acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions – Newsemia

acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions

IBUPROFEN Suspension [Actavis Pharma, Inc.]

July 17, 2018
0
Category:
- Pharma / Biotech
Tags: acute renal failure in patients with pre-existing significantly impaired renal function Other adverse reactions anaphylactoid reactions anemia aplastic anemia appetite changes Cardiovascular system - arrhythmia aseptic meningitis Respiratory - apnea asthenia bloating cerebrovascular accident coma confusion conjunctivitis constipation contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.Close decreased creatinine clearance depression diarrhea dizziness dream abnormalities drowsiness dry eyes duodenitits dyspepsia dyspnea Skin and appendages - alopecia dysuria edema elevated liver enzymes emotional lability hallucinations eosinophilia epigastric pain erythema multiforme esophagitis exfoliative dermatitis flatulence fluid retention gastric or duodenal ulcer with bleeding and/or perforation gastritis gastrointestinal bleeding gastrointestinal experiences (including abdominal pain gingival ulcer glomerulitis glossitis headaches hearing impairment Urogenital - azotemia heartburn hematemesis hematuria hemolytic anemia hepatitis hepatorenal syndrome hypertension hypotension In patients taking ibuprofen or other NSAIDs increased bleeding time infection insomnia interstitial nephritis jaundice leukopenia liver failure liver necrosis lymphadenopathy malaise melena myocardial infarction nausea nervousness neutropenia oliguria/polyuria palpitations pancreatitis Hemic and lymphatic system - agranulocystosis pancytopenia Metabolic and nutritional - hyperglycemia Nervous system - convulsions paresthesia photosensitivity pneumonia proteinuria pruritus purpura rashes (including maculopapular) and tinnitus. Additional adverse experiences reported occasionally include: Body as a whole - fever rectal bleeding Hemic and lymphatic system - ecchymosis renal papillary necrosis respiratory depression rhinitis Skin and appendages - angioedema scotomata and/or changes in color vision)sepsis Cardiovascular system - congestive heart failure in patients with marginal cardiac function somnolence Stevens-Johnson syndrome stomatitis sweat Special senses - blurred vision Urogenital system - cystitis syncope Digestive system - dry mouth tachycardia the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Abnormal renal function thrombocytopenia Metabolic and nutritional - weight changes Nervous system - anxiety toxic epidermal necrosis tremors tubular necrosis To report SUSPECTED ADVERSE EVENTS urticaria vasculitis Digestive system - eructation vertigo Respiratory system - asthma vesiculobullous eruptions Special senses - amblyopia (blurred and/or diminished vision vomiting which occur rarely are: Body as a whole - anaphylactic reactions

Updated Date: Jul 17, 2018 EST

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