Medical Editor: John P. Cunha, DO, FACOEP
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.
QUESTION
Medically speaking, the term "myalgia" refers to what type of pain? See AnswerGet emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.
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;
- shortness of breath (even with mild exertion);
- swelling or rapid weight gain;
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
- high blood pressure--severe headache, pounding in your neck or ears, nosebleed, anxiety, confusion;
- low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; 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.
Common side effects may include:
- indigestion, gas, stomach pain, nausea, vomiting;
- diarrhea, constipation;
- headache, dizziness, drowsiness;
- stuffy nose;
- itching, increased sweating;
- 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.
Read the entire detailed patient monograph for Cataflam (Diclofenac Potassium Immediate-Release Tablets)
SLIDESHOW
Back Pain: 16 Back Pain Truths and Myths See SlideshowSIDE 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 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)
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.