Cataflam Side Effects

Generic Name: diclofenac

Please note - some side effects for Cataflam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Cataflam - for the Consumer

Cataflam Immediate-Release Tablets

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cataflam Immediate-Release Tablets:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Cataflam Side Effects - for the Professional

Cataflam

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, liver failure, 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

Side Effects by Body System

Gastrointestinal

In one safety review, gastrointestinal bleeding was reported in 0.16% to 0.17% of patients following short-term (duration not defined) and long-term (up to 58 weeks) treatment, respectively. The manufacturer reports a higher incidence, 2% to 4%, of serious gastrointestinal events in patients treated with diclofenac for up to 1 year.

Colonic strictures, ulcerations, and bleeding have been reported in the literature. Several authors have speculated that the enteric, or "delayed release", form of diclofenac may be at fault, as tablet fragments have been found at the site of the pathology.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects.

Gastrointestinal side effects have been reported in up to 10% of patients. The most common side effects, despite the use of an enteric coated formulation, have included gastric upset or discomfort. Diarrhea, nausea, vomiting, and constipation have been reported in 3% to 9% of patients. Gastric ulcer (0.79%), peptic ulceration (with or without bleeding and perforation) (0.16% to 0.34%), duodenal ulcer (0.33%), anastomotic ulcer (0.01%), obstruction (0.01%), small bowel ulceration, pseudomembranous colitis, colonic strictures, and ileocolitis have been reported.

Hepatic

Elevations in serum transaminases three times normal values have been reported in up to 2% of patients during the first 2 months of diclofenac therapy. Elevations eight times normal values occurred in 1% of patients over 2 to 6 months of therapy. In one review of 26 cases of diclofenac-induced hepatitis, the authors found a correlation between the cumulative diclofenac dose and severity of liver damage as well as the logarithm of the peak and mean transaminase levels. Elevations in serum transaminases are generally reversible upon cessation of diclofenac therapy.

Fatal cases of fulminant hepatitis have been reported in the literature. Autopsies in these cases revealed massive hepatic necrosis and cholestasis. Diclofenac-induced hepatitis may be a result of a hypersensitivity in some cases. Three reported cases had features of autoimmune chronic active hepatitis, with accompanying positive ANA titers. Eosinophilia, maculopapular rash, fever, and lymphadenopathy have also been present in some cases.

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients as well as rare cases of hepatitis, jaundice, and fatal fulminant hepatitis. Liver injury is most likely to occur in older females in the first 6 months of use.

Renal

Diclofenac may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for diclofenac-induced renal insufficiency are advanced age and concomitant use of diuretics.

A 56-year-old man with chronic renal failure and liver cirrhosis developed transient anuria after being administered a single oral 100 mg dose of diclofenac.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Renal side effects have included rare reports of nephrotic syndrome, interstitial nephritis, renal papillary necrosis, acute renal failure, urinary frequency, nocturia, proteinuria, and hematuria. A case of transient anuria has been reported.

Dermatologic

A pruritic maculopapular eruption with hives, erythema, and vomiting developed in a 57-year-old female one hour after treatment with diclofenac 100 mg orally for gonarthrosis. After treatment with dexchlorpheniramine, symptoms subsided. Upon rechallenge with diclofenac 75 mg as well as desensitization attempts with increasing diclofenac doses, the patient developed similar symptoms as well as hypotension, conjunctivitis, and mild dyspnea which were resolved with dexchlorpheniramine, corticosteroids, and subcutaneous epinephrine.

A 34-year-old female with pubic pain after delivery experienced nicolau syndrome after an intramuscular dose of diclofenac on the upper outer quadrant of the right buttock. Immediately after the injection, the patient complained of an intense pain of the right buttock radiating to the posterior side of the leg. She was diagnosed with nicolau syndrome and administered treatment. She was completely healed after four months.

Dermatologic side effects have included rash (1% to 3%), pruritus (1% to 3%), eczema, alopecia, bullous eruptions, allergic purpura, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Severe pustular psoriasis has been reported. At least one case of pruritic maculopapular eruption has been reported, in addition to a case of nicolau syndrome.

Hematologic

Autoimmune hemolytic anemia and thrombocytopenia have been associated with the development of autoantibodies as well as drug- or metabolite-dependent antibodies, implicating a drug hypersensitivity. Evidence of the dyscrasia may be preceded by other signs of hypersensitivity such as rash, pruritus, and fever. In one case, diclofenac-induced thrombocytopenic purpura was accompanied by renal and hepatic toxicity.

Agranulocytosis and aplastic anemia have been reported, and have resulted in patient death despite proper management.

A disproportionate amount of postoperative hemorrhage requiring operative intervention has been reported with the use of diclofenac when used for analgesia after adenotonsillectomy.

Hematologic side effects have included anemia, leukopenia, thrombocytopenia, hemolytic anemia, spontaneous bruising associated with increased bleeding times, purpura, agranulocytosis, and aplastic anemia. Blood dyscrasias are usually reversible upon cessation of diclofenac, although rare fatalities are reported. Postoperative hemorrhage has also been reported.

Musculoskeletal

A 44-year-old man with recurring knee pain treated himself with diclofenac 75 mg intramuscularly for 6 days followed by 75 mg orally three times a day for seven days. During the last three days of diclofenac treatment, he became anorexic and complained of nausea, epigastric pain and developed erythematous pruritic eruptions over his back, abdomen, chest, face and scalp. He denied use of other medications or any drug allergies. Serum LDH, SGOT, SGPT were all elevated. His muscle strength gradually decreased. Serum CPK levels peaked at 83,770 units/L 11 days following diclofenac cessation. The patient was diagnosed with erythema multiforme and rhabdomyolysis due to diclofenac. Six months following cessation of diclofenac, the patient was asymptomatic and strength was normal.

Musculoskeletal side effects including at least one case of rhabdomyolysis have been reported.

Hypersensitivity

Hypersensitivity side effects including urticaria, rash, angioedema, bronchospasm, anaphylactoid reactions, and anaphylaxis have been reported in approximately 0.5% of patients.

A 44-year-old male with gout experienced urticarial rash coincident with diclofenac therapy. He was administered a 75 mg diclofenac tablet approximately 10 hours prior to presentation to the hospital. A diagnosis of anaphylaxis was made. He was treated with IV fluids, steroids, antihistamines and intramuscular epinephrine. He was discharged from the hospital one day after presentation.

Metabolic

Hyperkalemic quadriparesis in a 76-year-old woman who had received diclofenac sodium 100 mg/ day for 10 months for the treatment of gouty arthritis was reversed upon discontinuation of diclofenac therapy and the emergency treatment of the hyperkalemia with dextrose, insulin, and intravenous calcium gluconate.

Metabolic side effects have included rare reports of azotemia, hypoglycemia, syndrome of inappropriate antidiuretic hormone (SIADH) secretion, and a case report of diclofenac-induced porphyria. At least one case of hyperkalemic quadriparesis has also been reported.

Nervous system

Aseptic meningitis was reported in a 42-year-old female following two weeks of therapy with diclofenac 50 mg three times a day. CSF eosinophilia was present in the absence of peripheral eosinophilia, a finding similar to that seen with other cases of NSAID-induced aseptic meningitis. The patient's symptoms spontaneously resolved over 48 hours following the discontinuation of diclofenac.

Nervous system side effects including headache, drowsiness, dizziness, insomnia, and tremor have been uncommonly reported. In addition, aseptic meningitis has been reported.

Cardiovascular

Cardiovascular side effects have included myocardial infarction (0.74%), ischemic cerebrovascular stroke (0.81%), unstable angina pectoris (0.31%), peripheral venous thrombosis (0.16%), pulmonary embolism (0.15%), sudden cardiac death (0.14%), transient ischemic attack (0.13%), peripheral arterial thrombosis (0.03%), cardiac thrombus (0.02%), resuscitated cardiac arrest (0.01%), and cerebrovascular venous thrombosis (0.01%). Fluid retention and edema which may be important in patients with heart failure have been reported. In addition, blood pressure may be elevated by diclofenac which may have clinical relevance in patients with comorbid illnesses. Heart rate suppression has been reported.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Evidence suggests that extensive use of diclofenac substantially increases the risk (by around twofold) of acute myocardial infarction in patients with no prior strong risk factors.

Psychiatric

Psychiatric side effects have included rare reports of depression, anxiety, irritability, nightmares, and psychotic reactions.

Other

Other side effects have included tinnitus, taste disturbance, and reversible hearing loss.

Ocular

Ocular side effects including peripheral corneal infiltrates have been reported. Blurred vision, dry eyes, scotoma, night blindness, and amblyopia have been reported. Transient stinging or burning have been reported.

A 37-year-old physician receiving therapy for back pain experienced peripheral corneal infiltrates coincident with diclofenac therapy. The adverse event occurred two days after initiation of therapy at three different times. The peripheral corneal infiltrates resolved completely within 7 days, at each event, after discontinuation of therapy.

Diclofenac eye drops (0.1%) may cause transient stinging or burning.

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