Zobid Injection

Zobid Injection Adverse Reactions

diclofenac

Manufacturer:

SM Pharmaceuticals

Distributor:

SM Pharmaceuticals
Full Prescribing Info
Adverse Reactions
Including adverse reactions observed using other dosage forms of Zobid.
A review of worldwide clinical studies with diclofenac has reported the incidence of drug-associated adverse effects to be about 12%; about 2% of patients discontinued therapy because of adverse effects. The most frequently reported adverse effects were gastro-intestinal and were reported in 7.6% of patients. CNS-related adverse effects were reported in 0.7% of patients and allergy or local reactions in 0.4%. Adverse effects associated with diclofenac are usually mild and transient and appears to be unrelated to the dose of drug given.
Gastrointestinal Tract: Occasional: Epigastric pain, other gastrointestinal symptoms, e.g. nausea, vomiting, diarrhoea, abdominal cramps, dyspepsia, flatulence and anorexia. Rare: Gastrointestinal bleeding, haematemesis, melaena, peptic ulcer with or without bleeding or perforation, bloody diarrhoea. Isolated cases: Lower gut disorders (e.g. non-specific haemorrhagic colitis and exacerbation of ulcerative colitis or Crohn's disease), apthous stomatitis, glossitis, oesophageal lesions, and constipation.
Central (and Peripheral) Nervous System: Occasional: Headache, dizziness or vertigo.
Rare: Tiredness. Isolated cases: Sensory disturbances including paraesthesia, memory disturbances, disorientation, disturbances of vision (blurred vision, diplopia), impaired hearing, tinnitus, insomnia, irritability, convulsions, depression, anxiety, nightmares, tremor, psychotic reactions, taste disturbances.
Skin: Occasional: Skin rash or skin eruptions. Rare: Urticaria. Isolated cases: Bullous eruptions, eczema, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome (acute toxic epidermolysis), erythroderma (exfoliative dermatitis), loss of hair, photosensitivity reactions, purpura (including allergic purpura).
Kidney: Isolated cases: Acute renal failure, haematuria, proteinuria, interstitial nephritis, nephrotic syndrome, papillary necrosis.
Liver: Occasional: Elevated serum aminotransferase values (SCOT, SGPT). Rare: Hepatitis with or without jaundice. Isolated cases: Fulminant hepatitis.
Blood: Isolated cases: Thrombocytopenia, leucopenia, agranulocytosis, hemolytic anaemia, aplastic anaemia.
Hypersensitivity Reactions: Rare: Asthma, systemic anaphylactic/anaphylactoid reactions (including hypotension).
Other Organ Systems: Rare: Oedema symptoms at the site of injection, e.g. local pain and induration; in isolated cases abscesses and local necrosis. Isolated cases: Impotence (association with Diclofenac questionable), palpitation, chest pain, hypertension.
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