Cataflam Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Cataflam?

Cataflam (diclofenac potassium) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis or ankylosing spondylitis. Cataflam is available in generic form.

What Are Side Effects of Cataflam?

Common side effects of Cataflam include:

upset stomach,
stomach pain,
nausea,
heartburn,
diarrhea,
constipation,
bloating,
gas,
headache,
drowsiness,
dizziness,
nervousness,
skin rash or itching,
blurred vision, or ringing in your ears.

Tell your doctor if you have unlikely but serious side effects of Cataflam including:

swelling of the hands or feet (edema),
sudden or unexplained weight gain,
hearing changes (such as ringing in the ears),
mental/mood changes,
difficult or painful swallowing, or
unusual tiredness.

Dosage for Cataflam?

For treatment of pain the recommended dosage of Cataflam is 50 mg, taken two to four times daily, depending on the cause.

What Drugs, Substances, or Supplements Interact with Cataflam?

Cataflam may interact with blood thinners, cyclosporine, isoniazid, lithium, methotrexate, pronbenecid, rifampin, secobarbital, sertraline, sulfamethoxazole, teniposide, zafirlukast, diuretics, steroids, antifungals, aspirin or other NSAIDs, cholesterol-lowering medicines, or heart or blood pressure medications. Tell your doctor all medications and supplements you use.

Cataflam During Pregnancy and Breastfeeding

During pregnancy, Cataflam should be used only when prescribed. Tell your doctor if you are pregnant or if you plan to become pregnant. This drug may cause miscarriage. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the fetus and interference with normal labor/delivery. This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breastfeeding.

Additional Information

Our Cataflam (diclofenac potassium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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.

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow

Cataflam Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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;
flu-like symptoms;
heart problems--swelling, rapid weight gain, feeling short of breath;
kidney problems--little or no urinating, painful or difficult urination, swelling in your arms or legs, feeling tired or short of breath;
liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, jaundice (yellowing of the skin or eyes); or
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common side effects may include:

indigestion, gas, nausea, vomiting, stomach pain;
diarrhea, constipation;
headache, dizziness, drowsiness;
abnormal lab tests;
itching, sweating;
stuffy nose;
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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer

Cataflam Professional Information

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 diclofenac potassium 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 diclofenac potassium tablets (N=196) versus diclofenac sodium delayedrelease tablets (N=197) versus ibuprofen (N=197), adverse reactions were similar in nature and frequency.

In patients taking diclofenac potassium tablets or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1% to 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

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

DRUG INTERACTIONS

See Table 2 for clinically significant drug interactions with diclofenac.

Table 2: Clinically Significant Drug Interactions with Diclofenac

Drugs That Interfere with Hemostasis
Clinical Impact:	Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention:	Monitor patients with concomitant use of diclofenac with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding (see WARNINGS, Hematological Toxicity).
Aspirin
Clinical Impact:	Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS, Gastrointestinal Bleeding, Ulceration And Perforation).
Intervention:	Concomitant use of diclofenac and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see WARNINGS, Hematological Toxicity). Diclofenac potassium tablets is not a substitute for low dose aspirin for cardiovascular protection.
ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:	NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or betablockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:	During concomitant use of diclofenac potassium tablets and ACEinhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac potassium tablets and ACEinhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function (see WARNINGS, Renal Toxicity And Hyperkalemia). When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact:	Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of diclofenac with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects (see WARNINGS, Renal Toxicity And Hyperkalemia)
Digoxin
Clinical Impact:	The concomitant use of diclofenac potassium tablets with digoxin has been reported to increase the serum concentration and prolong the halflife of digoxin.
Intervention:	During concomitant use of diclofenac and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact:	NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention:	During concomitant use of diclofenac potassium tablets and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact:	Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention:	During concomitant use of diclofenac potassium tablets and methotrexate, potassium tablets and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact:	Concomitant use of diclofenac and cyclosporine may increase cyclosporine's nephrotoxicity.
Intervention:	During concomitant use of diclofenac potassium tablets and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact:	Concomitant use of diclofenac with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy (see WARNINGS, Gastrointestinal Bleeding, Ulceration And Perforation).
Intervention:	The concomitant use of diclofenac with other NSAIDs or salicylates is not recommended.
Pemetrexed
Clinical Impact:	Concomitant use of diclofenac potassium tablets and pemetrexed may increase the risk of pemetrexed associated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention:	During concomitant use of diclofenac potassium tablets and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity. NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed. In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
CYP2C9 Inhibitors or Inducers
Clinical Impact:	Diclofenac is metabolized by cytochrome P450 enzymes, predominantly by CYP2C9. Co-administration of diclofenac with CYP2C9 inhibitors (e.g. voriconazole) may enhance the exposure and toxicity of diclofenac whereas coadministration with CYP2C9 inducers (e.g. rifampin) may lead to compromised efficacy of diclofenac.
Intervention:	A dosage adjustment may be warranted when diclofenac is administered with CYP2C9 inhibitors or inducers (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

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

Health Solutions From Our Sponsors