Brustan Adverse Reactions

Ibuprofen: The most frequent type of adverse reaction occurring with Ibuprofen Tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when ibuprofen was compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin or indomethacin treated patients.
Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the following paragraphs. Those reactions listed under the heading, incidence >1% (but less than 3%) Probable Causal Relationship, encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.
Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Precise Incidence Unknown (but less than 1%) Probable Causal Relationship lists reactions with therapy with ibuprofen where the probability of a causal relationship exists: Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown lists reactions where a causal relationship with ibuprofen has not been established.
Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the following paragraphs.
Incidences greater than 1% (but less than 3%) Probable Causal Relationship: Gastrointestinal: nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract (bloating and flatulence).
Central Nervous System: dizziness*, headache, nervousness.
Dermatologic: rash* (including maculopapular type), pruritus.
Special Senses: tinnitus.
Metabolic/Endocrine: decreased appetite.
Cardiovascular: edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS).
Precise Incidence Unknown (but less than 1%) Probable Causal Relationship**: Gastrointestinal: gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests, pancreatitis.
Central Nervous System: depression, insomnia, confusion, emotional lability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS).
Dermatologic: vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia.
Special Senses: hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS).
Hematologic: neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decrease in hemoglobin and hematocrit (see PRECAUTIONS).
Cardiovascular: congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations.
Allergic: syndrome of abdominal pain, fever, chills, nausea and vomiting, anaphylaxis, bronchospasm (see Contraindications).
Renal: acute renal failure (see PRECAUTIONS), decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria.
Miscellaneous: dry eyes and mouth, gingival ulcer, rhinitis.
Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown**: Central Nervous System: paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri.
Dermatologic: toxic epidermal necrolysis, photoallergic skin reactions.
Special Senses: conjunctivitis, diplopia, optic neuritis, cataracts.
Hematologic: bleeding episodes (e.g., epistaxis, menorrhagia).
Metabolic/Endocrine: gynecomastia, hypoglycemic reaction, acidosis.
Cardiovascular: arrhythmias (sinus tachycardia, sinus bradycardia).
Allergic: serum sickness, lupus erythematosus syndrome, Henoch-Schonlein vasculitis, angioedema.
Renal: renal papillary necrosis.
* Reactions occurring in 3% to 9% of patients treated with ibuprofen. (Those reactions occurring in less than 3% of the patients are unmarked.)
** Reactions are classified under "Probable Causal Relationship (PCR)" if there has been one positive rechallenge or if three or more cases occur which might be causally related. Reactions are classified under "Causal Relationship Unknown" if seven of more events have been reported but the criteria for PCR have not been met.
Paracetamol: Gastrointestinal System: Nausea, vomiting, stomach pain or cramps, diarrhoea, loss of appetite, hepatotoxicity, hepatic failure, hepatic encephalopathy, gastro-intestinal tract bleeding, pancreatitis.
Central Nervous System: Convulsions, respiratory depression, cerebral oedema, coma.
Haematological: Leucopenia, thrombocytopenia, neutropenia, pancytopenia, agranulocytosis, disseminated intravascular coagulation.
Metabolic: Hypoglycaemia, metabolic acidosis.
Cardiovascular System: Cardiac arrhythmias, cardiovascular collapse.
Renal System: Renal tubular necrosis, renal failure.
Dermatological: Skin rashes and other allergic reactions. The rash is usually erythematous or urticarial but sometimes more serious and may be accompanied by fever and mucosal lesions.