and vomiting; abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes, and tinnitus.

Genitourinary

Common (1% to 10%): Urinary tract infection
Frequency not reported: Cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria

Immunologic

Frequency not reported: Infection, sepsis

Local

Common (1% to 10%): Local reactions such as itching, burning, and increased bowel movement with suppository use
Very rare (less than 0.01%): Exacerbation of hemorrhoids with suppository use

Respiratory

Common (1% to 10%): Sinusitis, upper respiratory infection, nasopharyngitis, bronchitis
Rare (less than 0.1%): Pneumonia
Frequency not reported: Asthma, dyspnea

Some side effects of diclofenac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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.

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.

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.

• Different formulations of diclofenac may not be equivalent; do not interchange products without first talking with your doctor or pharmacist.
• May make your skin more sensitive to the sun; wear sunblock SPF 30-50+ when outside; see a doctor as soon as possible if you develop a skin rash.
• Should not be taken for for long periods of time, especially in seniors.
• Blood counts and liver enzymes may need monitoring periodically.
• NSAIDs should not be used in the last 3 months of pregnancy; always ask your doctor before using any medication during pregnancy.
• If you have experienced asthma-like symptoms, developed hives (urticaria) or other allergic-type reactions in the past after taking aspirin or other NSAIDs (like ibuprofen), do not take diclofenac.
• Combining diclofenac with alcohol may increase the risk of stomach ulcers or bleeding.

• Time to peak effect varies from 30 minutes to 3-5 hours depending on the formulation of diclofenac taken.

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

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

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 naproxen.

Ask your doctor before using diclofenac 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:

• cyclosporine;

• lithium;

• methotrexate;

• rifampin;

• antifungal medicine;

• a blood thinner (warfarin, Coumadin, Jantoven);

• heart or blood pressure medication, including a diuretic or "water pill";

• other forms of diclofenac (Flector, Pennsaid, Solaraze, Voltaren Gel);

• other NSAIDs--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others; or

• steroid medicine (prednisone and others).

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