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Cataflam (Diclofenac Potassium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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



REPORTS OF SUSPECTED CATAFLAM SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Cataflam. The information is not vetted and should not be considered as verified clinical evidence.

Possible Cataflam side effects / adverse reactions in 3 month old female

Reported by a pharmacist from Costa Rica on 2011-10-19

Patient: 3 month old female

Reactions: Death, Skin Discolouration

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Cataflam



Possible Cataflam side effects / adverse reactions in 83 year old female

Reported by a health professional (non-physician/pharmacist) from Hungary on 2011-10-20

Patient: 83 year old female

Reactions: Haemorrhage, Pain in Extremity, Oedema Peripheral, International Normalised Ratio Increased, Drug Interaction

Suspect drug(s):
Cataflam

Other drugs received by patient possibly interacting with the suspect drug:
Atorvastatin
    Dosage: unk

Simvastatin

Sintrom

Other drugs received by patient: Perindopril Erbumine; Indapamide; Metformin HCL; Allopurinol



Possible Cataflam side effects / adverse reactions in 24 year old female

Reported by a consumer/non-health professional from Brazil on 2011-10-31

Patient: 24 year old female

Reactions: Anxiety, Migraine, Vomiting, Dehydration

Suspect drug(s):
Cataflam
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Migraine

Diclofenac Sodium
    Dosage: 50 mg, unk
    Indication: Migraine

Other drugs received by patient: Naratriptan; Omeprazole



See index of all Cataflam side effect reports >>

Drug label data at the top of this Page last updated: 2011-02-23

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