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Diclofenac (Diclofenac Potassium) - Side Effects and Adverse Reactions

 
 



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



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



See index of all Diclofenac side effect reports >>

Drug label data at the top of this Page last updated: 2014-07-21

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