Xevolac Adverse Reactions

Gastro-intestinal Disorders: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, constipation, dyspepsia, abdominal pain / discomfort, melaena, haematemesis, stomatitis, ulcerative stomatitis, eructation, flatulence, oesophagitis, gastrointestinal ulceration, rectal bleeding, pancreatitis, dry mouth, fullness, exacerbation of colitis and Crohn's disease have been reported following administration. Less frequently, gastritis has been observed.
Infection: meningitis aseptic. (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation.
Blood and Lymphatic System Disorders: thrombocytopenia.
Additionally purpura, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia have been observed.
Immune System Disorders: anaphylaxis, anaphylactoid reactions, anaphylactoid reactions like anaphylaxis, may have a fatal outcome, hypersensitivity reactions such as bronchospasm flushing, rash, hypotension, laryngeal oedema.
These may also occur in individuals with a history of angioedema, bronchospastic reactivity (e.g. asthma and nasal polyps).
Metabolic and Nutrition Disorders: anorexia, hyperkalaemia, hyponatraemia.
Psychiatric Disorders: abnormal thinking, depression, insomnia, anxiety, nervousness, psychotic reactions, abnormal dreams, hallucinations, euphoria, concentration ability impaired, drowsiness.
Confusion and stimulation have been observed.
Nervous System Disorders: headache, dizziness, convulsions, paresthesia, hyperkinesias, taste abnormality.
Eye Disorders: abnormal vision, visual disturbances, optic neuritis.
Ear Disorders: tinnitus, hearing loss, vertigo.
Renal and Urinary Disorders: acute renal failure, increased urinary frequency, interstitial nephritis, nephrotic syndrome, urinary retention, oliguria, haemolytic uremic syndrome, flank pain (with or without haematuria +- azotemia). As with other drugs that inhibit renal prostaglandin synthesis, signs of renal impairment, such as, but not limited to elevations of creatinine and potassium can occur after one dose of Ketorolac IV.
Cardiac Disorders: palpitations, bradycardia, cardiac failure.
Vascular Disorders: hypertension, hypotension, haematoma, flushing, pallor, postoperative wound haemorrhage.
Reproductive System and Breast Disorders: female infertility.
Respiratory, Thoracic and Mediastinal Disorders: asthma, dyspnoea, pulmonary oedema. Additionally epistaxis has been observed.
Hepatobiliary Disorders: hepatitis, cholestatic jaundice, liver failure.
Skin and Subcutaneous Tissue Disorders: exfoliative dermatitis, maculopapular rash, pruritus, urticaria, purpura, angioedema, sweating, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis (very rare).
Additionally erythema multiforme and skin photosensitivity has been observed.
Musculoskeletal and Connective Tissue Disorders: myalgia, functional disorder.
General Disorders and Administration Site Condition: excessive thirst, asthenia, oedema, injection site reactions and pain, fever, chest pain.
Additionally, malaise, fatigue and weight gain has been observed.
Investigations: bleeding time prolonged, serum urea increased, creatinine increased, abnormal liver function tests.