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Cataflam

Last reviewed on RxList: 6/7/2016
Cataflam Side Effects Center

Last reviewed on RxList 10/25/2016

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. 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.

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

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.

Cataflam Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using diclofenac and call your doctor at once if you have a serious side effect such as:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools;
  • coughing up blood or vomit that looks like coffee grounds;
  • swelling or rapid weight gain, urinating less than usual or not at all;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • bruising, severe tingling, numbness, pain, muscle weakness;
  • neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions); or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

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

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.

Read the entire detailed patient monograph for Cataflam (Diclofenac Potassium Immediate-Release Tablets)

Cataflam Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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 CATAFLAM® (diclofenac potassium immediate-release 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 CATAFLAM (N=196) versus Voltaren® (diclofenac sodium delayed-release tablets) (N=197) versus ibuprofen (N=197), adverse reactions were similar in nature and frequency.

In patients taking CATAFLAM or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-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

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

Related Resources for Cataflam

Read the Cataflam User Reviews »

© Cataflam Patient Information is supplied by Cerner Multum, Inc. and Cataflam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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