ADVERSE REACTIONS
In patients taking diclofenac sodium extended-release tablets, USP 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
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REPORTS OF SUSPECTED DICLOFENAC SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Diclofenac. The information is not vetted and should not be considered as verified clinical evidence.
Possible Diclofenac side effects / adverse reactions in 18 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-03
Patient: 18 year old female
Reactions: Blood Bilirubin Increased, Liver Injury, Complications of Transplanted Liver, Pulmonary Hypertension, Hepatic Necrosis, Prothrombin Time Prolonged, Graft Ischaemia, Lung Abscess, Cardiac Disorder, Cerebral Haemorrhage, Acute Respiratory Distress Syndrome, Right Ventricular Dysfunction, Encephalopathy, Hepatic Artery Occlusion, Brain Stem Syndrome, Pulmonary Haemorrhage, Aspartate Aminotransferase Increased, Septic Shock, Jaundice, Cholestasis, Multi-Organ Failure, Overdose, Intracranial Pressure Increased, Perforation Bile Duct, Blood Iron Increased, Pulmonary Toxicity, Incorrect Dose Administered, Condition Aggravated, Blood Lactic Acid Increased, Renal Failure, Lung Disorder, Sepsis, Aspergillosis, Acute Hepatic Failure, Neurogenic Shock, Shock
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Folic Acid
Dosage: unk ukn, unk
Diclofenac
Dosage: 600 mg, unk
Ferrous Sulfate TAB
Dosage: unk ukn, unk
Diazepam
Dosage: 60 mg, unk
Ascorbic Acid
Dosage: unk ukn, unk
Possible Diclofenac side effects / adverse reactions in 78 year old female
Reported by a physician from Sweden on 2011-10-04
Patient: 78 year old female
Reactions: Feeling Abnormal, Pulmonary Fibrosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Lyrica
Dosage: unk
Administration route: Oral
Indication: Depression
Start date: 2009-12-17
End date: 2010-01-01
Diclofenac
Dosage: unk
Indication: Pain
Start date: 2009-10-01
End date: 2009-10-01
Ibuprofen
Dosage: unk
Administration route: Oral
Indication: Pain
Start date: 2009-10-01
End date: 2009-10-01
Amitriptyline HCL
Dosage: 25 mg, unk
Administration route: Oral
Indication: Depression
Start date: 2010-01-05
End date: 2010-02-01
Other drugs received by patient: Simvastatin; Plendil; Amiloride HCL and Hydrochlorothiazide
Possible Diclofenac side effects / adverse reactions in 27 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-04
Patient: 27 year old female
Reactions: PH Body Fluid Decreased, Blood Bilirubin Increased, Intentional Overdose, Coagulopathy, Acidosis, Haematemesis, Multi-Organ Failure, Blood Calcium Decreased, Overdose, Hepatotoxicity, Multiple Drug Overdose, Electrolyte Imbalance, Analgesic Drug Level Increased, Blood Creatinine Increased, Blood Iron Increased, White Blood Cell Count Increased, Blood Pressure Diastolic Decreased, Vomiting, Metabolic Acidosis, Nausea, Alanine Aminotransferase Increased, International Normalised Ratio Increased, Hypotension, Anaemia, General Physical Health Deterioration, Blood Bicarbonate Decreased, Blood Lactic Acid Increased, Blood Phosphorus Decreased, Acute Hepatic Failure, Platelet Count Decreased, Sinus Tachycardia
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Ibuprofen
Dosage: 7000 mg, unk
Indication: Product Used FOR Unknown Indication
CO-Dydramol
Dosage: 16 df, unk
Indication: Product Used FOR Unknown Indication
Ferrous Sulfate TAB
Dosage: 86 df, unk
Indication: Product Used FOR Unknown Indication
Diclofenac
Dosage: 2800 mg, unk
Indication: Product Used FOR Unknown Indication
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